(90 days)
The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in² (12.5cm²) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 cm) would be an acceptable defect size.
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.
The provided text describes the Cerafix® Dura Substitute, a medical device intended for the repair of dura mater, and its journey through FDA 510(k) clearance. The document details the device's characteristics, indications for use, and the non-clinical testing performed to establish its substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for many of the mechanical and biological tests were framed as "Equivalent to Predicate or Reference Device" or "Meets Final Device Specification." For some, specific thresholds were mentioned.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ||
| Thickness | Equivalent to Predicate or Reference Device | PASS |
| Mass per Area | Equivalent to Predicate or Reference Device | PASS |
| Tensile Strength | Equivalent to Predicate or Reference Device | PASS |
| Suture Pull-Out Strength | Equivalent to Predicate or Reference Device | PASS |
| Burst Strength | Equivalent to Predicate or Reference Device; and burst strength greater than anticipated intracranial pressures | PASS (burst strength greater than anticipated intracranial pressures) |
| Shrink Temperature | Show stability at applicable temperatures | PASS (showed stability) |
| Fiber Diameter | Meets Final Device Specification | PASS (meets specification) |
| Pore Size | Meets Final Device Specification | PASS (meets specification) |
| Biocompatibility Testing | ||
| ISO Cytotoxicity MEM Elution | Non-cytotoxic | Cell culture exhibited no reactivity; non-cytotoxic. |
| Guinea Pig Maximization - Sensitization | Non-irritating, no sensitization response | Did not elicit a sensitization response; non-irritant. |
| Intracutaneous Irritation Reactivity | Non-irritating | Non-irritating. |
| Hemolysis Assay | Non-hemolytic | Found to be non-hemolytic. |
| Genotoxicity (Mouse Lymphoma Assay) | Non-genotoxic | Equivalent to negative control; non-genotoxic. |
| Genotoxicity (Mouse Micronucleus Assay) | Non-mutagenic | Considered non-mutagenic. |
| Genotoxicity (Bacterial Mutagenicity) | Non-mutagenic | Considered non-mutagenic. |
| Pyrogenicity (Rabbit Pyrogen Test) | Non-pyrogenic | Exhibited a negative response; non-pyrogenic. |
| Acute Systemic Toxicity | Non-toxic | Considered non-toxic. |
| Endotoxin Testing | Less than 2.15 EU/device | Less than 2.15 EU/device; non-pyrogenic. |
| Subchronic Toxicity (90-day animal study) | Non-toxic | Showed the device to be non-toxic. |
| Chronic Toxicity (180-day animal study) | Non-toxic | Showed the device to be non-toxic. |
| Side-by-Side Animal Study | Equivalent safety and performance to predicate device | Showed equivalent safety and performance. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each mechanical test (e.g., number of samples tested for tensile strength or burst strength). It mentions "side-by-side bench testing versus the predicate or commercially available reference device" for mechanical tests, and for biocompatibility, it refers to standard ISO/ASTM tests using animals (e.g., guinea pigs, rabbits, mice) and cell cultures. The data provenance is pre-clinical testing, likely conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human data, as this is a pre-market clearance based on non-clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device's clearance is based on established scientific principles and comparison to legally marketed predicate devices through defined acceptance criteria in mechanical and biocompatibility testing, not on expert consensus of clinical data.
4. Adjudication method for the test set
Not applicable. This device clearance relies on objective laboratory and animal testing, not human-based adjudication of clinical outcomes or images.
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
Not applicable. This document pertains to the pre-market clearance of a physical medical implant (dura substitute), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for this regulatory submission is a combination of:
- Predicate Device Equivalence: The primary ground truth is established by demonstrating that the Cerafix® Dura Substitute's technological characteristics, performance, and safety are substantially equivalent to a legally marketed predicate device (Ethisorb™ Dura Patch) and a reference device (DuraGen Plus™ Dural Regeneration Matrix).
- Established Scientific Standards: Compliance with ISO and ASTM standards for biocompatibility and mechanical properties (e.g., non-cytotoxic, non-pyrogenic, appropriate burst strength).
- Animal Study Outcomes: Equivalence in safety and performance based on side-by-side animal implantation studies compared to the predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device's pre-market clearance, as it's not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
March 24, 2016
Acera Surgical. Inc. % Linda Braddon, PhD Consultant Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K153613
Trade/Device Name: Cerafix Dura Substitute Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: December 17, 2015 Received: December 17, 2015
Dear Dr. Braddon:
This letter corrects our substantially equivalent letter of March 16, 2016.
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 device
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related 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.
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 yours,
Carlos L. Pena -S
Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153613
Device Name Cerafix Dura Substitute
Indications for Use (Describe)
The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in2 (12.5 cm2) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 cm) would be an acceptable defect size.
| 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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510(k) Summary
Image /page/3/Picture/1 description: The image shows the logo for Acera Surgical. The logo consists of a green triangle on the left, with the word "ACERA" in green letters to the right of the triangle. Below the word "ACERA" is the word "SURGICAL" in smaller, green letters. The logo is simple and modern, and the use of green suggests a focus on health and wellness.
