(200 days)
No
The device description focuses on the material properties and biological function of a collagen membrane, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for use in guided tissue regeneration and bone regeneration procedures, and provides a passive, resorbable scaffold to facilitate healing and new bone formation, which are therapeutic functions.
No
The device is described as a bioabsorbable collagen membrane used for tissue and bone regeneration, acting as a scaffold. Its purpose is therapeutic and restorative, not to diagnose conditions.
No
The device description clearly states it is a physical, bioabsorbable collagen membrane matrix derived from porcine tissue, supplied as layered sheets. It is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly 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 description details a physical implantable device made of biological material, designed to be placed within the body to facilitate healing. This is not consistent with the nature of an IVD.
- Mechanism of Action: The device works by providing a physical scaffold for tissue growth in vivo. IVDs work by analyzing biological samples to detect or measure substances or characteristics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, DynaMatrix is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DynaMatrix is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to enhance alveolar ridges, or to contain or prevent migration of graft material. The device is supplied sterile and intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
DynaMatrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are lyophilized, packaged in a Tyvek pouch, and sterilized using ethylene oxide to an SAL of 10°. The device is available in sheets ranging from 2 cm2 to 12 cm2, and can be trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane maintains suture tear resistance. It is considered to be a permanent contact implanted device, and is fully biocompatible.
DynaMatrix is available by prescription only and is intended for use in an oral surgery setting for guided tissue regeneration and 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 or prevent migration of graft material. Dynamatrix achieves its intended use by providing a passive, resorbable scaffold to guide epithelial tissue ingrowth and angiogenesis of the epithelial layer in order to maintain space around the bony defect, prevent epithelial down-growth, and allow for new bone formation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, periodontal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, oral surgery setting
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)
No additional testing was required.
Successful risk analysis and completion of verification activities provide evidence to support the conclusion that the size modification does not introduce new risks and that the subject device performs comparably and is substantially equivalent to the predicate device that is currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
This Special 510(k) describes a dimensional change to supply additional DynaMatrix graft sizes (within the cleared size range of the reference device). The indication for use remains identical to that of the predicate device.
The subject device is identical to the predicate with regard to intended use, indications for use, target population, anatomical site, use setting, performance, materials, compatibility with the environment and other devices, chemical safety, design, standards met, biocompatibility, and sterility. The subject differs from the predicate device solely in regard to its dimension as detailed in the Substantial Equivalence Table (Table 5-1). The introduction of new device sizes does not affect the intended use or the substantial equivalence of the product.
Any potential new risks associated with the additional device sizes have been identified by appropriate risk analysis methods. These potential new risks have been addressed with verification activities in a manner satisfactory to pre-determined acceptance criteria to ensure that no change to device substantial equivalence has occurred. Specifically, biocompatibility qualification was performed to ensure that no new risks of biocompatibility were present. Validation activities were comprised of a swine pilot study that showed successful incorporation and no foreign body response for devices matching the nominal thickness of the subject device, and FDA clearance of another SIS device with the same nominal thickness (K133306).
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2017
Cook Biotech Incorporated Perry Guinn VP Regulatory Affairs And Quality Assurance 1425 Innovation Place West Lafayette, Indiana 47906
Re: K161762
Trade/Device Name: Dynamatrix/dynamatrix Plus Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: June 24, 2016 Received: June 27, 2016
Dear Perry Guinn:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161762
Device Name DynaMatrix/DynaMatrix Plus
Indications for Use (Describe)
DynaMatrix is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to enhance alveolar ridges, or to contain or prevent migration of graft material. The device is supplied sterile and intended for one-time use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Submitted by: Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 497-3355 24 June, 2016
Name of Device:
| Trade/Proprietary Names: | DynaMatrix™, DynaMatrix Plus™ |
|---|---|
| Common/Usual Names: | Barrier, animal source, intraoral |
| Proposed Classification Name: | Bone Grafting Material |
| Product Code: | NPL |
| Device Class: | 21 CFR §872.3930, Class II |
Performance Standards: No performance standards that have been established under Section 514 of the Food, Drug and Cosmetic Act apply to this device.
Predicate Device:
The predicate device is DynaMatrix (K082058), cleared October 2, 2008.
Reference Device:
The reference device is Surgisis Periodontal Membrane (K010952), cleared June 10, 2002.
Intended Use:
DynaMatrix is intended for use in guided tissue regeneration and 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 or prevent migration of graft material.
The device is provided sterile and is intended for one-time use.
This intended use is identical to that of the predicate device cleared under K082058.
Device Description:
DynaMatrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are lyophilized, packaged in a Tyvek pouch, and sterilized using ethylene oxide to an SAL of 10°. The device is available in sheets ranging from 2 cm to 12 cm2, and can be trimmed or shaped to the appropriate size to
4
fit the defect to be treated. When hydrated, the membrane maintains suture tear resistance. It is considered to be a permanent contact implanted device, and is fully biocompatible.
