TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM

K131966 · Twin Star Medical, Inc. · LXC · Feb 7, 2014 · OR

Device Facts

• Record ID: K131966
• Device Name: TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
• Applicant: Twin Star Medical, Inc.
• Product Code: LXC · OR
• Decision Date: Feb 7, 2014
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

Intended Use

The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) is intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.

Device Story

System consists of introducer (tear-away sheath over stainless steel trocar), pressure monitoring/fluid collection (PMFC) catheter, fluid collection (FC) catheter, and compartment pressure monitor. Introducer provides access to muscle compartment; indwelling catheter monitors intramuscular pressure and samples interstitial fluid for up to 24 hours. Monitor displays intracompartmental pressure. Used in clinical settings by healthcare providers to aid in diagnosis of compartment syndrome. Benefits include real-time pressure monitoring and fluid access for analysis, facilitating timely clinical decision-making regarding compartment syndrome management.

Clinical Evidence

Bench testing only. Testing included ASTM 4169-09 (Distribution Cycle 13), electrical safety (IEC 60601-1), and EMC emissions/immunity (IEC 60601-1-2). No clinical data presented.

Technological Characteristics

Components: stainless steel trocar, tear-away plastic sheath, indwelling catheters. Sensing: intracompartmental pressure monitoring. Energy: electrical (monitor). Connectivity: not specified. Sterilization: not specified. Software: not specified. Standards: ASTM 4169-09, IEC 60601-1, IEC 60601-1-2.

Indications for Use

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

Predicate Devices

• Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) (K090961)

Submission Summary (Full Text)

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FEB – 7 2014

## 510(k) Summary

| Twin Star Extremity Compartment Monitor and Fluid Collection System<br>(ECM-III) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of 21<br>C.F.R § 807.92. |
| Submission Sponsor | Twin Star Medical, Inc.<br>700 South 10th Avenue, Suite 120<br>Minneapolis, MN 55415<br>Tel: [phone]<br>Fax: [phone] |
| Submission Consultant | Sachs & Associates, Inc.<br>Gregory W. Sachs, President<br>5116 Birch Road<br>Minnetonka, MN 55345<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared | January 15, 2014 |
| Device Trade Name | Twin Star Extremity Compartment Monitor and Fluid Collection<br>System (ECM-III) |
| Device Common Name | Monitor, Pressure, Intracompartmental |
| Classification Name | Unclassified, Product Code LXC |
| Classification Panel | Orthopedic |
| Predicate Devices | Twin Star Compartment Pressure Monitor and Fluid Collection<br>Catheter System (CMS-II). |
| Intended use | The Twin Star Extremity Compartment Monitor and Fluid<br>Collection System (ECM-III) is intended for the immediate or<br>continuous measurement of intracompartmental pressures<br>and/or the withdrawal of fluid for subsequent analysis. The<br>measured compartmental pressures can be used as an aid in<br>the diagnosis of compartment syndrome. |
| Device Description | The Twin Star Extremity Compartment Monitor and Fluid<br>Collection System (ECM-III) consists of four major<br>components; an Introducer, a Pressure Monitoring and Fluid<br>Collection (PMFC) Catheter, a Fluid Collection (FC) Catheter,<br>and a Compartment Pressure Monitor. The Introducer consists<br>of tear-away plastic sheath placed over a stainless steel trocar.<br>The Introducer provides an access to the targeted muscle |
| | compartment to facilitate the placement of the indwelling<br>Pressure Monitoring Fluid Collection / Fluid Collection catheter.<br>The indwelling Catheter is designed to monitor intramuscular<br>compartment pressure as well as provide a means to sample<br>interstitial fluid for laboratory analysis. The indwelling Catheter<br>is designed for use up to 24 hours. The Twin Star Extremity<br>Compartment Monitor and Fluid Collection System (ECM-III)<br>provides a means of displaying the intracompartmental pressure. |
| Performance data | A risk assessment was conducted which covered (1) all aspects<br>of the possible effects on the safety and effectiveness of the<br>modified device, (b) described each device modification under<br>consideration, (c) the verification and validation activities with<br>acceptance criteria, (d) scientific justification for each activity<br>and (e) acceptance criteria. Testing included ASTM 4169-09,<br>Distribution Cycle 13, electrical safety (IEC 60601-1 - Medical<br>Electrical Equipment Part 1: General Requirements for Safety<br>1988 + A1: 1991 + A2; 1995) and EMC Emissions and<br>Immunity (IEC 60601-1-2:2001 + A1:2004 Ed. 2, Medical<br>Electrical Equipment, Part 1: General Requirements for Safety<br>2. Collateral Standard: Electromagnetic Compatibility<br>Requirements and Tests - Class A Radiated and Conducted<br>Emissions and Immunity for Non Life-Supporting Equipment).<br>Results from this testing provide assurance that the proposed<br>device has been designed and tested to assure conformance to<br>the requirements for its intended use. |
| Summary of Substantial<br>Equivalence | The Twin Star Extremity Compartment Monitor and Fluid<br>Collection System (ECM-III) utilizes substantially equivalent<br>performance attributes and safety components as the predicate<br>device. It shares the following similarities to the predicate<br>device:<br>Monitoring Pressure Electrical Safety Vacuum Source Principles of operation |
| Conclusion | Based on the similar indications for use, technological<br>characteristics and performance testing, Twin Star Medical, Inc.<br>believes the proposed device, the Twin Star Extremity<br>Compartment Monitor and Fluid Collection System (ECM-III),<br>is substantially equivalent to the Twin Star Compartment<br>Pressure Monitor and Fluid Collection Catheter System (CMS-II,<br>K090961). |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Twin Star Medical Incorporated % Mr. Gregory W. Sachs Sachs & Associates Incorporated 5116 Birch Road Minnetonka, Minnesota 55345

February 7, 2014

Re: K131966

Trade/Device Name: Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) Regulatory Class: Unclassified Product Code: LXC Dated: January 15, 2014 Received: January 16, 2014

Dear Mr. Sachs:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Gregory W. Sachs

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua FOXlipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

## Indications for Use Statement

510(k) Number (if known): K131966

## Device Name: Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III)

Indications for Use:

1. 1. 1. 1. 1.

The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) is intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Long H<br>Chen -A | |
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| Digitally signed by Long H. Chen -A | |
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| Date: 2014.02.07 07:18:51 -05'00 | |

for BSA

(Division Sign-off)

Division of Surgical Devices510(k) Number: K131966