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Acera Surgical Cerafix® Dura Substitute is provided below.
| Date Summary Prepared | March 16, 2016 |
|---|---|
| Submitted by | Acera Surgical, Inc.10880 Baur BlvdSt. Louis, MO 63132Phone 844-879-2237 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681 (direct)855-MED-DEV1 (office)LGB@SecureBME.com |
| Trade Name | Cerafix® Dura Substitute |
| Common Name | Dura substitute |
| Code —Classification | GXQ 21 CFR 882.5910 : Class II |
| Primary Predicate Device | K991413 Ethisorb™ Dura Patch |
| Reference Device | K092388 DuraGen Plus™ Dural Regeneration Matrix |
Device Description
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.
Indications for Use
The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in? (12.5cm²) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 cm) would be an acceptable defect size.
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Technological Characteristics
The materials used in the subject device are equivalent to the predicate device. Additionally, comparative mechanical testing was performed using the commercially available dura substitute reference device. The comparative mechanical testing showed equivalent performance of the subject device to the reference device. Lastly, physical characteristics are comparable to the predicate device, reference device, and that of native human dura.
Based on test results included in this submission, a maximum allowable defect size has been prescribed for the subject device. The subject device has the same technological characteristics as the predicate device and reference device in terms of principles of operation, materials of construction, material performance, and biocompatibility. Additionally, side-by-side animal studies show the subject device is equivalent for the indicated use of a dura substitute for the repair of dura mater. The subject device has the same technological characteristics as the predicate and reference device as follows:
| Characteristic | Cerafix® DuraSubstitute(subject device) | Ethisorb™ Dura Patch(predicate device) | DuraGen™ Plus DuralRegeneration Matrix(reference device) | Comparison |
|---|---|---|---|---|
| 510(k) | K153613 | K991413 | K092388 | N/A |
| Principles ofOperation | Device can be cut bysurgeon and placed ondural defect withtensionless sutureapplication. Suture lineshould be 2-3 mmfrom edge of implant.Implant should belarge enough tooverlap edge of theremaining dura by atleast one (1)centimeter. | Device can be cut bysurgeon and placed ondural defect with arunning or interruptedsuture application.Avoid tensioning ofsutures. Suture lineshould be 2 mm fromedge of implant. | Device can be cut bysurgeon and placed ondural defect in eitheran onlay or tensionlesssuture application.Implant should belarge enough tooverlap edge of theremaining dura by atleast one (1)centimeter. | Equivalent |
| Material ofConstruction | Porous polymer matrix | Porous polymer matrix | Bovine collagen matrix | Equivalent topredicatedevice |
| Indications forUse | Indicated as a durasubstitute for therepair of dura mater.This device is indicatedfor defects of 1.9 in²(12.5cm²) or less inarea. For example, 1.2in x 1.6 in (3 cm x 4cm) would be anacceptable defect size. | Indicated as anabsorbable, syntheticimplant for bridgingdefects of the duramater. | Indicated as a durasubstitute for therepair of dura mater. | Equivalent |
| Size | Variety of Sizes | Variety of Sizes | Variety of Sizes | Equivalent |
| MaterialComposition | Porous PGLA / PDOmatrix | Porous PGLA / PDOmatrix | Bovine collagen matrix | Equivalent topredicatedevice |
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| SurgicalApplicationRestrictions | Device does not haverequirement forspecific orientation | On one side theporous structure ofthe VICRYL fleeceallows tissue on-growth while the PDSfilm coating minimizesleakage ofcerebrospinal fluid. | Device does not haverequirement forspecific orientation | Equivalent toreferencedevice |
|---|---|---|---|---|
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Equivalent |
| Packaging | Double sterile pack.Nested pouchconfiguration within achipboard envelope. | Foil pouch within achipboard box | Double sterile pack.Nested thermoformedtrays with Tyvek lidswithin a chipboardbox. | Equivalent toreferencedevice |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Equivalent |
| Resorbable | Yes | Yes | Not Applicable | Equivalent topredicatedevice |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent |
The following technological differences exist between the subject and predicate devices:
- Subject device is manufactured with non-woven fiber technique versus the predicate device, which is manufactured with a woven technique
- The predicate device has a polymer film dyed with D&C Violet No. 2, while the subject device has neither a film layer nor dyes.
- Subject device does not have a requirement for specific orientation
- The predicate device does not specify how much overlap should exist between the edge of the device and the remaining dura. The subject device specifies a minimum distance of one centimeter. (Note: the reference device specifies a minimum distance of one centimeter as well).
- . Although the maximum thickness of the subject device is comparable to the predicate device, the subject device has a lower minimum thickness that is comparable to native dura human dura.
