(126 days)
OsteoMed Hand Plating System is intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device.
The OsteoMed Hand Plating System implants are intended for single use only.
The OsteoMed Hand Plating System is a rigid fixation system consisting of plates and screws in various configurations. Plates are provided in a variety of shapes and sizes, and offer surgeons compression and locking hole designs. The Hand Plating System includes angulated locking, nonlocking, lag, and cannulated screws as well as a buttress pin and K-wire implants. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).
The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
The provided 510(k) summary for the OsteoMed Hand Plating System (K090522) does not contain any data from a study demonstrating the device meets specific acceptance criteria.
The submission focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles. It explicitly states: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices we believe that the OsteoMed Hand Plating System does not raise any new safety or effectiveness issues." This indicates that the regulatory pathway chosen was primarily reliant on comparison to existing, cleared devices, rather than new performance studies with pre-defined acceptance criteria.
Therefore, I cannot provide the requested information for the following sections:
- A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented in this document.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set data is provided.
- 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): Not applicable, as no test set requiring ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: This device is a physical hand plating system, not an AI or imaging device. Therefore, an MRMC study with human readers and AI assistance is not relevant or applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical hand plating system, not an algorithm. Therefore, standalone algorithm performance is not relevant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study requiring ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary that establishes substantial equivalence through comparison to predicate devices, rather than through presenting new performance data from a primary study with acceptance criteria.
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510(k) Summary
OsteoMed Hand Plating System
Device Proprietary Name:
Device Common Name:
Classification Name:
Product Code:
Name of Submitter:
HRS, HWC
fixation fastener
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4781 Fax: (972) 677-4778
bone fixation appliances and accessories
OsteoMed Hand Plate and Screw Fixation System
21 CFR § 888.3030: Single/multiple component metallic
21 CFR § 888.3040: Smooth or threaded metallic bone
Contact Person:
Date Prepared:
Alma Relja, RAC February 23, 2009
Summary:
This submission describes the OsteoMed Hand Plating System intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device. The OsteoMed Hand Plating System implants are intended for single use only.
The OsteoMed Hand Plating System is a rigid fixation system consisting of plates and screws in various configurations. Plates are provided in a variety of shapes and sizes, and offer surgeons compression and locking hole designs. The Hand Plating System includes angulated locking, nonlocking, lag, and cannulated screws as well as a buttress pin and K-wire implants. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).
The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
Equivalence for this system is based on similarities in intended use, material, design and operational principle to the OsteoMed M3 System (K911936/Addendum K924138/K030448), Synthes Modular Mini Fragment LCP System (K06349) and Synthes Stainless Steel Modular Hand System (K030310), SBI Hand Fixation System (K050462), and Stryker Small Bone Plating System (K061497). Furthermore, OsteoMed also notes that some sections of this system could have been letter to file based on the OsteoMed previously cleared submissions. Due to the similarity of materials and design to both pre-enactment and post-enactment devices we believe that the OsteoMed Hand Plating System does not raise any new safety or effectiveness issues.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2009
OsteoMed L.P .. % Ms. Alma Relja 3885 Arapaho Road Addison, Texas 75001
Re: K090522
Trade/Device Name: OsteoMed Hand Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II
Product Code: HRS, HWC Dated: June 25, 2009 Received: June 30, 2009
Dear Ms. Relja:
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.
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. Alma Relja
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Barbara Buchin
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
510(k) Number (if known): _K090S 22 Device Name: OsteoMed Hand Plating System
Indications for Use:
OsteoMed Hand Plating System is intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device.
The OsteoMed Hand Plating System implants are intended for single use only.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omitu
(DKvision Sign, dr)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090522
Page 1 of 1
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(Posted November 13, 2003)
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.