(54 days)
The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.
The current Clavicle Fracture Fixation System accommodates fractures covering the mid-section and distal portions of the clavicle. As proposed in this 510(k) notification, the sponsor wishes to extend the product line by including a plate specifically designed for mid-shaft (i.e., non-distal) clavicle fractures. Because the proposed mid-shaft plate would not cover the distal aspect of the clavicle, its design will be slightly different. The proposed mid-shaft plate will be approximately 2/3 of the length of the current large size clavicle plate. Because the proposed mid-shaft plate will not engage the articular capsule of the clavicle, the distal screw holes of the current plate are eliminated.
The proposed mid-shaft plate will be available in one size only with an overall length of approximately 100mm. The thickness of the plate will be the same as the Suspension™ clavicle plates now on the market. Likewise, the width of the mid-shaft plate will be the same as the mid-shaft portion of the current plates. The screws used to secure the proposed mid-shaft plate to the clavicle are the same as those used for the current Suspension™ clavicle plates.
As with the current Suspension™ Clavicle Fracture Fixation plates, the proposed mid-shaft plate will be composed exclusively of 316L stainless steel. Implantable components are intended for re-sterilization, but are for single-use only.
A hex driver with a handle and a hex driver shaft for hand-tightening bone screws is supplied with the device. These accessories are intended for re-use and re-sterilization. Drill bits are required for creating pilot holes for bone screws. These drill bits are included supplied with the clavicle plates and are steam sterilized by the hospital center.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:
This 510(k) pertains to a device modification (a line extension) of an already cleared device, not a new device requiring extensive de novo performance studies. The core of the submission is to demonstrate that the modified device has not changed its performance characteristics and is substantially equivalent to its predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating this equivalence rather than establishing new performance benchmarks for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device K102095) | Reported Device Performance (for K113405) |
|---|---|
| Mechanical Performance: Equivalent functional test results as specified in ASTM F382-99 for the predicate Suspension™ Clavicle Fracture Fixation System plate. | Functional tests conducted in accordance with ASTM F382-99 show the device to have equivalent performance characteristics as the predicate Suspension™ Clavicle Fracture Fixation System plate. |
| Material Composition: Composed exclusively of 316L stainless steel. | Composed exclusively of 316L stainless steel. |
| Biocompatibility: Demonstrated biocompatibility by predicate device materials. | No new biosafety testing was conducted; materials have not changed from those described in K102095. |
| Sterilization: Cleaning and sterilization methods as described for the predicate device. | No changes to the cleaning or sterilization methods from those described in K102095. |
| Indications for Use: Fixation of clavicle fractures in adult patients. | Same indications for use as the predicate device: fixation of clavicle fractures in adult patients. |
| Design Considerations & Assembly: Similar design considerations and assembly configurations. | Same design considerations, assembly configurations. |
Interpretation: The "acceptance criteria" here are essentially the established performance and safety profile of the predicate device (K102095). The new device (K113405) meets these criteria by demonstrating that it has not changed in material, performance characteristics (via a functional test), or safety profile from the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the physical devices (the proposed mid-shaft clavicle plates) that were subjected to functional testing.
- Sample Size: The document does not specify the exact number (sample size) of mid-shaft clavicle plates used for the functional tests. It states "Functional test conducted in accordance with ASTM F382-99." ASTM F382-99, "Standard Specification for Metallic Bone Plates for Osteosynthesis," outlines testing methodologies and often includes recommendations for sample size for various tests (e.g., fatigue, static bending). Without the full test report, the specific sample size performed by the sponsor is unknown.
- Data Provenance: Not applicable in the traditional sense of patient data. The "data" comes from in vitro functional testing of the device itself. Therefore, there's no country of origin or retrospective/prospective distinction for patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This is a mechanical device submission, not an AI/software device that relies on expert interpretation for ground truth. The "ground truth" for this device is its mechanical properties as measured by standardized engineering tests.
4. Adjudication Method for the Test Set
- Not Applicable: As above, this is a mechanical device, not an image-based or diagnostic AI/software device that would require adjudication of interpretations. The "test" results are objective measurements from mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: No MRMC study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. This submission is for a surgical implant, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Yes (in concept, but for mechanical performance): The functional test performed according to ASTM F382-99 is a standalone performance test of the device's mechanical characteristics without human-in-the-loop performance influencing the device itself. The device's performance is objectively measured.
