(8 days)
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Not Found
No
The document describes a mechanical external fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to stabilize fractures and aid in bone reconstruction, which directly impacts the structure and function of the body for therapeutic purposes.
No
The descriptions of "Intended Use / Indications for Use" and "Device Description" clearly state that the device is an external fixation system used for stabilizing fractures and in reconstruction procedures. It is a treatment device, not one for diagnosis.
No
The device description clearly states it is an "external fixation frame component" and mentions "lengthener components," which are physical hardware used in external fixation systems. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the stabilization and fixation of bone fractures and for reconstruction procedures. This is a direct intervention on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details components of an external fixation system, which is a physical device applied externally to the body to support and stabilize bones.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used to treat bone injuries.
N/A
Intended Use / Indications for Use
The Hoffmann ® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Osteotomy
- Arthrodesis .
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
- Compression/distraction and lengthening .
Product codes
KTT
Device Description
This line extension is to modify the lengthener components to the Hoffmann® II Micro™ External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro " External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact" External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax "External Fixation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children and adults
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 5 - 2005
Special 510(k)
510(k) Summary of Safety and Effectiveness for the Hoffmann® II Micro™ Lengthener Line Extension
| Proprietary Name: | Hoffmann® II Micro™ 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: | July 28, 2005 |
Description:
This line extension is to modify the lengthener components to the Hoffmann® II Micro™ External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro " External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact" External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax "External Fixation System.
Intended Use:
The Hoffmann® II Micro" External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- Osteotomy .
- Arthrodesis
- . Correction of deformity
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
- . Compression/distraction and lengthening
Substantial Equivalence:
Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right and is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
AUG 5 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K052037 Trade/Device Name: Hoffmann® II Micro™ External Fixation System Regulation Number: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances Regulation Name: and accessories Regulatory Class: II Product Code: KTT Dated: July 28, 2005 Received: July 28, 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.
2
Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter watification. The FDA finding of substantial equivalence of your device to a legally premated noticated 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 vours,
A. Hytl. Rlurdu
Mark N. Melkerson
Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
13-12-14-14-1
510(k) Number (if known):
Device Name: Hoffmann® II Micro™ External Fixation System
. . . . .
Indications for Use:
The Hoffmann ® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Osteotomy
- Arthrodesis .
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
- Compression/distraction and lengthening .
Over-The-Counter Use Prescription Use >