(216 days)
No
The document describes a mechanical external fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical and MR compatibility tests.
Yes
The device is described as an external fixation system intended to stabilize fractures, which is a therapeutic purpose.
No
The device is an external fixation system used to stabilize fractures. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists physical components made of materials like steel, titanium, and a coating, and the performance studies involve mechanical testing of these physical components.
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." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device components (Rods, Posts, Couplings, Clamps, and Pins) are all physical components used to construct an external fixation frame. This is consistent with a surgical or therapeutic device, not a diagnostic one that analyzes samples from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on mechanical properties and safety in an MRI environment, which are relevant to a therapeutic device used in conjunction with imaging, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Hoffmann 3 Modular External Fixation System is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other means of internal fixation.
The indications for use of external fixation devices include:
- Bone fracture fixation .
- . Osteotomy
- . Arthrodesis
- . Correction of deformity
- . Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures .
The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, 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 rods, casts or other means of internal fixation.
Product codes (comma separated list FDA assigned to the subject device)
87 KTT
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the Hoffmann 3 Modular External Fixation System as a line extension to the currently marketed Hoffmann II MRI External Fixation System. The Hoffmann 3 Modular External Fixation System consists of Rods, Posts, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The components for the subject device where manufactured from a variety of materials including austentic steel, titanium, and a Vectran coating. This line extension is intended to add additional components for connecting rods and fixed posts, design and material modifications to the couplings, pin clamp, rods and posts. Although the Hoffmann II MRI External Fixation System will continue to be marketed, the Hoffmann 3 Modular External Fixation System will be available with additional components for connecting rods and include design and material modifications to the couplings, pin clamp, rods and posts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Testing:
Non-clinical laboratory testing was performed on the Hoffmann 3 Modular External Fixation System to determine substantial equivalence. The following testing was performed:
- Frame Testing .
- . Bending Strength Testing
- Torsion Strength Testing .
- . Pull-Out Testing
- . Rotation Strength Testing
Magnetic Resonance Environment Testing:
- Radio Frequency Heating Testing .
- Force and Torque Testing .
- . Artifact Testing
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 MRI External Fixation System
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.
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
K111786 (pg. 1 of 3)
JAN 2 6 2012
: Summary of Safety and Effectiveness Hoffmann 3 Modular External Fixation System
| Proprietary Name: | Hoffmann 3 Modular External Fixation System |
|---|---|
| Common Name: | External Fixation System |
| Classification Name and Reference: | Single Multiple component metallic bone fixation appliance and accessories, 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Product Codes: | 87 KTT: Appliance, Fixation, Nail/Blade/Plate Combination, |
| Multiple Components | |
| Predicate Devices: | Hoffmann II MRI External Fixation System |
| For Information contact: | Estela Celi, Regulatory Affairs Associate |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6461 Fax: (201) 831-6038 | |
| estela.celi@stryker.com | |
| Date Prepared: | October 5, 2011 |
·
1
K111786 (pg. 2 of 3)
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the Hoffmann 3 Modular External Fixation System as a line extension to the currently marketed Hoffmann II MRI External Fixation System. The Hoffmann 3 Modular External Fixation System consists of Rods, Posts, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The components for the subject device where manufactured from a variety of materials including austentic steel, titanium, and a Vectran coating. This line extension is intended to add additional components for connecting rods and fixed posts, design and material modifications to the couplings, pin clamp, rods and posts. Although the Hoffmann II MRI External Fixation System will continue to be marketed, the Hoffmann 3 Modular External Fixation System will be available with additional components for connecting rods and include design and material modifications to the couplings, pin clamp, rods and posts.
Intended Use
The Hoffmann 3 Modular External Fixation System is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other means of internal fixation.
The indications for use of external fixation devices include:
- Bone fracture fixation .
- . Osteotomy
- . Arthrodesis
- . Correction of deformity
- . Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures .
Indications for Use
The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, 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 rods, casts or other means of internal fixation.
2
K111786 (pg. 3 of 3)
Summary of Technologies
Device comparisons showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the Hoffmann II MRI System, previously cleared in K051306, K053038, and K053472. The subject Hoffmann 3 Modular External Fixation System components share the same intended use and basic design concepts as that of the currently available Hoffmann II MRI External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components. Testing in a Magnetic Resonance Environment established that the Hoffmann 3 Modular External Fixation System could be safely used in Magnetic Resonance Imaging under predetermined conditions.
Non-Clinical Testing
Non-clinical laboratory testing was performed on the Hoffmann 3 Modular External Fixation System to determine substantial equivalence. The following testing was performed:
- Frame Testing .
- . Bending Strength Testing
- Torsion Strength Testing .
- . Pull-Out Testing
- . Rotation Strength Testing
Magnetic Resonance Environment Testing
- Radio Frequency Heating Testing .
- Force and Torque Testing .
- . Artifact Testing
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
JAN 2 6 2012
Re: K111786
Trade/Device Name: Hoffmann 3 Modular External Fixation System Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories.
Regulatory Class: Class II Product Code: KTT Dated: January 9, 2012 Received: January 10, 2012
Dear Ms. Celi:
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
4
Page 2 - Ms. Estela Celi
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yo
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Hoffmann 3 Modular External Fixation System
Indications for Use:
The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, 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 rods, casts or other means of internal fixation.
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)
ta V. Shegti
for (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111786