(21 days)
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.
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.
The provided document describes a 510(k) submission for Apex Kirschner Wires and Steinmann Pins, focusing on changing the offering from "sterile" to "non-sterile" with validated sterilization instructions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 10^-6 | Achieved with recommended sterilization instructions. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the sterility validation study, nor does it specify the data provenance (country of origin, retrospective or prospective). It only mentions that "a sterility validation study was performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The device is a physical medical instrument (Kirschner Wires and Steinmann Pins), and its performance in this context relates to sterilization effectiveness, not diagnostic interpretation requiring expert medical review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective medical interpretations (e.g., image reading), which is not relevant for a sterility validation study of a medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This type of study relates to diagnostic aids, particularly AI-assisted ones, which is not relevant for Kirschner Wires and Steinmann Pins.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. A standalone algorithm performance study is relevant for AI or diagnostic software, not for basic medical instruments like Kirschner Wires and Steinmann Pins.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the sterility validation study would be the absence of viable microorganisms after the sterilization process, meeting the defined Sterility Assurance Level (SAL) of 10^-6. This is established through microbiological testing.
8. The sample size for the training set
This information is not applicable and not provided in the document. The concept of a "training set" is relevant for machine learning or AI models, not for traditional medical device manufacturing and sterilization validation.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document. As mentioned above, "training set" and its associated ground truth establishment are not relevant to this type of device and study.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states that a sterility validation study was performed to support the change from "sterile" to "non-sterile" Kirschner Wires and Steinmann Pins. The acceptance criterion for this study was achieving a Sterility Assurance Level (SAL) of 10^-6 with the recommended sterilization instructions. The study successfully confirmed that this SAL was achieved.
The specific details of the sterility validation study, such as the protocol, the number of samples tested, or the methods used to determine the SAL, are not provided in this summary. However, the FDA's acceptance of the 510(k) submission indicates that the agency found the validation study results sufficient to demonstrate that the device, when sterilized according to instructions, meets the required sterility standards.
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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, GETDDGuangzhou, Guangdong,CN-511356CHINAPhone: 86 20 82986918Fax: 86 20 82986913 |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (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.
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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.
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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.
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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
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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
§ 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.