(268 days)
No
The summary describes a mechanical implant for toe reconstruction and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe, which are therapeutic interventions.
No
Explanation: The device is indicated for reconstruction of lesser toes following correctional procedures, which means it is a treatment device, not a diagnostic one. It is used to assemble components for toe reconstruction, not to identify or detect a disease or condition.
No
The device description clearly states it is comprised of "two mated components (proximal and middle phalangeal)" which are physical implants, not software. The performance studies also focus on mechanical properties and cadaveric use, further indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- GraMedica opti-Toe Function: The description clearly states that the GraMedica opti-Toe Device is an implant used for the reconstruction of lesser toes following surgical procedures. It is a physical device that is surgically placed within the body.
The information provided about the device's intended use, description, performance studies, and predicate devices all point to it being a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The GraMedica opti-Toe is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. The implants are offered in two sizes, small and large, and the middle phalangeal component is offered with and without a 10 degree angulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes
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)
The GraMedica opti-Toe was tested for clinical ease of use via:
• Cadaveric Simulated Use Study
• Assembly force
• Disassembly force
Additionally, mechanical performance was evaluated via:
• Static and dynamic bending
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.
K122031 NextraTM Ti Hammertoe Correction System, K142490 ProxiFuse Hammer Toe Device
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.
K990804 StayFuse, K960385 DePuy K-Wire
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2015
Graham Medical Technologies, LLC (d.b.a.GraMedica) % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K142478
Trade/Device Name: opti-Toe Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 27, 2015 Received: April 28, 2015
Dear Dr. Braddon:
This letter corrects our substantially equivalent letter of May 29, 2015.
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
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Page 2 - Linda Braddon, Ph.D.
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142478
Device Name opti-Toe
Indications for Use (Describe)
The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × 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 GraMedica opti-Toe is provided below.
| Date | 5/22/2015 |
|---|---|
| Sponsor | GraMedica |
| 16137 Leone Drive | |
| Macomb, MI 48042 | |
| 586-677-9600 (office) | |
| 586-677-9615 (fax) | |
| ARecchia@GraMedica.com (email) | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 (direct) | |
| 855-MED-DEV1 (office) | |
| LGB@SecureBME.com | |
| Trade Name | opti-Toe |
| Common Name | Pin, fixation, smooth |
| Code—Classification | HTY 21 CFR 888.3040 : Class II |
| Predicate Devices | K122031 NextraTM Ti Hammertoe Correction System |
| K142490 ProxiFuse Hammer Toe Device | |
| Reference Devices | K990804 StayFuse |
| K960385 DePuy K-Wire | |
| Device Description | The GraMedica opti-Toe is comprised of two mated components (proximal |
| and middle phalangeal) which join together to form a single intramedullary | |
| fixation unit. The implants are offered in two sizes, small and large, and the | |
| middle phalangeal component is offered with and without a 10 degree | |
| angulation. | |
| Intended Use | The GraMedica opti-Toe Device is indicated for reconstruction of the lesser |
| toes following correction procedures for hammertoe, claw toe, and mallet | |
| toe. The GraMedica opti-Toe components are to be cemented in place and | |
| assembled for reconstruction of the toe. Patients should protect their | |
| weight-bearing or heel weight-bearing only until soft tissue healing has | |
| occurred. | |
| Technological | |
| Characteristics | The GraMedica opti-Toe is of similar sizes, material choices and |
| configurations as compared to the predicate. The GraMedica opti-Toe is to | |
| be cemented. | |
| Non-Clinical | |
| Performance Testing | |
| Conclusion | The GraMedica opti-Toe was tested for clinical ease of use via: |
| • Cadaveric Simulated Use Study | |
| • Assembly force | |
| • Disassembly force |
Additionally, mechanical performance was evaluated via:
• Static and dynamic bending |
| Substantial
Equivalence Summary | Based on the indications for use, technological characteristics, and
comparison to predicate devices, the GraMedica opti-Toe is shown to be |
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| (Conclusion) | substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use. |
|---|---|
| -------------- | -------------------------------------------------------------------------------------------------------------- |