ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm² (3.87 in²) or less in area. For example, 6 cm X 4 cm (24 cm²) would be an acceptable defect size.

Device Description

ArtiFascia is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia is packaged in a single-use peelable package and is provided sterile, nonpyrogenic. ArtiFascia readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.

The provided document describes the K223445 premarket notification for the ArtiFascia device, a dura substitute. The studies primarily focus on demonstrating the device's substantial equivalence to a legally marketed predicate device (Cerafix Dura Substitute). As such, the "acceptance criteria" discussed are largely in the context of equivalence testing and meeting safety and performance benchmarks comparable to the predicate, rather than an AI/ML specific performance metric. The studies described are primarily bench testing, biocompatibility studies, and animal studies, followed by a clinical study. There is no mention of Artificial Intelligence or Machine Learning in the provided document, so there will be no information on acceptance criteria or studies related to AI/ML device performance (e.g., sensitivity, specificity, MRMC studies, standalone performance).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the tests performed and the results demonstrating compliance or superiority to the predicate device. For the clinical study, the primary endpoint served as the key acceptance criterion for effectiveness.

Test Type	Acceptance Criteria (Implied / Explicit)	Reported Device Performance and Compliance
Bench Testing
Morphological Evaluation	Compliance with predefined acceptance criteria set per the morphology test protocol.	All evaluated test articles were found to comply.
Tensile Strength	Withstand specific tensile forces.	The ArtiFascia patch can withstand tensile forces [Mpa] that are far greater than the predefined acceptance criteria.
Burst Pressure	Withstand specific applied pressure (twice the expected intracranial pressures).	The ArtiFascia patch can withstand applied pressure [PSI] that is far greater than the predefined acceptance criteria.
Suture Retention Strength	Withstand suture retention forces at least comparable to the predicate device.	The ArtiFascia patch can withstand suture retention forces [N] that are (on average) greater than the predefined acceptance criteria, i.e., the average results as obtained for the predicate device.
Shrinkage	No notable shrinkage when properly used.	When suspension, such as suturing, is utilized, no shrinkage is noted.
In-Vitro Degradation	Equivalent physical properties for e-beam and gamma sterilization after 126 days.	The results show that, after 126 days, the physical properties of the e-beam are equivalent to gamma-sterilized ArtiFascia.
Biocompatibility	Compliance with ISO 10993-1:2018 requirements for human use.	Non-cytotoxic, Non-sensitizing, Non-irritating, Non-toxic, Non-pyrogenic, No treatment-related adverse effects observed in implantation (up to 12 months in rabbits, with ongoing minor inflammatory response consistent with longer resorption; predicate resorbed by 6 months), Non-hemolytic, Non-mutagenic, Non-genotoxic. Chemical analysis showed safe margins of safety.
Animal Study Data	Excellent local tissue response and tolerability, comparable to predicate.	ArtiFascia (e-beam/gamma) and DuraGen Plus showed excellent local tissue response and tolerability. ArtiFascia was well-tolerated throughout degradation. Minor inflammation at 12 months consistent with longer resorption, but comparable to DuraGen's response. Mostly resorbed by 12 months.
Clinical Study	Non-inferiority to commercially available dural grafts regarding effectiveness and safety. Absence of CSF fistula and pseudomeningocele within 6 months post-operative.	Primary Endpoint Met: No reported cases of CSF fistula in either group. Only one case of CSF pseudomeningocele in the control group at 6 months; no cases in ArtiFascia group. Secondary Endpoints Met: Wound healing, device handling (ease of use, strength suturability, seal quality) were assessed. MRI at 6 months showed no adverse findings for ArtiFascia (compared to control with one pseudomeningocele). Safety Endpoints Met: No changes in neurological status or other neurological symptoms at ≥12 months post-surgery (except one control case unrelated to device/procedure). No abnormal findings at surgical site.

