(77 days)
The Periarticu!ar Clamp is intended to be used with the components of the Hoffmann® II Compact External Fixation System and the Half Pins or Transfixing Pins of the Hoffmann® 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.
The Periarticular Clamp is an additional component of the Hoffmann® II Compact System and 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. It is manufactured from a lightweight plastic material which is radiographically transparent and allows for fracture or joint visibility on x-ray. The clamp can be used with the existing rods, couplings, clamps and fixation pins of the existing Hoffmann® II Compact System.
Acceptance Criteria and Device Performance Study for Hoffmann® II Compact Periarticular Clamp
This document outlines the acceptance criteria and details of the study conducted to demonstrate the performance of the Hoffmann® II Compact Periarticular Clamp.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states that "Testing was performed to demonstrate an equivalence in performance to the Original Hoffmann® Small Four-Hole Ball Joint." However, specific numerical acceptance criteria (e.g., minimum load, deflection, fatigue cycles) for mechanical performance and the corresponding reported performance values for the new clamp are not explicitly stated in the provided text. The summary only broadly asserts equivalence to the predicate device in performance.
Therefore, based only on the provided text, a table detailing specific acceptance criteria and reported device performance cannot be fully constructed. The document does not offer the granular data required for such a table.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a medical implant (external fixation clamp) and the performance evaluation is based on mechanical testing, not interpretation of medical images or data requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for mechanical testing. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic or screening devices that involve human interpretation of outputs (e.g., medical images). The Hoffmann® II Compact Periarticular Clamp is a physical medical device.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. Standalone performance studies are pertinent to algorithmic or AI-based devices. The Hoffmann® II Compact Periarticular Clamp is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the performance evaluation of the Hoffmann® II Compact Periarticular Clamp is based on mechanical performance metrics (though not explicitly detailed in the provided text). This would typically involve measuring characteristics such as ultimate strength, stiffness, fatigue life, and clamping force under various loading conditions. The stated goal was to demonstrate equivalence to a predicate device's established mechanical performance.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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510(k) Summary
Trade Name: Common Name: Classification Name: Hoffmann® II Compact Periarticular Clamp External Fixation Device Smooth or Threaded Metallic Bone Fixation Fastener 888.3040
The Periarticular Clamp is an additional component of the Hoffmann® II Compact System and 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. It is manufactured from a lightweight plastic material which is radiographically transparent and allows for fracture or joint visibility on x-ray. The clamp can be used with the existing rods, couplings, clamps and fixation pins of the existing Hoffmann® II Compact System.
The substantial equivalence of this device is based on similarities in intended use, design and operational principles to the Original Hoffmann® Small 4-Hole Ball Joint, Hoffmann® II Compact External Fixation System and an equivalence in material and intended use to the Agee-Wristjack (Hand Biomechanics Lab, Inc) and the Radiolucent Wrist Fixation System (Orthofix).
Testing was performed to demonstrate an equivalence in performance to the Original Hoffmann® Small Four-Hole Ball Joint.
The basic operational principles for the construction of external fixation frames is similar for this new clamp to those of the named external fixation devices, that is to provide external stabilization of a fracture by means of percutaneous pins connected to a frame by means of clamps, couplings and rods. The method of site preparation, relative indications and contraindications for all the external fixation devices is similar.
| For information contact: | John Dichiara |
|---|---|
| Group Regulatory Affairs Manager | |
| Howmedica Inc. | |
| 359 Veterans Boulevard | |
| Rutherford, NJ 07070 | |
| (201) 507-7386 |
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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Mr. John Dichiara Group Regulatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
Re: K973321 Hoffmann® II Compact Periarticular Clamp Requlatory Class: II Product Code: KTT September 3, 1997 Dated: Received: September 4, 1997
Dear Mr. Dichiara:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John Dichiara
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
n Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Not Known
Device Name: Hoffmann® II Compact Periarticular Clamp
Indications for Use:
The Periarticu!ar Clamp is intended to be used with the components of the Hoffmann® II Compact External Fixation System and the Half Pins or Transfixing Pins of the Hoffmann® 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_ ___________________________________________________________________________________________________________________________________________________ . . . . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
510(k) Numbe
§ 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.