(217 days)
Not Found
No
The summary describes a mechanical device for controlling bleeding and does not mention any AI or ML components or functionalities.
Yes
The device is intended to control difficult bleeds, which is a therapeutic intervention aimed at treating injuries.
No
The device is designed to control bleeding, which is a therapeutic function, not a diagnostic one. It is used to treat a condition (difficult bleeds) rather than to identify or characterize it.
No
The device description clearly describes a physical device ("The CRoC™ is designed to be used by emergency medical personnel... The device is designed to control bleeding..."). The performance studies also involve testing with a cadaver model, indicating a physical interaction.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The CRoC™ is described as a device used to control bleeding in specific anatomical areas (inguinal, axilla, carotid artery) on the battlefield. It is a physical device applied externally to the body to exert pressure and stop blood flow.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely mechanical and external.
Therefore, the CRoC™ falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CRoC™ is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The CRoCTM is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The CRoC™ is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal and axilla areas, carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
emergency 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To establish substantial equivalence the CRoC™ was tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure on neck area wounds.
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.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that suggests movement or flight. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Combat Medical Systems, LLC % Callev Herzog Biologics Consulting Group, Inc, 400 N Washington St., Suite 100 Alexandria, VA 22314
Re: K141685
Trade/Device Name: Combat Ready Clamp (CroC) Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: December 17, 2014 Received: December 18, 2014
Dear Calley 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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141685
Device Name Combat Ready Clamp (CRoCTM)
Indications for Use (Describe)
The CRoC™ is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the CroC™ is provided below.
| Device Common Name: | Vascular Clamp |
|---|---|
| Device Proprietary Name: | Combat Ready Clamp (CROCTM) |
| Submitter: | Combat Medical Systems, LLC |
| 5555 Harrisburg Industrial Park Drive | |
| Harrisburg, NC 28075 | |
| Contact: | Calley Herzog |
| Biologics Consulting Group, Inc. | |
| Consultant | |
| Email: cherzog@bcg-usa.com | |
| Phone: 720-883-3633 | |
| Date Prepared: | January 26, 2015 |
| Classification Regulation: | 21 CFR 870.4450, Class II, Vascular Clamp |
| Panel: | Cardiovascular |
| Product Code: | DXC |
| Predicate Device: | K130482, Combat Ready Clamp (CROCTM) |
Indication for Use:
The CRoC™ is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.
Device Description:
The CRoCTM is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The CRoC™ is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.
Performance Data:
To establish substantial equivalence the CRoC™ was tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure on neck area wounds.
Substantial Equivalence:
The subject device is the exact same device as that cleared in K130482. There have been no changes to the design or materials of the device. The additional indication for life threatening bleeds of the carotid artery does not alter the intended use. The safety concerns are the same as
4
those for other anatomical areas and the revised instructions for use address any additional concerns related to treating life threatening bleeding in the neck area. The technological characteristics are compared to the predicate device in Table 1.
| New Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K141685 | K130482 |
| Device Name | Combat Ready Clamp (CROCTM) | Combat Ready Clamp (CROCTM) |
| Manufacturer | Combat Medical Systems, LLC | Combat Medical Systems, LLC |
| Picture | Image: Combat Ready Clamp (CROCTM) | Image: Combat Ready Clamp (CROCTM) |
| Indication | The CROCTM is indicated for use in the | |
| battlefield to control difficult bleeds in | ||
| the inguinal and axilla areas. The CROC | ||
| is also indicated for use as a last resort | ||
| for life threatening bleeds of the carotid | ||
| artery. | The Combat Ready Clamp (CROCTM) is | |
| indicated for use in the battlefield to control | ||
| difficult bleeds in the inguinal and axilla areas. | ||
| Dimensions | 8"x12 1/4"x9" (extended) | 8"x12 1/4"x9" (extended) |
| Weight | 1.25 lbs with disc attached | 1.25 lbs with disc attached |
Table 1: Device Comparison Table
Substantial Equivalence Summary
Based on technological characteristics and performance data the CRoC™ has been shown to be substantially equivalent to the predicate device, the Combat Ready Clamp as cleared in K130482.