2. Sample Sizes Used for the Test Set and Data Provenance

Bench Testing:
- In-Vitro Degradation: 96 samples (overall)
- Other bench tests: Specific sample sizes are not explicitly stated for individual tests, but implied to be sufficient for statistical significance.
- Data Provenance: Not explicitly stated, implied to be laboratory-generated.
Biocompatibility Studies:
- Implantation (ISO 10993-6:2007) / First Animal Study: 19 animals (rabbits)
- Implantation (ISO 10993-6:2016) / Second Bridging Study: 9 animals (rabbits)
- Other biocompatibility tests: Sample sizes are not explicitly stated but are standard for the ISO methods referenced (e.g., cell cultures for cytotoxicity, animal subjects for sensitization/irritation/toxicity).
- Data Provenance: Laboratory research, animal studies conducted under Good Laboratory Practices (GLP).
Clinical Study (NEOART study):
- Test Set (Initial Study): 78 subjects treated (58 in ArtiFascia group, 20 in control group). Total enrolled randomized and treated subjects was 85.
- Test Set (Long-term data collection): 32 subjects underwent MRI and/or neurological assessment (25 ArtiFascia, 7 control).
- Data Provenance: Multi-center, prospective, randomized, controlled, single-blinded, parallel group study. Conducted at 7 clinical sites outside-of-the-US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Bench Testing: Ground truth is established by standardized test methods and measurements. Expert interpretation is often part of the process (e.g., visual examination for morphological irregularities), but the number and qualifications of experts are not specified.
Biocompatibility Studies: Ground truth is based on standard test results and observations (e.g., "Non-cytotoxic," "Non-sensitizing"). Pathologists/toxicologists would interpret results, but specific numbers and qualifications are not provided.
Animal Studies: Assessments included clinical assessments of animal well-being and histological examination of the treatment area. Pathologists/veterinarians would be involved in interpretation, but specific numbers and qualifications are not provided.
Clinical Study:
- Primary Endpoint (CSF fistula/pseudomeningocele): Assessed by MRI imaging and direct observation by clinicians.
- Secondary Endpoint (MRI assessment): "confirmed in an assessment of a blinded, independent radiologist." The specific number of radiologists is not mentioned, nor are their detailed qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

Bench Testing, Biocompatibility, Animal Studies: Adjudication methods are not explicitly described but are inherent to following validated test protocols and reporting objective measurements.
Clinical Study:
- Primary Endpoint: Assessment was based on MRI imaging and clinical observation. No explicit multi-reader adjudication method (e.g., 2+1, 3+1) is mentioned for the primary endpoint's determination.
- MRI assessment (Secondary/Long-term): Confirmed by a "blinded, independent radiologist." This implies a single independent read, rather than a multi-reader consensus/adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

No. The provided text does not mention any AI or Machine Learning components. Therefore, no MRMC study involving AI-assisted human readers was conducted or reported.

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

No. The provided text does not mention any AI or Machine Learning components. Therefore, no standalone algorithm performance study was conducted or reported.

7. The Type of Ground Truth Used

Bench Testing: Objective physical measurements and observations based on standardized test methods (e.g., force, pressure, visual inspection, length measurements).
Biocompatibility: Results derived from established ISO standard test methods, involving cell culture assays, animal models, and chemical analysis, interpreted by qualified personnel (e.g., toxicologists, pathologists).
Animal Studies: Histological examination of tissues and clinical observation of animal well-being.
Clinical Study:
- Primary Endpoint: Clinical observations (wound drainage), and MRI imaging interpreted by clinicians and an independent, blinded radiologist. This is effectively expert consensus/clinical outcome based on imaging and direct observation.
- Secondary Endpoints: Direct observation for wound healing/device handling, and MRI imaging for tissue changes.
- Long-term follow-up: MRI imaging and neurological assessment (clinical observation).

8. The Sample Size for the Training Set

Not applicable/Not mentioned. Since no AI/ML component is mentioned, there is no discussion of a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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August 10, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is a blue square with the letters "FDA" in white. Next to the square, the words "U.S. FOOD & DRUG" are written in blue, followed by the word "ADMINISTRATION" in a smaller font size.

Nurami Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K223445

Trade/Device Name: ArtiFascia Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: July 11, 2023 Received: July 11, 2023

Dear Janice Hogan:

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 medical devices and radiation-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).

Sincerelv.

Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce -S" in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Adam D. Pierce -S Date: 2023.08.10 20:56:18 -04'00'" is present. The text on the right side of the image indicates that the name on the left side of the image is a digital signature.

Adam D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below

510(k) Number (if known)

K223445

Device Name

ArtiFascia

Indications for Use (Describe)

ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm² (3.87 in2) or less in area. For example, 6 cm X 4 cm (24 cm²) would be an acceptable defect size.

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

区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□ Over-The-Counter Use (21 CFR 801

Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number

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K223445 510(k) SUMMARY Nurami Medical Ltd.'s ArtiFascia Device

Submitter:

Nurami Medical Ltd. 36 Ha-Namal St., Haifa, Israel P.O.B 33964 Phone: +972 74 7408822 Contact Person: Hannoch Marksheid, CEO

Regulatory Correspondent:

Janice Hogan Hogan Lovells US LLP 1735 Market Street, 23 Philadelphia, PA 19102 (T) (267) 675-4611 (F) (267) 675-4601 Janice.hogan@hoganlovells.com

Date Prepared: August 7, 2023

Name of Device: ArtiFascia

Common or Usual Name: Dural Substitute

Classification Name: Dura Substitute

Predicate Devices: Cerafix Dura Substitute (K161278) Acera Surgical, Inc.