- Subject device needs to be hydrated prior to placement, whereas the predicate device can be used without hydration.
Pre-clinical testing confirmed that despite differences in manufacturing techniques, the Cerafix® Dura Substitute is equivalent in function, indication for use, device classification product code, environment of use, and principles of operation to the predicate device.
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Non-Clinical Testing – Mechanical
The subject device was evaluated in side-by-side bench testing versus the predicate or commercially available reference device. The results showed that the subject device demonstrated equivalent properties in the following areas:
| Test | Test Method Summary | Acceptance CriteriaResults |
|---|---|---|
| Thickness | Comparison of Cerafix® DuraSubstitute thickness to other durasubstitutes on the market | Equivalent to Predicateor Reference DevicePASS |
| Mass per Area | Comparison of Cerafix® DuraSubstitute mass per area to otherdura substitutes on the market | Equivalent to Predicateor Reference DevicePASS |
| Tensile Strength | Comparison of Cerafix® DuraSubstitute tensile strength to otherdura substitutes on the market | Equivalent to Predicateor Reference DevicePASS |
| Suture Pull-Out Strength | Comparison of Cerafix® DuraSubstitute suture pull-out strength toother dura substitutes on the market | Equivalent to Predicateor Reference DevicePASS |
| Burst Strength | Comparison of Cerafix® DuraSubstitute burst strength to otherdura substitutes on the market | Equivalent to Predicateor Reference Device; andburst strength greater than anticipatedintracranial pressuresPASS |
| Shrink Temperature | Evaluation of Cerafix® DuraSubstitute stability at varioustemperatures | Show stability at applicabletemperaturesPASS |
| Fiber Diameter | Evaluation of Cerafix® DuraSubstitute fiber diameter via SEM | Meets Final Device SpecificationPASS |
| Pore Size | Evaluation of Cerafix® DuraSubstitute pore size via SEM | Meets Final Device SpecificationPASS |
Non-Clinical Testing - Biocompatibility
Biocompatibility testing was performed in compliance with ISO 10993. The results are summarized in the following table:
| Biocompatibility Tests | Results |
|---|---|
| ISO Cytotoxicity MEM ElutionAccording to ISO 10993-5 Biological evaluation of medicaldevices: Part 5 Tests for In vitro Cytotoxicity | Cell culture treated with test sampleexhibited no reactivity. Therefore, non-cytotoxic. |
| Guinea Pig Maximization - SensitizationAccording to ISO 10993-10 Biological evaluation of medicaldevices: Part 10 Tests for irritation and delayed hypersensitivity | Albino guinea pigs treated with test sampledid not elicit a sensitization response.Therefore, non-irritant. |
| Intracutaneous Irritation ReactivityAccording to ISO 10993-10 Biological evaluation of medicaldevices: Part 10 Tests for irritation and delayed hypersensitivity | Rabbits treated with test samples werenon-irritating. Therefore, non-irritant. |
| Hemolysis AssayAccording to ASTM F756-08FDA Consensus Standard Number 2-154 | Rabbit blood treated with test samples wasfound to be non-hemolytic. |
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| Biocompatibility Tests | Results |
|---|---|
| GenotoxicityIn Vitro Mouse Lymphoma AssayISO 10993-3:2003 | Cell culture with mouse lymphoma cells inthe presence of trifluorothymidineexhibited a mean mutant frequencyequivalent to the negative controlTherefore, non-genotoxic. |
| GenotoxicityIn vivo Mouse Micronucleus AssayISO 10993-3:2003 | Adult CD-1 mice treated with test samplewere considered non-mutagenic |
| GenotoxicityBacterial Mutagenicity Test - Ames AssayISO 10993-3:2003 | Salmonella typhimurium histidineauxotrophs and E. coli were considerednon-mutagenic |
| PyrogenicityMaterials Mediated Rabbit Pyrogen Test | Albino rabbits treated with test samplesexhibited a negative response.Therefore, non-pyrogenic. |
| Acute Systemic ToxicityISO 10993-11 | Albino mice treated with test samples wereconsidered non-toxic. |
| Endotoxin Testing | Less than 2.15 EU/device. Non-pyrogenic. |
| Subchronic Toxicity90 day animal study | Rabbits treated with test samples for 90days show the device to be non-toxic. |
| Chronic Toxicity180 day animal study | Rabbits treated with test samples for 180days show the device to be non-toxic. |
Non-Clinical Testing – Side-by-Side Animal Study Comparison
Side-by-side animal implantation studies were performed between the subject and predicate device. Results show equivalent safety and performance between the subject and predicate device.
Conclusions
The subject and predicate device underwent non-clinical evaluation that confirmed device equivalency in the indication for use, device classification, product code, biocompatibility, safety, efficacy, environment of use, and the principles of operation. Therefore, the subject device demonstrates equivalence to the predicate device.
§ 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).