(21 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and sterilization of bone fixation pins, with no mention of AI or ML.
No
The device, Apex Kirschner Wires and Steinmann Pins, is used for fixation of bone fractures and reconstruction, acting as a structural support or guide rather than delivering a therapeutic agent, energy, or actively performing a healing function.
No
The device is used for fixation of bone fractures, bone reconstructions, and as guide pins, which are therapeutic and procedural uses, not diagnostic.
No
The device description clearly states it is a physical medical device (Kirschner Wires and Steinmann Pins) and the performance study focuses on sterilization, indicating a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in fixation of bone fractures, bone reconstructions, and as guide pins for surgical procedures. These are all direct interventions on the human body.
- Device Description: The description details physical characteristics like diameter, length, threading, and point geometries, which are relevant to surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention or support within the body.
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 (comma separated list FDA assigned to the subject device)
HTY and 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 fractures
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)
To support the change from "sterile" to "non-sterile" Kirschner Wires and Steinmann Pins, a sterility validation study was performed to confirm that a sterility assurance level (SAL) of 10 was achieved with the recommended sterilization instructions.
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
APR 2 4 2012
5. 510(k) Summary
| 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: | April 2, 2012 |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | HTY and IDW |
Reason for Special 510(k) Submission:
The purpose of this 510(k) is to provide the Apex Kirschner Wires and Steinmann Pins in "non-sterile" form as well as the previously cleared "sterile" form. There have been no changes to the intended use of the device or its fundamental scientific technology.
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.
1
Predicate Devices:
The modified Apex Kirschner Wires and Steinmann Pins are substantially equivalent to the predicate Apex Kirschner Wires and Steinmann Pins (K112254) with respect to indications, design, function, materials, and sterility assurance level.
Substantial Equivalence:
The Apex Kirschner Wires and Steinmann Pins are substantially equivalent to predicate devices with respect to indications, materials, and technological characteristics. To support the change from "sterile" to "non-sterile" Kirschner Wires and Steinmann Pins, a sterility validation study was performed to confirm that a sterility assurance level (SAL) of 10 € was achieved with the recommended sterilization instructions.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, with three curved lines representing the body and wings of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Apex Tools & Orthopedics Company % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Hollace Saas Rhodes 1331 H Street, Northwest 12th Floor Washington, District of Columbia 20005
APR 2 4 2012
Re: K121004
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: April 2, 2012 Received: April 6, 2012
Dear Ms. Rhodes:
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 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.
3
Page 2 - Ms. Hollace Saas Rhodes
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/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 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.goy/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): ____________________________________________________________________________________________________________________________________________________
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 V (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, Office of Device Evaluation (ODE)
(Division Sign-Oft) -Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number C121004