(90 days)
Not Found
No
The document describes a mechanical device (suture wires and wire loops) for bone fixation and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on biocompatibility and mechanical strength.
Yes.
The device, suture wires and wire loops, is indicated for bone fracture fixation and other bone reconstruction procedures, which are therapeutic interventions aimed at treating a medical condition.
No
Explanation: This device is for bone fracture fixation and reconstruction (a treatment), not for identifying or investigating a disease or condition.
No
The device description clearly states it is comprised of "suture wires and wire loops," which are physical hardware components used for bone fracture fixation. The performance studies also focus on the biocompatibility and mechanical strength of these physical materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bone fracture fixation, osteotomy, arthrodesis, etc. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as suture wires and wire loops used for bone fracture fixation. This is a physical implant used to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on these in vitro tests.
Therefore, this device falls under the category of a surgical implant or device used for internal fixation, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Suture wires and wire loops are indicated for use for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.
Product codes
JDQ
Device Description
Suture wires and wire loops are used for bone fracture fixation during the healing process. These wires are available in multiple diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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
Non-Clinical Performance and Conclusions:
- Biocompatibility – Biocompatibility testing on the suture wire and wire loop materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
- Performance Evaluation The engineering analysis shows the bending strength of the subject devices is substantially equivalent to the predicate devices. The evaluation shows the differences in materials, diameter and length between the subject devices and the predicate devices do not affect the clinical strength of the subject suture wires and wire loops.
Clinical Performance and Conclusions: - Clinical data and conclusions were not needed for these devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized graphic. The graphic depicts a human figure in profile, with three overlapping faces suggesting a sense of community and support. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are clearly visible in the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
Zimmer, Incorporated Dorothy Snyder Associate Director, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K150889
Trade/Device Name: Suture Wires and Wire Loops Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: May 26, 2015 Received: May 28, 2015
Dear Ms. Snyder:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Suture Wires and Wire Loops
Indications for Use (Describe)
Suture wires and wire loops are indicated for use for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.
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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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized letter "Z" in a blue circle. Below the circle, the word "zimmer" is written in lowercase letters, also in blue. The font used for "zimmer" is sans-serif and appears to be a custom design.
510(k) Summary
| Sponsor: | Zimmer. Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dorothy A. Snyder
Associate Director, Regulatory Affairs
Telephone: (574) 372-4092
Fax: (574) 371-8760 |
| Date: | March 23, 2015 |
| Trade Name: | Suture Wires and Wire Loops |
| Common Name: | Suture Wires and Wire Loops |
| Classification Names
and References: | Cerclage, fixation (JDQ) per 21 § CFR 888.3010, Bone
fixation cerclage |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Ortho Solutions Limited, Ortho Solutions Trauma
Implants for Osteosynthesis, Cerclage Wires (K110895 -
cleared 12/19/2011) |
| Purpose and Device Description: | Suture wires and wire loops are used for bone fracture
fixation during the healing process. These wires are
available in multiple diameters and lengths. |
| Intended Use: | Suture wires and wire loops are indicated for use for bone
fracture fixation, osteotomy, arthrodesis, correction of
deformity, revision procedures where other treatments or
devices have been unsuccessful, and bone reconstruction
procedures. |
| Comparison to Predicate Device: | The Zimmer suture wires and wire loops are identical in
intended use and similar in materials, basic shape and
performance characteristics to the predicate devices. |
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Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
- . Biocompatibility – Biocompatibility testing on the suture wire and wire loop materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
- Performance Evaluation The engineering analysis . shows the bending strength of the subject devices is substantially equivalent to the predicate devices. The evaluation shows the differences in materials, diameter and length between the subject devices and the predicate devices do not affect the clinical strength of the subject suture wires and wire loops.
Conclusions: The data presented in this submission demonstrates that the subject devices are substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
- Clinical data and conclusions were not needed for . these devices.