(64 days)
The "new" SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments. Weil osteotomy Mono-cortical fixation Osteotomies and fractures fixation in the foot and hand
The SPIN ® SNAP-OFF SCREW is self drilling and self tapping snap-off screw One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. In comes in lengths from 11 to 14 mm. The length varies whereas the head diameter is constant ( 2 mm) and the distal thread length is 7 mm to 10 mm.
K011946 refers to the SPIN® SNAP-OFF SCREW. The provided text, however, does not contain a study that proves the device meets specific acceptance criteria in the typical format of a clinical or performance study.
The document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence to existing predicate devices. It focuses on demonstrating that the "new" SPIN® SNAP-OFF SCREW is as safe and effective as previously cleared devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the format of acceptance criteria and performance metrics. The document instead highlights "technical equivalence" and "same torque."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as specific numerical acceptance criteria. | The "new" SPIN® SNAP-OFF SCREW is technically equivalent to the currently cleared SPIN® SNAP-OFF screw (K991477). |
| Assumed requirement for comparable mechanical properties (e.g., torque). | The torque of the "new" SPIN® SNAP-OFF SCREW is the same as the "old" (currently cleared) SPIN® SNAP-OFF screw. The active part design has not changed. |
2. Sample Size for the Test Set and Data Provenance
No specific test set or associated sample size is mentioned for a formal study. The evaluation likely relied on pre-existing data or comparison of design specifications and material properties to predicate devices.
- Sample Size (Test Set): Not applicable, as a formal test set for a comparative effectiveness study is not described.
- Data Provenance: Not applicable in the context of a clinical study. The comparison is based on the design, materials, and intended use relative to predicate devices. The sponsor is NewDeal SA in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set. The substantial equivalence determination is made by the FDA based on the provided technical comparative analysis.
4. Adjudication Method for the Test Set
Not applicable, as no external adjudication of a test set is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
No MRMC comparative effectiveness study is described. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device's characteristics to cleared predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This is not applicable as the device is a mechanical bone fixation screw, not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The new device is deemed "substantially equivalent" if it shares the same intended use, technological characteristics, and performs as safely and effectively as the predicate without raising new questions of safety or effectiveness. This is based on a technical comparative analysis, rather than a direct clinical "ground truth" derived from patient outcomes or pathology for the "new" device in a de novo study.
8. Sample Size for the Training Set
Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study (as described in the 510(k) document):
The "study" presented is a technical comparison and declaration of substantial equivalence to previously cleared predicate devices.
- Objective: To demonstrate that the "new" SPIN® SNAP-OFF SCREW is substantially equivalent to the currently approved SPIN® SNAP-OFF screw (K991477) and other predicate devices like the Depuy Twist-off Screw (K962233), the Howmedica Luhr Screw system (K950595), Synthes Cortex Screws (K952272 and K002271), and the Osteomed M3 Screw (K924018, K924138).
- Methodology: The sponsor asserts that the "new" device has the "same intended use" and that the "design of the active part (screw itself) has not changed." Key comparability points include:
- Intended Use: Identical to the currently cleared SPIN® SNAP-OFF screw and similar to other predicates (fixation of bone fractures or reconstruction, particularly small bone fragments, Weil osteotomy, mono-cortical fixation in foot and hand).
- Technological Characteristics:
- The torque of the "new" SPIN® SNAP-OFF SCREW is the "same" as the "old" (currently cleared) SPIN® SNAP-OFF screw.
- All comparable devices are made from Titanium alloys (except Luhr and 2.4mm Synthes which are Cobalt-Chrome and SS respectively), a material commonly used in orthopedics.
- Similar dimensions (e.g., 2.0mm diameter for most, with a range for others).
- Most have a low profile head, are self-drilling, and self-tapping.
- Conclusion: Based on this comparative analysis, the FDA found the device "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to the market.
This 510(k) submission does not present a de novo clinical trial with specific acceptance criteria and direct patient outcome data for the new device. Instead, it leverages the established safety and efficacy of previously cleared devices.
