TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) by TWIN STAR MEDICAL, INC.

The Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) 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 Description

The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System (CMS-II) consists of four major components; an Introducer, a Pressure Monitoring and Fluid Collection (PMFC) Catheter, a Fluid Collection (FC) Catheter, and a Compartment Pressure Monitor. The Introducer consists of tear-away plastic sheath placed over a stainless steel trocar. compartment to facilitate the placement of the indwelling Pressure Monitoring Fluid Collection / Fluid Collection catheter. The indwelling Catheter is designed to monitor intramuscular compartment pressure as well as provide a means to sample interstitial fluid for laboratory analysis. The indwelling Catheter is designed for use up to 24 hours. The Twin Star Compartment Pressure Monitoring provides a means of displaying the intracompartmental pressure.

AI/ML Overview

The provided text describes a 510(k) summary for the Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II). This document focuses on demonstrating substantial equivalence to predicate devices through performance testing rather than establishing acceptance criteria and detailed study results for a novel AI device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text, as these are typically part of studies for novel devices or AI algorithms.

However, based on the text, I can infer the following:

A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific reported device performance metrics like accuracy, sensitivity, or specificity. Instead, it indicates that "Bench testing was performed to support a determination of substantial equivalence and consisted of biocompatibility, electrical safety testing and design verification. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

The performance attributes considered for substantial equivalence are:
- Monitoring Pressure
- Fluid Collection
- Membrane Diameter
- Single Patient Use
- Pressure Sensor Location
- Electrical Safety
- Vacuum Source
- Principles of operation
While these are attributes, they are not presented as quantitative acceptance criteria with corresponding performance results.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not specified. The document only mentions "Bench testing" which implies laboratory-based tests rather than clinical data from a "test set" in the context of an AI study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The device's performance was evaluated through bench testing and design verification, not against expert-established ground truth from a test set of patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable (see point 3).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC study was not done. This device is a physical medical device (pressure monitor and catheter system), not an AI algorithm designed to assist human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm. Its "standalone" performance would be its inherent accuracy and reliability as a physical instrument, which would have been assessed during the "bench testing" and "design verification." However, specific metrics are not provided.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of clinical "ground truth" as might be used for an AI algorithm. For this device, the "ground truth" would be established by validated measurement standards and known physical properties during bench testing (e.g., a known pressure applied to calibrate the monitor, known fluid volumes).
The sample size for the training set:
Not applicable. This is not an AI algorithm with a training set.
How the ground truth for the training set was established:
Not applicable. This is not an AI algorithm with a training set.

Summary of the study and its purpose:

The document describes a submission for 510(k) clearance for the Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II). The purpose of the study (bench testing, design verification, and risk analysis) was to demonstrate substantial equivalence to previously cleared predicate devices, thereby ensuring the safety and effectiveness of the new device for its intended use (immediate or continuous measurement of intracompartmental pressures and/or fluid withdrawal for analysis to aid in the diagnosis of compartment syndrome). The studies performed confirmed biocompatibility, electrical safety, and overall system operation, but specific performance metrics are not detailed in this summary.

Summary

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510(k) Summary

Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System(CMS-II)
	510(k) Summary	This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21C.F.R § 807.92.
	Applicant	Twin Star Medical, Inc.
	Submitter	Twin Star Medical, Inc.1000 Westgate Drive, Suite 117St. Paul, MN 55114Tel: 612-990-0631Fax: 651-209-0556
	Contact Person	Jim Stice, President / CEO
	Date Prepared	March 27, 2009
	Device Trade Name	Twin Star Compartment Pressure Monitor and Fluid CollectionCatheter System (CMS-II)
	Device Common Name	Monitor, Pressure, Intracompartmental
	Classification Name	Unclassified, Product Code LXC
	Classification Panel	Orthopedic
	Predicate Devices	Twin Star Compartment Monitoring and Fluid CollectionCatheter System (Catheter, K041771), Twin Star CompartmentPressure Monitoring and Fluid Collection Monitor (CMSMonitor, K060963), Synthes (USA) Compartmental PressureMonitoring System (K031555), Stryker Compartment SyndromePressure Monitoring System (K844214).
	Intended use	The Twin Star Compartment Pressure Monitor and FluidCollection Catheter System (CMS-II) is intended for theimmediate or continuous measurement of intracompartmentalpressures and/or the withdrawal of fluid for subsequentanalysis. The measured compartmental pressures can be usedas an aid in the diagnosis of compartment syndrome.
	Device Description	The Twin Star Compartment Pressure Monitoring and FluidCollection Catheter System (CMS-II) consists of four majorcomponents; an Introducer, a Pressure Monitoring and FluidCollection (PMFC) Catheter, a Fluid Collection (FC) Catheter,and a Compartment Pressure Monitor. The Introducer consistsof tear-away plastic sheath placed over a stainless steel trocar.

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

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compartment to facilitate the placement of the indwelling Pressure Monitoring Fluid Collection / Fluid Collection catheter. The indwelling Catheter is designed to monitor intramuscular compartment pressure as well as provide a means to sample interstitial fluid for laboratory analysis. The indwelling Catheter is designed for use up to 24 hours. The Twin Star Compartment Pressure Monitoring provides a means of displaying the intracompartmental pressure.

Bench testing was performed to support a determination of substantial equivalence and consisted of biocompatibility, electrical safety testing and design verification. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operations.

The Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) utilizes substantially equivalent performance attributes and safety components as the predicate devices. It shares the following similarities to the predicate devices:

Monitoring Pressure .
Fluid Collection
Membrane Diameter
Single Patient Use .
Pressure Sensor Location
Electrical Safety .
Vacuum Source
Principles of operation

Based on the similar indications for use, technological characteristics and performance testing, Twin Star Medical, Inc. believes the proposed device, the Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II), is substantially equivalent to the Twin Star Compartment Monitoring and Fluid Collection Catheter System (Catheter, K041771). Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor, K060963), Synthes (USA) Compartmental Pressure Monitoring System (K031555) and the Stryker Compartment Syndrome Pressure Monitoring System (K844214).

Performance data

Summary of Substantial

Equivalence

Conclusion

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 1 2 2009

Re: K090961 ·

Trade/Device Name: Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)

Regulatory Class: II Product Code: LXC Dated: May 14, 2009 Received: May 15, 2009

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.

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);

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Page 2-Mr. Gregory W. Sachs

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Melkerson Division of Surgical. Orthoped and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)

Indications for Use:

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090961

Regulation Number and Section

N/A