(23 days)
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
The Combat Ready Clamp is designed to be used by Military medical personnel in the battlefield. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries or soldiers. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured soldier can be transferred to evacuation personnel for further treatment.
The Combat Ready Clamp is a vascular clamp designed for use in battlefield settings to control difficult bleeds in the inguinal area, where standard tourniquets cannot be used. It is intended to be used by military medical personnel for up to 4 hours until the injured soldier can be transferred for further treatment.
Here's an analysis of the acceptance criteria and study data provided in the FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics or thresholds. Instead, it describes performance in relation to functional demonstrations and equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to provide pressures equivalent to the predicate device | The Combat Ready Clamp was tested via bench testing to show that it could provide pressures equivalent to the predicate device (K002767 Compressar Femoral Access Compression Device). |
| Capability of stopping simulated vessel blood pressure | The Combat Ready Clamp was tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure. |
| Substantial equivalence to predicate device | Based on technological characteristics, the Combat Ready Clamp has been shown to be substantially equivalent to the predicate device, the Compressar Femoral Access Compression Device, for its indicated use (control difficult bleeds in the inguinal area where standard tourniquets cannot be used). |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the bench testing or the cadaver model testing. It simply states that the device "was tested."
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission, these would typically be prospective studies conducted in a controlled environment (e.g., a laboratory for bench testing, a medical facility/lab for cadaver studies).
3. Number and Qualifications of Experts for Ground Truth
- The document does not mention the use of experts to establish "ground truth" in the way it might for an AI/diagnostic device (e.g., radiologists interpreting images). The "ground truth" for this mechanical device's performance would be the direct results of the physical tests (pressure measurements in bench testing, successful control of simulated bleeding in cadaver models).
- No specific number or qualifications of experts are reported for establishing ground truth.
4. Adjudication Method
- Adjudication methods (like 2+1 or 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth for complex data (e.g., medical images). This is not applicable to the type of performance testing described for the Combat Ready Clamp (bench testing, cadaver model for mechanical function).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., AI-assisted image reading). The Combat Ready Clamp is a medical device for direct application, not a diagnostic tool where human readers assess its output.
6. Standalone Performance Study
- Yes, standalone performance testing was conducted. The bench testing and cadaver model testing described are examples of standalone performance evaluations, demonstrating the device's capabilities independent of human interaction (beyond the initial application and operation by personnel). These tests aim to show the algorithm (device's design and mechanism) works as intended.
7. Type of Ground Truth Used
- The ground truth used was direct physical measurement and functional demonstration.
- For bench testing: The ground truth was the measured pressure exerted by the clamp and its equivalence to the predicate device.
- For cadaver model testing: The ground truth was the observation of successful cessation of simulated vessel blood pressure.
8. Sample Size for the Training Set
- The concept of "training set" is not applicable here. The Combat Ready Clamp is a mechanical medical device, not an AI/machine learning algorithm that requires a training set of data. Its design and manufacturing processes are validated, not "trained" on data.
9. How Ground Truth for the Training Set Was Established
- As explained above, there is no "training set" for this type of device. The ground truth for its performance was established through physical testing and direct observation of its functional capabilities.
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5.0 510(k) Summary
AUG 1 1 2010
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Combat Ready Clamp is provided below.
| Device Common Name: | Vascular Clamp |
|---|---|
| Device Proprietary Name: | Combat Ready Clamp |
| Submitter: | Combat Medical Systems, LLC6441-D Yadkin RdFayettville, NC 28303 |
| Contact: | Calley HerzogConsultantBiologics Consulting Group, Inc.Phone: 720-883-3633Email: cherzog@bcg-usa.com |
| ClassificationRegulation: | 21 CFR 870.4450, Class II, 510(k) |
| Panel: | Cardiovascular |
| Product Code: | DXC |
| Predicates: | K002767 Compressar Femoral Access Compression Device |
Indication for Use:
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
Device Description:
The Combat Ready Clamp is designed to be used by Military medical personnel in the battlefield. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries or soldiers. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured soldier can be transferred to evacuation personnel for further treatment.
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Non-clinical Performance Testing:
The Combat Ready Clamp was testing via bench testing to show that it could provide pressures equivalent to the predicate device.
The Combat Ready Clamp was also tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure. ·
Substantial Equivalence:
Based on technological characteristics the Combat Ready Clamp has been shown to be substantially equivalent to the predicate device, the Compressar Femoral Access Compression Device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
AUG 1 1 2010
Combat Medical Systems, LLC c/o Biologics Consulting Group, Inc. Ms. Calley Herzog 13417 Quivas St. Westminster, CO 80234
Re: K102025
Trade/Device Name: Combat Ready Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: DXC Dated: July 16, 2010 Received: July 19, 2010
Dear Ms. Herzog:
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.
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Page 2 - Ms. Calley Herzog
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.
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/CDRHOffices/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/MedicalDevices/Safety/ReportaProblem/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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYour/Industry/default.htm.
Sincerely yours,
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use Statement
510(k) Number (if known): _K102025
AUG 1 1 2010
Device Name: Combat Ready Clamp
Indications For Use:
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
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)
Page 1 of 1
(Division Sign-Off) of Cardiovascular Devices 510(k) Number
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).