(224 days)
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.
The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) 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. The Introducer provides an access to the targeted muscle 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 Extremity Compartment Monitor and Fluid Collection System (ECM-III) provides a means of displaying the intracompartmental pressure.
The provided document is a 510(k) summary for the Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III). It describes the device, its intended use, and its substantial equivalence to a predicate device (Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)).
However, the document does not provide specific acceptance criteria in a quantitative format, nor does it detail a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. Instead, the performance data section focuses on verification and validation activities related to safety standards rather than clinical efficacy.
Therefore, many of the requested bullet points cannot be answered based on the information provided in this 510(k) summary.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance:
The document states: "A risk assessment was conducted which covered (1) all aspects of the possible effects on the safety and effectiveness of the modified device, (b) described each device modification under consideration, (c) the verification and validation activities with acceptance criteria, (d) scientific justification for each activity and (e) acceptance criteria."
However, it then only lists the types of testing performed (ASTM 4169-09, electrical safety IEC 60601-1, EMC Emissions and Immunity IEC 60601-1-2) and concludes: "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."
It does not explicitly state the quantitative acceptance criteria for device performance (e.g., accuracy, precision) related to its intended use (measurement of intracompartmental pressures) or the reported numerical performance outcomes against those criteria. It only implies that the device conforms to safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in this document. The listed tests are engineering/safety compliance tests, not clinical performance studies with patient data.
3. 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. No clinical expert-driven ground truth establishment is mentioned for this type of device (a pressure monitor).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. 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:
Not applicable. This device is a measurement tool, not an AI-assisted diagnostic imaging system requiring reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device for direct measurement, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For device performance in terms of pressure measurement accuracy, the "ground truth" would typically come from calibrated reference instruments. The document implies such testing was part of the "verification and validation activities with acceptance criteria," but it does not detail the specifics of how this ground truth was established or what values were considered ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
In summary:
This 510(k) document primarily addresses the safety and the claim of substantial equivalence to a predicate device based on similar technological characteristics and performance attributes (like "Monitoring Pressure Electrical Safety Vacuum Source Principles of operation"). It describes engineering and safety compliance testing, but it does not provide the kind of detailed clinical performance acceptance criteria, study data, or ground truth methodologies that would typically be found for diagnostic devices involving human interpretation or complex algorithms.
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FEB – 7 2014
510(k) Summary
| Twin Star Extremity Compartment Monitor and Fluid Collection System(ECM-III) | |
|---|---|
| 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. |
| Submission Sponsor | Twin Star Medical, Inc.700 South 10th Avenue, Suite 120Minneapolis, MN 55415Tel: 612-382-0888Fax: 612-338-9181 |
| Submission Consultant | Sachs & Associates, Inc.Gregory W. Sachs, President5116 Birch RoadMinnetonka, MN 55345Tel: 612-840-1568Fax: 952-931-0531 |
| Date Prepared | January 15, 2014 |
| Device Trade Name | Twin Star Extremity Compartment Monitor and Fluid CollectionSystem (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 CollectionCatheter System (CMS-II). |
| Intended use | The Twin Star Extremity Compartment Monitor and FluidCollection System (ECM-III) is intended for the immediate orcontinuous measurement of intracompartmental pressuresand/or the withdrawal of fluid for subsequent analysis. Themeasured compartmental pressures can be used as an aid inthe diagnosis of compartment syndrome. |
| Device Description | The Twin Star Extremity Compartment Monitor and FluidCollection System (ECM-III) 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.The Introducer provides an access to the targeted muscle |
| compartment to facilitate the placement of the indwellingPressure Monitoring Fluid Collection / Fluid Collection catheter.The indwelling Catheter is designed to monitor intramuscularcompartment pressure as well as provide a means to sampleinterstitial fluid for laboratory analysis. The indwelling Catheteris designed for use up to 24 hours. The Twin Star ExtremityCompartment Monitor and Fluid Collection System (ECM-III)provides a means of displaying the intracompartmental pressure. | |
| Performance data | A risk assessment was conducted which covered (1) all aspectsof the possible effects on the safety and effectiveness of themodified device, (b) described each device modification underconsideration, (c) the verification and validation activities withacceptance criteria, (d) scientific justification for each activityand (e) acceptance criteria. Testing included ASTM 4169-09,Distribution Cycle 13, electrical safety (IEC 60601-1 - MedicalElectrical Equipment Part 1: General Requirements for Safety1988 + A1: 1991 + A2; 1995) and EMC Emissions andImmunity (IEC 60601-1-2:2001 + A1:2004 Ed. 2, MedicalElectrical Equipment, Part 1: General Requirements for Safety2. Collateral Standard: Electromagnetic CompatibilityRequirements and Tests - Class A Radiated and ConductedEmissions and Immunity for Non Life-Supporting Equipment).Results from this testing provide assurance that the proposeddevice has been designed and tested to assure conformance tothe requirements for its intended use. |
| Summary of SubstantialEquivalence | The Twin Star Extremity Compartment Monitor and FluidCollection System (ECM-III) utilizes substantially equivalentperformance attributes and safety components as the predicatedevice. It shares the following similarities to the predicatedevice:Monitoring Pressure Electrical Safety Vacuum Source Principles of operation |
| Conclusion | Based on the similar indications for use, technologicalcharacteristics and performance testing, Twin Star Medical, Inc.believes the proposed device, the Twin Star ExtremityCompartment Monitor and Fluid Collection System (ECM-III),is substantially equivalent to the Twin Star CompartmentPressure Monitor and Fluid Collection Catheter System (CMS-II,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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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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:
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) | |
|---|---|
| -- | -------------------------------------------------------- |
| Long HChen -A | |
|---|---|
| ------------------- | -- |
| Digitally signed by Long H. Chen -A | |
|---|---|
| Date: 2014.02.07 07:18:51 -05'00 |
for BSA
(Division Sign-off)
Division of Surgical Devices510(k) Number: K131966
N/A