HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM

K071269 · Smiths Medical Asd, Inc. · CBT · Aug 1, 2007 · Anesthesiology

Device Facts

• Record ID: K071269
• Device Name: HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
• Applicant: Smiths Medical Asd, Inc.
• Product Code: CBT · Anesthesiology
• Decision Date: Aug 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1100
• Device Class: Class 1

Intended Use

The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.

Device Story

HemoDraw™ Arterial Blood Sampling Set facilitates blood withdrawal from arterial pressure monitoring lines. Device maintains closed system during sampling to reduce risk of contamination or blood loss. Used in clinical settings by healthcare professionals. System integrates with existing arterial monitoring lines; allows clinician to draw blood samples without opening the line to atmosphere. Benefits include simplified sampling process and maintenance of sterile closed-loop environment for patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Closed-system arterial blood sampling set. Components designed for integration with arterial pressure monitoring lines. Materials and sterilization methods consistent with standard medical device requirements for blood-contacting components.

Indications for Use

Indicated for patients requiring hemodynamic pressure monitoring and arterial blood gas sampling. Used in clinical settings for blood withdrawal via arterial lines while maintaining a closed system.

Regulatory Classification

Identification

An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes, resembling a person with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2007

Ms. Barbara Law Regulatory Affairs Manager Smiths Medical ASD, Incorporated 6250 Shier Rings Road Dublin, Ohio 43016

Re: K071269

Trade/Device Name: HemoDraw™ Arterial Blood Sampling Set Regulation Number: 868.1100 Regulation Name: Arterial Blood Sampling Kit Regulatory Class: II Product Code: CBT Dated: July 18, 2007 Received: July 20, 2007

Dear Ms. Law:

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 Eederal Register.

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Page 2 - Ms. Law

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/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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## SECTION 4: Indications for Use Statement

## Indications for Use

510(k) Number (if known):

Device Name: HemoDraw™ Arterial Blood Sampling Set

Indications for Use:

The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

L
(acting B.C.)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:

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