(67 days)
No
The device description and performance studies focus on physical characteristics and material equivalence, with no mention of AI/ML or related concepts.
Yes
The device is indicated for use in fixation of bone fractures and bone reconstructions, which are therapeutic interventions.
No
The device is described as Kirschner wires and Steinmann pins used for fixation of bone fractures, bone reconstructions, and as guide pins, which are therapeutic or surgical functions, not diagnostic.
No
The device description clearly states it is a physical medical device (Kirschner wires and Steinmann pins) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in the fixation of bone fractures, bone reconstructions, and as guide pins for surgical procedures. These are all in vivo applications, meaning they are used within a living organism.
- Device Description: The description of wires and pins used for bone fixation aligns with surgical implants, not diagnostic tests performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Product codes
HTY, IDW
Device Description
Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102215, K960385, K070555, K083912
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K112254(1/2)
OCT | 1 2011
510(k) Summary 5.
| Device Trade Name: | Apex Kirschner Wires and Steinmann Pins |
|---|---|
| Manufacturer: | Apex Tools & Orthopedics Co. |
| Contact: | Apex Tools & Orthopedics Co. |
| 25 Yonghua, Yonghe, GETDD | |
| Guangzhou, Guangdong, | |
| CN-511356 | |
| CHINA | |
| Phone: 86 20 82986918 | |
| Fax: 86 20 82986913 | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | August 4, 2011 |
| Classifications: | 21 CFR 888.3040, Smooth or threaded metallic bone |
| fixation fasteners. | |
| Class: | II |
| Product Codes: | HTY and IDW |
Indications For Use:
The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Device Description:
Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
Substantial Equivalence
The Apex Kirschner Wires and Steinmann Pins are substantially equivalent to the following devices: Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215); DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385); OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555); Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912); with respect to indications, materials, and technological characteristics.
1
K112254(z/z)
Preclinical Testing:
The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Apex Tools & Orthopedies Co. % Mr. Scott Liang General Manager 25 Yonghua, Yonghe, GETDD Guangzhou, Guangdong CN-511356 CHINA
00T 1 1 2011
Re: K112254
Trade/Device Name: Apex Kirschner Wires and Steinmann Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: August 4, 2011 · Received: August 5, 2011
Dear Mr. Liang:
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 markcted 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.
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 (11 he 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 not me 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
3
Page 2 - Mr. Scott Liang
device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safetv/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): K112254
Device Name: Apex Kirschner Wires and Steinmann Pins
The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Prescription Use 1/ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Offige of Device Avaluation (ODE)
(Division Sign-Oft)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K11225.4