(6 days)
The AutoTac System™ Titanium Tack is intended to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use or fixation.
The proposed membrane fixation tack is fabricated from titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. This material was selected because of its known biocompatibility and mechanical properties. The tack is comprised of a low-profile, round, lens shaped head and a cvlindrical shaft that is tapered to a point at its free end. The shaft is provided with a circular rib (barb) that aids in retention of the tack under normal loading conditions. Three opposing tabs extend from the head of each tack and are designed to secure the tack within the delivery mechanism while transporting to the surgical site. The tack is designed for implantation during the healing period during which tissue regeneration takes place. The tacks are provided non-sterile and are to be sterilized by the user using accepted steam sterilization techniques. The autoclavable tack holder is manufactured from ULTEM medical grade material and consists of 21 receptacles for the tacks. A rotating lid serves to capture the tacks during handling so that the tacks do not dislodge from the autoclavable tack holder. Titanium inserts serve to hold the tack so that the end of the tack does not create wear debris after continued use. The autoclavable tack holder can hold up to 21 tacks.
Here's an analysis of the provided 510(k) summary regarding the BioHorizons Implant Systems, Inc. Titanium Tack, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Ability to insert into bone without pre-drilling. | The tack penetrated the bone analogs to a depth adequate enough to engage the tack barb. |
| Structural Integrity | No structural deformation after insertion. | The tacks showed no structural deformation. |
| Retention/Fixation | Membrane tears before the tack dislodges. | Further in-vitro testing demonstrated that the membrane would tear before the tack could be dislodged. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the "non-clinical testing." It generally refers to "bone analogs" and "in-vitro testing" without quantifiable sample numbers for tacks or tests performed.
The data provenance is in-vitro laboratory testing. There is no information provided about the country of origin, nor is it stated whether the data is retrospective or prospective, as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the "non-clinical testing" described. The "ground truth" for this type of testing is established by engineering and material science principles, measured directly through physical tests on bone analogs and the device itself, rather than expert interpretation.
4. Adjudication Method
This information is not applicable. Adjudication methods are typically used in clinical studies or multi-reader image interpretations to resolve discrepancies among experts. The non-clinical tests described are objective, physical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The provided information details non-clinical, in-vitro mechanical testing of the device itself, not a study involving human readers or assessment of AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not conducted. This device is a physical medical implant, not an AI algorithm. Therefore, "algorithm only" performance is not relevant.
7. Type of Ground Truth Used
The ground truth used for the non-clinical testing was based on:
- Objective physical measurements: Assessing the depth of penetration into bone analogs.
- Visual inspection: Confirming the absence of structural deformation.
- Mechanical force testing: Demonstrating that the membrane would tear before the tack dislodged, indicating superior retention force of the tack.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set for a physical device).
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BioHorizons Implant Systems, Inc. Titanium Tack 510(k) Notification: Special 510(k) - Device Modification 08/21/02
510(k) summary
21 CFR 807.92 Date:
08/21/2002
AUG 2 8 2002
Official Contact: Winston Greer
BioHorizons Implant Systems, Inc. Manufacturer: One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: (205) 967-7880 Fax: (205) 870-0304
Proprietary Name
The AUTOTAC System™
Common Name
Membrane fixation pin
Classification Name
Screw, fixation, intraosseous
Predicate Device
The primary predicate device is The AUTOTAC System ™ consisting of bioresorbable membrane fixation pins, components and instruments manufactured and distributed by BioHorizons Implant Systems Inc. Authorization to legally market the predicate BioHorizons AUTOTAC System has been documented under the following 510(k) numbers: K993493, K011675
The predicate devices for the titanium tack are the IMZ Bone Tack System manufactured and distributed by INTERPORE Systems Inc. and IMTEC Bone Tac manufactured and distributed by IMTEC Corporation. Authorization to market the IMZ Bone Tack System has been documented under 510(k) numbers K952167. Authorization to market the IMTEC Bone Tac has been documented under 510(k) numbers K973180.
Device Description
The proposed membrane fixation tack is fabricated from titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. This material was selected because of its known biocompatibility and mechanical properties. The tack is comprised of a low-profile, round, lens shaped head and a cvlindrical shaft that is tapered to a point at its free end. The shaft is provided with a circular rib (barb) that aids in retention of the tack under normal loading conditions. Three opposing tabs extend from the head of each tack and are designed to secure the tack within the delivery mechanism while transporting to the surgical site. The tack is designed for implantation during the healing period during which tissue regeneration takes place. The tacks are provided non-sterile and are to be sterilized by the user using accepted steam sterilization techniques.
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BioHorizons Implant Systems, Inc. Titanium Tack 510(k) Notification: Special 510(k) - Device Modification 08/21/02
Device Description (cont'd)
The autoclavable tack holder is manufactured from ULTEM medical grade material and consists of 21 receptacles for the tacks. A rotating lid serves to capture the tacks during handling so that the tacks do not dislodge from the autoclavable tack holder. Titanium inserts serve to hold the tack so that the end of the tack does not create wear debris after continued use. The autoclavable tack holder can hold up to 21 tacks.
Intended Use
The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.
Technological Characteristics
The Fundamental Scientific Technology of the modified device has not changed. The proposed AUTOTAC System fixation tack is substantially equivalent to all features of the predicate devices, which could affect safety or effectiveness due to the similarities in design and intended use.
Non Clinical Testing
Testing was conducted to validate that the metal tissue tack could be inserted into bone without pre-drilling the site and the tacks would not deform. Results showed the tack penetrated the bone analogs to a depth adequate enough to engage the tack barb. The tacks showed no structural deformation. Further in-vitro testing demonstrated that the membrane would tear before the tack could be dislodged.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Mr. Winston Greer
Director, Quality Assurance & Regulatory Affairs Biohorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243
Re: K022790
Trade/Device Name: The AutoTac System™ Titanium Tack Regulation Number: 872.4880 and 880.3040 Regulation Name: Intrasseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: August 21, 2002 Received: August 22, 2002
Dear Mr. Greer:
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, 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 (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.
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Page 2 - Mr. Greer
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.
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) 594-4613. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BioHorizons Implant Systems, Inc. Titanium Tack 510(k) Notification: Special 510(k) - Device Modification 08/21/02
Page 1 of 1
510(k) Number (if known):
Device Name: The AutoTac System™ Titanium Tack
Indications for Use:
The AutoTac System™ Titanium Tack is intended to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use or fixation.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Der
510(k) Number: K022196
Prescription Use (per 21 CFR 801.109 OR
Over-the-Counter Use
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.