Who is the manufacturer of Cerafix Dura Substitute?

Acera Surgical, Inc. filed the 510(k) submission for Cerafix Dura Substitute (K172603).

What is the FDA product code for Cerafix Dura Substitute?

GXQ. It is classified under 21 CFR 882.5910 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Cerafix Dura Substitute?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cerafix Dura Substitute?

DuraMatrix Collagen Dura Substitute Membrane (K040888).

Who can help prepare an FDA 510(k) submission like Cerafix Dura Substitute?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cerafix Dura Substitute

K172603 · Acera Surgical, Inc. · GXQ · Nov 27, 2017 · Neurology

Device Facts

Record ID	K172603
Device Name	Cerafix Dura Substitute
Applicant	Acera Surgical, Inc.
Product Code	GXQ · Neurology
Decision Date	Nov 27, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5910
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.

Device Story

Cerafix Dura Substitute is a resorbable, soft, white, pliable, nonfriable, porous polymer matrix (PGLA/PDO) used for dural repair. It is applied by a surgeon in a clinical setting as an onlay matrix or sutured in place over dural defects. The device acts as a scaffold for tissue repair; it is supplied sterile in a single-use nested pouch. By providing a physical barrier for the dura mater, it facilitates healing and prevents cerebrospinal fluid leakage. The device is cut to size by the surgeon to overlap the defect edges by at least 1 cm.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical bench testing from previous submissions (K153613, K161278) and a side-by-side animal implantation study in a canine duraplasty model. The animal study compared the subject device to the predicate using 18 mm x 25 mm dural defects applied as an onlay (without sutures), demonstrating equivalent safety and performance.

Technological Characteristics

Porous PGLA/PDO polymer matrix; resorbable; sterile (SAL 10^-6); non-pyrogenic; supplied in double sterile nested pouch configuration. Dimensions vary (1"x1" to 5"x7"). No specific orientation required.

Indications for Use

Indicated for repair of dura mater in patients with dural defects of 4.9 in2 (31.7 cm2) or less.

Regulatory Classification

Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Predicate Devices

DuraMatrix Collagen Dura Substitute Membrane (K040888)

Reference Devices

Cerafix Dura Substitute (K153613)
Cerafix Dura Substitute (K161278)

