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.

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DynaMatrix/DynaMatrix Plus device.

Based on the provided text, this document is a 510(k) Summary for a medical device (DynaMatrix/DynaMatrix Plus) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing clinical studies to prove new efficacy.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical or performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device (DynaMatrix, K082058) and a reference device (Surgisis Periodontal Membrane, K010952).

The key "acceptance criterion" in this context is that the subject device (DynaMatrix/DynaMatrix Plus) is substantially equivalent to the predicate device, meaning it has the same intended use, fundamental scientific technology, and comparable safety and effectiveness.

The "device performance" is primarily presented as being identical to the predicate in all critical aspects except for a dimensional change (additional sizes).

Here's an interpretation based on the provided text:

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (Subject Device)
Intended Use (identical to predicate)	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. (Identical to predicate)
Indications for Use (identical to predicate)	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. (Identical to predicate)
Material Composition (identical to predicate)	Porcine small intestinal submucosa; primarily collagen types I and III (Identical to predicate)
Sterilization Method (identical to predicate)	Ethylene Oxide (Identical to predicate)
Biocompatibility (no new risks)	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).
Safety and Effectiveness (comparable to predicate)	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 introduction of new device sizes does not affect the intended use or the substantial equivalence of the product.
Dimensional Characteristics (Sizes) (within reference range)	2 cm² to 12 cm² (Expanded from predicate which ranged 3 cm² to 12 cm², but within the reference device range of 0.5 cm² to 50 cm²)
Thickness (within reference range)	100-800 µm (nominal) (Predicate was 100-300 µm; Reference was 100-800 µm)
Resorption Profile (comparable based on thickness)	DynaMatrix: 16 weeks, DynaMatrix Plus: 26 weeks. (Predicate was 16 weeks. The "Plus" variant with increased thickness likely accounts for the 26-week profile, implicitly deemed acceptable due to the reference device's range and prior clearance of similar thickness).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The primary "test set" mentioned for evaluation of the dimensional change is a swine pilot study.

Sample Size: Not explicitly stated as a numerical count beyond "a swine pilot study."
Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Likely prospective, as it was conducted for verification activities related to the new device sizes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The text does not specify the number of experts or their qualifications for evaluating the swine pilot study or establishing any specific "ground truth" through expert consensus. The assessment seems to be based on observed "successful incorporation and no foreign body response."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No information is provided regarding an adjudication method for the swine pilot study results. It's implied that the findings of "successful incorporation and no foreign body response" were straightforward and did not require complex adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biomaterial (bone grafting material), not an AI-assisted diagnostic or therapeutic device. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, this is not an algorithm-only device. It is a physical biomaterial.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the swine pilot study, the "ground truth" appears to be based on histopathological evaluation or direct observation of biological response, specifically "successful incorporation and no foreign body response."

8. The sample size for the training set

This is not applicable as the device is a biomaterial and does not involve AI/machine learning requiring a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable for the reasons mentioned in point 8.

Summary

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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)

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:

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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.

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/ DynaMatrixPlus (Subject Device)	DynaMatrix(Predicate Device)	SURGISIS PeriodontalMembrane(Reference Device)
Manufacturer	Cook Biotech Inc.	Cook Biotech Inc.	Cook Biotech Inc.
510(k) number	unassigned	K082058	K010952
Product Code	NPL	NPL	NPL
Materialcomposition	Porcine small intestinalsubmucosa; primarilycollagen types I and III	Porcine small intestinalsubmucosa; primarilycollagen types I and III	Porcine small intestinalsubmucosa; primarilycollagen types I and III
Supplied sterile?	Yes	Yes	Yes
Sterilization method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Intended for singleuse?	Yes	Yes	Yes
Device	DynaMatrix/ DynaMatrixPlus (Subject Device)	DynaMatrix(Predicate Device)	SURGISIS PeriodontalMembrane(Reference Device)
Intended forprescription useonly?	Yes	Yes	Yes
Target population	Human, oral, periodontal	Human, oral, periodontal	Human, oral, periodontal
Location of intendedapplication	Setting appropriate for oralsurgery	Setting appropriate fororal surgery	Setting appropriate fororal surgery
Frequency andduration of use	Device is intended to beimplanted once and remainin the body until resorbed(implant with contact >30days)	Device is intended to beimplanted once andremain in the body untilresorbed (implant withcontact >30 days)	Device is intended to beimplanted once andremain in the body untilresorbed (implant withcontact >30 days)
Materials requiredfor use	No additional materials arerequired	No additional materialsare required	No additional materialsare required
Packagingconfiguration	Tyvek® Pouch	Tyvek® Pouch	Tyvek® Pouch
Shelf life	18 months	18 months	18 months
Intended Use	DynaMatrix™ is intendedfor use in guided tissueregeneration and boneregeneration procedures. Itmay be used for boneregeneration and healing ofperiodontal defects, forgingival augmentation, tomaintain or enhancealveolar ridges, or to containor prevent migration of graftmaterial.	DynaMatrix™ is intendedfor use in guided tissueregeneration and boneregeneration procedures.It may be used for boneregeneration and healingof periodontal defects, forgingival augmentation, tomaintain or enhancealveolar ridges, or tocontain or preventmigration of graftmaterial.	SURGISIS® PeriodontalMembrane is abioabsorbable,implantable materialintended to aid in thetreatment of periodontaldefects.
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 resorbedwithin)	DynaMatrix: 16 weeksDynaMatrix 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

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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.

Regulation Number and Section

§ 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.