(24 days)
HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
The HyProCure II is an implant which stabilizes the talus on the tarsal mechanism. The system consists of an implant designed to be inserted into the sinus tarsi and corresponding instrumentation to facilitate insertion.
This document is a 510(k) summary for the HyProCure II device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment is not present in the provided text.
Here is an attempt to address the points based only on the provided text, with clear indications where the information is missing:
1. A table of acceptance criteria and the reported device performance
Based on the document, direct acceptance criteria and reported device performance in the context of a formal study with quantitative metrics are not provided. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. (from Intended Use) | The document focuses on demonstrating substantial equivalence to a predicate device (K042030 HyProCure Subtalar Implant System) based on:Similar sizesMaterial choicesConfigurationsIntended UseTechnological CharacteristicsNo specific performance data (e.g., in terms of degrees of motion, force resistance, or patient outcome scores) is provided in this summary. The conclusion states it is "safe and effective for its intended use" based on this comparison. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. The document explicitly states: "Non-clinical data was not necessary to show substantial equivalence." This implies a performance study (with a test set) comparing the device to performance criteria was not conducted for this 510(k) submission.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided, as no traditional test set requiring expert ground truth was mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided, as no traditional test set requiring expert adjudication was mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was mentioned. The device, HyProCure II, is a physical implant (sinus tarsi implant), not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided, as no traditional test set requiring ground truth was mentioned. The basis for safety and effectiveness is substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable/Not provided. The device is a physical implant and does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Graham Medical Technologies, L.L.C. dba GraMedica October 3, 2014 % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K142534
Trade/Device Name: HyProCure II (HYP II and HYP IIs) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 5, 2014 Received: September 9, 2014
Dear Dr. Linda Braddon:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Linda Braddon
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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name HyProCure II (HYP II and HYP IIs)
Indications for Use (Describe)
HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the GraMedica HyProCure II is provided below.
| Date Summary Prepared | September 5, 2014 |
|---|---|
| Manufacturer/ Distributor/ 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 | HyProCure II (HYP II and HYP IIs) |
| Common Name | Sinus Tarsi Implant |
| Code -Classification | HWC 21 CFR 888.3040 : Class II |
| Predicate Devices | K042030 HyProCure Subtalar Implant System |
| Device Description | The HyProCure II is an implant which stabilizes the talus on the tarsalmechanism. The system consists of an implant designed to be inserted intothe sinus tarsi and corresponding instrumentation to facilitate insertion. |
| Intended Use | HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in thetreatment of hyperpronating instability of the hindfoot. The implant isdesigned to stabilize the talus to prevent excessive anterior, and/or medial,and/or plantarflexion of the talus, while allowing normal talotarsal jointmotion. |
| Technological Characteristics | HyProCure II is of similar sizes, material choices and configurations ascompared to the predicate. |
| Non-Clinical PerformanceTesting Conclusion | Non-clinical data was not necessary to show substantial equivalence |
| Substantial EquivalenceSummary (Conclusion) | Based on the indications for use, technological characteristics, andcomparison to predicate devices, the HyProCure II system has been shownto be substantially equivalent to legally marketed predicate devices, and safeand 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.