(50 days)
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.
The SHC is an internal fixation device consisting of multiple components; Standard Hip Nail, Fin Hip Nail (Intramedullary Nails), Bone Plates, Interlocking Screws, Compression Screws, Bone Screws, and a set of Surgical Instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138 or F139. All implants are single use and provided nonsterile.
This document is an FDA 510(k) Premarket Notification for the SIGN Hip Construct (SHC). It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets clinical acceptance criteria. Therefore, much of the requested information regarding clinical studies, sample sizes, expert involvement, and ground truth generation is not available in this document.
Here's a breakdown of the available and unavailable information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance that would be found in a clinical study. Instead, it relies on bench testing to demonstrate equivalent mechanical performance to a previously cleared predicate device.
| Acceptance Criteria (typically for clinical performance) | Reported Device Performance (based on non-clinical testing) |
|---|---|
| Not Applicable (Clinical performance criteria not defined in this document) | Cyclic fatigue testing simulating walking gait was performed. |
| Not Applicable (Clinical performance criteria not defined in this document) | Results "did not raise any issues on the safety or effectiveness of the device" compared to predicates. |
| Not Applicable (Clinical performance criteria not defined in this document) | Device demonstrated "equivalent mechanical performance, based on intended use" to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable and not mentioned. This document describes non-clinical bench testing, not a clinical trial with a "test set" of patient data.
- Data provenance: Not applicable. The "data" refers to results from mechanical bench testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for clinical cases is not established as this document describes non-clinical bench testing.
4. Adjudication method for the test set
Not applicable. There is no clinical test set requiring adjudication.
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 is a medical device (intramedullary fixation rod), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" here is the physical properties and mechanical performance of the device as measured in controlled laboratory settings (bench testing), compared against established standards and predicate device performance.
8. The sample size for the training set
Not applicable. This document does not describe the development of a machine learning model or an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for an algorithm.
Summary of what the document does provide regarding device performance:
The document focuses on demonstrating substantial equivalence for the SIGN Hip Construct (SHC) to its predicate devices, primarily K083582 (SIGN Hip Construct (SHC)), K022632 (SIGN IM Nail), and K021932 (Synthes 6.5mm Cannulated Screw).
The study that proves the device meets the acceptance criteria (of substantial equivalence) is non-clinical performance data (bench testing).
- Type of Study: Cyclic fatigue testing simulating walking gait. These tests were explicitly stated to be duplicates of tests performed for the primary predicate device.
- Purpose: To validate that the device can withstand patient use until fracture consolidation occurs and to ensure safety and effectiveness given the expanded indications (reverse oblique fractures and osteotomies) and additional lengths compared to the predicate SHC.
- Results: "The results did not raise any issues on the safety or effectiveness of the device." The conclusion states that the testing data indicates the proposed device is "safe and effective, and performs as well or better than the predicates," supporting the substantial equivalence claim.
- Grounds for Acceptance: Substantial equivalence is established based on the similar design, performance, functions, intended use, and materials to the predicate devices, substantiated by the non-clinical bench testing results.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
SIGN Fracture Care International Mr. Rob Teeter Regulatory Affairs/Quality Assurance Manager 451 Hills Street, Suite B Richland, Washington 99354
Re: K152757
Trade/Device Name: Sign Hip Construct (SHC) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, KTT, HRS Dated: September 24, 2015 Received: September 24, 2015
Dear Mr. Teeter:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/ResourcesforYou/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 yours,
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
510(k) Number (if known) K 152757
Device Name SIGN Hip Construct (SHC)
Indications for Use (Describe)
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.
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 the logo for SIGN Fracture Care International. The logo features a stylized green figure running or leaping, positioned to the left of the word "SIGN" in bold, black letters. Below "SIGN" are the words "FRACTURE CARE" in a smaller font, followed by "INTERNATIONAL" in an even smaller font. The overall design is clean and professional, conveying a sense of movement and global reach.
