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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK060036 Letter

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville. MD 20852-1448

January 3, 2007

Biosafe SA
Attention: Dr. James Kenimer
Biologics Consulting Group
1317 King Street
Alexandria, VA 22314

Regulation Number: 21 CFR 864.9900
Classification: Class II
Product Code: OAO
Re: BK060036, Sepax Cell Separation System and single use kits

Dear Dr. Kenimer,

The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its review of your petition for classification of the Sepax Cell Separation System and single use kits that is intended for laboratory use in exclusive combination with a compatible single-use separation kit supplied by Biosafe. The Sepax system allows the fast, automated and reproducible separation of cord blood in a closed and sterile environment. The SEPAX system is not intended for use in transfusion applications at bedside, where blood circulates directly between a patient and the SEPAX unit. FDA concludes that this device, and substantially equivalent devices of this generic type, should be classified into class II. This order, therefore, classifies the Sepax Cell Separation System and single use kits, and substantially equivalent devices of this generic type into class II under the generic name, Cord blood processing system and storage container. This order also identifies the special controls applicable to this device and substantially equivalent devices of this generic type.

FDA identifies this generic type of device as:

21 CFR 864.9900 Cord blood processing system and storage container.

(a) Identification. A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is a functionally closed processing system that includes containers, other soft goods, and a centrifugation system for cord blood concentration, and a final container for the cryopreservation and the storage of a cord blood product.

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)) (the act), devices that were not in commercial distribution prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976 (the amendments)), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and Part 807 of the FDA regulations (21 CFR 807).

Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) for a device may, with in 30 days after receiving an order classifying the device in class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA shall, within 60 days of receiving such a request classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register classifying the device type.

On November 1, 2006, FDA filed your petition requesting classification of the Sepax Cell Separation System and single use kits into class II. The petition was submitted under section 513(f)(2) of the act. In accordance with section 513(f)(1) of the act, FDA had issued an order on October 6, 2006 automatically classifying the Sepax Cell Separation System and single use kits in class III, because it was not within a type of device which was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, which was subsequently reclassified into class I or class II.

In order to classify the Sepax Cell Separation System and single use kits into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.After review of the information submitted in the petition, FDA has determined that the Sepax Cell Separation System and single use kits can be classified in class II with the establishment of special controls. FDA believes that class II special controls provide reasonable assurance of the safety and effectiveness of the device.

FDA has identified several risks associated with use of cord blood processing systems and storage containers. These risks include lack of biocompatible components; toxicity of residual chemical sterilants used to sterilize device components; toxicity of leached materials from or that permeate through plastic device components; insufficient mechanical strength of device containers, tubing, and seals resulting in integrity failure of the device; contamination; instability of soft goods over time; physical damage to or loss of the cord blood product; software failure; operator/user injury; electromagnetic interference; and electrical hazards.

The special controls that are established to mitigate these risks are the guidance document, "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container," which contains recommendations for the contents of premarket notification submissions including performance characteristics and labeling. FDA believes that these special controls, along with the general controls of the act, will be sufficient to provide reasonable assurance of the safety and effectiveness of cord blood processing systems and storage containers.

Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device and, therefore, the device is not exempt from the premarket notification requirements. Thus, persons who intend to market this device must submit to FDA a premarket notification submission containing information on the cord blood processing system and storage container they intend to market prior to marketing the device.

A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.

As a result of this order, you may immediately market this device, subject to the general control provisions of the act and the special controls identified in this order. If you have any questions concerning this classification order, please contact Deborah Lavoie at 301-827-5102.

Sincerely yours,

Celia M. Witten, Ph.D, M.D.
Director
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research