(90 days)
The SOLUSTAPLE® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
The SOLUSTAPLE® is indicated for:
● Akin type osteotomy
The SOLUSTAPLE® is a staple with two self-drilling tips. The treatment with a Solustaple allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available. In order to safeguard the fonction of the joint, the staple with oblique design will be used.
This submission is a 510(k) premarket notification for the SOLUSTAPLE®, a bone fixation staple, and therefore does not contain details about acceptance criteria or specific study results to prove meeting those criteria. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not to establish new safety and effectiveness standards through comprehensive clinical trials with pre-defined acceptance criteria.
The provided documents indicate:
- Predicate Device: The SOLUSTAPLE® is substantially equivalent to the Depuy, Inc. Varisation Staple.
- Technological Characteristics Comparison: Both staples are made of stainless steel conforming to ASTM F138 & F139 for bone fixation. This comparison of material properties is the extent of the "proof" provided for the 510(k) submission.
Therefore, the requested information components related to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission. The FDA clearance is based on the material equivalence and intended use comparison.
No study details are provided in this 510(k) submission. The FDA's decision is based on the comparison of technological characteristics to a predicate device already legally marketed.
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AUG - 3 1999
Image /page/0/Picture/1 description: The image shows the logo and contact information for a company called NEWDEAL SA. The logo features the word "newdeal" in a stylized font. Below the logo is the company's address, which is 31 RUE DE LA CONVENTION, PARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE. The phone number is (33) 04 74 78 15 15, and the fax number is (33) 04 74 78 15 16.
INTERNET EMAIL : NEWDEALFR@AOL.COM
SUMMARY OF SAFETY AND EFFECTIVENESS 3.
SPONSOR IDENTIFICATION A.
NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE
Tél. : (33) 4 74 78 15 15
Fax : (33) 4 74 78 15 16
ESTABLISHMENT B. REGISTRATION NUMBER: Pending
OFFICIAL CONTACT PERSON C.
Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854
Tel. : (301) 279 -2899 Fax : (301) 294-0126
DATE OF PREPARATION OF THIS SUMMARY: D.
SOLUSTAPLE® PROPRIETARY (TRADE) NAME: E.
- F. COMMON NAME: Bone fixation staple
- CLASSIFICATION NAME AND REFERENCE: (21 CFR, Section 888.3030) G.
- PROPOSED REGULATORY CLASS: Class II н.
- I. DEVICE PRODUCT CODE: 87JDR
- J. PANEL CODE: 21 CFR par. 888.3030
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K. DESCRIPTION OF DEVICE:
The SOLUSTAPLE® is a staple with two self-drilling tips. The treatment with a Solustaple allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available. In order to safeguard the fonction of the joint, the staple with oblique design will be used.
L. INTENDED USE:
The SOLUSTAPLE® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
M. INDICATIONS FOR USE:
The SOLUSTAPLE® is indicated for:
- · Akin type osteotomy
PREDICATE DEVICE: N.
The SOLUSTAPLE® is substantially equivalent to the Depuy, inc Varisation Staple.
0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
Both the SOLUSTAPLE® ,the Depuy, inc Varisation Staple are made in stainless steel
according to ASTM F138 & F139 for bone fixation.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the agency's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -3 1999
Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. Representing New Deal S.A. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K991566
Trade Name: Solustaple® Regulatory Class: II Product Code: JDR Dated: May 4, 1999 Received: May 5, 1999
Dear Dr. Estrin:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 Regulation (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 regulation 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.
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.
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Page 2 - Dr. Norman F. Estrin
If you desire specific advice for your device on our labeling regulation (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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia 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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510(k) Number (if known):
SOLUSTAPLE ® Device Name:
Indications for Use:
The SOLUSTAPLE® is indicated for:
● Akin type osteotomy
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X (Per 21 CFR 801.109) |
|---|---|
| ------------------ | ------------------------ |
OR
| Over-the-Counter Use | (Optional Format 1-2-96) |
|---|---|
| ---------------------- | -------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991566 |
§ 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.