(26 days)
Not Found
Not Found
No
The summary describes modifications to an external fixation system to make it MRI conditional, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The text explicitly states the device is intended for "stabilization of open and/or unstable fractures," which is a therapeutic purpose.
No
The device is an external fixation system used for stabilizing fractures, not for diagnosis. The mention of "MRI diagnostic procedures" refers to the conditions under which the device can be safely used during an MRI, not to the device itself performing diagnostic functions.
No
The device description explicitly states it is addressing modifications to "components" of an external fixation system, which are physical hardware. The performance studies also describe mechanical testing and testing in an MRI environment, further indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "stabilization of open and/or unstable fractures" and is used with external fixation systems. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description focuses on modifications to an external fixation system to make it compatible with MRI procedures. This is about the physical properties and safety of the device in a specific environment, not about analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is an external fixation system with components designed to be safe for use in an MRI environment.
N/A
Intended Use / Indications for Use
Intended Use: The subject and predicate devices are external fixation frames intended to provide stabilization of open and/or unstable fractures of the upper and lower extremities.
Indications for Use: The Hoffmann® II Compact™ MRI components are intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, and other means of internal fixation.
Product codes (comma separated list FDA assigned to the subject device)
87 KTT, 87 LXT & 87 JEC, KTT, JEC, LXT
Device Description
This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Compact "External Fixation Systems to include MRI conditional components for use in Magnetic Resonance Imaging (MRI) procedures under predetermined conditions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities (fractures of)
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)
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 MRI diagnostic procedures under predetermined conditions.
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.
Hoffmann® II Compact "External Fixation Systems (no K or DEN number cited)
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
§ 888.3030 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.
0
NOV 2 2 2005
KOS3038 (pg 10f
Summary of Safety and Effectiveness Hoffmann® II Compact™ MRI External Fixation System
| Proprietary Name: | Hoffmann® II Compact™ MRI External Fixation
System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Components |
| Classification Name and Reference | Single/multiple component metallic bone fixation
appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 KTT, 87 LXT & 87 JEC |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5581
Fax: (201) 831-6038 |
| Date Summary Prepared: | October 25, 2005 |
Description:
This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Compact "External Fixation Systems to include MRI conditional components for use in Magnetic Resonance Imaging (MRI) procedures under predetermined conditions
Intended Use:
The subject and predicate devices are external fixation frames intended to provide stabilization of open and/or unstable fractures of the upper and lower extremities.
Indications for Use:
The Hoffmann® II Compact™ MRI components are intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, and other means of internal fixation.
Substantial Equivalence:
The subject Hoffmann® II Compact™MRI components share the same intended use, and basic design concepts as that of the currently available Hoffmann® II Compact™ 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 MRI diagnostic procedures under predetermined conditions.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular seal with the words "U.S. Public Health and Human Services" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them. The image is in black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2005
Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K053038 Trade/Device Name: Hoffman® II Compact™ 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: KTT, JEC, LXT Dated: October 25, 2005 Received: October 27, 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 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 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 comply with all the 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 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 - Vivian Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson
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): \५०५३०३८
Device Name: Hoffmann® II Compact™ MRI External Fixation Systems
Indications for Use:
The Hoffmann® II Compact™ MRI components are intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, and other means of internal fixation.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
signature
(Division Sign-Git) Division of General, Restorative. and Neurological Devices
510(k) Numberko 53038
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