Reference Devices: DuraGen Plus Dural Regeneration Matrix (K092388)

Codman Ethisorb Dura Patch (K991413)

Intended Use / Indications for Use:

Technological Characteristics

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Performance Data

Comprehensive bench testing has been performed to confirm that the ArtiFascia has appropriate mechanical attributes for its intended use and performs in an equivalent manner to the predicate device. These tests include the following:

Test	Test Method Summary	Results
Morphological Evaluation	All the test articles underwent avisual examination for anymorphological irregularities,thickness was measured, andthe edges of each patch werevisually examined to verify thatthe layers are not separated.	All evaluated test articles werefound to comply with thepredefined acceptance criteriaset per the morphology testprotocol.
Tensile Strength	A "Dog-bone" shaped testarticles were cut from eacharticle and tensile test wasperformed at a constant speedof 50mm/min. The maximalforce and displacement foreach test article wasrecorded.	The ArtiFascia patch canwithstand tensile forces [Mpa]that are far greater than thepredefined acceptance criteria,
Burst Pressure	A burst pressure test wasperformed in accordance withASTM F2392-04 - "StandardTest Method for Burst Strengthof Surgical Sealants," withsome modifications. A custom-made testing apparatus wasbuilt according to the ASTMstandard. Each evaluated testarticle was mounted upon a testfixture base and secured withan o-ring. Saline was injectedinto the test fixture at a flow rateof 2mL/min and burst strengthwas calculated for each sampleas the peak pressure thatallowed fluid leakage from thesample.	The ArtiFascia patch canwithstand applied pressure[PSI] that is far greater than thepredefined acceptance criteria(twice the expected intracranialpressures).
Suture Retention	Suture retention tests wereadapted from the methoddescribed in ANSI/AAMI/ISO	The ArtiFascia patch canwithstand suture retentionforces [N] that are (on average)
Suture Retention Strength	7198:1998/2001/(R) 2004standard and ASTM D882-12:Standard test method fortensile properties of thin plasticsheeting. The sample was thenplaced between the tensiletesting machine grippers, byconnecting the patch to the firstgrip and the suture to the otherand tested to failure undertensile conditions.	greater than the predefinedacceptance criteria, i.e., theaverage results as obtained forpredicate device.
Shrinkage	The ArtiFascia 5cm X 5cm testarticles were submerged in asaline solution heated to 37°Cfor a period of 15min. Two ofeach articles' edge weremeasured (length and width)before and after the hydrationprocess.	Whenformsomeofsuspension, such as suturing,is utilized when applying thedevice, no shrinkage is noted.
In-Vitro Degradation	In-vitro degradation propertieswere assessed per ISO 13781.96 samples were evaluated(overall) for this test procedure.Testing was performed tocompare gamma and e-beamirradiated samples.	The results show that, after126 days, the physicalproperties of the e-beam areequivalent to gamma- sterilizedArtiFascia.

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Biocompatibility

The ArtiFascia device was evaluated per ISO 10993-1:2018 and found to comply with the requirements of the standard thus biocompatible for human use.

Study type (standard in effect at the time thestudy was initiated)	Result
Cytotoxicity - MEM elution (ISO 10993-5:2009)	Non-cytotoxic
Sensitization - GPMT (ISO 10993-10:2010)	Non- sensitizing
Irritation - Intracutaneous Reactivity (ISO10993-10:2010)	Non-irritating
Systemic Toxicity - Acute (ISO 10993-11:2017)	Non-toxic

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Study type (standard in effect at the time thestudy was initiated)	Result
Systemic Toxicity - Material-mediatedpyrogenicity (ISO 10993-11:2017)	Non-pyrogenic
Implantation in rabbits (ISO 10993-6:2007)	No treatment-related adverse effects observedup to 12 months although there is still anongoing, minor inflammatory response (seeanimal study section for more detail).Substantially resorbed by 12 months withremnants of the implanted mesh remaining,whereas the predicate control is resorbed by 6months.
Implantation in rabbits (ISO 10993-6:2016)	No treatment-related adverse effects observed
Hemocompatibility - Hemolysis (ISO 10993-4:2017)	Non-hemolytic
Genotoxicity - Bacterial reverse mutation (Amesassay) (ISO 10993-3:2014)	Non-mutagenic
Genotoxicity - Mouse lymphoma assay (ISO10993-3:2014)	Non-genotoxic

In addition, chemical analysis of all compounds contained in the final device were chemically analyzed and their toxicological risk was assessed under worst-case assumptions. All identified compounds exhibited safe marqins of safety.

