(212 days)
The SIGN IM Nail System is indicated for tibiotalcaneal arthrodesis. Specific examples of indications include primary or post traumatic or previously infected arthrosis, failed ankle arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuromuscular deformity or instability of the ankle, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibia, malunited tibial pilon fracture, charcot foot, severe arthritis, severe defects after tumor resection, pantalar arthrodesis. IM Nail sizes recommended for these indications are 10-12mm diameter and 200-300mm in length.
The SIGN IM Nail System consists of multiple components; Standard IM Nail, Interlocking Screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided non-sterile.
This is a 510(k) premarket notification for the SIGN IM Nail System, an orthopedic intramedullary rod. The document discusses the device's indications for use, its comparison to predicate devices, and non-clinical performance data.
Here's an analysis of the provided text in relation to your request:
Key Takeaway: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily extensive clinical trials proving novel efficacy. The "performance data" mentioned refers to non-clinical testing. Therefore, many of your requested points related to human clinical studies, ground truth establishment, and MRMC studies will not be found in this type of submission.
Here is the information extracted and organized according to your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, specific numerical acceptance criteria (e.g., minimum tensile strength, fatigue cycles) for mechanical performance tests are not explicitly stated. The document broadly states that "The results of the performed tests support substantial equivalence to legally marketed predicate devices and did not raise any issues on the safety or effectiveness of the device."
The criteria are implicitly related to demonstrating equivalent mechanical performance to predicate devices under relevant ASTM standards or internal protocols.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate devices (e.g., Stryker T2 Ankle Arthrodesis Nail System (K051590)) | "Analysis of strength of the SIGN IM Nail System" performed. |
| No issues raised on safety or effectiveness. | "Results...did not raise any issues on the safety or effectiveness of the device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document refers to "non-clinical tests," which would typically involve a specific number of devices tested, but this number is not disclosed.
- Data Provenance: The tests are "non-clinical," meaning they were conducted in a lab environment. There is no mention of country of origin of data or whether it was retrospective or prospective, as these terms apply to clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This point is not applicable as the document discusses non-clinical mechanical testing, not a clinical study involving experts establishing ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This point is not applicable as the document discusses non-clinical mechanical testing, not a clinical study requiring adjudication of expert interpretations.
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
This point is not applicable. The device is an orthopedic intramedullary nail, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness was assessed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This point is not applicable. The device is a surgical implant, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, "ground truth" would correspond to established engineering standards, material properties, and biomechanical principles. For example, testing to ASTM F138 for Stainless Steel, or specific fatigue and load-bearing tests. The document indicates "analysis of strength" and implies comparison to predicate devices, suggesting that the "ground truth" is engineering performance data, not clinical outcomes or expert diagnoses.
8. The Sample Size for the Training Set
This point is not applicable as the device is a physical implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This point is not applicable as the device is a physical implant, not an AI model that requires a training set.
Summary of Study Type:
The study described is a non-clinical performance evaluation (mechanical testing) aimed at demonstrating substantial equivalence of the SIGN IM Nail System to existing predicate devices (specifically, the Stryker T2 Ankle Arthrodesis Nail System (K051590)). This type of study focuses on the device's physical and mechanical properties rather than clinical outcomes or diagnostic accuracy.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.
July 20, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sign Fracture Care International Robert Schmitt Regulatory Affairs/Ouality Assurance Manager 451 Hills Street, Suite B Richland, Washington 99354
Re: K163589
Trade/Device Name: Sign IM Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, KTT Dated: June 29, 2017 Received: July 7, 2017
Dear Robert Schmitt:
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 devicerelated 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.
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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" (21 CFR 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,
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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name SIGN IM Nail System
Indications for Use (Describe)
The SIGN IM Nail System is indicated for tibiotalocalcaneal arthrodesis. Specific examples of indications include primary or post traumatic or previously infected arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuromuscular deformity or instability of the ankle, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibial pilon fracture, charcot foot, severe arthritis, severe defects after tumor resection, pantalar arthrodesis. IM Nail sizes recommended for these indications are 10-12mm diameter and 200-300mm in length.
| 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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Image /page/3/Picture/0 description: The image contains a logo for SIGN Fracture Care International. On the left side of the logo is a green rectangle with rounded corners. Inside the rectangle is a white silhouette of a person running. To the right of the rectangle is the word "SIGN" in bold, black letters. Below the word "SIGN" are the words "FRACTURE CARE INTERNATIONAL" in smaller, gray letters.
