(224 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the screws and pins, with no mention of AI or ML.
Yes
The device is intended for the treatment of fractures and fusions of bone, which are therapeutic medical interventions.
No
Explanation: The device is described as a "Compression Screw System" intended for the "treatment of fractures, and fusions of bone." This indicates a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly details physical components (screws, pins) made of Ti-6Al-4V, indicating it is a hardware medical device.
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 "treatment of fractures, and fusions of bone". This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a system of screws and pins designed for surgical implantation to stabilize bone. This is a physical medical device, not a reagent, instrument, or system intended for use in vitro (outside the body) to examine specimens from the human body.
- Performance Studies: The performance studies focus on biomechanical testing, biocompatibility, and reprocessing/sterilization, which are relevant to implanted medical devices, not IVDs.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
N/A
Intended Use / Indications for Use
Tandry Compression Screw System is intended for the treatment of fractures, and fusions of bone with the appropriate screw size.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
Tandry Compression Screw System consists of 2.8mm, 4.1mm, 4.7mm, 5.5, and 7.5mm cannulated compression screw, 2.0mm compressions screw and 2.0mm compression pin. The 2.0mm compression pin features a beak-off groove between a shaft and compression screw body, the shaft can be separated from the compression screw body by bending it back and forth. The screw system has multiple lengths depending on the diameter of the screws and pins are fabricated from Ti-6Al-4V and anodized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Test:
- Biomechanical Test: Based on the testing results and assessment, results indicate the Tandry Compression Screw System meets the acceptance criteria defined in the FDA guidance document, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, to support substantial equivalence.
- Biocompatibility: According to the evaluation of the FDA guideline "Use of International Standard ISO 10993-1, Biological evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management process", and the proposed device meets biocompatibility requirement.
- 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 as well.
- The Tandry Compression Screw System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Tandry Compression Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
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.
Not Found
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
§ 888.3040 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.
0
September 20, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
Microware Precision Co., Ltd. Harrison Du General Manager No. 12, Keyuan 2nd Rd., Situn District Taichung, 40763 Taiwan
Re: K220359
Trade/Device Name: Tandry Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 22, 2022 Received: August 22, 2022
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 approv al 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.
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
1
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 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).
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 Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220359
Device Name Tandry Compression Screw System
Indications for Use (Describe)
Tandry Compression Screw System is intended for the treatment of fractures, and fusions of bone with the appropriate screw size.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary K220359
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: September, 20, 2022
Registration Number: 3007738812
Trade Name: Tandry Compression Screw System
Common Name: Screw, Fixation, Bone
Classification Name: Smooth or threaded metallic bone fixation fastener
Classification: Class II
Classification Number: 21 CFR 888.3040
Product Code: HWC
Predicate Device Information:
Primary Predicate: APTUS® Cannulated Compression Screws (K133460) Additional Predicates: Tandry Locking Plate System (K171904)
Device Description:
Tandry Compression Screw System consists of 2.8mm, 4.1mm, 4.7mm, 5.5, and 7.5mm cannulated compression screw, 2.0mm compressions screw and 2.0mm compression pin. The 2.0mm compression pin features a beak-off groove between a shaft and compression screw body, the shaft can be separated from the compression screw body by bending it back and forth. The screw system has multiple lengths depending on the diameter of the screws and pins are fabricated from Ti-6Al-4V and anodized.
4
Indication for use:
Tandry Compression Screw System is intended for the treatment of fractures, osteotomies, and fusions of bone with the appropriate screw size.
Technological Characteristics:
The Tandry Compression Screw System is fabricated from titanium alloy per ASTM F136. The design feature for the Tandry Compression Screw System is similar to the predicate devices including dimensions, shape and sizes.
Summary of Performance Data (Nonclinical and/or Clinical)
Clinical Test
Clinical studies are not required to support substantially equivalent.
Non-Clinical Test
-
Biomechanical Test
Based on the testing results and assessment, results indicate the Tandry Compression Screw System meets the acceptance criteria defined in the FDA guidance document, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, to support substantial equivalence. -
Biocompatibility
According to the evaluation of the FDA guideline "Use of International Standard ISO 10993-1, Biological evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management process", and the proposed device meets biocompatibility requirement. -
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 as well.
-
The Tandry Compression Screw System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Tandry Compression Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Summary of Substantial Equivalence:
The Tandry Compression Screw System is substantially equivalent to the predicated devices. Result of non-clinical tests and the similarities with the legally marketed predicate the device will perform within the intended use and no new issues of safety or efficacy have been raised. Furthermore, the indications of the subject and primary predicate are equivalent.
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Microware
Standards utilized for non-clinical performance testing
- ASTM F-543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws
- Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
- ANSVAAMI/ISO 10993-1: 2018, Biological evaluation of medical devices – Part1: 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 – Part1: 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.