(224 days)
Not Found
No
The device description and performance studies focus on pressure measurement, fluid collection, and electrical/EMC safety testing, with no mention of AI or ML algorithms for data analysis or diagnosis.
No
The device is used for diagnosis and measurement, not for treatment or therapy. It measures intracompartmental pressures to aid in the diagnosis of compartment syndrome and collects fluid for analysis.
Yes
The device measures intracompartmental pressures, and these measurements "can be used as an aid in the diagnosis of compartment syndrome," which explicitly states its role in diagnosis.
No
The device description clearly outlines multiple hardware components including an Introducer (trocar and sheath), PMFC Catheter, FC Catheter, and a Compartment Pressure Monitor. The performance studies also include testing related to electrical safety and EMC, which are relevant to hardware components.
Based on the provided information, the Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The ECM-III is designed to:
- Measure intracompartmental pressures: This is a direct measurement within the body (in vivo).
- Withdraw fluid for subsequent analysis: While fluid is collected, the device itself is not performing the analysis. The analysis is done subsequently, implying it will be performed using other methods or devices, potentially in a laboratory setting. The ECM-III is a tool for collecting the sample, not analyzing it.
- Intended Use: The intended use clearly states the measurement of pressure and withdrawal of fluid. The pressure measurement is an in vivo diagnostic aid. The fluid withdrawal is for subsequent analysis, which would be the in vitro part, but the ECM-III is not the device performing that analysis.
Therefore, the primary function of the ECM-III is an in vivo measurement device and a sample collection tool, not a device that performs in vitro diagnostic testing on the collected sample.
N/A
Intended Use / 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.
Product codes
LXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. Testing included ASTM 4169-09, Distribution Cycle 13, electrical safety (IEC 60601-1 - Medical Electrical Equipment Part 1: General Requirements for Safety 1988 + A1: 1991 + A2; 1995) and EMC Emissions and Immunity (IEC 60601-1-2:2001 + A1:2004 Ed. 2, Medical Electrical Equipment, Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests - Class A Radiated and Conducted Emissions and Immunity for Non Life-Supporting Equipment). 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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 is |
| being submitted in accordance with the requirements of 21 | |
| C.F.R § 807.92. | |
| Submission Sponsor | Twin Star Medical, Inc. |
| 700 South 10th Avenue, Suite 120 | |
| Minneapolis, MN 55415 | |
| Tel: 612-382-0888 | |
| Fax: 612-338-9181 | |
| Submission Consultant | Sachs & Associates, Inc. |
| Gregory W. Sachs, President | |
| 5116 Birch Road | |
| Minnetonka, MN 55345 | |
| Tel: 612-840-1568 | |
| Fax: 952-931-0531 | |
| Date Prepared | January 15, 2014 |
| Device Trade Name | Twin Star Extremity Compartment Monitor and Fluid Collection |
| 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 |
| Catheter System (CMS-II). | |
| 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 Description | 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. | |
| Performance data | 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. Testing included ASTM 4169-09, | |
| Distribution Cycle 13, electrical safety (IEC 60601-1 - Medical | |
| Electrical Equipment Part 1: General Requirements for Safety | |
| 1988 + A1: 1991 + A2; 1995) and EMC Emissions and | |
| Immunity (IEC 60601-1-2:2001 + A1:2004 Ed. 2, Medical | |
| Electrical Equipment, Part 1: General Requirements for Safety |
- Collateral Standard: Electromagnetic Compatibility
Requirements and Tests - Class A Radiated and Conducted
Emissions and Immunity for Non Life-Supporting Equipment).
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. |
| Summary of Substantial
Equivalence | The Twin Star Extremity Compartment Monitor and Fluid
Collection System (ECM-III) utilizes substantially equivalent
performance attributes and safety components as the predicate
device. It shares the following similarities to the predicate
device:
Monitoring Pressure Electrical Safety Vacuum Source Principles of operation |
| Conclusion | Based on the similar indications for use, technological
characteristics and performance testing, Twin Star Medical, Inc.
believes the proposed device, the Twin Star Extremity
Compartment Monitor and Fluid Collection System (ECM-III),
is substantially equivalent to the Twin Star Compartment
Pressure 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.
3
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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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:
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 H
| Chen -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