(308 days)
No
The summary describes a mechanical orthopedic implant (plates and screws) and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is used for fixation of bone fractures, which is a therapeutic intervention.
No.
The device is a locking plate system used for the fixation of bone fractures, not for diagnosing medical conditions.
No
The device description explicitly states it is a combination of plates and screws made of titanium, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures in specific anatomical locations (ulna, radius, humerus, femur, and tibia). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a combination of plates and screws made of titanium, designed for surgical implantation to fix fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, radius, humerus, femur and tibia.
Indicated Patient Age Range
adult patients with age above 21
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
| Primary
Person: | Contact | Mike Gu
Regulatory Affairs Manager
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Tel: (+86)-20-6231 6262
Fax: (+86) -20-8633 0253 | | | | | | | |
|----------------------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|
| Secondary
Person: | Contact | ZhouYu
Quality Manager
Jiangsu Trauhui Medical Instrument Co., Ltd
Tel: (+86) 519-88769966
Fax: (+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 fixation
appliances and accessories | | | | | | | |
| Regulation Class: | | II | | | | | | | |
| Product Code: | | HRS, HWC | | | | | | | |
| Classification Name | | Single/multiple component metallic bone fixation
appliances 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.
5
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.