(51 days)
aap's Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's Washers may be used with the screws in certain applications. Specific indications, which are dependent in part on the diameter of the screw, include: scaphoid fractures and other fractures of the hand; metatarsal fractures and other fractures of the foot; malleolar fractures, ligament fixation of the proximal humerus; wrist, ankle, shoulder and elbow fractures; fractures of the pelvis and acetabulum: femoral neck and fractures: femoral supracondvlar fractures; and tibial plateau fractures.
The aan Cannulated Screws and Washers are manufactured of Titanium Allov (Ti 6A1 4V E.L.I.) and 316 L Stainless steel. The age Cannulated Screws are available in various lengths and various thread diameters. The aap Washers are available in the appropriate sizes to fit with the screws and are manufactured of Titanium Alloy (Ti 6A1 4V E.L.I.) and 316 L Stainless Steel.
Unfortunately, the provided text does not contain specific acceptance criteria or details of a study proving the device meets them. The document is a 510(k) summary for a medical device (aap Cannulated Screws and Washers) and a letter of substantial equivalence from the FDA.
Here's why it doesn't provide the requested information:
- 510(k) Summary Purpose: A 510(k) summary is primarily intended to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, not to present detailed study results proving performance against specific acceptance criteria. Substantial equivalence means it has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness.
- Focus on Equivalence, Not Performance Standards: The document focuses on comparing the new device's materials, intended use, and technological characteristics to existing predicate devices. It states that the "ago Cannulated Screws and Washers are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This is a regulatory statement, not a performance metric from a study.
- "Performance Standards" Section: The "Performance Standards" section only states: "Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable Harmonized Standards ISO 9001/ EN 46001." These are manufacturing and quality system standards, not specific performance acceptance criteria for the device itself (e.g., tensile strength, fatigue life, screw pull-out force, etc.) and there is no study described to show the device meets these. The mention of ASTM requirements implies that certain material properties meet ASTM standards, but specific values or a study where these were measured and compared to an acceptance criterion are absent.
Therefore, I cannot fill out the requested table or answer most of the detailed questions about a performance study, as that information is not present in the provided text.
If this were a document containing such a study, the information would typically be found in sections detailing mechanical testing, clinical trials, or benchtop evaluations with explicit endpoints and statistical analyses.
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/c 990776
4/29/99
510(K) Summary of Safety and Effectiveness
| Submitters Name: | aap Implants Inc.15 Caswell LanePlymouth, MA 02360Ph: 508-747-6098 Fax: 508-747-5118 | |
|---|---|---|
| Contact Name: | Ellen Henke-Knupp, Regulatory Affairs Specialist | |
| Name of Device: | aap Cannulated Screws and Washers | |
| Classification Name: | Smooth or threaded metallic bone fixation fastener | |
| Common/Usual Name: | Cannulated Bone Screw | |
| Proprietary Name: | aap Cannulated Screw | |
| Classification: | Class II | Screw, Fixation, Bone # 87 HWC Reg. # 888.3040 |
| Classification Name: | Washer, Bolt, Nut, Orthopedic | |
| Common/Usual Name: | Washers | |
| Proprietary Name: | aap Washers | |
| Classification: | Class II | Washer, Bolt, Nut, Orthopedic # 87 HTN Reg. # 888.3030 |
Performance Standards: Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable Harmonized Standards ISO 9001/ EN 46001.
The age Cannulated Screws and Washers are manufactured of Titanium Allov (Ti 6Al Material Composition: 4V E.L.I. = ASTM F-136-96 & ASTM F-1295-97) and 316 L Stainless steel (ASTM F-138-92),
Intended Use: aan's Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aan's Washers may be used with the screws in certain applications. Specific indications, which are dependent in part on the diameter of the screw, include: scaphoid fractures and other fractures of the hand; metatarsal fractures and other fractures of the foot; malleolar fractures, ligament fixation of the proximal humerus; wrist, ankle, shoulder and elbow fractures; fractures of the pelvis and acetabulum: femoral neck and fractures: femoral supracondvlar fractures; and tibial plateau fractures.
Device Description: The aan Cannulated Screws and Washers are manufactured of Titanium Allov (Ti 6A1 4V E.L.I.) and 316 L Stainless steel. The age Cannulated Screws are available in various lengths and various thread diameters. The aap Washers are available in the appropriate sizes to fit with the screws and are manufactured of Titanium Alloy (Ti 6A1 4V E.L.I.) and 316 L Stainless Steel.
Predicate Devices for Substantial Equivalency: aap Bone Screws (Stainless Steel & Titanium), OSTEOTECH Cannulated Screws (including Navicular and Cancellous Cannulated Screws)(Stainless Steel 316 L); SYNTHES -Small and Large Cannulated Screw System (Stainless Steel 316L) HOWMEDICA ASNIS II Guided Bone Screws (Stainless Steel 316L), BIODYNAMIC TECHNOLOGIES EZ-Fix™ Cannulated Screw System (Ti 6 A1 4 V E.L.I.), DePuy Cannulated Bone Screw (Stainless Steel 316 LVM), MECRON Cannulated Bone Screws (Stainless Steel 316L) and the ZIMMER Magna-Fx & Mini Magna-Fx Cannulated Screw Fixation System (Stainless Steel),
Comparison of Technological Characteristics: The ago Cannulated Screws and Washers are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics.
Sterilization Information: These devices are distributed non-sterilizations for sterilization are contained in the package insert. Note: These devices are sterilized by the end users utilizing the approved/ outlined guidelines found in the AAMI Guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and in ANSI/AAMI/ISO 11737 guidelines to achieve the acceptable Sterility Assurance Level ( $AL) of 10-6.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Ms. Ellen J. Henke-Knupp Regulatory Affairs Specialist aap Implants, Inc. Boat Yard Square 15 Caswell Lane Plymouth, Massachusetts 02332
Re: K990776 aap Cannulated Screws Trade Name: Requlatory Class: II Product Code: HWC Dated: March 4, 1999 Received: March 9, 1999
Dear Ms. Henke-Knupp:
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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮੈ 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 In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Ellen J. Henke-Knupp
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asborizoof 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 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.D.
Director
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): __ K 99071
Device Name: aap Cannulated Screws and Washers
Indications For Use:
aap's Cannulated Screws are intended for use over a guide pin or wire aap's Cannulated Screws are Incended Logment fixation. aap's
for bone fracture fixation and bone fragment on annligations for bone fracture fringtion and beas in certain applications.
Specific Indications amy include:
- Specific indications and ther fractures of the hand
- scaphold fractures andocher fractures of the footr
- malleolar fractures
- Marreoful fracean of the proximal humerus
- wrist, ankle, shoulder and elbow fractures
- condylar fractures
- Fractures of the pelvis and acetabulum
- fractall neck and femoral head fractures
- femoral supracondylar fractures
- tibial plateau fractures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of General Restorative Devices
510(k) Number K990776
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter 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.