SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SYNTHECEL® Dura Repair is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

AI/ML Overview

The document provided is a 510(k) premarket notification for the SYNTHECEL Dura Repair device, seeking substantial equivalence to previously cleared predicate devices. It describes the device, its intended use, and the non-clinical performance data used to support its equivalence.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing and biocompatibility. The reported performance is a statement of equivalence rather than meeting pre-defined numerical thresholds for a novel device.

However, based on the "Non-Clinical Performance Data" section, we can infer the areas of evaluation and the general outcome:

Evaluation Area	Reported Device Performance (SYNTHECEL Dura Repair)
Mechanical Testing	Burst Strength: Demonstrated to be substantially equivalent to predicate devices. Suture Pull-Out Strength: Demonstrated to be substantially equivalent to predicate devices.
Biocompatibility	Tested according to ISO 10993-1. Demonstrated to be non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, non-pyrogenic, and of appropriate pH.
Packaging	Justified via prior shelf-life qualification. Further transit qualification performed to support new carton and shipping configurations related to the larger size offering.
Sterilization	Validated per ISO 11137-1, ISO 11137-2, and AAMI TIR29. Dose substantiation qualification performed to encompass the larger size per ISO 11137-2 and AAMI TIR33.

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

The document does not provide specific sample sizes for the mechanical testing (e.g., number of samples for burst strength or suture pull-out strength). It also does not specify the country of origin of the data or whether the non-clinical performance data was retrospective or prospective. It simply states that "Mechanical testing data was collected," implying lab-based testing.

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):

This information is not applicable to the provided document. The submission is for a medical device (dura repair), and the "test set" in this context refers to physical samples undergoing mechanical and biological evaluations, not diagnostic outputs requiring expert interpretation for ground truth establishment.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies. The provided document focuses on non-clinical performance data of a physical device.

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:

This is not applicable. The device is SYNTHECEL Dura Repair, a physical medical device, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

This is not applicable. The device is a physical dura repair product, not an algorithm.

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

For the non-clinical performance data:

Mechanical Testing (Burst Strength, Suture Pull-Out Strength): The "ground truth" is established through standardized laboratory testing methods that quantify physical properties according to accepted engineering and medical device standards. The comparison is against predicate device performance, implying the predicate's performance serves as the benchmark.
Biocompatibility: The "ground truth" is established by adhering to international standards (ISO 10993-1) which define acceptable biological responses (e.g., non-irritating, non-cytotoxic).

8. The sample size for the training set:

This is not applicable. The submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 28, 2022

Synthes (USA) Products, LLC Doug Steinberger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K212943

Trade/Device Name: SYNTHECEL Dura Repair Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: December 22, 2021 Received: December 27, 2021

Dear Doug Steinberger:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212943

Device Name SYNTHECEL Dura Repair

Indications for Use (Describe)

SYNTHECEL Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared	January 28, 2022
Submitter	Synthes (USA) Products LLC1230 Wilson DriveWest Chester, PA 19380
Contact	Doug Steinberger(419) 307-0674 (phone)DSTEINB1@ITS.JNJ.COM
Device Name	SYNTHECEL® Dura Repair
Regulation Number	21 CFR 882.5910
Device Class	2
Product Code(s)	GXQ
Predicate Devices	SYNTHECEL® Dura Replacement Devices (K113071)SYNTHECEL® Dura Repair (K131792)
Reference Device	Durepair Dura Regeneration Matrix (K161370)
Device Description	SYNTHECEL® Dura Repair is composed of biosynthesized cellulose andwater with a unique construction of non-woven, interconnected cellulosefibers. SYNTHECEL® Dura Repair functions as a mechanical layer whichprotects and repairs the dural defect while preventing further CSF leakage.SYNTHECEL® Dura Repair is immunologically inert and has demonstratedminimal foreign body response. It is non-resorbable.
Indications for Use	SYNTHECEL® Dura Repair is indicated as a dura replacement forthe repair of dura mater in adults.
TechnologicalCharacteristics	The SYNTHECEL® Dura Repair is equivalent to the predicate devices (K113071& K131792) in terms of intended use. Both are designed for dura replacementfor the repair of dura mater. The material, physical properties, resorbability,and mechanical performance are identical to the predicate devices. Thissubmission covers a larger size offering that is dimensionally different in lengthand width compared to predicates but is similar in length and width to thelargest Durepair product (K161370) as a reference.
ClinicalPerformance Data	No new clinical performance data were collected in support of this submission.Clinical data were previously collected to evaluate the safety and effectivenessof the SYNTHECEL® Dura Replacement Devices (K113071) as compared to theControl.
Non-ClinicalPerformance Data	Mechanical testing data was collected to support substantial equivalence ofSYNTHECEL® Dura Repair to predicate devices. Burst strength and suture pull-out strength were tested and SYNTHECEL® Dura Repair was demonstrated tobe substantially equivalent to predicate devices.Biocompatibility testing according to standards set forth in ISO 10993-1demonstrated that the material is non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, non-pyrogenic and of appropriatepH.Device packaging was justified via prior shelf-life qualification. Sterilization wasvalidated per ISO 11137-1, ISO 11137-2, and AAMI TIR29. Dose substantiationqualification was performed to encompass the larger size per ISO 11137-2 and
	AAMI TIR33. Additionally, packaging was rationalized by prior data and further
	transit qualification was performed to support the new carton and shipping
	configurations related to the larger size offering.
SubstantialEquivalence toPredicate Devices	Based on the information presented in this submission, the proposed
	changes do not raise new questions of safety and effectiveness.
	Therefore, it can be concluded that the SYNTHECEL® Dura Repair is
	substantially equivalent to the predicate device.

510(k) Summary – SYNTHECEL Dura Repair

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Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).