(157 days)
No
The summary describes a mechanical orthopedic implant system (plates, screws, and instruments) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is described as providing fixation during fractures, fusions, and osteotomies and consists of plates, screws, and instruments, indicating it is an orthopedic implant system and not a therapeutic device in the sense of delivering active treatment or therapy.
No
Explanation: The device is a locking plate system intended for fixation of fractures, fusions, and osteotomies. Its purpose is to provide structural support, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the system consists of various sized plates, screws, and instruments, which are physical hardware components used in surgical procedures.
Based on the provided information, the Tandry Locking Plate System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "fixation during fractures, fusions, and osteotomies." This describes a surgical implant used to stabilize bones.
- Device Description: The description details plates, screws, and instruments used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. The Tandry Locking Plate System is an implantable surgical device used inside the body to treat bone conditions.
N/A
Intended Use / Indications for Use
The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavics, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.
Each plate is indicated for the following anatomic regions:
- 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm locking plates Radius, wrist, and ulna
- 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
- 5.0 mm locking plates Femur and tibia
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavics, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. Also, specifically for the Tandry Locking Hip Plate System, the proximal femur, including trochanteric, pertrochanteric, and basilar neck fracture regions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test: Clinical studies are not required to support substantially equivalent.
Non-Clinical Test:
- Biomechanical Test: Since the proposed device is substantial equivalence to Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device.
- Biocompatibility: Representative samples of subject devices was subjected to the following: "Biocompatibility sample preparation was made according to ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1. Cytotoxicity testing was performed per ISO 10993-5.
- Reprocessing and sterilization: Since the proposed device is substantial equivalence to Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device. The testing results support the proposed device to meet the validation requirement. The steam sterilization instructions are validated to a sterility assurance level (SAL) of 10^-6 using the biological indicator overkill method. The sterilization test is performed in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937. The subject device is a single-use device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name in blue text.
August 17, 2023
Microware Precision Co., Ltd. Harrison Du General Manager No. 12, Keyuan 2nd Rd., Situn District Taichung, 40763 Taiwan
Re: K230690/S001
Trade/Device Name: Tandry Locking Plate 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: March 10, 2023 Received: March 13, 2023
Dear Harrison Du:
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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542 of the Act); 21 CFR 1000-1050.
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-
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 mediation-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).
Sincerelv.
Shumaya Ali-S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230690
Device Name Tandry Locking Plate System
Indications for Use (Describe)
The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavics, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.
Each plate is indicated for the following anatomic regions:
- · 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
- · 2.4mm locking plates Radius, wrist, and ulna
- · 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
- · 5.0 mm locking plates Femur and tibia
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|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
Submitter's Name: Microware Precision Co., Ltd. Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Fax: +886-4-24636276 Tel: +886-4-24636275 # 100
Contact Name: Harrison Du
Preparation Date: August 02, 2023
Registration Number: 3007738812
Device Name: Tandry Locking Plate System
Common Name:
- Plate, Fixation, Bone (Primary)
- Screw, Fixation, Bone
Classification Name:
- Single/multiple component metallic bone fixation appliances and accessories (Primary)
- Smooth or threaded metallic bone fixation fastener
Code of Federal Regulations (CFR)
- 21 CFR 888.3030 (Primary) ●
- 21 CFR 888.3040
Product Code:
- HRS (Primary)
- HWC ●
Device Class
- | Class II
Predicate Device Information:
Primary device: Tandry Locking Plate System (K171904)
Reference device: VariAx Distal Radius Plating System, VariAx 2 System (K162841)
4
Device Description:
The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.
Indication for use:
The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, intertrochanteric, and basilar neck fracture.
Each plate is indicated for the following anatomic regions:
- 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm locking plates Radius, wrist, and ulna
- 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
- 5.0 mm locking plates Femur and tibia
Technological Characteristics:
The design, features, materials, and Indications for use of the proposed device remain unchanged compared to the previously cleared device K171904 (predicate device). The modifications in this submission extend all plates to two specifications: pure titanium alloy; extend the type 2-anodized for screws and plates and some length specifications for the plates. These modifications do not change the intended use, fundamental scientific technology, or the biocompatibility requirement of the device system. The comparison table for the modification of Tandry Locking Plate System and the predicate devices are following Table 1.
Summary of Performance Data (Nonclinical and/or Clinical)
Clinical Test
Clinical studies are not required to support substantially equivalent.
Non-Clinical Test
5
-
Biomechanical Test
Since the proposed device is substantial equivalence to Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device. -
Biocompatibility
Representative samples of subject devices was subjected to the following: "Biocompatibility sample preparation was made according to ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1. Cytotoxicity testing was performed per ISO 10993-5. -
Reprocessing and sterilization
Since the proposed device is substantial equivalence to Tandry Locking Plate System K171904, the performance and testing result of the predicate can be utilized in the proposed device. The testing results support the proposed device to meet the validation requirement.
The steam sterilization instructions are validated to a sterility assurance level (SAL) of 10° using the biological indicator overkill method. The sterilization test is performed in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937. The subject device is a single-use device.
- The Tandry Locking Plate System has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of the Tandry Locking Plate System in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction.
Summary of Substantial Equivalence:
Based on the information contained within this submission, it is concluded that the Tandry Locking Plate System is substantially equivalent to the identified predicate device.
Standards utilized for non-clinical performance testing:
- ASTM F-543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws ●
- ANSI/AAMI/ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
- AAMI TIR30: 2011(R2016), A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
- ANSI/AAMI/ISO 17665-1: 2006/(R)2013, Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- ANSI/AAMI/ISO 14937: 2009(R)2013, Sterilization of healthcare products General requirements ● for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.