(73 days)
DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.
DynaMatrix™ is a bioabsorbable, extracellular collagen membrane matrix that is identical to the predicate SURGISIS® Periodontal Membrane (K010952), also manufactured by Cook Biotech Incorporated. This premarket notification is being submitted to expand the indications for use and to introduce a new product name.
The provided text is a 510(k) summary for a medical device called DynaMatrix™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a comparative study with a strict set of performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Instead, the submission focuses on establishing substantial equivalence based on:
- Device Description: DynaMatrix™ is described as a bioabsorbable, extracellular collagen membrane matrix that is identical to a previously cleared predicate device, SURGISIS® Periodontal Membrane (K010952).
- Intended Use: The intended uses are provided, which expand upon those of the predicate device while maintaining the same design principles. These uses include guided tissue regeneration, guided bone regeneration, healing of periodontal defects, gingival augmentation, maintaining/enhancing alveolar ridges, and containing/preventing graft material migration.
- Equivalence to Marketed Device: The core of the 510(k) is the claim that DynaMatrix™ is substantially equivalent in indications and design principles to existing predicate devices. This implies that the safety and effectiveness are established by the predicate devices, rather than through new performance studies against specific acceptance criteria.
In summary, the document states that the device is substantially equivalent to a predicate device, which allows it to be marketed. It does not provide the details of a study with acceptance criteria and measured performance as requested.
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510(k) Summary
K082058
510(k) Summary
DynaMatrix™M
p
Cook Biotech Incorporated DynaMatrix
OCT 02 2008
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Cook Biotech Incorporated1425 Innovation PlaceWest Lafayette, Indiana 47906Telephone: +1 (765) 807-1942Fax: +1 (765) 807-7709 |
|---|---|
| Official Contact: | Perry W. Guinn |
| Representative/Consultant: | David Collette, M.D.Floyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236email: dcollette@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations: Product Code: Classification Panel: Reviewing Branch:
DynaMatrix™ Barrier, animal source, intraoral Class II, 21 CFR 872.3930 NPL Dental Products Panel Dental Devices Branch
INTENDED USE
DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.
Page 19 of 124 (revised)
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510(k) Summary
DynaMatrix™
Image /page/1/Picture/3 description: The image contains a handwritten text string that appears to read "-g2" with a horizontal line underneath. The characters are written in a cursive style, with the 'g' having a distinct loop. The number '2' is written to the right of the 'g'. The line is positioned directly below the characters, possibly indicating an underline or a separation.
DEVICE DESCRIPTION
DynaMatrix™ is a bioabsorbable, extracellular collagen membrane matrix that is identical to the predicate SURGISIS® Periodontal Membrane (K010952), also manufactured by Cook Biotech Incorporated. This premarket notification is being submitted to expand the indications for use and to introduce a new product name.
EQUIVALENCE TO MARKETED DEVICE
Cook Biotech Incorporated demonstrated that, for the purposes of FDA's regulation of medical devices, DynaMatrix is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
Page 20 of 124 (revised)
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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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the top right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 02 2008
Cook Biotech, Incorporated C/O Dr. David J. Collette Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K082058
Trade/Device Name: DynaMatrixTM Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: September 26, 2008 Received: September 29, 2008
Dear Dr. Collette:
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.
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Page 2 - Dr. Collette
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 (OS) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.
Sincerely vours.
J.K. Mueller, M.D. for U
Chiu S. Lin. Ph. D Division 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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510(k) Premarket Notification
DynaMatrix™
1071
Indications for Use
510(k) Number (if known): K082058
Device Name: DynaMatrix TM
Indications for Use:
DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bonc regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or cnhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.
Susan Rooney
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K052258
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Page 17 of 124 (revised)
§ 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.