(83 days)
InterTAN CHS Limited Collapse Set Screw is indicated for:
- Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures.
- Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.
- Hip osteotomy .
InterTAN CHS Limited Collapse Set Screw is for single use only and is to be used with InterTANY CHS Plating System.
Subject of this Traditional 510(k) premarket notification is the InterTAN® CHS Limited Collapse Set Screw. The subject device is a line addition to the InterTAN® CHS Plate System cleared via K080434. The Limited Collapse Set Screw is designed to limit the amount of allowable collapse and prevent lateral advancement of the plate.
This document describes a submission for a medical device, specifically a "Limited Collapse Set Screw" for orthopedic use. The information provided is primarily focused on regulatory approval (510(k)) and establishing substantial equivalence to existing devices, rather than detailed performance studies against specific acceptance criteria in the way one might see for an AI algorithm or a diagnostic test.
Therefore, many of the requested categories for AI/diagnostic device performance studies (like sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance) are not applicable to this type of submission.
However, I can extract the relevant information regarding acceptance criteria and the "study" (mechanical testing) that helped meet them for this orthopedic device.
Here's the breakdown of the provided information within the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand expected in vivo loading without failure (Mechanical) | "A review of the mechanical data indicates that the Limited Collapse Set Screw is capable of withstanding expected in vivo loading without failure." |
| Substantial Equivalence to Predicate Devices (Regulatory/Design) | The device's "similarities in indications for use, design features, operational principles, and material composition" to predicate devices (InterTAN® CHS Plate System K080434 and DePuy PEAK FX Hip Plate K063509) were established. |
| Intended Use Adherence (Clinical/Indications) | The device is indicated for specific types of proximal femur fractures and hip osteotomy, aligning with predicate devices. |
| Material Composition Safety/Biocompatibility (Implied) | Not explicitly detailed in the provided text, but implied by substantial equivalence to metallic bone fixation fasteners. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. For this type of orthopedic device, there isn't a "test set" of patient data in the sense of a diagnostic algorithm. Performance is assessed via mechanical testing and comparison to predicate devices.
- Data Provenance: The "mechanical data" is generated in a lab setting, not from clinical patient data. The provenance of the "design features, operational principles, and material composition" is from the manufacturer's internal development and testing, benchmarked against existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of typical AI/diagnostic device studies. "Ground truth" for this device's performance against mechanical criteria would be established by engineering standards and measurement equipment.
- Qualifications of Experts: The review of mechanical data would typically be conducted by qualified engineers and materials scientists within Smith & Nephew, and subsequently by FDA reviewers (e.g., orthopedic device specialists).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "adjudication" of a test set in the clinical/human-perception sense for this mechanical device. The mechanical testing results would be compared directly to pre-defined engineering pass/fail criteria.
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
- MRMC Study: No, not applicable. This is a mechanical implant, not a diagnostic imaging device or an AI application that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device (screw) that is implanted; it does not have an "algorithm-only" performance mode in the context of diagnostics. Its performance is its mechanical integrity and function within the human body.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Mechanical Performance: Established by quantitative measurements against engineering specifications and validated test methods (e.g., load testing, fatigue testing). This is a simulated performance ground truth against known physical stress.
- Substantial Equivalence: Pertains to comparison with the established characteristics (indications, design, materials) of legally marketed predicate devices, which have their own established performance and safety profiles. This is a regulatory/design ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This type of device does not involve machine learning or a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
Summary for K090656:
This 510(k) submission for the Smith & Nephew InterTAN® CHS Limited Collapse Set Screw focuses on demonstrating substantial equivalence to previously cleared predicate devices and confirming its mechanical integrity. The "study" mentioned is mechanical testing which demonstrated the device's ability to withstand expected in vivo loading. The acceptance criteria for this device are primarily related to its mechanical performance and its comparability in design, materials, indications for use, and operational principles to existing, legally marketed devices. The concept of "acceptance criteria" and "study" in this context is different from what would be applied to an AI or diagnostic device and therefore many of the specific questions are not directly relevant.
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K090656 # 4,
Summary of Safety and Effectiveness Smith & Nephew, Inc. InterTAN® CHS Limited Collapse Set Screw
Contact Person and Address
Shereen Myers Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T (901) 399-6325
Date of Summary: March 5, 2009
JUN - 3 2009
Name of Device: Smith & Nephew, Inc. InterTAN® CHS Limited Collapse Set Screw Common Name: Screw Device Classification Name and Reference: 21 CFR 888.3040, smooth or threaded metallic bone fixation fastener
Device Class: Class II Panel Code: Orthopaedics/87 HWC
Device Description
Subject of this Traditional 510(k) premarket notification is the InterTAN® CHS Limited Collapse Set Screw. The subject device is a line addition to the InterTAN® CHS Plate System cleared via K080434. The Limited Collapse Set Screw is designed to limit the amount of allowable collapse and prevent lateral advancement of the plate.
Mechanical Testing
A review of the mechanical data indicates that the Limited Collapse Set Screw is capable of withstanding expected in vivo loading without failure.
Intended Use
InterTAN CHS Limited Collapse Set Screw is indicated for:
- Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be . more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures. �
- Stable and unstable fractures of the proximal femur in which medial cortex stability can be � restored.
- Hip osteotomy .
InterTAN CHS Limited Collapse Set Screw is for single use only and is to be used with InterTANY CHS Plating System.
Substantial Equivalence Information
The substantial equivalence of the InterTAN® CHS Limited Collapse Set Screw is based on its similarities in indications for use, design features, operational principles, and material composition to the Smith & Nephew, Inc. InterTAN® CHS Plate System (K080434) and the DePuy PEAK FX Hip Plate (Limited collapse cap] (K063509).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew , Incorporated % Ms. Shereen Myers Regulatory Affairs Specialist I 1450 East Brooks Road Memphis, Tennessee 38116
Re: K090656
Trade/Device Name: InterTAN CHS Limited Collapse Set Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 5, 2009 Received: March 12, 2009
Dear Ms. Myers:
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.
JUN - 3 2009
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
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Page 2-Ms. Shereen Myers
(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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Boehme
Mark N. Melkerson 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): K090656
Device Name: Smith & Nephew, Inc. InterTAN® CHS Limited Collapse Set Screw
Indications for Use:
InterTAN CHS Limited Collapse Set Screw is indicated for:
-
- Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures.
- Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.
- Hip osteotomy .
The Limited Collapse Set Screw is for single use only and is intended to be used with InterTANY CHS Locked Plating System.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Onetu
vision Sigt Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090657
§ 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.