SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

K024097 · Summit Medical , Ltd. · CAC · Feb 14, 2003 · Anesthesiology

Device Facts

• Record ID: K024097
• Device Name: SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
• Applicant: Summit Medical , Ltd.
• Product Code: CAC · Anesthesiology
• Decision Date: Feb 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.

Device Story

The CellTrans™ Postoperative Autotransfusion Set is a convenience kit combining the CellTrans™ Postoperative Autotransfusion System and a Transfusion Filter in a single transit bag. The device collects, filters, and reinfuses blood lost postoperatively. It is intended for use in clinical settings, such as hospitals, following orthopedic joint replacement surgery. By facilitating autologous blood transfusion, the device reduces the need for homologous blood products, potentially benefiting the patient by minimizing transfusion-related risks.

Clinical Evidence

No clinical data provided; device is a combination of previously cleared predicate devices.

Technological Characteristics

The device consists of two individually sterilized components (CellTrans™ system and Transfusion Filter) packaged together in a non-sterile polyethylene transit bag. Components are packaged using Tyvek and film. No changes to the underlying mechanical or filtration technology of the predicate devices.

Indications for Use

Indicated for autologous blood transfusion in patients undergoing postoperative recovery, specifically following orthopedic joint replacement surgery.

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

• Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489)
• Summit Medical Transfusion Filter (K022477)

Submission Summary (Full Text)

{0}------------------------------------------------

K024097

FEB 1 4 2003

## Summit Medical Ltd

## 510(k) Premarket Notification

for the

CellTrans™ Postoperative Autotransfusion Set

# Attachment 7

# 510(k) Summary

Attachment 7 Page 2 of 4

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### 510(k) Summary

#### Summit Medical CellTrans™ Postoperative Autotransfusion Set

#### Manufacturer

Summit Medical Ltd Bourton on the Water Gloucestershire GL54 2HQ United Kingdom.

#### Contact

James Bradburv Regulatory Affairs Manager

| Phone: | 011 (44) 1451 821311 |
|---------|-------------------------------------|
| Fax: | 011 (44) 1451 821092 |
| E-mail: | [e-mail] |

#### Device Name

CellTrans™ Postoperative Autotransfusion Set

#### Classification Name

Autotransfusion Apparatus

#### Predicate Product(s)

- Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) .
- Summit Medical Transfusion Filter (K022477) ●

#### Product Description

The CellTrans™ Postoperative Autotransfusion Set consists of two individually sterilized packages, containing the Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) and the Summit Medical Transfusion Filter (K022477) respectively, presented for ease of handling and reordering in a non-sterile. polvethylene slide lock transit bag. Inside the transit bag the CellTrans™ device is double-wrapped, whilst the Transfusion Filter is single wrapped, both using Tyvek & Film packaging.

The transit bag also contains an additional copy of the CellTrans™ Instructions For Use to facilitate use of the Transfusion Filter.

> Attachment 7 Page 3 of 4

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#### Substantial Equivalence

The Summit Medical CellTrans™ Autotransfusion Set is substantially equivalent to the Summit Medical CellTrans™ Autotransfusion System (K022489) and Summit Medical Transfusion Filter (K022477).

#### Indications for Use

The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.

#### Safety and Effectiveness

No safety or effectiveness issues are raised when the Summit Medical CellTrans™ Postoperative Autotransfusion Set is compared to the predicate products and therefore the CellTrans™ Postoperative Autotransfusion Set is substantially equivalent to the Summit Medical CellTrans™ Postoperative Autotransfusion System and the Summit Medical Transfusion Filter.

Cacely

James Bradbury Regulatory Affairs Manager Summit Medical Ltd.

04.12.02

Date

Attachment 7 Page 4 of 4

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and head. The eagle is facing to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Summit Medical Ltd. c/o Mr. Neil R. Armstrong Managing Director MeddiQuest Ltd. Business and Technology Center Bessemer Drive Stevenage, Hertfordshire, SG1 2DX United Kingdom

Re: K024097

Trade Name: Summit Medical CellTrans™ Postoperative Autotransfusion Set Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: December 4, 2002 Received: December 12, 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. Iisting 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 (OS) 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

W. Walter Telle

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

Enclosure

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Summit Medical Ltd CellTrans™ Postoperative Autotransfusion Set 510(k) Attachment 8

### Indications for Use

| 510(k) Number: | 024097 |
|----------------|--------------------------------------------------------------|
| Device Name: | Summit Medical CellTrans ™ Postoperative Autotransfusion Set |

Indications for Use:

The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly 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) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| (Division Sign-Off) |
|------------------------------------|
| Division of Cardiovascular Devices |

| 510(k) Number | 12024097 |
|---------------|----------|
|---------------|----------|

| Prescription Use | | OR | Over-the-counter Use |
|------------------|--|----|----------------------|
|------------------|--|----|----------------------|

(Per 21 CFR 801.109)

Attachment 8

Attachment 8 Page 3 of 3