(308 days)
Comus Locking Plate systems can be used for adult patients with age above 21 as indicated for fixation of Bone fracture in ulna, radius, humerus, femur and tibia.
The proposed device Comus Locking Plate systems are a combination of plates and screws, which can be used for adult patients with age above 21 as indicated for fixation of fractures. The plate is made of Titanium, which meet ASTM F67, and the screw is made of titanium allov (Ti-6A-14V ELI) which conforms to ASTM F136, which both are widely used for surgical implants with well-known biocompatibility and mechanical properties.
The provided text describes a 510(k) premarket notification for the "Comus Locking Plate systems." This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared predicate devices, not on proving effectiveness through clinical trials with specified acceptance criteria as one might expect for a novel AI/software medical device.
Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test sets, expert qualifications, MRMC studies, training set details) are not applicable or not present in this type of submission.
Here's a breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the chosen ASTM standards and the demonstration of "substantial equivalence" to predicate devices. The reported performance is that the subject device's mechanical testing results were "comparable" to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Meets ASTM F382-14 (Static four-point bending of plate) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F382-14 (Dynamic four-point bending of plate) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F543-17 (Torsional properties of screw) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F543-17 (Driving torque of screw) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F543-17 (Pull-out test of screw) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Biocompatibility of materials (Titanium, Ti-6A-4V ELI) | Materials meet ASTM F67 and ASTM F136; widely used with known biocompatibility. Risk analysis and validation confirm production process does not affect biological performance. |
| Same indications for use as predicate devices | Comus Locking Plate systems have the same indications for use as predicates (adult patients > 21 for bone fracture fixation in ulna, radius, humerus, femur, tibia). |
| Similar patient population as predicate devices | Comus Locking Plate systems have similar patient population as predicates. |
| Similar material as predicate devices | Comus Locking Plate systems use similar materials as predicates. |
| Similar sterilization method as predicate devices | Comus Locking Plate systems use similar sterilization method as predicates. |
| Similar design specifications (bone position, geometric shape) | Similar bone positions (cortical/cancellous), similar plate geometric shape, similar number of holes, similar screw design structure, similar size/dimension ranges (though subject device has a smaller size dimension range). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the mechanical tests (e.g., how many plates/screws were tested for each criterion). The data provenance is from non-clinical comparative performance tests conducted by or for the manufacturer, Jiangsu Trauhui Medical Instrument Co., Ltd. The specifics of where the testing was physically conducted (e.g., in China) are not detailed but can be inferred to be related to the manufacturer's location. This is retrospective in the sense that it's comparing a new device to existing predicate devices based on established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, expert consensus, or clinical experts are not used for this type of mechanical and material comparative study. The "truth" is established by adherence to recognized ASTM standards and direct comparison of physical properties.
4. Adjudication method for the test set
This is not applicable. There is no adjudication in the context of mechanical performance testing. The results are quantitative measurements against predefined standards.
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 is not applicable. This submission is for a physical medical device (locking plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or software device.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Mechanical Testing Standards: Adherence to ASTM F382-14 and ASTM F543-17.
- Material Standards: Adherence to ASTM F67 and ASTM F136 for biocompatibility and material properties.
- Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and design are substantially equivalent (comparable) to legally marketed predicate devices.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of mechanical device testing.
9. How the ground truth for the training set was established
This is not applicable.
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February 3, 2020
Jiangsu Trauhui Medical Instrument Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou, Guangdong 510006 China
Re: K190842
Trade/Device Name: Comus Locking Plate systems 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: March 28, 2019 Received: April 1, 2019
Dear Mike Gu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
Device Name Comus Locking Plate systems
Indications for Use (Describe)
Comus Locking Plate systems can be used for adult patients with age above 21 as indicated for fixation of Bone fracture in ulna, radius, humerus, femur and tibia.
