(95 days)
The Operativ 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.
The Operativ internal/external fixation devices consist of various fixation pins and wires for in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. Calibrated wires provide etched markings every 1/2 inch. All Operativ internal/external fixation devices included in this submission are manufactured from stainless steel and will be offered non-sterile.
The provided document is a 510(k) summary for medical devices (Kirschner wires and Steinmann pins). It states that the determination of substantial equivalence was based on a detailed description and conformance with voluntary standards, and that "Based upon the similarities in materials and design to the predicate devices, the technological characteristics are sufficient to support a determination of substantial equivalence."
This type of submission does not include the kind of performance study data and acceptance criteria typically found for software or AI/ML-based devices. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document explicitly states that the substantial equivalence was determined based on material and design similarities to predicate devices, not on performance data from a clinical or analytical study.
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K102215
pg. 1/2
5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | Evergreen Orthopedics Research Labd/b/a Operativ11321 NE 120th St.Kirkland, WA 98034 | NOV 9 2010 |
|---|---|---|
| 510(k) CONTACT: | Wayne Morse, CCE, FACCEwayne.morse@operativ.com | |
| DATE PREPARED: | July 15, 2010, Revised October 8, 2010 | |
| TRADE NAME: | Kirschner wires and Steinmann Pins | |
| COMMON NAME: | Internal/external bone fixation devices | |
| CLASSIFICATION: | 888.3040 smooth or threaded bone fixationfasteners |
II
DEVICE PRODUCT CODE:
PRODUCT CLASS:
SUBSTANTIALLY EQUIVALENT DEVICES:
DEVICE DESCRIPTION:
INTENDED USE:
DePuy Kirschner wires and Steinmann pins (K960385), Smith and Nephew (K994143), Orthopro (K070555), and Telflex (K030336)
HTY pin, fixation, smooth JDW pin, fixation, threaded
The Operativ internal/external fixation devices consist of various fixation pins and wires for in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. Calibrated wires provide etched markings every 1/2 inch. All Operativ internal/external fixation devices included in this submission are manufactured from stainless steel and will be offered non-sterile.
The Kirschner wires and Steinmann pins are indicated for use in fixation of bone
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K102215 PG. 2/2
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.
SUBSTANTIAL EQUIVALENCE:
The device is similar in intended use, materials, design, and performance characteristics to the DePuy K-wires, Steinmann pins. The determination of substantial equivalence for this device was based on a detailed description and conformance with voluntary standards.
SUMMARY OF TESTING:
Based upon the similarities in materials and design to the predicate devices, the technological characteristics are sufficient to support a determination of substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Evergreen Orthopedics Research Lab % Operativ Mr. Wayne Morse, CCE, FACCE 11321 Northeast 120th Street Kirkland, Washington 98034
Re: K102215
Trade/Device Name: Operativ Steinman pins and 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: October 8, 2010 Received: October 12, 2010
Dear Mr. Mr. Morse:
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, Orug 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 misfarandi, mand adulteration. Please note: CDRH does not evaluate information related to contractly and 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 (1711) 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements set
NOV - 9 2010
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Page 2 - Mr. Wayne Morse, CCE, FACCE
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/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Koubare brechup
Mark N Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE:
K102215 510(k) Number (if known)
Operativ Steinman pins and Kirschner Wires Device Name:
Indications for Use:
Operativ Steinman pins and Kirschner wires indication for use
The Operativ 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 X (Part 21 CFR 801 subpart D) Over the counter use (Part 21 CFR 801 subpart C)
bare buehr
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102215
Operativ Steinman pins and Kirschner wires
NOV - 9 2010
§ 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.