DynaMatrix is available by prescription only and is intended for use in an oral surgery setting for guided tissue regeneration and 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 or prevent migration of graft material. Dynamatrix achieves its intended use by providing a passive, resorbable scaffold to guide epithelial tissue ingrowth and angiogenesis of the epithelial layer in order to maintain space around the bony defect, prevent epithelial down-growth, and allow for new bone formation.
Comparison to Predicate Device:
This Special 510(k) describes a dimensional change to supply additional DynaMatrix graft sizes (within the cleared size range of the reference device). The indication for use remains identical to that of the predicate device.
The subject device is identical to the predicate with regard to intended use, indications for use, target population, anatomical site, use setting, performance, materials, compatibility with the environment and other devices, chemical safety, design, standards met, biocompatibility, and sterility. The subject differs from the predicate device solely in regard to its dimension as detailed in the Substantial Equivalence Table (Table 5-1). The introduction of new device sizes does not affect the intended use or the substantial equivalence of the product.
Summary of Non-Clinical Tests:
No additional testing was required.
Substantial Equivalence:
Table 5-1 below provides a comparison of the subject device, its predicate and the reference device.
| Device | DynaMatrix/ DynaMatrix
Plus (Subject Device) | DynaMatrix
(Predicate Device) | SURGISIS Periodontal
Membrane
(Reference Device) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Inc. | Cook Biotech Inc. | Cook Biotech Inc. |
| 510(k) number | unassigned | K082058 | K010952 |
| Product Code | NPL | NPL | NPL |
| Material
composition | Porcine small intestinal
submucosa; primarily
collagen types I and III | Porcine small intestinal
submucosa; primarily
collagen types I and III | Porcine small intestinal
submucosa; primarily
collagen types I and III |
| Supplied sterile? | Yes | Yes | Yes |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Intended for single
use? | Yes | Yes | Yes |
| Device | DynaMatrix/ DynaMatrix
Plus (Subject Device) | DynaMatrix
(Predicate Device) | SURGISIS Periodontal
Membrane
(Reference Device) |
| Intended for
prescription use
only? | Yes | Yes | Yes |
| Target population | Human, oral, periodontal | Human, oral, periodontal | Human, oral, periodontal |
| Location of intended
application | Setting appropriate for oral
surgery | Setting appropriate for
oral surgery | Setting appropriate for
oral surgery |
| Frequency and
duration of use | Device is intended to be
implanted once and remain
in the body until resorbed
(implant with contact >30
days) | Device is intended to be
implanted once and
remain in the body until
resorbed (implant with
contact >30 days) | Device is intended to be
implanted once and
remain in the body until
resorbed (implant with
contact >30 days) |
| Materials required
for use | No additional materials are
required | No additional materials
are required | No additional materials
are required |
| Packaging
configuration | Tyvek® Pouch | Tyvek® Pouch | Tyvek® Pouch |
| Shelf life | 18 months | 18 months | 18 months |
| Intended Use | DynaMatrix™ is intended
for use in guided tissue
regeneration and 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
or prevent migration of graft
material. | DynaMatrix™ is intended
for use in guided tissue
regeneration and 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 or prevent
migration of graft
material. | SURGISIS® Periodontal
Membrane is a
bioabsorbable,
implantable material
intended to aid in the
treatment of periodontal
defects. |
| Sizes | 2 cm2 to 12 cm2 | 1.5 cm x 2.0 cm (3 cm2)
2.0 cm x 3.0 cm (6 cm2)
3.0 cm x 4.0 cm (12 cm2)
(3 cm2 to 12 cm2) | 0.5 cm2 to 50 cm2 |
| Thickness (µm) | 100-800 (nominal) | 100-300 (nominal) | 100-800 (nominal) |
| Resorption profile
(Fully resorbed
within) | DynaMatrix: 16 weeks
DynaMatrix Plus: 26 weeks | 16 weeks | 16 weeks |
Table 5-1. Substantial Equivalence Information
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Discussion of Similarities and Differences:
The subject device (DynaMatrix Plus) has been compared to the predicate device (DynaMatrix, K082058) on the bases of fundamental scientific technology and intended use. The intended use and material composition of both subject and predicate devices are identical. The sole difference is the addition of new sizes to the product line. Any potential new risks associated with the additional device sizes have been identified by appropriate risk analysis methods. These potential new risks have been addressed with verification activities in a manner
6
satisfactory to pre-determined acceptance criteria to ensure that no change to device substantial equivalence has occurred. Specifically, biocompatibility qualification was performed to ensure that no new risks of biocompatibility were present. Validation activities were comprised of a swine pilot study that showed successful incorporation and no foreign body response for devices matching the nominal thickness of the subject device, and FDA clearance of another SIS device with the same nominal thickness (K133306).
Conclusion:
Successful risk analysis and completion of verification activities provide evidence to support the conclusion that the size modification does not introduce new risks and that the subject device performs comparably and is substantially equivalent to the predicate device that is currently marketed for the same intended use.