(24 days)
Not Found
No
The summary describes a physical implant and surgical instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used in the treatment of a medical condition (hyperpronating instability of the hindfoot) and is designed to stabilize the talus to prevent excessive motion, which indicates a therapeutic purpose.
No
Explanation: The device is described as an "implant stabilization device" used for treatment, indicating a therapeutic rather than diagnostic function. It is designed to stabilize the talus and prevent excessive motion.
No
The device description explicitly states it is an "implant" and includes "corresponding instrumentation to facilitate insertion," indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "implant stabilization device used in the treatment of hyperpronating instability of the hindfoot." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description confirms it is an "implant which stabilizes the talus on the tarsal mechanism," designed for insertion into the sinus tarsi. This is a physical device implanted into a patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or diagnostic testing.
Therefore, the HyProCure II is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot, talus, tarsal mechanism, sinus tarsi
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Non-clinical data was not necessary to show substantial equivalence
Key Metrics
Not Found
Predicate Device(s)
K042030 HyProCure Subtalar Implant System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, overlapping each other to create a sense of depth and unity.
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
1
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
2
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)
3
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 | 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 | 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 tarsal |
| mechanism. The system consists of an implant designed to be inserted into | |
| the sinus tarsi and corresponding instrumentation to facilitate insertion. | |
| Intended Use | 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 medial, | |
| and/or plantarflexion of the talus, while allowing normal talotarsal joint | |
| motion. | |
| Technological Characteristics | HyProCure II is of similar sizes, material choices and configurations as |
| compared to the predicate. | |
| Non-Clinical Performance | |
| Testing Conclusion | Non-clinical data was not necessary to show substantial equivalence |
| Substantial Equivalence | |
| Summary (Conclusion) | Based on the indications for use, technological characteristics, and |
| comparison to predicate devices, the HyProCure II system has been shown | |
| to be substantially equivalent to legally marketed predicate devices, and safe | |
| and effective for its intended use. |