(67 days)
Not Found
No
The summary describes a system for measuring pressure and collecting fluid, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as aiding in the diagnosis of compartment syndrome by measuring pressure and collecting fluid, not as providing treatment or therapy for the condition itself.
Yes
The stated "Intended Use" explicitly mentions that "The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome," which categorizes it as a diagnostic device.
No
The device description explicitly lists multiple hardware components: an Introducer (plastic sheath and stainless steel trocar), a Pressure Monitoring and Fluid Collection (PMFC) Catheter, a Fluid Collection (FC) Catheter, and a Compartment Pressure Monitor. The performance studies also include electrical safety testing, which is relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is the measurement of intracompartmental pressures to aid in the diagnosis of compartment syndrome. While it also allows for the withdrawal of fluid for subsequent analysis, the core function described is pressure monitoring within the body.
- Device Description: The components are designed for in-vivo (within the body) measurement and fluid collection from within a compartment.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease. This device operates inside the body to directly measure a physical parameter (pressure).
The fluid collection aspect is for subsequent analysis, which would likely be performed using separate IVD devices or laboratory methods on the collected fluid. The Twin Star system itself is not performing the diagnostic analysis on the fluid.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LXC
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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), Stryker Compartment Syndrome Pressure Monitoring System (K844214)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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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 is | |
| being submitted in accordance with the requirements of 21 | ||
| C.F.R § 807.92. | ||
| Applicant | Twin Star Medical, Inc. | |
| Submitter | Twin Star Medical, Inc. | |
| 1000 Westgate Drive, Suite 117 | ||
| St. Paul, MN 55114 | ||
| Tel: 612-990-0631 | ||
| Fax: 651-209-0556 | ||
| Contact Person | Jim Stice, President / CEO | |
| Date Prepared | March 27, 2009 | |
| Device Trade Name | Twin Star Compartment Pressure Monitor and Fluid Collection | |
| Catheter 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 Collection | |
| Catheter System (Catheter, K041771), Twin Star Compartment | ||
| Pressure Monitoring and Fluid Collection Monitor (CMS | ||
| Monitor, K060963), Synthes (USA) Compartmental Pressure | ||
| Monitoring System (K031555), Stryker Compartment Syndrome | ||
| Pressure Monitoring System (K844214). | ||
| Intended use | 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. |
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K090961
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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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Page 1 of 1
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:
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.
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