(53 days)
The NuGait™ Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System is intended for the following pathological conditions resulting from disease, injury, or other trauma: • Hypermobile pes valgus; • Posterior tibial • tendon dysfunction; • Severe pronation; • Subtalar instability; • Hypermobile flexible congenital flat foot.
The NuGait Subtalar Implant System consists of a one-piece arthroereisis implant designed to stabilize the subtalar joint of the hyperpronated foot and associated instrumentation. The NuGait implant is constructed of Ti-6Al-4V ELI titanium alloy and is offered in 5 sizes to fit a range of anatomies. The subject device is also cannulated to allow precise insertion when used with a guide wire and system instrumentation. The outer surface of the implant features a helical thread to aid fixation within the sinus tarsi. Each NuGait is packaged individually and sterilized via gamma radiation. These devices are intended for single use only.
This document is a 510(k) premarket notification for a medical device (NuGait™ Subtalar Implant System) and, as such, outlines the basis for substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the typical sense of a clinical trial for a new drug or novel medical device.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from the given document. This document focuses on demonstrating that the new device is as safe and effective as an already legally marketed device through technological characteristics and non-clinical data.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:
1. Table of acceptance criteria and the reported device performance
The document does not present a table of quantitative acceptance criteria for device performance in the way one might expect for a diagnostic or efficacy study. Instead, the basis for approval is "substantial equivalence" to a predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Intended Use Equivalence: The device's intended use should be the same as the predicate device. | The NuGait Subtalar Implant System has the same intended use as the predicate device (Sub-Talar Lok™ Arthroereisis Implant System; K080280). Both restrict excessive subtalar pronation for specified pathological conditions. |
| Technological Characteristics Equivalence: The device should have similar technological characteristics to the predicate device, or differences should not raise new issues of safety or effectiveness. | The NuGait Subtalar Implant System has same technological characteristics as the predicate device. It is also manufactured from equivalent materials and designed to stabilize the subtalar joint of the hyperpronated foot. |
| Material Equivalence: Materials used should be equivalent. | Manufactured from equivalent materials (Ti-6Al-4V ELI titanium alloy) to the predicate device. |
| Performance Safety (Non-Clinical): Adequate non-clinical data to support substantial equivalence. | Bending Strength Evaluation was performed. The document states, "These points and engineering analysis form the basis for substantial equivalence, and the differences between the subject device and predicate do not raise new issues of safety or effectiveness." |
| Clinical Performance: No new clinical performance data needed if substantial equivalence is demonstrated through non-clinical data and technological/material equivalence. | "Clinical performance data were not needed for this device." |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set data was used or required for this 510(k). The evaluation relied on non-clinical (engineering/bench) testing and comparison to a predicate device.
- Data Provenance: Not applicable for a clinical test set. The non-clinical data would have been generated internally by Ascension Orthopedics, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical test set requiring expert-established ground truth.
4. Adjudication method for the test set
- Not applicable. No clinical test set was used.
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
- Not applicable. This device is a subtalar implant, not an AI-assisted diagnostic tool or system designed for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate device (Sub-Talar Lok™ Arthroereisis Implant System) and the demonstration that the NuGait™ device has comparable intended use, technological characteristics, and material properties, supported by non-clinical bench testing (e.g., bending strength).
8. The sample size for the training set
- Not applicable. This device is a physical implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical implant, not a machine learning model.
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ascension orthopedics, inc .8700 Cameron Road, Suite 100 AUSTIN, TEXAS 78754
Summary of Safety and Effectiveness
Summary of Safety and Effectiveness
| Sponsor: | Ascension Orthopedics, Inc.8700 Cameron Road, Suite 100Austin, TX 78754-3832AUG 19 2011 |
|---|---|
| Contact Person: | Bradley W. StrasserRegulatory Affairs Specialist512-836-5001 ext. 1541 |
| Date: | 24 June 2011 |
| Trade Name: | NuGait ™ Subtalar Implant System |
| Common Name: | Subtalar Arthroereisis Implant |
| Product Code: | HWC - Screw, Fixation, Bone |
| Classification: | 21 CFR §888.3040 - Smooth or threaded metallic bone fixation fastener. |
| Panel: | Orthopedic |
| Predicate Device: | Sub-Talar Lok ™ Arthroereisis Implant System; K080280, cleared 14 March 2008; manufactured by Instratek, Inc. |
| Device Description: | The NuGait Subtalar Implant System consists of a one-piece arthroereisis implant designed to stabilize the subtalar joint of the hyperpronated foot and associated instrumentation. The NuGait implant is constructed of Ti-6Al-4V ELI titanium alloy and is offered in 5 sizes to fit a range of anatomies. The subject device is also cannulated to allow precise insertion when used with a guide wire and system instrumentation. The outer surface of the implant features a helical thread to aid fixation within the sinus tarsi. Each NuGait is packaged individually and sterilized via gamma radiation. These devices are intended for single use only. |
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Intended Use: The NuGait Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System is intended for the following pathological conditions resulting from disease, injury, or other trauma: • Hypermobile pes valgus; • Posterior tibial • tendon dysfunction; • Severe pronation; • Subtalar instability; • Hypermobile flexible congenital flat foot. Basis of Substantial Equivalence: The NuGait Subtalar Implant System has the same technological characteristics and intended use as the predicate device. The subject device is also manufactured from equivalent materials. These points and engineering analysis form the basis for substantial equivalence, and the differences between the subject device and predicate do not raise new issues of safety or effectiveness. Non-Clinical Performance Data: In order to support substantial equivalence, the following non-clinical performance data was gathered: . Bending Strength Evaluation Clinical Performance Data: Clinical performance data were not needed for this
device.
Confidential Pane 15 of 87
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ascension Orthopedies, Inc. % Mr. Bradley W. Strasser 8700 Cameron Road, Suite 100 Austin, TX 78754-3832
AUG 1 9 2011
Re: K111799
Trade/Device Name: NuGaif™ Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 24th, 2011 Received: June 27th, 2011
Dear Mr. Strasser,
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.
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Page 2 - Mr. Bradley W. Strasser
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Eric P. Kettl
مرحم Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 111799
Device Name:
NuGait™ Subtalar Implant System
Indications for Use:
The NuGait™ Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System is intended for the following pathological conditions resulting from disease, injury, or other trauma:
- Hypermobile pes valgus; .
- . Posterior tibial tendon dysfunction;
- Severe pronation;
- . Subtalar instability;
- . Hypermobile flexible congenital flat foot.
The NuGait Subtalar Implant System implants are intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (ODE)
for M. Melkerm
(Division Sigh Off) Division of Surgical, Orthopedic, and Restorative Devices
10(k) Number K111799
Confidential Pane 13 of 87
§ 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.