510(k) Summary
| 510(k) Submitter: | SIGN Fracture Care International451 Hills Street, Suite BRichland, WA 99354 |
|---|---|
| Establishment #: | 3034525 |
| Contact Person: | Robert Schmitt, Regulatory Affairs / Quality Assurance ManagerPhone: 509-371-1107Fax: 509-371-1316E-Mail: Bob.Schmitt@signfracturecare.org |
| Date Prepared: | July 12, 2016 |
| Regulatory Class: | Class II |
| Panel: | Orthopedic |
| Trade Name: | SIGN IM Nail System |
| Common Name: | Orthopedic Intramedullary Rod |
| Classification Name: | 21CFR 888.3030: Rod, fixation, intramedullary and accessories |
| Device Product Code: | HSB, KTT |
Predicate Device: The SIGN IM Nail System is similar in design, function, and use to the following fixation devices.
- Stryker T2 Ankle Arthrodesis Nail System (K051590) - Primary Predicate
- SIGN IM Nail System (K022632)
- Small Bone Innovations A3 Interlocking Nail System (K112982) ●
- . Carbofix Piccolo Composite Nailing System (K123810)
Device Description
The SIGN IM Nail System consists of multiple components; Standard IM Nail, Interlocking Screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided non-sterile.
Intended Use
The SIGN IM Nail System is indicated for tibiotalocalcaneal arthrodesis. Specific examples of indications include primary or post traumatic or previously infected arthrosis, failed ankle arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuromuscular deformity or instability of the ankle, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibia, malunited tibial pilon fracture, charcot foot, severe arthritis, severe defects after
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Image /page/4/Picture/0 description: The image shows the logo for SIGN Fracture Care International. On the left is a green square with a white figure of a person running. To the right of the square is the word "SIGN" in large, bold, black letters. Below the word "SIGN" are the words "FRACTURE CARE INTERNATIONAL" in smaller, gray letters.
tumor resection, pantalar arthrodesis. IM Nail sizes recommended for these indications are 10-12mm diameter and 200-300mm in length.
Comparing the Indications for Use statement to that of the primary predicate shows that all indications of the subject device are included by the primary predicate. The differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices share the intended use of ankle fusions.
Substantial Equivalence Comparison
The SIGN IM Nail System is substantially equivalent to the predicate Stryker T2 Ankle Arthrodesis Nail System (K051590), in design, performance, functions, and intended use.
The SIGN IM Nail System was included as a predicate because the instruments and implants were previously cleared under K022632.
Comparison of Technological Characteristics
The predicate and proposed devices have a similar intended use and basic fundamental scientific technology and share the following similarities.
- Similar indications for use
- Similar design features
- Incorporate the same or similar materials
- . Equivalent mechanical performance, based on intended use
The proposed SIGN IM Nail System has an intended use largely similar to the predicate Stryker T2 Ankle Arthrodesis Nail System (K051590). The technical features of the proposed device prompted non-clinical performance testing to ensure safety and effectiveness. Differences between the subject device and primary predicate are summarized as following; the subject device is not cannulated, uses different implant materials, has differing IM Nail lengths, differing IM Nail bend angles, differing screw hole diameters, differing screw hole distances, and differing slot lengths. Accompanying screw differences include major and minor diameters, screw length, and full/partially threaded screw options.
The technological characteristics evaluated and found to be similar to one or more of the predicate devices named above include IM nail diameter, IM nail lengths, IM nail lengths, IM nail bend angles, static/dynamic interlocking options, screw hole diameter, number of proximal and distal screws, distance between holes, screw length, screw thread major diameter, screw shank diameter, screw pitch, screw length, full or partially threaded screws, and implant material.
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Image /page/5/Picture/0 description: The image contains the logo for SIGN Fracture Care International. The logo features a stylized green figure running or jumping to the left, next to the word "SIGN" in bold, black letters. Below "SIGN" are the words "FRACTURE CARE" in a smaller font size, and below that is the word "INTERNATIONAL" in an even smaller font size.
Performance Data (non-clinical)
The non-clinical tests performed by the company include an analysis of strength of the SIGN IM Nail System. The results of the performed tests support substantial equivalence to legally marketed predicate devices and did not raise any issues on the safety or effectiveness of the device.
Conclusion
Non-clinical testing was conducted, as well as an analysis of technological characteristics comparing the subject device to the predicate devices. The results support the conclusion that the SIGN IM Nail System is substantially equivalent to its predicate device.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.