Animal Study Data

Two animal studies were conducted under Good Laboratory Practices (GLP): first a controlled experiment in which the biological response and in vivo degradation of the subject (ArtiFascia) and the reference devices (DuraGen Plus) were evaluated at 1, 6, and 12 months (19 animals in total) and a second bridging, 1-month study (9 animals in total). Both studies used a rabbit model, in which a craniotomy, durotomy, and subsequent repair were performed. Assessments included clinical assessments of animal well-being as well as histological examination of the treatment area. The control for the first study was DuraGen Plus, whereas e-beam sterilized ArtiFascia was compared to gamma sterilized ArtiFascia as the control in the second study. The first animal study was conducted on gamma sterilized ArtiFascia grafts as this was the sterilization method used at the time of testing. During product development, the sterilization method was changed to e-beam. Therefore, the company conducted a second bridging in-vivo study in which the biological response and degradation profile of e-beam sterilized subject devices vs. reference devices (DuraGen Plus) were compared up to 1 month. The one-month timepoint was selected because the only difference between devices due to the sterilization method was the starting molecular weight.

Results from the studies showed excellent local tissue response and tolerability to the 3 types of patches, ArtiFascia (e-beam), ArtiFascia (gamma), and DuraGen Plus. The results of both studies demonstrated that the ArtiFascia device was well-tolerated throughout its degradation process. Although minor inflammation was observed at 12 months in the first animal study, consistent with the longer resorption period, overall, the nature and severity of the biological response was comparable to that of the DuraGen device, which was fully degraded and without an associated inflammatory response by 6 months. ArtiFascia was mostly resorbed by 12 months with only sporadic ghost remnants of the implanted mesh remaining. It should be noted that the macrophage reaction was not accompanied with any other type of inflammation, or necrosis, and therefore it was judged to reflect

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expected absorptive reaction of well tolerated biodegradable materials. No difference in tissue response was observed between the e-beam and gamma sterilized devices.

Clinical Study

The NEOART study, a prospective, randomized, controlled, multi-center, single-blinded, parallel group study, collected clinical data to evaluate the safety and effectiveness of ArtiFascia in comparison with commercially available dural substitutes in subjects requiring dural repair following neurosurgery. The basic hypothesis was that ArtiFascia is non-inferior in terms of effectiveness and safety to commercially available dural grafts.

A total of 85 subjects were enrolled randomized and treated, of which 78 received either Artifascia or an FDA-cleared control (58 in the investigational ArtiFascia treatment group and 20 in the control commercially dural substitutes group) at 7 clinical sites outside-of-the-US. Subjects were evaluated intra-operatively and immediate post operatively followed by evaluation at 4-6 weeks and at 6 months.

At each evaluation time-point, physical examination of the surgical site and a standard assessment of general neurological health were evaluated. Magnetic Resonance Imaging (MRI) was performed at 6 months. Adverse events were assessed on a continuous basis from the baseline through the study completion at 6 months.

The primary endpoint was the absence of CSF fistula (drainage from wound or sinus) and pseudomeninqocele within 6 months post-operative as evaluated by MRI imaging. Secondary endpoints were the following:

1. Wound healing assessment
1. Device handling Characteristics (i.e., Ease of Use, strength suturability, Seal Quality)
1. Magnetic Resonance Imaging at the 6-month follow-up, to determine the presence or absence of the following measures: adhesion formation, new tissue formation, and brain edema adjacent to device implant site.

Inclusion Criteria:

1. Subject between the ages of 18-75

Subject is scheduled for an elective cranial surgery with a dural damage that can be completely repaired/closed by a suturable dural substitute (ArtiFascia device or other commercially available dural substitutes)
Subiect has undergone imaging (such as. MRI) in the past 6 months before enrolment
Surgical wound is expected to be Class I/clean
Subject understands the study requirements and the treatment procedures and provides

written Informed Consent before any study-specific tests or procedures are performed

1. Subject is able and willing to adhere to the required follow-up visits and testing

Exclusion Criteria:

Pregnant women or interest in becoming pregnant during the duration of the study

1. Subject has known hydrocephalus
1. Subject is unable to undergo MRI after the surgery
1. Subiect's life expectancy is less than 12 months

Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, positive blood culture and/or a positive chest xray for acute infectious process
Subject will require use of dural adhesive or sealant
Subject is intended to undergo craniectomy wherein bone flap will not be returned
Subject with suspected low success in wound healing due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other conditions (e.g. severe peripheral vascular disease, long standing steroids treatment)
Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C>6.5%), sepsis, systemic collagen disease.
Subject had chemotherapy and/or radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery.

