(217 days)
The Small Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- Opening wedge osteotomies of Hallux Valgus
- Evans lengthening osteotomies
- Metatarsal/cuneiform arthrodesis.
The Small Bone Wedge is not intended for use in the spine.
The Small Bone wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered in two distinct designs with varying widths and thicknesses to accommodate a variety of small bone applications.
Here's a breakdown of the acceptance criteria and study information for the Small Bone Wedge, based on the provided text:
It's important to note that the provided document is a 510(k) summary for a medical device (Small Bone Wedge), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, expert ground truth establishment, and comparative effectiveness studies, is not present in this type of regulatory submission. The document primarily confirms that the device is "substantially equivalent" to existing devices based on design, material, and intended use.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied by 510(k) process) | Reported Device Performance (Implied by 510(k) clearance) |
|---|---|---|
| Substantial Equivalence | Design features are similar to predicate. | Design features (titanium metal foam wedge, two designs, varying widths/thicknesses) are deemed substantially equivalent to predicate devices. |
| Material | Material is similar to predicate and suitable for implant. | Titanium metal foam is deemed substantially equivalent to predicate device materials. |
| Intended Use | Indications for use are similar to predicate. | Intended use for internal bone fixation for fractures, fusions, or osteotomies in the ankle and foot (e.g., Hallux Valgus osteotomies, Evans lengthening osteotomies, metatarsal/cuneiform arthrodesis) is deemed substantially equivalent to predicate devices. Exclusion of spine use is noted. |
| Safety & Effectiveness | Device is as safe and effective as predicate devices. | "The safety and effectiveness of the WMT Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." (Implies no new safety/effectiveness concerns beyond predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Not provided. This 510(k) summary does not describe a performance study with a test set of data. The submission relies on a comparison to predicate devices.
- Data Provenance: Not applicable/Not provided. No specific data provenance for a test set is mentioned as no such study is detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not provided. The 510(k) process for this type of device does not typically involve expert consensus to establish ground truth for a performance study in the same way an AI device might. The "ground truth" for substantial equivalence is based on regulatory standards and comparison to legally marketed predicate devices.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided. No test set requiring expert adjudication is described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This document does not describe a MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI tools, not for a bone fixation wedge.
- Effect Size of Human Readers with AI vs. Without AI: Not applicable, as no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No. This device is a physical bone fixation wedge, not an algorithm. Therefore, a standalone algorithmic performance study is not relevant or described.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) clearance is the established regulatory acceptance of predicate devices. The device is considered safe and effective because it is substantially equivalent to devices already on the market, which have a history of safe and effective use. This is primarily a regulatory and engineering assessment rather than a clinical ground truth derived from pathology or outcomes data for a new device performance evaluation.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This device is a physical implant, not an AI algorithm, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable/Not provided. As above, this concept does not apply to a physical medical implant in the context of this 510(k) submission.
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K070592 pg 1 of 2
UCT 6 2007
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Small Bone Wedge.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | June 27, 2007 |
| Contact Person: | Brian Young |
| Sr. Director, Regulatory Affairs | |
| Proprietary Name: | Small Bone Wedge |
| Common Name: | Wedge |
| Classification Name and Reference: | 21 CFR 888.3040/ HWC Smooth or threaded metallic bone fixation fastener - Class II |
| 21 CFR 888.3030/ HRS Single/multiple component metallic bone fixation appliances and accessories – Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/HWC & Orthopedics/87/HRS |
DEVICE INFORMATION
A. INTENDED USE
INDICATIONS
The Small Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Opening wedge osteotomies of Hallux Valgus
- · Evans lengthening osteotomies
- · Metatarsal/cuneiform arthrodesis.
The Small Bone Wedge is not intended for use in the spine.
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B. DEVICE DESCRIPTION
The Small Bone wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered in two distinct designs with varying widths and thicknesses to accommodate a variety of small bone applications.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the WMT Wedge are substantially equivalent to the predicate devices. The safety and effectiveness of the WMT Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Brian Young Senior Director, Regulatory Affairs 5677 Airline Road Arlington, TN 38002
OCT 5 " 2007
Re: K070592 Trade/Device Name: Small Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: HRS, HWC Dated: June 25, 2007 Received: July 10, 2007
Dear Mr. Young:
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, isting 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.
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Page 2 - Mr. Brian Young
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Barchum
Mark N. Melke 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
K 070592 510(k) Number (if known):
Device Name: Small Bone Wedge
Indications For Use:
The Small Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Opening wedge osteotomies of Hallux Valgus
- Evans lengthening osteotomies
- · Metatarsal/cuneiform arthrodesis.
The Small Bone Wedge is not intended for use in the spine.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 of 1
Barbara Vincent Arnon
eneral, Restorative, and Neurological Devices
510(k) Numb: K070592
§ 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.