7. The Type of Ground Truth Used
- Engineering/Mechanical Performance Standards: The "ground truth" here is adherence to established engineering standards (ASTM F382-99) and demonstrating equivalent mechanical performance to a legally marketed predicate device. This is based on objective, quantifiable physical properties (e.g., strength, stiffness, fatigue resistance).
8. The Sample Size for the Training Set
- Not Applicable: This is not an AI/machine learning device. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not relevant.
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510(k) SUMMARY
Premarket Notification: K113405
January 9, 2011
DEVICE: Suspension™ Clavicle Fracture Fixation System
SPONSOR/MANUFACTURER:
Suspension Orthopaedic Solutions, LLC 1507 Ritchie Highway - Suite 101 Arnold, MD 21012
SUMBITTER/REGULATORY CONTACT:
Curtis Raymond Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: 203-922-0105
FDA ESTABLISHMENT REGISTRATION NUMBER: 3008770958
TRADE NAME, COMMON NAME, CLASSIFICATION:
| TRADE NAME: | Suspension™ Clavicle FractureFixation System |
|---|---|
| COMMON NAME: | Clavicle Plate |
| PRODUCT CODE: | HRS |
| HWC | |
| CLASSIFICATION: | Class II - ref.: 21 CFR 888.3030Single/multiple componentmetallic bone fixation appliancesand accessories |
PREDICATE DEVICE(S):
Suspension™ Clavicle Fracture Fixation System (K102095)
DESCRIPTION OF SUBJECT DEVICE:
The current Clavicle Fracture Fixation System accommodates fractures covering the mid-section and distal portions of the clavicle. As proposed in this 510(k) notification, the sponsor wishes to extend the product line by including a plate specifically designed for mid-shaft (i.e., non-distal) clavicle fractures. Because the proposed mid-shaft plate would not cover the distal aspect of the clavicle, its design will be slightly different. The proposed mid-shaft plate will be approximately 2/3 of the length of the current large size clavicle plate. Because the proposed mid-shaft plate will
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KII3405
not engage the articular capsule of the clavicle, the distal screw holes of the current plate are eliminated.
The proposed mid-shaft plate will be available in one size only with an overall length of approximately 100mm. The thickness of the plate will be the same as the Suspension™ clavicle plates now on the market. Likewise, the width of the mid-shaft plate will be the same as the mid-shaft portion of the current plates. The screws used to secure the proposed mid-shaft plate to the clavicle are the same as those used for the current Suspension™ clavicle plates.
As with the current Suspension™ Clavicle Fracture Fixation plates, the proposed mid-shaft plate will be composed exclusively of 316L stainless steel. Implantable components are intended for re-sterilization, but are for single-use only.
A hex driver with a handle and a hex driver shaft for hand-tightening bone screws is supplied with the device. These accessories are intended for re-use and re-sterilization. Drill bits are required for creating pilot holes for bone screws. These drill bits are included supplied with the clavicle plates and are steam sterilized by the hospital center.
INTENDED USE:
The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.
PERFORMANCE CHARACTERISTICS:
Performance characteristics of the proposed mid-shaft plate have not changed from those described in K102095. Functional test conducted in accordance with ASTM F382-99 shows the device to have equivalent performance characteristics as the predicate Suspension™ Clavicle Fracture Fixation System plate.
SAFETY CHARACTERISTICS:
Implantable components of the Suspension™ Clavicle Fracture Fixation System as well as the accessory surgical instruments are supplied non-sterile and are to be steam sterilized by hospital personnel. There have been no changes to the cleaning or sterilization methods from those described in K102095.
The subject device is a permanent implant. All metal parts are composed of 316L stainless steel. Keeping in mind the nature of these materials, new biosafety testing was not conducted by the sponsor. None of these materials has changed from those described in K102095.
CONCLUSION(S):
The proposed modification consists solely of a line extension of the existing Suspension™ Clavicle Fracture Fixation System to address clavicle fractures not involving distal fractures. The subject device has the same design considerations, assembly configurations, materials, performance characteristics and indications for use as the predicate device. The subject has the same safety and efficacy profile as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Suspension Orthopaedic Solutions, LLC % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, Connecticut 06484
JAN 1 1 2012
Re: K113405
Trade/Device Name: Suspension™ Clavicle Fracture Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 14, 2011 Received: December 16, 2011
Dear Mr. Raymond
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
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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,
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): K113405
Device Name: Suspension™ Clavicle Fracture Fixation System
The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.
AND/OR Over-The-Counter Use Prescription Use x (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth Frank
of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113405
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.