| Type of Use (Select one or both, as applicable) |
|---|
| Residential Use (Part 61, SFD 901, Select D) |
| Com. Theater Use (61, SFD 901, Select C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Jiangsu Trauhui Medical Instrument Co., Ltd No.2 Longqing Road, Wujin Hi-Tech Industrial Zone, Changzhou, Jiangsu, China Tel: (+86) 519-88769966 Fax: (+86) 519-88738899
| PrimaryPerson: | Contact | Mike GuRegulatory Affairs ManagerGuangzhou Osmunda Medical Device Technical Service Co., Ltd.Tel: (+86)-20-6231 6262Fax: (+86) -20-8633 0253 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| SecondaryPerson: | Contact | ZhouYuQuality ManagerJiangsu Trauhui Medical Instrument Co., LtdTel: (+86) 519-88769966Fax: (+86) 519-88738899 | |||||||
| Date prepared | Feb 03, 2020 | ||||||||
| 2. DEVICE | |||||||||
| Device Name: | Comus Locking Plate systems | ||||||||
| Common/Usual Name: | Comus Locking Plate systems | ||||||||
| Regulation number | 21 CFR 888.3030 and 888.3040 | ||||||||
| Regulation Name | Single/multiple component metallic bone fixationappliances and accessories | ||||||||
| Regulation Class: | II | ||||||||
| Product Code: | HRS, HWC | ||||||||
| Classification Name | Single/multiple component metallic bone fixationappliances and accessories |
-
- PREDICATE DEVICES
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Primary predicate device: K143002, Changzhou Dingjian Medical Appliance Company, Ltd
Reference device: K142943, Canwell Medical Co., Ltd.
These predicates have not been subject to a design-related recall.
DEVICE DESCRIPTION 4.
The proposed device Comus Locking Plate systems are a combination of plates and screws, which can be used for adult patients with age above 21 as indicated for fixation of fractures.
The plate is made of Titanium, which meet ASTM F67, and the screw is made of titanium allov (Ti-6A-14V ELI) which conforms to ASTM F136, which both are widely used for surgical implants with well-known biocompatibility and mechanical properties.
INDICATIONS FOR USE 5.
Comus Locking Plate systems can be used for adult patients with age above 21 as indicated for fixation of Bone fracture in ulna, radius, humerus, femur and tibia.
Comus Locking Plate systems have same indications for use, patient population, material and sterilization with the predicates.
In design specification aspect, the plate of the subject device and the predicates all have the same clinical using bone position: cortical bone and cancellous bone, and they have the same plate geometric shape. The subject plate has a similar but a smaller size dimension range than the predicates. In addition, the subject plates have the similar number of holes in the plate design.
The screw of the subject device has the same design structure with the predicates, and has a similar dimension range than the predicates.
The subject device has a similar mechanical performance with the predicates. Section 7 shows that the testing comparison results of the subject and predicate device is comparable.
NON-CLINICAL DATA 7.
The following non-clinical data were provided in support of the substantial equivalence determination.
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Performance testing
Comparative performance tests were conducted between Comus Locking Plate systems and the predicate device, according to ASTM F382-14 and ASTM F543-17. The specific conducted tests are listed below.
- l Static four-point bending test of the plate
- 트 Dynamic four-point bending test of the plate
- 트 Torsional properties of the screw
- 트 Driving torque of the screw
- . Pull-out test of the screw
The test result shows that the subject device is substantial equivalent with the predicate device.
Biocompatibility
The plate is made of Titanium, which meet ASTM F67, and the screw is made of titanium alloy (Ti-6A-l4V ELI) which conforms to ASTM F136, which both are widely used for surgical implants with well-known good biocompatibility. After conducting risk analysis and validation, the production process does not affect the raw material's biological performance.
Animal Study
The subject of this premarket submission, Comus Locking Plate systems do not require animal studies to support substantial equivalence.
8. CLINICAL DATA
The subject of this premarket submission, Comus Locking Plate systems did not require clinical studies to support substantial equivalence.
9. CONCLUSION
The non-clinical data support the safety of the device and the performance testing report demonstrate that the Comus Locking Plate system should perform as intended in the specified use conditions.
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TRAUHUI
From the comparison analysis and the results of comparative performance testing described, Jiangsu Trauhui Medical Instrument Co., Ltd concludes that the Comus Locking Plate systems are substantial equivalent to the predicate devices.
§ 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.