Related Devices

K153613 — Cerafix Dura Substitute · Acera Surgical, Inc. · Mar 16, 2016
K161278 — Cerafix Dura Substitute · Acera Surgical, Inc. · Aug 8, 2016
K041000 — DUREPAIR DURA REGENERATION MATRIX · Medtronic Neurosurgery · Jul 27, 2004
K032693 — DURAGEN PLUS DURAL GRAFT MATRIX · Integra Lifesciences Corp. · Sep 30, 2003
K150825 — Collagen Dural Regeneration Matrix · Collagen Matrix, Inc. · Nov 20, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 27, 2017 Acera Surgical, Inc. % Linda Braddon, Ph.D. President and CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188 Re: K172603 Trade/Device Name: Cerafix Dura Substitute Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: August 29, 2017 Received: August 30, 2017 Dear Dr. Braddon: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Michael J. Hoffmann -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172603 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 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <label><input checked="true" type="checkbox"/> Transactional Use (Per 31 CFR 990.3, Subject to Change)</label> | <label><input type="checkbox"/> For The Institution (Per 31 CFR 990.3, Subject to Change)</label> | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| |× | Prescription Use (Part 21 CFR 801 Subpart D) | | 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "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." {3}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness Image /page/3/Picture/1 description: The image shows the logo for Acera Surgical. The logo consists of a stylized triangle on the left, with the text "ACERA" in large, sans-serif font to the right of the triangle. Below "ACERA" is the word "SURGICAL" in a smaller, sans-serif font. The triangle is a gradient of light green and blue, and the text is a light green color. 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 | November 24, 2017 | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted by | Acera Surgical, Inc. 10880 Baur Blvd St. Louis, MO 63132 Phone 844-879-2237 | | 510(k) Contact | Secure BioMed Evaluations Linda Braddon, Ph.D. 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 (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 | K040888 DuraMatrix™ Collagen Dura Substitute Membrane | | Reference Device | K153613, K161278 Cerafix® Dura Substitute | #### Device Description Cerafix® Dura Substitute is a resorbable implant for repair of dural defects. The device can be applied as an onlay matrix or sutured in place. 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. {4}------------------------------------------------ # 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 4.9 in2 (31.7 cm²) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size. # Technological Characteristics The subject device is the exact same device as the previously approved Cerafix® Dura Substitute (K161278, K153613). The only updates pertain to: 1) the method of fixation / application as cited in the surgical technique guide, and 2) the acceptable defect size within the indications for use. Now, the subject device may be applied as an onlay matrix, as well as sutured in place, and utilized in defects up to 4.9 in2 (31.7 cm²). This instruction is consistent with the method of fixation used by the primary predicate device as well as other commercially available dural substitutes. The subject device has identical technological characteristics to the reference device, including the principles of operation, indications for use, sizing, material performance and biocompatibility. The subject device is equivalent to the reference device in terms of materials of construction. Additionally, side-by-side animal studies show the subject device performed equivalently to the predicate device when applied without suture (onlay) in a canine duraplasty model. The subject device has the following technological characteristics in common with the predicate and reference devices: | Characteristic | Cerafix® Dura Substitute (subject device) | Cerafix® Dura Substitute (Reference Device) | DuraMatrix™ Collagen Dura Substitute (Primary Predicate) | Comparison | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | 510(k) | N/A | K153613, K161278 | K040888 | N/A | | Principles of Operation | Device can be cut by surgeon and placed on dural defect and used as an onlay matrix or sutured in place. If sutured, suture line should be 2-3 mm from edge of implant. Implant should be large enough to overlap edge of the remaining dura by at least one (1) centimeter. | Device can be cut by surgeon and placed on dural defect with tensionless suture application. Suture line should be 2-3 mm from edge of implant. Implant should be large enough to overlap edge of the remaining dura by at least one (1) centimeter. | Device can be cut by surgeon and placed on dural defect and used as an onlay membrane or sutured in place. | Equivalent | | Material of Construction | Porous PGLA / PDO polymer matrix | Porous PGLA / PDO polymer matrix | Bovine collagen matrix | Equivalent to reference device | | | | | | | | Indications for Use | Indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in² (31.7 cm²) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size. | Indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 in² (28.3cm²) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size. | Indicated as a dura substitute for the repair of dura mater. | Data included in this submission to justify defect increase | | Sizing | 1"x1" 1"x3" 2"x2" 3"x3" 4"x5" 5"x7" | 1"x1" 1"x3" 2"x2" 3"x3" 4"x5" 5"x7" | 1"x1" 1"x3" 2"x2" 3"x3" 4"x5" 5"x7" | Equivalent | | Application Restrictions | Device does not have a requirement for specific orientation | Device does not have a requirement for specific orientation | Device does not have a requirement for specific | Equivalent | | Sterility | Sterile, SAL 10⁻⁶ | Sterile, SAL 10⁻⁶ | Sterile | Equivalent | | Packaging | Double sterile pack. Nested pouch configuration within a chipboard envelope. | Double sterile pack. Nested pouch configuration within a chipboard envelope. | Double sterile pack. Nested pouch configuration within a chipboard envelope. | Equivalent | | Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Equivalent | | Resorbable | Yes | Yes | Not Applicable | Equivalent to reference device | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent | {5}------------------------------------------------ There are no technological differences between the subject and the reference device. {6}------------------------------------------------ # Non-Clinical Testing – Mechanical No new mechanical testing was conducted for this submission. All mechanical testing for the Cerafix® Dura Substitute device was submitted in K153613 and K161278. ### Non-Clinical Testing - Biocompatibility No new biocompatibility testing was conducted for this submission. All biocompatibility testing for the Cerafix® Dura Substitute device was submitted in K153613 and K161278. # Non-Clinical Testing – Side-by-Side Animal Study Comparison Side-by-side animal implantation studies were performed between the subject and predicate device in a canine duraplasty model utilizing dural defects (18 mm x 25 mm) without the use of suture (onlay). 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 in dural defects, and can be applied as an onlay matrix or sutured in place.