SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514

K022489 · Summit Medical , Ltd. · CAC · Oct 9, 2002 · Anesthesiology

Device Facts

• Record ID: K022489
• Device Name: SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
• Applicant: Summit Medical , Ltd.
• Product Code: CAC · Anesthesiology
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.

Device Story

Postoperative autotransfusion system; collects blood lost post-surgery via low-vacuum suction. Components: needle/drain assemblies, patient drain connection line, compressible bellows collection vessel, blood transfer bags. Operation: bellows compression creates vacuum; blood flows from wound through gross filter into transfer bags. Non-return valves prevent backflow. Once bag is full, it is removed for patient reinfusion; system supports second bag collection. Can function as standard wound drainage device after autotransfusion use. Used in clinical settings; operated by healthcare professionals. Benefits: enables autologous blood recovery, reducing need for homologous transfusion.

Clinical Evidence

Bench testing only. Performance validation included vacuum testing, pressure leak decay tests, functional testing using water and time-expired blood, and mechanical testing of bonded joints. Biocompatibility testing conducted per ISO 10993 and FDA Blue Book Memo G95-1 (cytotoxicity, sensitization, irritation, systemic toxicity, haemocompatibility). Haemocompatibility testing per ISO 10993-4 compared blood processed through the system against homologous (banked) blood, demonstrating performance consistent with design specifications.

Technological Characteristics

Sterile, single-use autotransfusion apparatus. Components include compressible bellows, gross filter, and transfer bags with non-return valves. Materials validated for biocompatibility per ISO 10993. Sterilization via Gamma radiation (ISO 11137, EN552). Mechanical operation via vacuum-assisted collection. No software or electronic components.

Indications for Use

Indicated for autologous blood transfusion in patients following surgery, including orthopaedic joint replacement, to collect and reinfuse lost blood.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Betatrans Orthopaedic Autotransfusion System (K951592)

Submission Summary (Full Text)

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CellTrans™ 510(k) Attachment 7

# 510(k) Summary

### Summit Medical CellTrans™ Postoperative Autotransfusion Device

### Manufacturer

Summit Medical Ltd Industrial Park Bourton on the Water Gloucestershire GL54 2HQ nk

#### Contact

James Bradbury Regulatory Affairs Manager

011 (44) 1451 821311 Phone: Fax: [phone] [e-mail] e-mail:

#### Device Name

CellTrans 100 Postoperative Autotransfusion Transfusion System

### Classification Name

Autotransfusion Apparatus

#### Predicate Product

Betatrans Orthopaedic Autotransfusion System (K951592), Duxbury Scientific Inc.

#### Product Description

The CellTrans 10 device consists of a sterile, double wrapped package, containing two needle and drain assemblies, a blood collection assembly with patient drain connection line and a compressible bellows collection vessel with twin outlet ports, and two blood Transfer bags. The patient and transfer bag lines are fitted with pinch clamps, and in addition the transfer bag connection luers are fitted with sealing caps, for use after a

> Attachment 7 Page 3 of 5

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filled bag is removed from the collection vessel. The collection bellows and transfer bags are fitted with non-return valves to prevent backflow of exudate to the patient.

The drains are placed in the patient, and connected to the collection system via the twin drain Y-connector. The transfer bags are fitted to the collection vessel outlet ports. Blood collection is initiated by compressing the bellows to apply a low vacuum to the wound, the collected blood then transferring into one of the transfer bags, via the gross filter. When the baq is full, or in accordance with the American Association of Blood Banks Guidelines for Blood Recovery and Reinfusion in Surgery (AABB), the bag can be removed from the collection system, and transferred for reinfusion to the patient. Blood collection can continue with the second transfer bag.

Following use of the second bag, the device can be used as a wound drainage device if this is clinically desirable, by draining into a standard wound drainage bag.

### Substantial Equivalence

The Summit Medical CellTrans™ Postoperative Autotransfusion System is substantially equivalent to a number of legally marketed Autotransfusion systems, specifically the Duxbury Scientific Inc. Betatrans Orthopaedic Autotransfusion system (K951592), in that they are designed with the same design principles, made of similar materials, and have the same indications and contraindications for use.

### Indications for Use

The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.

### Safety and Effectiveness

Performance testing carried out includes vacuum testing, pressure leak decay tests, functional testing using both water and time-expired blood, mechanical testing of bonded joints, microbiological bioburden and endotoxin validation.

The CellTrans TM device is Gamma sterilised, validation of which was carried out in accordance with ISO 11137 and EN552.

Biocompatibility testing was carried out in accordance with ISO 10993 and FDA Blue Book Memo G95-1, including Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity and Haemocompatibility.

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Detailed Haemocompatibility testing was carried out in accordance with ISO 10993-4, with the focus of the testing on the evaluation of a number of blood cell parameters, comparing blood collected and passed through the CellTrans™ system with homologous (banked) blood.

The test results achieved demonstrate that the CellTrans™ device meets the applicable standards, is biocompatible, performs in accordance with design specifications.

No safety or effectiveness issues are raised when the Summit Medical CellTrans™ is compared with the predicate product, and therefore the Summit Medical CellTrans™ is substantially equivalent to the Duxbury Scientific Betatrans Orthopaedic Autotransfusion System (K951592).

Javes Brooks

James Bradbury Regulatory Affairs Manager Summit Medical Ltd.

25. July 2002

Date

Attachment 7 Page 5 of 5

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# 0 9 2002

Summit Medical Ltd. c/o Mr. Neil R. Armstrong MeddiQuest Ltd. Business and Technology Centre Bessemer Drive Stevenage SG1 2DX United Kingdom

Re: K022489

Cell Trans™ Postoperative Autotransfusion System Regulation Number: 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: II (two) Product Code: CAC Dated: July 26, 2002 Received: July 29, 2002

Dear Mr. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Neil R. Armstrong

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

l Qalath

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Summit Medical Ltd

# Indications for Use

510(k) Number:

KO22489

Device Name:

# Summit Medical CellTrans™ Postoperative Autotransfusion System

Indications for Use:

The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use

(Per 21 CFR 801.109)

ાર Over-the-counter Use _

Division of Cardiova 510(k) Number

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