ARTERIA BLOOD FILTER

K021293 · Arteria Medical Science, Inc. · FPB · Aug 22, 2002 · General Hospital

Device Facts

• Record ID: K021293
• Device Name: ARTERIA BLOOD FILTER
• Applicant: Arteria Medical Science, Inc.
• Product Code: FPB · General Hospital
• Decision Date: Aug 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The ArteriA Blood Filter is intended as an accessory for use in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.

Device Story

The ArteriA Blood Filter is a blood transfusion filter and drip chamber assembly. It consists of a filter/drip chamber integrated with flexible medical-grade tubing. The input side features a three-way stopcock valve with male and female Luer connections; the outlet features a male Luer connector for attachment to a venous access device (e.g., catheter or sheath). The device is used by clinicians to filter blood or solutions during administration into the patient's vascular system. It functions as a passive mechanical accessory to facilitate safe fluid delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is constructed of medical-grade materials. It utilizes a passive filtration principle within a drip chamber. The form factor includes flexible tubing with standard Luer connectors (male/female) and a three-way stopcock. It is a non-powered, mechanical device.

Indications for Use

Indicated for use as an accessory in the administration of blood, blood components, or solutions into a patient's vascular system via a venous access device.

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

• Baxter healthcare Corporation, Blood Administration Set, K993120

Submission Summary (Full Text)

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K02/293

Image /page/0/Picture/2 description: The image shows a logo with a circular design on the left and the word "ArteriA" on the right. The circular design is divided into three sections, with a pattern of small circles inside. The word "ArteriA" is written in a stylized font.

#### 510(k) Summary ArteriA Blood Filter

### Date Prepared: July 31, 2002

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

### A. Submitter

ArteriA Medical Science, Inc. The Presidio, Building 220, Suite 120 San Francisco, CA 94129

#### B. Company Contact

Alan Hinton, Quality Assurance

#### C. Device Name

| Trade Name: | ArteriA Blood Filter |
|----------------------|----------------------------------|
| Common Name: | Blood administration filter |
| Classification Name: | Intravascular Administration Set |

#### D. Predicate Devices

Baxter healthcare Corporation, Blood Administration Set, K993120

### E. Description of Device

The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible medical grade tubing having a connector on each end. The input side to the dripchamber/filter has a three-way stopcock valve that has both a male and female Luer connections available for use. The outlet of the drip-chamber/filter has a male Luer connector that facilitates connection to a venous access device such as a catheter or sheath. It may also be connected to another stopcock.

### F. Intended Use

The ArteriA Blood Filter is intended for use as an accessory in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.

### G. Comparison of Technological Characteristics

The basic technologies, design and function of ArteriA Medical Science, Inc.'s ArteriA Blood Filter are substantially equivalent in design, materials of construction, and intended us to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Hinton Director, Quality Assurance Arteria Medical Science, Incorporated 22 Hill Street Newburyport, Massachusetts 01950

Re: K021293

Trade/Device Name: Arteria Blood Filter Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPB and BRZ Dated: July 31, 2002 Received: August 2, 2002

Dear Mr. Hinton:

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.

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.

# AUG 2 2 2002

AUG 22 2002

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Page 2 - Mr. Hinton -

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ouis G/fr
Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 02/293

Page 1 of 1

510(k) Number :

Device Name :

Indications for Use :

The ArteriA Blood Filter is intended as an accessory for use in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Patraici Cucembe

Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: K022/293