510(k) Summary
| 510(k) Submitter: | SIGN Fracture Care International451 Hills Street, Suite BRichland, WA 99354 |
|---|---|
| Establishment #: | 3034525 |
| Contact Person: | Rob Teeter, Regulatory Affairs / Quality Assurance ManagerPhone: 509-371-1107Fax: 509-371-1316E-Mail: Rob.Teeter@signfracturecare.org |
| Date Prepared: | September 8, 2015 |
| Regulatory Class: | Class II |
| Panel: | Orthopedic |
| Trade Name: | SIGN Hip Construct (SHC) |
| Common Name: | Hip Fixation System |
| Classification Name: | 21CFR 888.3020: Intramedullary fixation rod |
| Device Product Code: | HSB, KTT, HRS |
Predicate Device: The SIGN Hip Construct (SHC) is similar in design, function, and use to the following fixation devices.
SIGN Hip Construct (SHC) (K083582) - Primary Predicate SIGN IM Nail (K022632) Synthes 6.5mm Cannulated Screw (K021932)
Device Description
The SHC is an internal fixation device consisting of multiple components; Standard Hip Nail, Fin Hip Nail (Intramedullary Nails), Bone Plates, Interlocking Screws, Compression Screws, Bone Screws, and a set of Surgical Instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138 or F139. All implants are single use and provided nonsterile.
Intended Use
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.
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Image /page/4/Picture/0 description: The image shows the logo for SIGN Fracture Care International. On the left side of the logo is a green graphic of a person running. To the right of the graphic is the word "SIGN" in bold, black letters. Below the word "SIGN" are the words "FRACTURE CARE INTERNATIONAL" in a smaller, gray font.
The Indications for Use statement is not identical to the predicate device: however, 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 treating proximal femur fractures.
Substantial Equivalence Comparison
The SIGN Hip Construct (SHC) is substantially equivalent to the predicate SHC in design, performance, functions, and intended use. The safety and effectiveness of the SHC is also based on a history of use of this device in SIGN Humanitarian Programs.
The proposed device is very similar to the predicate Hip Construct. The difference in indications is that they have expanded to include reverse oblique fractures, and osteotomies. Osteotomies can be described as a deliberate fracture of the subtrochanteric region, which was already included as an indication of the predicate device. Reverse oblique fractures are commonly treated with intramedullary nails and systems such as the predicate SHC. These differences in indication are not critical to the surgical use of the device.
The modified device adds the option of a hip IM nail with standard interlocking and an updated plate design which allows for less prominence from the bone. The SIGN IM Nail was included as a predicate because it uses the same interlocking features and encompasses the size range of the proposed device.
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
Though the proposed modified SHC device has features largely similar to the predicate SHC, the additional lengths and expanded indications prompted non-clinical performance testing. The predicate SHC device only includes an IM Nail length of 240mm but the SIGN IM Nail design incorporates nails up to 420mm in length, therefore it was included as a predicate and non-clinical testing was performed to ensure safety and effectiveness.
Performance Data (non-clinical)
Fatigue tests simulating walking gait were performed to validate that the device can withstand patient use until fracture consolidation occurs. The primary predicate device was cleared in part based on the results of bench testing. These bench tests were duplicated using the modified
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Image /page/5/Picture/0 description: The image contains the logo for SIGN Fracture Care International. On the left is a green rectangle with a white silhouette of a person running. To the right of the rectangle is the word "SIGN" in large, bold, black letters. Below the word "SIGN" are the words "FRACTURE CARE" in smaller, gray letters, and below that is the word "INTERNATIONAL" in the same font and color.
device. Specific tests performed include cyclic fatigue testing. The results did not raise any issues on the safety or effectiveness of the device.
Conclusion
The testing data and design information provided in this submission indicate that the proposed device is safe and effective, and performs as well or better than the predicates. This supports the conclusion that the SIGN Hip Construct (SHC) 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.