TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM

K041771 · Twin Star Medical, Inc. · LXC · Sep 14, 2004 · OR

Device Facts

• Record ID: K041771
• Device Name: TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
• Applicant: Twin Star Medical, Inc.
• Product Code: LXC · OR
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is intended for the immediate or continuous measurement of intracompartmental pressure and is intended for the withdrawal of fluid for subsequent analysis. The measured pressures and the withdrawal of fluid are used as an aid in the diagnosis of compartment syndrome.

Device Story

System comprises introducer (sheath over stainless steel trocar) and indwelling catheter; used for intramuscular compartment pressure monitoring and interstitial fluid sampling. Introducer facilitates access to targeted muscle compartment; catheter allows pressure measurement and fluid withdrawal for up to 24 hours. Device interfaces with external equipment including vacuum pump, infusion pump, pressure transducer, and monitor. Operated by clinicians in clinical settings. Output (pressure readings and fluid samples) assists physicians in diagnosing compartment syndrome.

Clinical Evidence

Evidence includes animal model testing and human clinical studies comparing the subject device to the predicate system for measuring intracompartmental pressure.

Technological Characteristics

System includes introducer (sheath and stainless steel trocar) and indwelling catheter. Designed for use with external pressure transducers, monitors, and pumps. Intended for short-term (up to 24 hours) use.

Indications for Use

Indicated for patients requiring immediate or continuous intracompartmental pressure measurement and interstitial fluid withdrawal to aid in the diagnosis of compartment syndrome.

Predicate Devices

• Stryker Intra-Compartment Pressure Monitor System

Submission Summary (Full Text)

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SEP 1 4 2004

K041771 1 of 1

# 510(k) Summary Summary of Safety and Effectiveness Information

# Sponsor:

Twin Star Medical, Inc. 914 South 8th Street Mail Code 860c Minneapolis, Minnesota 55404 Tele: 763.576.5172 Fax: [phone]

# Device Name:

Twin Star Compartment Monitoring and Fluid Collection Catheter System

#### Device Classification:

Class II - Monitor, Pressure, Intracompartmental

#### Device Description:

The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System The Twin Oth Othpartners i.e., an Introducer and an indwelling Catheter. The Consists of two major componentic sheath placed over a stainless steel trocar. The Introducer provides an access to the targeted muscle compartment to facilitate the Introducer provides an associety in the Monitoring and Fluid Collection Catheter. The placement of the mawelling intramuscular compartment pressure as well indwelling outhority a sample interstitial fluid for laboratory analysis. The indwelling as provide a means to campio into 24 hours. The Twin Star Compartment Pressure Oather is dong. But as a long Catheter System is designed to be used with currently Monitoring and Find equipment including a vacuum pump, infusion pump, pressure transducer and monitor.

# Indications:

Includions:
The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is intended for the immediate or continuous measurement of intracompartmental 15 intended for the withdrawal of fluid for subsequent analysis. The measured pressures and the withdrand of the diagnosis of compartment syndrome.

# Substantial Equivalence:

Substantial Equivalences
Documentation has been provided which demonstrates that the Twin Star Compartment Documentation nas boon provided with Niew Catheter System is substantially Synuronie Tressure Moniconing and devices such as the Stryker Intra-Compartment equivalent to other logally mamorean testing during animal and human clinical studies Fressure Monitor Oyoton: Semparisone Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System with the predicate system to measure intracompartment pressure in an animal model and a human clinical study.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

SEP 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Twin Star Medical, Inc. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, NW Washington, DC 20004

Re: K041771

Trade/Device Name: Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System

Regulatory Class: Unclassified Product Code: LXC Dated: June 22, 2004 Received: June 30, 2004

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use battled in 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 r ou may, merere, mains 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. You must or any I 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.

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Page 2 - Mr. Jonathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse organ finding of substantial equivalence of your device to a legally prematicated 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 If you desire specific arrioliance 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 other general 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,

Muriam C. Purvost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO417 1_ of 1

# Indications for Use

510(k) Number (if known): #041771

Device Name: Device Name.
Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System

Indications For Use:

Indications For Ose.
The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System The Twill Star Oompartment Prossation.ous measurement of intracompartmental ls intended for the immediate of contificassubsequent analysis. The freessured pressures and the withdrawarer half for oubseques has an aid in the diagnosis of compartment syndrome.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Miriam C. Provost
(Division Sign-Off)

Concurrentision of Gefficeal; Restoration (ODE) and Neurological Devices

**510(k) Number** k04177/