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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK080038 Summary

Section 7 - 510(k) Summary

Applicant: Haemonetics Corporation
Regulatory Affairs Specialist
400 Wood Road
Braintree, MA 02184
Primary Contact: Michael Chang
Haemonetics Corporation
Regulatory Affairs Specialist
400 Wood Road
Braintree, MA 02184
781-356-9553 (phone)
781-356-3558 (fax)
mchang@haemonetics.com
Date 510(k) Summary Prepared: September 4 , 2008

Proposed Device Name:

Proprietary Name: MCS+ 9000 System
List Number: LN09000-110-EW
Common Name: LN9000
Classification Name: Automated Blood Cell Separator (CFR 864.9245)
Classification: II
Product Code: GKT

Indications For Use:

The MCS+ 9000 System with wireless capable modification is intended for use as an automated blood cell separator system and blood component collector in conjunction with single use sterile disposable sets. Products that can be collected using the MCS+ 9000 System include single donor platelets and concurrent plasma.

The LN994 is a functionally closed system intended to be used to collect one unit of Platelets, Pheresis with or without Plasma, or two units of Platelets Pheresis from donors using the MCS+ LN9000.

The LN994CF and LN994CF-CPP are functionally closed systems intended to be used to collect one unit of Platelets, Pheresis Leukocyte Reduced with or without Plasma, or two units of Platelets, Pheresis, Leukocyte Reduced from donors using the MCS+ LN9000.

The indications for use for the wireless capable modified MCS+ 9000 system are the same as the currently marketed MCS+ 9000 System.

Device Description and Comparison:

The MCS+ 9000 System was originally cleared for market via BK930013 in 1993. Subsequent 510(k)s were cleared via BK950034, K953681, BK970034, BK970041, BK980040, BK010035, and BK050047 for modifications to the single donor platelet protocols, and inclusion of LN994, LN994CF, and LN994CF-CPP disposable sets. The subject of this Special 510(k) is for wireless capable modification in the MCS+ 9000 System which does not change the intended use of the MCS+ 9000 System. Coexistence testing (simulated production environment) of the wireless modification for the MCS+ 9000 System was done as a broader effort to verify wireless coexistence using the HaemoConnect (eLynx) System (5D Information Management, cleared via BK060051), PCS2 and MCS+ 8150. Wireless capable modification was initially cleared for use in Haemonetics ® PCS2 Plasma Collection System via BK060033 on March 27, 2008. The software and disposables for the MCS+ 9000 System have remained unchanged, are not affected by the wireless modification and are not the subject of this Special 510(k) submission. The hardware was modified for wireless hardware components. As with the PCS2 System with wireless capability (cleared via BK060033), the MCS+ 9000 System wireless capable modification consists of an adaptor, fitted to the device to concert data to a wireless format to transmit information by a radiofrequency transmitter to a computer system that is configured to accept and display the data.

To assist the reviewer the FDA guidance “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” dated March 20, 1998 was used, which allows a Special 510(k) to be filed for a change of an existing device, if the change does not affect the intended use or alters the fundamental scientific technology of the device. The only change being made is for wireless capable modification in the MCS+ 9000 System which is currently being used in the PCS2. Testing was done concurrently with PCS2 wireless testing as a broader effort to verify functionality of the wireless in the MCS+ 8150, PCS2, and MCS+ 9000 Systems. EMC, Electrical Safety, and Coexistence testing were done similarly to MCS+ 9000 as with the PCS2 system and were completed successfully.

A fitted adaptor has been developed to convert data to a wireless format to transmit the information by a radiofrequency transmitter to a computer system that is configured to accept and display the data. The wireless technology enables the MCS+ 9000 to:

  • Transmit procedure data electronically to an 802.11b compatible wireless access point connected to the center’s local area network;
  • Transmit data in a standard format (WEP encrypted, TCP/IP), that may be used for electronic data collection and management with a compatible, customer validated software system; and
  • Allow easier movement of devices in the center by eliminating the need for cabling.

The wireless hardware components consist of the following:

  • An antenna located on the rear panel, designed for connection to wireless devices; and
  • A wireless module communication component, designed to provide connectivity in several type of applications (not visible, the modules is inside the device).

The indications for use for the wireless capable modified MCS+ 9000 System are the same as the currently marketed MCS+ 9000 System.

Performance:

Testing has been conducted to verify the safety and performance of the MCS+ 9000 System with Wireless Modification. EMC, Electrical Safety, Validation, and Coexistence testing were completed successfully. Testing was completed similarly to the PCS2 wireless modification, which was cleared via BK060033. All testing with the MCS+ 9000 and PCS2 were conducted with an active wireless connection. Questions and issues from the FDA regarding the PCS2 wireless modification testing and manuals were properly addressed and cleared in FDA conference calls and communication during the PCS2 wireless modification 510(k) submission process.

Substantial Equivalence:

 

 

New

Predicate

Manufacturer Haemonetics Corporation Haemonetics Corporation
Trade/Device Name MCS+ 9000 MCS+ 9000
Regulation Number 21 CFR 864.9245 21 CFR 864.9245
Regulation Name Automated Blood Cell Separator Automated Blood Cell Separator
Device Class II as per “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” dated November 2007. II as per “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” dated November 2007.
FDA Product Code GKT GKT
510(k) number BK080038 BK050047
Indications for Use (same)

The MCS+ 9000 System with wireless capable modification is intended for use as an automated blood cell separator system and blood component collector in conjunction with single use sterile disposable sets. Products that can be collected using the MCS+ 9000 System include single donor platelets and concurrent plasma.

 

The LN994 is a functionally closed system intended to be used to collect one unit of Platelets, Pheresis with or without Plasma, or two units of Platelets Pheresis from donors using the MCS+ LN9000.

 

The LN994CF and LN994CF-CPP are functionally closed systems intended to be used to collect one unit of Platelets, Pheresis Leukocyte Reduced with or without Plasma, or two units of Platelets, Pheresis, Leukocyte Reduced from donors using the MCS+ LN9000.

 

The indications for use for the wireless capable modified MCS+ 9000 system are the same as the currently marketed MCS+ 9000 System.

The MCS+ 9000 System is intended for use as an automated blood cell separator system and blood component collector in conjunction with single use sterile disposable sets. Products that can be collected using the MCS+ 9000 System include single donor platelets and concurrent plasma.

 

The LN994 is a functionally closed system intended to be used to collect one unit of Platelets, Pheresis with or without Plasma, or two units of Platelets Pheresis from donors using the MCS+ LN9000.

 

The LN994CF and LN994CF-CPP are functionally closed systems intended to be used to collect one unit of Platelets, Pheresis Leukocyte Reduced with or without Plasma, or two units of Platelets, Pheresis, Leukocyte Reduced from donors using the MCS+ LN9000.

Hardware The hardware was modified for wireless hardware components.
Disposable There were no changes to the MCS+ 9000 System disposables that are subject of this 510(k) application.
Software There were no changes to the MCS+ 9000 System software that are subject of this 510(k) application.
Performance Haemonetics has conducted testing to verify the safety and performance of the wireless capable modified MCS+ 9000.