(60 days)
The Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) is intended for the measurement and monitoring of intracompartmental pressures and the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The CMS Monitor is intended to be used in conjunction with the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter).
The Twin Star Compartment Pressure Monitoring and Fluid Collection (CMS) Monitor displays and records pressure as measured by the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter). The Twin Star CMS Catheter has been previously cleared by 510k notification. The multi-task CSM Monitor consists of a single housing unit that incorporates a vacuum pump, an infusion pump and a pressure monitor with visual display and user interface. The CMS Monitor provides the necessary functions required by the CMS Catheter. In addition to monitoring pressure, the CMS Monitor provides a very low volume fluid infusion to maintain the CMS Catheter's pressure lumen patency and a vacuum to the second lumen for fluid collection; both infusion and vacuum are required for the functional operation of the CMS Catheter.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document is a 510(k) summary for a medical device (Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor) seeking substantial equivalence to predicate devices. It does not explicitly state specific numerical acceptance criteria (e.g., within 5% accuracy of predicate). Instead, it relies on demonstrating "substantial equivalence" through performance testing against predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pressure Measurement | Substantially equivalent to Stryker Intracompartmental Syndrome Pressure Monitor System. | "Statistically proven that the performance of the Twin Star CMS Monitor was substantially equivalent to the performance of the predicate devices." |
| Infusion Capabilities | Substantially equivalent to Stryker Intracompartmental Syndrome Pressure Monitor System (for maintaining catheter patency). | "Statistically proven that the performance of the Twin Star CMS Monitor was substantially equivalent to the performance of the predicate devices." |
| Vacuum Capabilities | Substantially equivalent to Medela Median Vacuum Pump. | "Statistically proven that the performance of the Twin Star CMS Monitor was substantially equivalent to the performance of the predicate devices." |
2. Sample Size and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Functional and performance testing."
3. Number of Experts and Qualifications:
The document does not mention the use of experts to establish ground truth or their qualifications. The performance testing described appears to be technical, comparing device against predicate devices, rather than clinical adjudication by experts.
4. Adjudication Method:
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of adjudication is typically used in studies involving human interpretation of data, which is not the primary focus of this technical comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's technical performance compared to predicate devices, not on how human readers improve with or without AI assistance. The device in question is a monitoring device, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance:
The study described is a standalone performance test in the sense that the device's technical functions (pressure, infusion, vacuum) were evaluated directly against those of predicate devices. There is no mention of human-in-the-loop performance in this context, as it's a hardware monitoring device.
7. Type of Ground Truth Used:
The ground truth used in this submission appears to be the performance of the legally marketed predicate devices. The Twin Star CMS Monitor's performance in terms of pressure measurement, infusion, and vacuum capabilities was compared directly to that of the Stryker and Medela predicate devices.
8. Sample Size for the Training Set:
The concept of a "training set" is relevant for machine learning or AI-driven devices. Since this submission describes a hardware monitoring device without explicit AI involvement, there is no mention of a training set or its sample size.
9. How Ground Truth for Training Set Was Established:
As there is no mention of a training set, this information is not applicable and not provided.
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Kobo963
JUN -6 2006
Twin Star Medical, Inc.
