(191 days)
Not Found
No
The device description and performance studies focus on a mechanical clamp for controlling bleeding and do not mention any computational or data-driven components.
Yes
The iTClamp50 is a medical device intended to provide temporary control of severe bleeding, which is a therapeutic action.
No
Explanation: The device is designed to control bleeding by closing the skin and creating a temporary hematoma, which is a therapeutic function, not a diagnostic one. It does not analyze or interpret physiological data for diagnosis.
No
The device description clearly outlines physical components (suture needles, plastic shell, locking mechanism, lock release mechanism) and its function is based on mechanical action (clamping, sealing skin, creating pressure). There is no mention of software being a component or integral to its function.
Based on the provided information, the iTClamp50 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to control severe bleeding in various anatomical locations. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a mechanical clamp that physically seals skin edges to create a hematoma and promote clotting. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information about a person's health. The iTClamp50 is used in vivo (inside or on the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.
Product codes
DXC
Device Description
The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.
The iTClamp controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.
The device is provided sterile and is for single use.
The iTClamp consists of the following components:
-
- Suture needles
-
- Plastic shell
-
- Locking mechanism
-
- Lock release mechanism
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, axilla, inguinal areas, scalp, and neck
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)
Biocompatibility Testing: Additional Biocompatibility Testing is not necessary to support the modified indication for use. Physical composition of the product, sterilization and packaging has not changed in anyway; therefore, biocompatibility testing provided in the previous 510(k) (K132651) is applicable to support this 510(k).
Performance Testing - Bench: Additional bench performance testing is not necessary. The physical composition of the product, packaging and sterilization has not changed in any way. Therefore, the bench testing provided in the previous 510(k) (K132651) is applicable to this 510(k).
Innovative Trauma Care has performed cadaver testing to demonstrate substantial equivalence of the iTClamp™50 for the new proposed indication for use on neck wounds. In addition, a second cadaver study was generated which compared the performance of the iTClamp™50 and standard of care, i.e. tamponade by direct manual pressure and balloon catheter inflation in a wound. The results of the Cadaver Studies demonstrate that the device is suitable for use on the neck and is substantially equivalent to the previous 510(k) K132651.
A user assessment was performed utilizing 15 trained first responders (fire fighters) to ensure the Directions for Use (DFU) were appropriate to support the clearance of K132651. The assessment utilized a bleeding arm simulator model. The simulator model uses a pulsing pump motor to delivery pulses of simulated blood (water) through a wound in the arm with pressure of 80-90 mmHg. The environmental conditions they were exposed to were: Normal conditions, cold hands, non-dominant hand, and dominant hands, low light, strobe lights, in a shower and underwater using a skin pad, fatigued hand exhausted), with fire gloves on. These were completed using both wet hands (to simulate blood they were wetted with glycerol/water solution) and dry hands wearing vinyl exam gloves (except when wearing firefighting gloves and gear). The primary assessment was external leakage of water from the wound while the pump continued to run. Additionally, user needle sticks were evaluated. The outcome of the user assessment identified that the training based upon the DFU provided sufficient information for all participants to successfully apply and remove the device; the occurrence of needle stick was
§ 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 the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2014
Innovative Trauma Care, Inc. Richard Waite Sr. Director of Quality Assurance/ Regulatory Affairs 3463 Magic Dr., Suite 120 San Antonio, Texas 78229
Re: K140805
Trade/Device Name: iTClamp50 Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 15, 2014 Received: August 29, 2014
Dear Mr. Waite:
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/ResourcesforYou/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
2
Indications for Use
510(k) Number (if known) K140805
Device Name iTClamp50
Indications for Use (Describe)
The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Premarket Notification Innovative Trauma Care, Inc. iTClamp™50
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the iTClamp™50 is provided below.
| Device Common Name: | Vascular Clamp |
|---|---|
| Device Proprietary Name: | iTClamp™50 |
| Submitter: | Innovative Trauma Care, Inc. |
| 3463 Magic Dr., Suite 120 | |
| San Antonio, TX 78229 | |
| Contact: | Richard Waite |
| Sr. Director of Quality Assurance/ Regulatory Affairs, | |
| 3463 Magic Dr., Suite 120 | |
| San Antonio, TX 78229 | |
| Office: 210-582-5850 ext. 1932 | |
| FAX: 210-582-5851 | |
| Cell: 214-662-9277 | |
| rwaite@innovativetraumacare.com | |
| Date Prepared: | February 17, 2014 |
| Classification | |
| Regulation: | 870.4450 |
| Panel: | Cardiovascular |
| Product Code: | DXC |
| Predicate Device | K132651 - iTClamp™50 |
Indication for Use
The iTClamp™50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.
The purpose of this 510(k) is to modify the already cleared indication for use to include use of the device on severe bleeding areas of the neck.
Device Description
The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to
4
510(k) Premarket Notification Innovative Trauma Care, Inc. iTClamp™50
reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.
The iTClamp controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.
The device is provided sterile and is for single use.
The iTClamp consists of the following components:
-
- Suture needles
-
- Plastic shell
-
- Locking mechanism
-
- Lock release mechanism
Biocompatibility Testing
Additional Biocompatibility Testing is not necessary to support the modified indication for use. Physical composition of the product, sterilization and packaging has not changed in anyway; therefore, biocompatibility testing provided in the previous 510(k) (K132651) is applicable to support this 510(k).
Performance Testing - Bench
Additional bench performance testing is not necessary. The physical composition of the product, packaging and sterilization has not changed in any way. Therefore, the bench testing provided in the previous 510(k) (K132651) is applicable to this 510(k).
Innovative Trauma Care has performed cadaver testing to demonstrate substantial equivalence of the iTClamp50 for the new proposed indication for use on neck wounds. In addition, a second cadaver study was generated which compared the performance of the iTClamp50 and standard of care, i.e. tamponade by direct manual pressure and balloon catheter inflation in a wound. The results of the Cadaver Studies demonstrate that the device is suitable for use on the neck and is substantially equivalent to the previous 510(k) K132651.
A user assessment was performed utilizing 15 trained first responders (fire fighters) to ensure the Directions for Use (DFU) were appropriate to support the clearance of K132651. The assessment utilized a bleeding arm simulator model. The simulator model uses a pulsing pump motor to delivery pulses of simulated blood (water) through a wound in the arm with pressure of 80-90 mmHg. The environmental conditions they were exposed to were: Normal conditions, cold hands, non-dominant hand, and dominant hands, low light, strobe lights, in a shower and underwater using a skin pad, fatigued hand exhausted), with fire gloves
5
510(k) Premarket Notification Innovative Trauma Care, Inc. iTClamp™50
on. These were completed using both wet hands (to simulate blood they were wetted with glycerol/water solution) and dry hands wearing vinyl exam gloves (except when wearing firefighting gloves and gear). The primary assessment was external leakage of water from the wound while the pump continued to run. Additionally, user needle sticks were evaluated. The outcome of the user assessment identified that the training based upon the DFU provided sufficient information for all participants to successfully apply and remove the device; the occurrence of needle stick was