(28 days)
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No
The 510(k) summary describes external fixation frame components and their mechanical and MRI compatibility testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is an external fixation system intended to provide stabilization of fractures, which is a therapeutic intervention.
No
Explanation: The device, the Hoffmann® II MRI, is described as an external fixation frame used to stabilize fractures. Its function is to treat or manage injuries, not to diagnose them.
No
The device description explicitly states it is adding "additional components" to an "External Fixation System," which are physical hardware components used for stabilizing fractures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments". This describes a surgical or orthopedic device used directly on the patient's body to stabilize bones.
- Device Description: The description refers to "external fixation frame components" and their use with other external fixation systems and pins. This further reinforces its nature as a physical device for external support of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the Hoffmann® II MRI components are an external fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 Svstem and in comjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injurv precludes the use of other fracture treatments such as 1M rodding or casting.
Product codes
87 KTT
Device Description
This Special 510(k) submission is intended to add additional components to the predicate Hoffmann® II MRI External Fixation System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper and lower extremities as well as the pelvic disruptions
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 Magnetic Resonance Imaging under predetermined conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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K053472 小
JAN 1 1 2006
Summary of Safety and Effectiveness Hoffmann® II MRI Components
| Proprietary Name: | Hoffmann® II 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 |
| 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: | December 13, 2005 |
Description:
This Special 510(k) submission is intended to add additional components to the predicate Hoffmann® II MRI External Fixation System.
Intended Use:
The modifications do not alter the intended use of the predicate systems as cleared in its respective premarket notifications. 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 as well as the pelvic disruptions. The indications for use for the Hoffmann® II MRI External Fixation System are provided below.
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 Svstem and in comjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injurv precludes the use of other fracture treatments such as 1M rodding or casting.
Substantial Equivalence:
The subject Hoffmann II MRI components share the same intended use, and basic design concepts as that of the currently available Hoffmann® II MRI External Fixation System and 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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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2006
Ms. Vivian Kelly Howmedica Osteonics Corp. 325 Corporate Dr. Mahwah, New Jersey 07430
Re: K053472
Trade/Device Name: Hoffmann II MRI External Fixation System Regulation Number: 21 CFR 888. 3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: December 13, 2005 Received: December 14, 2005
Dear Ms. Kelly:
We have reviewed your Scction 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 adultcration.
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/dsma/dsmamain.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):
Device Name: Hoffmann® II MRI External Fixation System
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 (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)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K053472