(62 days)
Not Found
No
The summary describes a mechanical implant for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as being used for the "treatment of long-bone fractures" and for "osteosynthesis," indicating its therapeutic purpose.
No
The device is described as being used for the treatment and fixation of long-bone fractures, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states the device is made of titanium alloy and is intended to be implanted, indicating it is a physical hardware device, not software only.
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 long-bone fractures through osteosynthesis (surgical fixation of bones). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an implantable nail made of titanium alloy, designed to be inserted into bones for fracture fixation. This is a physical device 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, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
Product codes
JDS
Device Description
The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to be implanted by insertion into long bones for fixation of fractures.
The purpose of this submission is:
- . To further identify and clarify cumulative changes made to the system since original clearance:
- o An extension to the WIN Flexible Nail product line offering;
- Added surface treatment to o aid in visual differentiation of nail sizes:
- A change to the o manufacturing location;
- o A change to the sterilization vendor site;
- . To update labeling in order to bring the Instructions for Use up to current practices.
This device is intended for osteosynthesis.
The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
Indicated Patient Age Range
pediatric patients
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 Tests:
- None provided .
Clinical Tests: - None provided
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 20, 2020
Biomet Inc. Dominique Dompor Regulatory Affairs Specialist 56 East Bell Drive, PO Box 587 WARSAW IN 46581
Re: K193533
Trade/Device Name: WIN Flexible Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDS Dated: December 19, 2019 Received: December 20, 2019
Dear Dominique Dompor:
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.
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
1
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,
for
Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193533
Device Name WIN Flexible Nail System
Indications for Use (Describe)
WIN Flexible Nail System
WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
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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3
K193533
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the WIN Flexible Nail System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number:
1825034 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Dominique Dompor
Regulatory Affairs Specialist
Telephone: (877) 652-0830 ext. 169 |
| Secondary Contact Person: | Stacy Hutchens
Scientific Affairs Manager
Telephone: (574) 371-9671 |
| Date: | December 19, 2019 |
| Subject Device: | Trade Name: WIN Flexible Nail System
Common Name: Nail, Fixation, Bone |
| | Classification Name:
Single/multiple component metallic bone
fixation appliances and accessories. |
| | • JDS - Nail, Fixation, Bone
(21 CFR §888.3030) |
Predicate Device(s):
| Primary Predicate | 510(k) Number |
|---|---|
| Pediatric Fixation Rods | K000764 |
| Alternate Predicate | 510(k) Number |
| 2mm Pediatric Flex Nail | K022531 |
Purpose and Device Description:
The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to
4
Intended Use and Indications for Use:
Summary of Technological Characteristics:
Summary of Performance Data: (Nonclinical and/or Clinical)
be implanted by insertion into long bones for fixation of fractures.
The purpose of this submission is:
- . To further identify and clarify cumulative changes made to the system since original clearance:
- o An extension to the WIN Flexible Nail product line offering;
- Added surface treatment to o aid in visual differentiation of nail sizes:
- A change to the o manufacturing location;
- o A change to the sterilization vendor site;
- . To update labeling in order to bring the Instructions for Use up to current practices.
This device is intended for osteosynthesis.
The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicate
- Indications for Use: Identical to ● predicate
- Materials: Identical to predicate ●
- Design Features: Similar to predicate
- Sterilization: Identical to predicate
Non-Clinical Tests:
- None provided .
Clinical Tests:
5
Substantial Equivalence Conclusion:
-
None provided
The subject WIN Flexible Nail System has identical intended use and indications for use as the predicate devices. The subject device has similar technological characteristics to the predicates, and the information provided herein demonstrates that: -
. any differences do not raise new questions of safety and effectiveness; and
-
the subject devices are at least as . safe and effective as the legally marketed predicate devices.