(33 days)
The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
The provided text, a 510(k) summary for the IFS Subtalar Implant, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics for the device itself. Therefore, detailed information required by your request about acceptance criteria, study design, expert involvement, and ground truth establishment is not available in the provided document.
Here's a breakdown of what can and cannot be extracted from the text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Available. This document describes the device's design, material, and intended use, and compares it to predicate devices. It does not contain a table of performance metrics (e.g., accuracy, sensitivity, specificity) against predefined acceptance criteria for the device itself. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence, not to statistical performance of an AI or diagnostic device.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable/Not Available. The provided document is a 510(k) submission for a medical implant (bone fixation fastener), not a study evaluating an AI or diagnostic device. There is no "test set" in the context of evaluating an AI's performance. The review focuses on the device's design, materials, and intended use as compared to existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable/Not Available. Same as above, there is no "test set" or "ground truth" establishment in the context of typical AI/diagnostic device evaluation. The "experts" involved are likely the FDA reviewers assessing the 510(k) submission and the engineers/clinical staff from Internal Fixation Systems, Inc. who designed, developed, and documented the device.
4. Adjudication Method for the Test Set:
- Not Applicable/Not Available. No test set as described for an AI/diagnostic device.
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/Not Available. This is a hardware implant, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Available. This is not an algorithm.
7. The Type of Ground Truth Used:
- Not Applicable/Not Available. No ground truth in the context of an AI/diagnostic device evaluation. The "ground truth" for this device would be its physical properties, biocompatibility, and mechanical performance, which are assessed through engineering tests and material analysis (though details are not in this summary).
8. The Sample Size for the Training Set:
- Not Applicable/Not Available. This is a physical implant, not an AI model. There is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable/Not Available. No training set.
Summary based on the provided document:
The IFS Subtalar Implant's acceptance criteria for market clearance (510(k)) were based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically:
The study proving this involved a comparison of technological characteristics, focusing on:
- Design: Similar overall diameters and lengths.
- Function: Intended to treat hyperpronated foot, stabilize the subtalar joint, and block excessive pronation, acting as a spacer.
- Material: Made of Ti 6Al-4V ELI, which is a common material for such implants and likely comparable to the predicates.
- Intended Use: Identical or very similar to the predicate devices (treating hyperpronated foot and stabilizing the subtalar joint).
The document explicitly states: "The IFS Subtalar Implant is substantially equivalent to the predicate devices with respect to the design, function, and material. The implants have the same overall diameters, lengths, and material composition. ... There are no significant differences between the subtalar implant and the other implants as listed in the Substantially Equivalent Devices. The IFS Subtalar Implant and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent."
This is a regulatory pathway for medical devices that are similar in technology and intended use to devices already on the market, meaning a full clinical trial demonstrating novel safety or effectiveness might not be required. The "study" in this context is the detailed comparison and justification provided in the 510(k) submission to the FDA.
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Image /page/0/Picture/0 description: The image shows the logo for Internal Fixation Systems (IFS). The logo consists of a circular graphic on the left and the letters "IFS" on the right. Below the logo, the words "Internal Fixation Systems" are written out in a smaller font. The graphic appears to be a stylized representation of bones or some other medical device.
KII3399
12
DEC 2 0 2011
Internal Fixation Systems, Inc. 510(k) Summary
| Company Name: | Internal Fixation Systems, Inc. 10100 N.W. 116th Way, Suite 18 Miami, Florida 33178 |
|---|---|
| Contact Name: | Christopher Endara 10100 N.W. 116th Way, Suite 18 Miami, Florida 33178 (305) 884-5993 |
| Trade Name: | IFS Subtalar Implant |
| Common Name: | Bone Fixation Fasteners |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Regulatory Class: | II |
| Device Product Code: | HWC |
| Substantially Equivalent Devices: | Nexa Subtalar Arthrorisis Implant (K032902) Osteomed Subtalar Implant System (K031155) |
| Device Description: | The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation. |
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Image /page/1/Picture/0 description: The image shows the logo for Internal Fixation Systems (IFS). The logo consists of a circle with a design inside, followed by the letters "IFS" in a bold, sans-serif font. Below the logo, the words "Internal Fixation Systems" are written in a smaller font.
- The IFS Subtalar Implant is intended to treat hyperpronated Intended Use: foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
- Technological The IFS Subtalar Implant is substantially equivalent to the Characteristics predicate devices with respect to the design, function, and Comparison: material. The implants have the same overall diameters, lengths, and material composition.
- Sterilization IFS Subtalar Implant will be distributed non-sterile. The devices are sterilized by the end user per the AAMI Guidelines Information: "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 10-6.
- Conclusion: There are no significant differences between the subtalar implant and the other implants as listed in the Substantially Equivalent Devices. The IFS Subtalar Implant and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent.
ally
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Internal Fixation Systems, Inc. % Mr. Christopher Endara 10100 N.W. 116th Way, Suite 18 Miami, Florida 33178
DEC 2 0 2011
Re: K113399 Trade/Device Name: IFS Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 7, 2011 Received: November 17, 2011
Dear Mr. Endara:
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 (reporting of medical
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Page 2 - Mr. Christopher Endara
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,
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): 长川33 ዓ
Device Name: IFS Subtalar Implant
Indications for Use: The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark Melfeeson
(Division Sig. Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
10113399 510(k) Number
§ 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.