(34 days)
Not Found
No
The device description and performance studies focus on mechanical function and sealing capabilities, with no mention of AI or ML.
Yes
The device is described as a "trauma clamp device for the temporary control of severe bleeding" and its function is to "control critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair," indicating a direct medical intervention for a health condition.
No.
The iTClamp50 is a medical device designed for temporary control of severe bleeding by physically sealing the skin and creating a hematoma for clot formation. Its function is interventional, not diagnostic, as it does not analyze or interpret physiological data to identify a condition or disease.
No
The device description clearly outlines a physical clamp with mechanical components (suture needles, locking mechanism, etc.) and the performance studies focus on physical properties and functionality of the hardware. There is no mention of software as a component or function of the device.
Based on the provided information, the iTClamp®50 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The iTClamp®50 is a physical device used externally on the body to control bleeding. Its function is mechanical and involves sealing skin edges and applying pressure, not analyzing biological samples.
The description clearly states its purpose is for "temporary control of severe bleeding" by "closing the skin to create a temporary, contained hematoma." This is a direct intervention on the body, not an in vitro test.
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 iTClamp50 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 iTClamp50 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 iTClamp50 consists of the following components:
-
- Suture needles
-
- Tray w/Tyvek lid
-
- 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)
Design verification and validation testing has demonstrated that the device meets predefined acceptance criteria and is substantially equivalent to the previously cleared device. This testing was conducted to verify suitability of the design characteristics of the device and provide evidence that the final design of the product meets previously established and cleared finished product specifications. The design verification and validation activities consisted of the following:
-
- Leakage Test- to verify that the device can create a liquid tight seal.
-
- Minimum Holding Torque to verify that the force applied to the device during function does not deform the needles or damage the pressure bars.
-
- Needle Pullout Force Test to verify that the needle pullout force of the device is within specification
-
- Maximum Arming Force Test to verify that the force required to arm the device is within specification
-
- Maximum Closing Force Test to verify that the force required to close the device is within specification
-
- Button Disengaging Force Test to verify that the force required to release the device is within specification
-
- Operational Environmental Tests to verify the function of the device within specified environments.
-
- Usability Tests to verify the technological modifications did not affect enduser usability of the device.
-
- Package Testing to verify that the updated packaging met specifications for sterility.
Based on the design verification and validation test results, the iTClamp50, is substantially equivalent to the iTClamp50 classified under 870.4450.
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
§ 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2015
Innovative Trauma Care, Inc. Ian Atkinson Chief Technology Officer 3463 Magic Dr., Suite 120 San Antonio, TX 78229
Re: K150813
Trade/Device Name: iTClamp50 Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: March 25, 2015 Received: March 31, 2015
Dear Ian Atkinson:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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
2
Indications for Use
510(k) Number (if known) K150813
Device Name iTClamp®50
Indications for Use (Describe)
The iTClamp®50 is a trauma clamp device for the temporary control of severe bleeding in the extremittes, axilla, inguinal areas, scalp, and neck.
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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3
Special 510(k): Device Modification Innovative Trauma Care, Inc. iTClamp®50
510(k) Summary 6.0
In accordance with 21 CFR 807.92 the 510(k) Summary for the iTClamp50 is provided below.
| Device Common Name: | Vascular Clamp |
|---|---|
| Device Proprietary Name: | iTClamp50 |
| Submitter: | Innovative Trauma Care, Inc. |
| 3463 Magic Dr., Suite 120 | |
| San Antonio, TX 78229 | |
| Contact: | Ian Atkinson, Chief Technology Officer |
| Office: 780-638-2485 | |
| Cell: 403-999-2462 | |
| Fax: 587-523-3958 | |
| Email: iatkinson@itraumacare.com | |
| Date Prepared: | March 25, 2015 |
| Classification | |
| Regulation: | 870.4450 |
| Panel: | Cardiovascular |
| Product Code: | DXC |
| Predicate Device | K140805 – iTClamp50, 510(k) Clearance October 9, 2014 |
Indication 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.
Device Description
The iTClamp50 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.
