(73 days)
No
The summary describes a bioabsorbable collagen membrane and does not mention any AI or ML components or functionalities.
No
The device aids in tissue and bone regeneration and contains graft material, which are supportive functions rather than direct therapeutic treatments.
No.
The device description indicates it is a bioabsorbable extracellular collagen membrane matrix used for tissue and bone regeneration and other related surgical procedures, not for identifying or investigating diseases or conditions.
No
The device description clearly states that DynaMatrix™ is a bioabsorbable, extracellular collagen membrane matrix, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for surgical procedures related to tissue and bone regeneration. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a bioabsorbable, extracellular collagen membrane matrix. This is a material implanted into the body, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD.
Therefore, DynaMatrix™ is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
NPL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
Not Found
§ 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
510(k) Summary
K082058
510(k) Summary
DynaMatrix™M
p
Cook Biotech Incorporated DynaMatrix
OCT 02 2008
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Cook Biotech Incorporated
1425 Innovation Place
West Lafayette, Indiana 47906
Telephone: +1 (765) 807-1942
Fax: +1 (765) 807-7709 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Perry W. Guinn |
| Representative/Consultant: | David Collette, M.D.
Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA 92130
Telephone: +1 (858) 792-1235
Fax: +1 (858) 792-1236
email: dcollette@paxmed.com
flarson@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.
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1
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.
3
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
4
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)
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