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AUG 2 4 2001
ACTIVITES & 38200
SUMMARY OF SAFETY AND EFFECTIVENESS
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 REGISTRATION NUMBER: B.
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 estrin(a)vourl DAconsultant.com
D. DATE OF PREPARATION OF THIS SUMMARY: June 20, 2001
- SPIN® SNAP-OFF SCREW E. PROPRIETARY (TRADE) NAME:
- F. COMMON NAME: Bone fixation screw,
- Self drilling and self tapping snap-off screw
- CLASSIFICATION NAME AND REFERENCE G.
- Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040) H. PROPOSED REGULATORY CLASS: Class II
SA au capital de 1.000.000 F - Nº Siret 412 111 510 000 19 - NAF 3318 - 412 111 510 RCS Vienne
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DEVICE PRODUCT CODE: 1.
87HWC 21 CFR par. 888.3040
J. PANEL CODE:
DESCRIPTION OF DEVICE: K.
The SPIN ® SNAP-OFF SCREW is self drilling and self tapping snap-off screw One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. In comes in lengths from 11 to 14 mm. The length varies whereas the head diameter is constant ( 2 mm) and the distal thread length is 7 mm to 10 mm.
L. INTENDED USE:
The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions.
M.
INDICATIONS FOR USE:
The "new" SPIN® SNAP-QFF SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
Fixation of small bone fragments.
- . Weil osteotomy
- Mono-cortical fixation .
- Osteotomies and fractures fixation in the foot and hand
PREDICATE DEVICE: N.
●
The "new" SPIN® SNAP-OFF SCREW is technically equivalent to the SPIN" SNAP-OFF screw currently approved (K991477). The "now" SPIN" SNAP-OFF SCREW is substantially equivalent to the Depuy Twist-off Screw (K962233), the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Screw (K924018, K924138).
0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The "new" SPIN® SNAP-OFF screw is technically equivalent to the device currently cleared. They have the same intended use, and the design of the active part (screw itself) has not changed. The "new" SPIN" SNAP-OFF screw, the Depuy Twist-off Screw, the howmedica Luhr Screw system, the 2.0mm and 2.4mm Synthes Cortex Screw and the Osteomed M3 Screw have the same intended use and all are indicated for fixing small fractures or osteotomics. All arc made from Titanium alloys, except the Luhr Scrow system which is provided in Cobalt-Chrome alloy, and the 2.4mm Synthes Cortex Screw which is provided in 316L. Stainless steel. The Titanium alloy used for the SPIN® SNAP-OFF SCREW is a matcrial commonly used among professionals in the orthopedic field. The "new" SPIN" SNAP-OFF screw, the Depuy Twist-off Screw, the howmedica Luhr Screw system, the 2.0mm Synthes Cortex Screw and the Ostcomed M3 Screw are 2.0mm diameter screws (range 1.2 - 3.0mm for the M3 screw system). Most have a low profile head, are self-drilling and self-tapping screws.
P. SUMMARY OF STUDIES:
to of the torque of the "bew" SPIN" SNAP-OFF SCREW is the same as live the line the line the line the line the line the line the line the line the lines not
changed, changed.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with its wings spread and head facing left. The design is simple and uses a bold, black color scheme.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2001
New Deal. S.A. C/O Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K011946
Trade Name: The Spin Snap-Off Screw Regulation Number: 888.3040 Regulatory Class: Class II Product Code: HWC Dated: June 20, 2001 Received: June 21, 2001
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 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). You may, therefore, market the device, subject to the general controls oosisions 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 regulations ( Feniance I Ippe any in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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
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Page 2 - Norman F. Estrin, Ph.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you dollio specific as 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, (301) 594-16th of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely vours.
Mark N. Wilkerson
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K01194b
SPIN® SNAP-OFF SCREW Device Name:
Indications for Use:
The "new" SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
- Fixation of small bone fragments. ।
- Weil osteotomy ।
- Mono-cortical fixation i
- Mono ocruced and fractures fixation in the foot and hand
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)
Mark N Millman
510(k) Number
00014
§ 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.