(29 days)
Not Found
Not Found
No
The summary describes modifications to an external fixation system to make it MRI-compatible and includes mechanical and MRI safety testing, with no mention of AI or ML.
Yes.
The device is described as an external fixation frame used to provide stabilization of open and/or unstable fractures, which indicates a therapeutic purpose.
No
The device is an external fixation system used for stabilizing fractures, not for diagnosing medical conditions.
No
The device description explicitly states it is addressing modifications to "external fixation frame components," which are hardware. The performance studies also describe "mechanical testing" and testing in a "Magnetic Resonance Environment" for these components, 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 "stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments". This describes a surgical or therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on external fixation frame components used for stabilizing fractures. This is a mechanical device used externally on the body.
- Lack of IVD Characteristics: An IVD device is 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 such specimens.
The mention of MRI is related to the safety of the device in an MRI environment, not its use as a diagnostic tool itself. The device is a physical implant/external fixation system.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
87 KTT, 87 LXT & 87 JEC
Device 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
upper and lower extremities as well as the pelvic disruptions.
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 Magnetic Resonance Imaging 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.
Not Found
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
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 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: | 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.
1
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.
2
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
3
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)
Page 1 of 1
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K65136