(60 days)
Not Found
No
The summary describes a device that measures and monitors pressure, infuses fluid, and applies vacuum. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used to measure and monitor intracompartmental pressures to aid in the diagnosis of compartment syndrome, and to withdraw fluid for analysis. It does not directly treat a condition.
Yes
The device measures and monitors intracompartmental pressures, and these measurements can be used as an aid in the diagnosis of compartment syndrome.
No
The device description explicitly states the CMS 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," indicating it is a hardware device with integrated software.
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 and monitoring of intracompartmental pressures and the withdrawal of fluid for subsequent analysis. While the fluid is collected for analysis, the device itself is not performing the diagnostic test on the fluid. It's a tool for collecting the sample and monitoring pressure in vivo.
- Device Description: The device is described as a monitor with a vacuum pump, infusion pump, and pressure monitor. These are all functions related to in vivo measurement and fluid collection, not in vitro analysis of a sample.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any other components typically associated with in vitro diagnostic testing. The device is interacting directly with the patient's body (intracompartmental).
The fluid collection aspect is for subsequent analysis, implying that the diagnostic testing on the collected fluid would be performed using a separate IVD device or laboratory method. The Twin Star CMS Monitor is a tool to aid in the diagnosis by providing pressure measurements and a fluid sample, but it is not performing the diagnostic test itself.
N/A
Intended Use / Indications for 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).
Product codes
LXC
Device Description
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 117 | |
| St. Paul, MN 55114 | |
| Contact: | |
| Phone: | |
| Fax: | Chet Sievert |
| 651.246.8621 | |
| 651.209.0556 | |
| Common Name of Device: | |
| Proprietary Device Name: | Pressure Monitor |
| Twin Star Compartment Pressure Monitoring and Fluid | |
| Collection Monitor (CMS Monitor) | |
| Classification Name: | Monitor, Pressure, Intracompartment |
| Predicate Devices: | Stryker Corporation |
| Intracompartmental Syndrome Pressure Monitor System | |
| (K844214) | |
| Medela Corporation | |
| Median 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).
.m.ll
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)
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