(268 days)
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.
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.
The document provided is a 510(k) premarket notification from the FDA for a medical device called "opti-Toe". This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the information typically requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML devices is not present in this regulatory filing.
However, I can extract the non-clinical performance testing information that was conducted to support the substantial equivalence claim for the opti-Toe device.
Here's a summary of the non-clinical performance testing performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a numerical or categorical format for the non-clinical tests. Instead, the testing was performed to demonstrate the device's functional integrity and similarity to predicate devices. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Ease of Use | Successfully demonstrated via Cadaveric Simulated Use Study, Assembly Force, and Disassembly Force measurements. |
| Mechanical Performance | Successfully evaluated via Static and Dynamic Bending tests. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Cadaveric Simulated Use Study: The document does not specify the number of cadavers used.
- Assembly/Disassembly Force, Static/Dynamic Bending: The document does not specify the number of devices or iterations tested for these mechanical evaluations.
- Data Provenance: The testing was non-clinical (laboratory and cadaveric) and conducted for regulatory submission purposes. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. For non-clinical tests like mechanical and cadaveric studies, "ground truth" as it relates to expert consensus on clinical findings is not established. The "ground truth" for these tests would be the measured physical properties and observations of functionality.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are typically for clinical trials or expert label review, not for non-clinical mechanical or cadaveric testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC study is a type of clinical study generally used for diagnostic devices involving human readers evaluating medical images. This document describes a K-wire equivalent fixation device and its non-clinical testing, so an MRMC study was not conducted or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical implant (a toe fixation device), not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the non-clinical tests:
- Cadaveric Simulated Use Study: "Ground truth" was the observed functionality and ease of use in a cadaveric model.
- Mechanical Testing (Assembly/Disassembly Force, Static/Dynamic Bending): "Ground truth" was the objective measurements of force and bending properties according to established engineering standards or internal protocols, likely compared against predicate device performance or relevant industry standards for similar devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for an AI/ML device, this question is not relevant.
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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 | GraMedica16137 Leone DriveMacomb, MI 48042586-677-9600 (office)586-677-9615 (fax)ARecchia@GraMedica.com (email) |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681 (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 SystemK142490 ProxiFuse Hammer Toe Device |
| Reference Devices | K990804 StayFuseK960385 DePuy K-Wire |
| Device Description | The GraMedica opti-Toe is comprised of two mated components (proximaland middle phalangeal) which join together to form a single intramedullaryfixation unit. The implants are offered in two sizes, small and large, and themiddle phalangeal component is offered with and without a 10 degreeangulation. |
| Intended Use | The GraMedica opti-Toe Device is indicated for reconstruction of the lessertoes following correction procedures for hammertoe, claw toe, and mallettoe. The GraMedica opti-Toe components are to be cemented in place andassembled for reconstruction of the toe. Patients should protect theirweight-bearing or heel weight-bearing only until soft tissue healing hasoccurred. |
| TechnologicalCharacteristics | The GraMedica opti-Toe is of similar sizes, material choices andconfigurations as compared to the predicate. The GraMedica opti-Toe is tobe cemented. |
| Non-ClinicalPerformance TestingConclusion | The GraMedica opti-Toe was tested for clinical ease of use via:• Cadaveric Simulated Use Study• Assembly force• Disassembly forceAdditionally, mechanical performance was evaluated via:• Static and dynamic bending |
| SubstantialEquivalence Summary | Based on the indications for use, technological characteristics, andcomparison 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. |
|---|---|
| -------------- | -------------------------------------------------------------------------------------------------------------- |
§ 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.