(23 days)
No
The description focuses on a mechanical device for applying pressure and does not mention any computational or data-driven components.
Yes
The device is used to control difficult bleeds in the inguinal area, which is a therapeutic intervention.
No
Explanation: The device is used to control bleeding, which is a therapeutic function, not a diagnostic one. It does not analyze patient data or provide information about a medical condition.
No
The device description clearly describes a physical clamp used to control bleeding, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Combat Ready Clamp is a mechanical device used directly on the body. Its purpose is to physically compress tissue to control bleeding. It does not analyze any biological samples.
The description clearly indicates that the device is used externally on the inguinal area to apply pressure and control bleeding. This falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
Product codes
DXC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Military medical personnel in the battlefield
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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, LLC |
| 6441-D Yadkin Rd | |
| Fayettville, NC 28303 | |
| Contact: | Calley Herzog |
| Consultant | |
| Biologics Consulting Group, Inc. | |
| Phone: 720-883-3633 | |
| Email: cherzog@bcg-usa.com | |
| Classification | |
| Regulation: | 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.
1
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.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
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.
3
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
4
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