1000 Westgate Drive Suite 117 St. Paul. MN 55114 Tel: (612) 990-0631 Fax: (651) 209-0556
510(k) SUMMARY
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
March 28, 2006
| Date of Submission: | March 28, 2006 |
|---|---|
| Submitter:Address: | Twin Star Medical, Inc.1000 West Gate Drive, Suite 117St. Paul, MN 55114 |
| Contact:Phone:Fax: | Chet Sievert651.246.8621651.209.0556 |
| Common Name of Device:Proprietary Device Name: | Pressure MonitorTwin Star Compartment Pressure Monitoring and FluidCollection Monitor (CMS Monitor) |
| Classification Name: | Monitor, Pressure, Intracompartment |
| Predicate Devices: | Stryker CorporationIntracompartmental Syndrome Pressure Monitor System(K844214) |
| Medela CorporationMedian Vacuum Pump (K983552) |
Description of the Device
The Twin Star Compartment Pressure Monitoring and Fluid Collection (CMS) Monitor displays and records pressure as measured by the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter). The Twin Star CMS Catheter has been previously cleared by 510k notification. The multi-task CSM Monitor consists of a single housing unit that incorporates a vacuum pump, an infusion pump and a pressure monitor with visual display and user interface. The CMS Monitor provides the necessary functions required by the CMS Catheter. In addition to monitoring pressure, the CMS Monitor provides a very low volume fluid infusion to maintain the CMS Catheter's pressure lumen patency and a vacuum to the second lumen for fluid collection; both infusion and vacuum are required for the functional operation of the CMS Catheter.
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Intended Use
The Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) is intended for the measurement and monitoring of intracompartmental pressures and the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The CMS Monitor is intended to be used in conjunction with the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter),
Comparison of Technical Characteristics
The Twin Star CMS Monitor is equivalent to the Stryker Intracompartmental Syndrome Pressure Monitor System in that it has the same indications for use, the same target patient population and the same technical characteristics including a fluid filled pressure measuring catheter, a pressure monitor and a method of fluid infusion to maintain catheter patency. The only significant difference between the Twin Star CMS Monitor and the Stryker predicate is fluid removal using a vacuum. A predicate device that provides a vacuum for fluid removal is the Median Vacuum Pump. The Medela predicate removes fluid via a vacuum pump with similar indications for use, similar patient populations and similar technical characteristics. The administration of therapy is essentially the same between the Twin Star CMS Monitor and the predicates.
Performance Testing
Functional and performance testing was performed on the Twin Star CMS Monitor and its predicates. The results of measuring pressure, infusion and vacuum capabilities were compared. It was statistically proven that the performance of the Twin Star CMS Monitor was substantially equivalent to the performance of the predicate devices.
Conclusion/Substantial Equivalence
The Twin Star CMS Monitor has the same intended use compared to the Stryker predicate i.e., for monitoring intracompartment pressure as an aid in the diagnosis of compartment syndrome. Both the proposed monitors utilize utilize fluid infusion as a method of maintaining catheter patency to insure measurement accuracy. Performance testing has demonstrated equivalent results. The CMS Monitor provides a vacuum capability that the Stryker predicate does not. The CMS Monitor has a substantially equivalent intended use compared to the Medela predicate i.e., for vacuum pump removal of bodily fluids from wounds at the patient's bedside. Performance testing has demonstrated equivalent results.
Therefore, by claiming similar intended uses, similar patient populations and by demonstration of equal performance it is concluded that the CMS Monitor is substantially equivalent to the identified predicates.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, yet recognizable, representing the department's role in promoting the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2006
Twin Star Medical, Inc. % Mr. Chet Sievert Regulatory Affairs 1000 Westgate Drive, Suite 117 St. Paul, Minnesota 55114
Re: K060963
Trade/Device Name: Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor)
Regulatory Class: Unclassified Product Code: LXC Dated: March 29, 2006 Received: April 7, 2006
Dear Mr. Sievert:
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 such 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); 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. Chet Sievert
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4.
INDICATIONS FOR USE
K060963 510(k) Number: Not known
Device Name: Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor)
Indications for Use:
The Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Moritor) is intended for the measurement and monitoring of intracomparimental nressures and the withdrawal of fluid for subsequent analysis. The measured probarto and the mo me used as an aid in the diagnosis of compartment syndrome. The CMS Monitor is intended to be used in conjunction with the Twin Star Syndrome: The Only Monitoring and Fluid Collection Catheter (CMS Catheter).
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sion Sion-Off
vision of General, Restorative, d Neurological Devices
KO60963 6 : ((k) Number___
YES Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use NO AND/OR (21 CFR 801 Subpart C)
4
N/A