(29 days)
The Hoffmann® II MRI components are external fixation frame components for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX" External Fixation System and in conjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
This Special 510(k) submission is intended to address modifications to the predicate Hoffmann This openal J ro(is) bachines to include components, which may be used safely for Magnetic Resonance Imaging (MRI).
This document describes a Special 510(k) submission for the Hoffmann® II MRI External Fixation System. The submission addresses modifications to existing Hoffmann external fixation devices to include components that can be safely used in a Magnetic Resonance Imaging (MRI) environment.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties: Comparable to predicate components. | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
| MRI Safety: Safe for use in Magnetic Resonance Imaging under predetermined conditions. | Testing in a Magnetic Resonance Environment established that the components could be safely used in Magnetic Resonance Imaging under predetermined conditions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for either the mechanical testing or the MRI environment testing. It also does not provide information about data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This document does not provide information about the number of experts, their qualifications, or how ground truth was established for the test data. This type of information would typically be relevant for studies involving diagnostic interpretation (e.g., image analysis by radiologists). For a device like an external fixation system, "ground truth" would relate to objective measurements of mechanical properties and MRI safety parameters, rather than expert interpretation.
4. Adjudication Method for the Test Set
This document does not describe any adjudication method. As mentioned above, since this involves objective mechanical and MRI safety testing, expert adjudication in the traditional sense is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic tools to assess how AI assistance impacts human reader performance. The Hoffmann® II MRI External Fixation System is a medical device, not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone study in the context of an "algorithm only" or "AI" performance was not done. The device is a physical medical device, not a software algorithm. The "testing in a Magnetic Resonance Environment" would be considered a standalone test of the device's physical properties under MRI conditions.
7. The Type of Ground Truth Used
For the mechanical properties, the ground truth would be established through objective measurements obtained from standardized mechanical testing protocols (e.g., tensile strength, fatigue testing, torsional stiffness). The "ground truth" for MRI safety would be established by objective measurements and observations according to recognized consensus standards for MRI compatibility (e.g., assessment of B1+ transmit field mapping, specific absorption rate (SAR), heating, artifact generation, force, torque, and image quality degradation). These are not typically "expert consensus" in the way a diagnostic image is, but rather adherence to established engineering and safety standards.
8. The Sample Size for the Training Set
This document does not refer to a "training set." This term is specific to machine learning and AI algorithms. The device undergoes engineering design, prototyping, and rigorous physical testing, not a "training" phase in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" as understood in machine learning/AI, this question is not applicable. The design and validation of this physical device rely on engineering principles, material science, and adherence to relevant national and international standards for medical device safety and performance.
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Hoffmann® II MRI External Fixation System
Image /page/0/Picture/1 description: The image shows the text "K051306" in a large, bold font. Below this, the text "Special 510(k) Premarket Notification" is printed in a smaller, regular font. The text appears to be part of a document or label, possibly related to a medical device or product requiring regulatory approval.
JUN 1 6 2005
Summary of Safety and Effectiveness Hoffmann® II MRI External Fixation System
| Proprietary Name: | Hoffmann® II MRI External Fixation System |
|---|---|
| Common Name: | External Fixation Frame Components |
| Classification Name and Reference | Single/multiple component metallic bonefixation appliances and accessories, 21 CFR$888.3030 |
| Device Product Code: | 87 KTT, 87 LXT & 87 JEC |
| For Information contact: | Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038 |
| Date Summary Prepared: | May 18, 2005 |
Description:
This Special 510(k) submission is intended to address modifications to the predicate Hoffmann This openal J ro(is) bachines to include components, which may be used safely for Magnetic Resonance Imaging (MRI).
Intended Use:
The subject and predicate devices are external fixation frames intended to provide stabilization The subject and preatures of the upper and lower extremities as well as the pelvic disruptions.
Indications for Use:
The Hoffmann® II MRI components are external fixation frame components for use with the The Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX * External Fixation System and in conjunction with Apex® Pins. oft is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
Substantial Equivalence:
The subject Hoffmann® II MRI components share the same intended use, and basic design concents as that of the currently available Hoffmann® II External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and testing in a Magnetic Resonance Environment established that the components could be safely used in Magnetic Resonance Imaging under predetermined conditions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as flowing, interconnected lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2005
Ms. Vivian Kelly, RAC Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K051306 Trade/Device Name: Hoffmann® II MRI External Fixation Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT, KTT, JEC Dated: May 18, 1005 Received: May 19, 2005
Dear Ms. Kelly:
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 for access of 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 such 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 or unf 1 catal bather act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set orth 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. Vivian Kelly, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mationing of substantial equivalence of your device to a legally premiarked notification. "The I Driving of casion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your don't and on on our and one of the regulation entitled, Colliact the Office of Complance at (210) = 16 = 16 = 18 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Hoffmann® II MRI External Fixation Systems
Indications for Use:
The Hoffmann® II MRI components are external fixation frame components for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX" External Fixation System and in conjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K65136
§ 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.