SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

K022477 · Summit Medical , Ltd. · CAK · Oct 25, 2002 · General Hospital

Device Facts

• Record ID: K022477
• Device Name: SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
• Applicant: Summit Medical , Ltd.
• Product Code: CAK · General Hospital
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.

Device Story

Device is a sterile, single-use transfusion filter assembly, optionally including an administration set with drip chamber and roller clamp. It connects to a blood bag via a spike port. Operation involves inverting the bag to prime the filter, then hanging the system on a drip stand. Flow rate is regulated by the roller clamp. The device uses a 40-micron absolute rated screen filter to remove microaggregates, lipid particles, anaphylatoxin C3a, leucocytes, and non-blood particulate matter from salvaged blood. Used in clinical settings for reinfusion of salvaged blood to patients. Benefits include reduction of potentially harmful components in salvaged blood prior to reinfusion.

Clinical Evidence

Bench testing only. Testing included bubble point, pressure leak, particulate cleanliness, mechanical and hydrostatic testing of bonded joints, microbiological bioburden, and endotoxin validation. Biocompatibility testing performed per ISO 10993 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, and Haemocompatibility). Sterilization validated per ISO 11137.

Technological Characteristics

40-micron absolute rated screen filter medium. Sterile, single-use assembly. Gamma sterilized per ISO 11137. Biocompatibility per ISO 10993. Low priming volume, free-flow design.

Indications for Use

Indicated for filtration of up to one unit of intra-operative or post-operative salvaged blood for reinfusion of blood derived from surgical sites or post-operative wound drainage.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• SQ40 Blood Transfusion Filter, Pall Biomedical Products Co. (K960993)

Submission Summary (Full Text)

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1622477

Summit Medical Ltd

Transfusion Filter 510(k) Attachment 7

#### 510(k) Summary

#### Summit Medical Transfusion Filter

#### Manufacturer

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

#### Contact

James Bradbury Requlatory Affairs Manager E-mail: [e-mail] 011 (44) 1451 821311 Tel [phone] Fax

#### Device Name

Transfusion Filter

#### Classification Name

Microfilter, Blood Transfusion

#### Predicate Product

SQ40 Blood Transfusion Filter, Pall Biomedical Products Co. (K960993)

#### Product Description

The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp.

The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to

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#### Summit Medical Ltd

#### Transfusion Filter 510(k) Attachment 7

force blood through the filter medium and to the desired level within the drip chamber.

The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.

#### Substantial Equivalence

The Summit Medical Transfusion Filter is substantially equivalent specifically to the Pall Biomedical Products Co. SQ40 Blood Transfusion Filter (K960993), in that they are designed with the same design principles, made of the same materials, and have the same indications and contraindications for use.

#### Indications for Use

The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surqical site or post-operative wound drainage.

#### Safety and Effectiveness

Performance testing carried out includes bubble point testing, pressure leak tests, particulate cleanliness, mechanical and hydrostatic testing of bonded joints, microbiological bioburden and endotoxin validation.

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

Biocompatibility testing was carried out in accordance with ISO 10993, and includes Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity and Haemocompatibility.

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

No safety or effectiveness issues are raised when the Summit Medical Transfusion Filter is compared with the predicate product, and therefore the Summit Medical Transfusion Filter is substantially equivalent to the Pall SQ40 Blood Transfusion Filter (K960993).

James Bradbury
Regulatory Affairs Manager

Summit Medical

Date: 25 July 2002

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K022477

Summit Medical Transfusion Filter Regulation Number: 880.5440 Regulation Name: Microfilter, Blood Transfusion Regulatory Class: II (two) Product Code: 74 CAK 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 vours.

W

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

Transfusion Filter 510(k) Attachment 8

### dications for Use

510(k) Number:

Device Name:

Summit Medical Transfusion Filter

Indications for Use:

The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or postoperative wound drainage.

| (PLEASE DO NOT WRITE BELOW THIS LINE) | |
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| Concurrence of CDRH, Office of Device Evaluation(ODE) | |
| Division of Cardiovascular & Devices | |
| 510(k) Number | K062447 |
| Prescription Use | <span style="text-decoration: underline;">✓</span> OR Over-the-counter Use <span style="text-decoration: underline;"></span> |
| (Per 21 CFR 801.109) | |

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# Description

The transfusion filter is a free-flow, low priming volume device which provides a 40 micron absolute rated screen filter medium for the removal of potentially harmful blood component microaggregates and non-blood component particulate matter.

# Indications

Transfusion of stored blood, packed red cells, platelet and granulocyte concentrations and filtration of ViaSpan® (Cold Storage Solution).*

* ViaSpan® is a registered trademark of Dupont-Merck.