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1. Subject is an acute cranial trauma surqical case

Subjects with a concurrent disease that would place the patient in excessive risk to the planned surgery

1. Subject had a previous neurosurgery in the same anatomical site
1. Subject with other undesirable symptoms defined by the principal investigator
1. Patient has clinically significant coaqulopathy as determined by the surgeon
1. Subject is participating in another clinical study using similar investigational devices/drugs.

There were no reported cases of CSF fistula in either ArtiFascia or Control patients during the entire follow-up period. There was only a single case of CSF pseudomeningocele in the Control group at the 6 months visit. There were no cases of CSF pseudomeningocele in ArtiFascia patients during the entire follow-up period, so that at 6 months, 100% of patients implanted with ArtiFascia did not have CSF fistula and pseudomeningocele.

The company collected additional long-term data from the study subjects who participated in the study. Collected data included neurological change of status and/or MRI imaging at least 1 year or longer after implantation of a dural graft in patients who participated in the study. Both MRI and neurological assessment were collected if available. Out of the 63 subjects screened, a total of 32 subjects, underwent MRI and/or neurological assessment, rendering them eligible for inclusion in the data collection study. 25 of the eligible subjects were implanted with ArtiFascia, whereas 7 were implanted with control grafts.

In all subjects implanted with ArtiFascia or control grafts, no cases of pseudomeningocele, edema or other abnormal findings were observed in the MRI assessment, which was confirmed in an assessment of a blinded, independent radiologist. All subjects who completed a neurological assessment, (n=29) showed no changes in neurological status or other neurological symptoms were observed at least 12 months post-surgery. There was only one case of neurological status change in a Control subject which was not related to the device or the procedure. No abnormal findings at the surgical site were observed.

The results indicate that the clinical study met all primary, secondary and safety endpoints and that ArtiFascia is non-inferior to dural grafts in the control group. Longer term follow-up demonstrated the safety of the product for periods of >12 months after implantation.

Substantial Equivalence Discussion

The ArtiFascia Dura Substitute is as safe and effective as the Cerafix Dura Substitute. ArtiFascia has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the ArtiFascia and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ArtiFascia is as safe and effective as Cerafix Dura Substitute Thus, the ArtiFascia is substantially equivalent.

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A table comparing the key features of the subject device and the predicate device is provided below:

Specification/Characterization	ArtiFascia	Cerafix Dura Substitute (K161278)
Indications for Use	ArtiFascia is indicated as a durasubstitute for the repair of dura mater.ArtiFascia is indicated for defects of25cm2 (3.87 in2) or less in area. Forexample, 6 cm X 4 cm (24 cm2) wouldbe an acceptable defect size.	The Cerafix Dura Substitute is indicatedas a dura substitute for the repair ofdura mater. This device is indicated fordefects of 4.4in2 (28.3cm2) or less inarea. For example, 4.0 in x 1.1 in(10.1cm x 2.8cm) would be anacceptable defect size.
Principle ofoperation	Device can be cut by surgeon andplaced on dural defect by suturingtechnique.Suture line should be 2-3mm fromedge of implant.	Device can be cut by surgeon andplaced on dural defect via onlay ortensionless suturing technique.Suture line should be 2-3mm from edgeof implant. Implant should be largeenough to overlap edge of theremaining dura by at least one (1)centimeter.
Material ofconstruction	Porous polymer matrix and a filmlayer	Porous polymer matrix
Sizing	3x4, 5x5, 7x7cm	1"x1", 1"x3", 2"x2", 3"x3", 4"x5", 5"x7"
Materialcomposition	Synthetic polymer	Synthetic polymer
Surgical applicationrestrictions	Device does not have requirement forspecific orientation	Device does not have requirement forspecific orientation
Resorbable	Yes	Yes
Pliable	Pliable	Pliable
Sterility	Sterile, SAL 10-6	Sterile, SAL 10-6
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Biocompatibility	Biocompatible	Biocompatible

Conclusions

The ArtiFascia performs in a manner that is substantially equivalent to the predicate Cerafix Dura Substitute. The ArtiFascia has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences do not alter the intended surgical use of the ArtiFascia device and do not raise different questions of safety or effectiveness. Thus, the ArtiFascia is substantially equivalent to the predicate device.

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).