(160 days)
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No
The device description and intended use focus on the material properties and physical function of a bioabsorbable mesh, with no mention of AI or ML technologies.
Yes
Explanation: The device is described as a barrier to provide temporary support during healing and to aid in the healing of periodontal defects, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a "barrier to provide temporary support during the early stages of the healing process following periodontal surgery" and an "implantable material intended to aid in the healing of periodontal defects." This indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states it is a "woven mesh" prepared from a "synthetic, bioabsorbable copolymer" and is a "bioabsorbable implantable material," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "barrier to provide temporary support during the early stages of the healing process following periodontal surgery" and an "implantable material intended to aid in the healing of periodontal defects." This describes a device that is implanted into the body to provide physical support and aid in healing, not a device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a "synthetic, bioabsorbable copolymer of glycolide and lactide" in a "woven mesh" form, provided sterile and with ligatures. This is consistent with an implantable medical device, not an IVD which would typically involve reagents, calibrators, controls, or instruments for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is mechanical support and aiding in tissue regeneration.
Therefore, VICRYL periodontal mesh is a medical device, specifically an implantable medical device, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VICRYL periodontal mesh is intended for use as a barrier to provide temporary support during the early stages of the healing process following periodontal surgery.
VICRYL periodontal mesh is a bioabsorbable implantable material intended to aid in the healing of periodontal defects.
Product codes (comma separated list FDA assigned to the subject device)
NPK
Device Description
VICRYL (polyglactin 910) Periodontal Mesh. VICRYL periodontal mesh is prepared from a synthetic, bioabsorbable copolymer of glycolide and lactide. The woven mesh is prepared from undyed strands identical to the strands used in VICRYL (polyglactin 910) synthetic, bioabsorbable suture. VICRYL periodontal mesh is provided sterile, available in various sizes and shapes each with synthetic, bioabsorbable VICRYL ligatures affixed to the barrier.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Periodontal defects / oral cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical characterization to assess thermal properties and molecular weight was conducted. Preclinical laboratory and clinical evaluations were conducted to ensure that the device functioned as intended. Sufficient data has been gathered from preclinical and clinical testing to assess the safety and effectiveness of the new device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GORE-TEX® Periodontal Material
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract emblem, resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
001 10 2007
John D. Paulson, Ph.D. Vice President, Regulatory Affairs Ethicon, Incorporated Route 22 West Somerville, New Jersey 08876
Re: K955646
Trade Name: Vicryl Peridontal Mesh Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: March 27, 1996 Received: March 28, 1996
Dear Dr. Paulson:
This letter corrects our substantially equivalent letter of May 20, 1996.
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 (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 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.
1
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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Syrite Y. Michie Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Image /page/1/Picture/7 description: The image is a circular seal with the text "CALIFORNIA, PROTECTION" around the top and "PUBLIC HEALTH" around the bottom. The seal also contains the years "1906-2006" at the top and the word "Centennial" in the center. The letters "FDA" are in the center of the seal in a bold, sans-serif font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
2
MAY 20 1996
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act. respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
NEW DEVICE NAME: VICRYL (polyglactin 910) Periodontal Mesh
PREDICATE DEVICE NAME: GORE-TEX® Periodontal Material
510(k) SUMMARY
Device Description
Intended Use
VICRYL periodontal mesh is prepared from a synthetic, bioabsorbable copolymer of glycolide and lactide. The woven mesh is prepared from undyed strands identical to the strands used in VICRYL (polyglactin 910) synthetic, bioabsorbable suture.
VICRYL periodontal mesh is provided sterile, available in various sizes and shapes each with synthetic, bioabsorbable VICRYL ligatures affixed to the barrier.
VICRYL periodontal mesh is intended for use as a barrier to provide temporary support during the early stages of the healing process following periodontal surgery.
Continued on next page
3
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
1 ..
510(k) SUMMARY, Continued
| Indications
Statement | VICRYL periodontal mesh is a bioabsorbable implantable
material intended to aid in the healing of periodontal defects. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The new device provides a membrane barrier to apical migration
of gingival epithelium during a period of periodontal ligament
regeneration. Unlike the predicate device, the new device does
not need to be removed post-implantation. |
| Performance Data | Analytical characterization to assess thermal properties and
molecular weight was conducted. Preclinical laboratory and
clinical evaluations were conducted to ensure that the device
functioned as intended. Sufficient data has been gathered from
preclinical and clinical testing to assess the safety and
effectiveness of the new device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug, and Cosmetic Act. |
| Contact | John D. Paulson, Ph.D.
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ
08876-0151 |
| Date | December 8, 1995 |