(86 days)
NEWDEAL K WIRE is indicated for : - use in Fixation of bone fractures, - bone reconstruction, - as guide pins for insertion of other implants. - The size of the K WIRE should be adapted to the specific indication.
The NEWDEAL K WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool equipment for insertion. The NEWDEAL K WIRES are made out of stainless steel within the frame of the standard NF ISO 5832-1, ASTM F138. They are dedicated to fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants. The range of NEWDEAL K WIRE includes three different diameters 1.0 mm, 1.6 and 2.5 mm and four lengths 70, 100, 150 and 200 mm.
The provided text is a 510(k) summary for the NEWDEAL K WIRE, a Kirschner wire. It details the device's characteristics and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or performance studies as typically found for complex medical devices requiring such validation.
Instead, the document explicitly states:
"SUMMARY OF STUDIES: NEWDEAL K WIRES are stainless steel wires with diameters not smaller than those featured in the predicate device systems Moreover, the NEWDEAL K WIRES conform to the international standard: ISO 5838-1 (1995). Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires."
This indicates that the device's acceptance was based on its conformance to International Standard ISO 5838-1 (1995) and its material properties (316L stainless steel) and dimensions being comparable to already legally marketed predicate devices (DePuy Kirschner wires and Steinmann pins, and Syntec-Taichung Medical Instruments Kirschner wires and Steinmann pins). The FDA's 510(k) clearance letter confirms this approach, stating the device is "substantially equivalent" to predicate devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document because a dedicated performance study demonstrating the device meets acceptance criteria was deemed unnecessary for this type of medical device due to its substantial equivalence to existing products and adherence to relevant standards.
The closest information to what was requested is:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Conformity to international standard for surgical implants (ISO 5838-1) | Conforms to ISO 5838-1 (1995) |
| Material properties (316L Stainless Steel) | Made from 316L stainless steel |
| Comparable range of sizes and diameters to predicate devices | Has comparable ranges of sizes and diameters to predicate devices |
| Intended use (fixation of bone fractures, bone reconstruction, guide pins) | Indicated for use in fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants |
Summary of missing information:
- Sample sizes for test set: Not applicable, no specific test set beyond material and dimensional comparison.
- Data provenance: Not applicable.
- Number of experts used to establish ground truth: Not applicable.
- Qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Ko2 2599
OCT 3 0 2002
Image /page/0/Picture/2 description: The image shows the logo for New Deal. The logo consists of a circle with four black dots equally spaced around the circumference. The word "newdeal" is written in black, sans-serif font to the right of the circle, with the "n" partially inside the circle. A registered trademark symbol is present to the right of the word "deal".
NEWDEAL SA • 31, RUE DE LA CONVENTION PARC D'ACTIVITÉS GARIGLIANO 3 8 2 0 0 0 V I E N NE . ● F R A N C E TEL : + 3 3 ( 0 ) 4 7 4 7 8 1 5 1 5 FAX : +33 (0) 4 74 78 15 16 w w w . nee w dre a l . i n f o E м А ı L :
3. SUMMARY OF SAFETY AND EFFECTIVENESS
- A. SPONSOR IDENTIFICATION 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
B. ESTABLISHMENT REGISTRATION NUMBER: 9615741
C. OFFICIAL CONTACT PERSON 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: August 3, 2002 D.
- E. PROPRIETARY (TRADE) NAME: NEWDEAL K WIRE
- F. COMMON NAME: Kirschner wire
660009
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G. CLASSIFICATION NAME AND REFERENCE
Pin, Fixation, smooth (21 CFR, Section 888.3040)
- H. PROPOSED REGULATORY CLASS: Class II
- DEVICE PRODUCT CODE: I. HTY
- J. PANEL CODE: 87 OR Orthopedic
K. DESCRIPTION OF DEVICE:
The NEWDEAL K WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool equipment for insertion.
The NEWDEAL K WIRES are made out of stainless steel within the frame of the standard NF ISO 5832-1, ASTM F138.
They are dedicated to fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants.
The range of NEWDEAL K WIRE includes three different diameters 1.0 mm, 1.6 and 2.5 mm and four lengths 70, 100, 150 and 200 mm.
L. INDICATIONS FOR USE: NEWDEAL K WIRE is indicated for use in Fixation of bone fractures, for bone reconstruction, as guide pins for insertion of other implants. The size of the K WIRE should be adapted to the specific indication. M. PREDICATE DEVICE: The NEWDEAL K WIRE is substantially equivalent to the DePuy Kirschner wires and Steinmann pins (K960385) and Kirschner wires and Steinmann pins from Syntec-
N. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
NEWDEAL K WIRES, Kirschner wires, Steinmann pins from Syntec-Taichung Medical Instruments and Kirschner wires, Steinmann pins from Depuy are intended to be implanted for fixation of bone fractures, for bone reconstruction, as guide pins for insertion of other implants.
Taichung Medical Instruments (K983121).
NEWDEAL K WIRES are made from 316 L stainless steel, which is the same material as the Kirschner wires and Steinmann pins from Syntec-Taichung Medical Instruments and from Depuy.
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2 ct 3
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The Kirschner wires and Steinmann pins manufactured by Depuy and Syntec-Taichung Medical Instruments and NEWDEAL K WIRE have comparable ranges of sizes and diameters.
O. SUMMARY OF STUDIES: NEWDEAL K WIRES are stainless steel wires with diameters not smaller than those featured in the predicate device systems Moreover, the NEWDEAL K WIRES conform to the international standard: ISO 5838-1 (1995). Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and three human profiles facing right. The caduceus and profiles are depicted in black, contrasting with the white background of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2002
NewDeal SA c/o Norman F. Estrin, Ph.D. Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K022599
Trade/Device Name: NewDeal K-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: July 28, 2002 Received: August 5, 2002
Dear Dr. Estrin:
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. Iisting 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Norman F. Estrin, Ph.D.
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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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 yours,
Marl N. Mikkelsen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K0225-99
Page 1 of 1
510 (k) Number (if known) :
Device Name :
Indications for Use :
NEWDEAL K WIRE is indicated for :
- use in Fixation of bone fractures, -
- bone reconstruction, -
- as guide pins for insertion of other implants. -
The size of the K WIRE should be adapted to the specific indication.
for Mark N. Mulhern
en-Off Division of ( meri cratorative and Neurological L _
510(k) Number K0225794
(PLEASE DO NOT WRITE BELOW THIS LINE –CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
6000
OR
Over -the-counter Use
(Per 21 CFR 801.109)
Prescription Use
(Optional format 1-2-96)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.