(161 days)
Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion implants. The size of Kirschner wire should be adapted to the specific indications
The Precifit Medical Kirschner wire is a stainless steel (316LVM) wire available with two point styles: smooth and threaded. The wires are available in various diameters (1.0 - 2.5mm) and lengths (120 -200mm). One end is fixed on standard surgical power tool equipment for insertion. The Precifit Medical Kirschner wire is supplied non-sterilized by the end user. It is intended for single use only.
This document is a 510(k) premarket notification for the Precifit Medical Kirschner Wires and does not contain information about an AI/ML powered device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and AI/ML specific metrics.
The document pertains to a medical device (Kirschner Wires) that are physical implants used for bone fixation, not a digital health product or algorithm. The sections referring to "Non-clinical testing" and "Clinical testing" confirm that the device conforms to an international standard (ISO 5838-1 (2013)) and that clinical testing was not required to demonstrate substantial equivalence. This indicates a traditional medical device submission, not one involving AI/ML performance evaluation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2017
Precifit Medical Ltd % Kellen Hills Quality And Regulatory Consultant Orchid Design 4600 E Shelby Dr Memphis. Tennessee 38118
Re: K163327
Trade/Device Name: Precifit Medical Kirschner Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: April 25, 2017 Received: April 28, 2017
Dear Mr. Hills:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
al Macleal Kirschne
Indications for Use (Describe)
Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion implants. The size of Kirschner wire should be adapted to the specific indications
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . . . . . . . . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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[As Required by 21 CFI
(a)(1) Submitted By: Address:
- Phone: Fax: Date: Contact Persons Primary: Secondary:
- Proprietary Name: (a)(2) Common Name: Classification Name and Reference:
Product Code:
(a)(3) Predicate Devices: Primary:
PRECIFIT MEDICAL LTD 951 Aviation Pkwy Ste 100, Morrisville, NORTH CAROLINA, 27560 901-433-1990 901-433-1989 November 22, 2016
Kellen Hills (Orchid Design Consulting) Eric Wu (Precifit Medical Ltd)
Precifit Medical Kirschner Wire Orthopedic wire 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener HTY, JDW
In2Bones® Kirschner wire (K153204);
(a)(4) Device Description:
The Precifit Medical Kirschner wire is a stainless steel (316LVM) wire available with two point styles: smooth and threaded. The wires are available in various diameters (1.0 - 2.5mm) and lengths (120 -200mm). One end is fixed on standard surgical power tool equipment for insertion. The Precifit Medical Kirschner wire is supplied non-sterilized by the end user. It is intended for single use only.
The purpose of this submission is to gain initial marketing authorization in the United States.
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(a)(5) Indications for Use:
Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of Kirschner wire should be adapted to the specific indications. -
(a)(6) Comparison of Technological Characteristics: The Precifit Medical Kirschner wire is identical in intended use and similar in basic shape, material and performance characteristics to the predicate device. The technological characteristics do not raise any new questions of safety and efficacy.
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(b)(1) Non-clinical testing: The Precifit Medical Kirschner wires conform to the international standard ISO 5838-1 (2013). Therefore, no additional mechanical testing is required
(b)(2) Clinical testing:
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
(b)(3) Conclusions:
Based on the information provided in this premarket notification, we believe that the subject Precifit Medical Kirschner wire demonstrates substantial equivalence to the identified predicate device.
N/A