4
Special 510(k): Device Modification Innovative Trauma Care, Inc. iTClamp®50
The iTClamp50 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 iTClamp50 consists of the following components:
-
- Suture needles
-
- Tray w/Tyvek lid
-
- Locking mechanism
-
- Lock release mechanism
Substantial Equivalence
The modified iTClamp50 has the following similarities to the previous version of the iTClamp (predicate), which have previously received 510(k) concurrence (K140805):
- Have the same indicated use
- . Have the identical shelf life of 4 years
- Use the same operating principle and fundamental scientific technology
- Incorporate the same basic design
- Have the same materials making point of contact with user and patient
Like the predicate device, the iTClamp50 is intended to control bleeding through the application of pressure to compressible areas (where application of direct pressure will control bleeding) in the scalp, extremities, and all junctional areas (inguinal areas, axilla and neck). It is not intended for internal bleeding into the chest or abdomen. The updated iTClamp50 is the same device that was previously cleared in K140805 in that it provides temporary bleeding control to wounds in the scalp, extremities, and all junctional areas (inguinal areas, axilla and neck) until medical and/or surgical repair can be obtained. The iTClamp50 (also the predicate) applies pressure to the severely bleeding wound by sealing off the everted skin surrounding the wound by direct external contact with the plastic pressure bar, which leads to pressure on the cut edges of the skin, allowing blood to pool under pressure and eventually resulting in clot formation.
The modified iTClamp50 has the following technological modifications compared to the predicate:
-
- Mechanical change to the one-way locking mechanism
-
- Material change to the one-way locking mechanism (non-patient contacting)
-
- Mechanical change to the lock release mechanism
5
Special 510(k): Device Modification Innovative Trauma Care, Inc. iTClamp®50
-
- Modifications to the opposing arms for improved grip
-
- Updated packaging from a polypropylene calm shell to a polypropylene tray with a tyvek lid.
The modified iTClamp raises no new or different types of effectiveness or safety questions. There is no change to the fundamental scientific principles of the technology. Design verification and validation testing has demonstrated that the device meets predefined acceptance criteria and is substantially equivalent to the previously cleared device. This testing was conducted to verify suitability of the design characteristics of the device and provide evidence that the final design of the product meets previously established and cleared finished product specifications. The design verification and validation activities consisted of the following:
-
- Leakage Test- to verify that the device can create a liquid tight seal.
-
- Minimum Holding Torque to verify that the force applied to the device during function does not deform the needles or damage the pressure bars.
-
- Needle Pullout Force Test to verify that the needle pullout force of the device is within specification
-
- Maximum Arming Force Test to verify that the force required to arm the device is within specification
-
- Maximum Closing Force Test to verify that the force required to close the device is within specification
-
- Button Disengaging Force Test to verify that the force required to release the device is within specification
-
- Operational Environmental Tests to verify the function of the device within specified environments.
-
- Usability Tests to verify the technological modifications did not affect enduser usability of the device.
-
- Package Testing to verify that the updated packaging met specifications for sterility.
Based on the design verification and validation test results, the iTClamp50, is substantially equivalent to the iTClamp50 classified under 870.4450.
A comparison of the new technologically modified iTClamp50 to the previous version of the iTClamp (predicate) is provided below.
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | TBD | K140805 |
| Classification / Procode | 870.4450 / DXC | 870.4450 / DXC |
| Subject Device | Predicate Device | |
| Device Name | iTClamp50 | iTClamp50 |
| Manufacturer | Innovative Trauma Care, | |
| Inc. | Innovative Trauma Care, | |
| Inc. | ||
| Indication for Use | same | The iTClamp50 is a trauma |
| clamp device for the | ||
| temporary control of severe | ||
| bleeding in the extremities, | ||
| axilla, inguinal areas scalp | ||
| and neck. | ||
| Device Design | same | iTClamp50 is a self-locking |
| surgical clamp with suture | ||
| needles that penetrate the | ||
| skin to evert the skin edges | ||
| 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 | ||
| or wound closure as desired. | ||
| Device Operation/ | ||
| Fundamental Scientific | ||
| Principle | same | Application of pressure by |
| applying clamp to | ||
| temporarily seal wound site | ||
| One-way locking | ||
| mechanism | One-way double-row | |
| ratchet | One-way clutch | |
| Packaging | Polypropylene tray with | |
| Tyvek lid | Polypropylene clam shell | |
| Arm | Inner and outer arm are | |
| textured, introduction of | ||
| thumbhole, increased | ||
| surface area to improve grip | Arm contains texturized | |
| gripping bar | ||
| Subject Device | Predicate Device | |
| Picture | Image: A clear plastic medical device with a red circular component in the center. | Image: A clear plastic medical device with two metal cylinders. |
6
Special 510(k): Device Modification Innovative Trauma Care, Inc.
7