(90 days)
K991413 Ethisorb™ Dura Patch
K092388 DuraGen Plus™ Dural Regeneration Matrix
No
The summary describes a resorbable implant for surgical repair and does not mention any computational or analytical functions that would typically involve AI/ML.
Yes
The device is indicated for the repair of dura mater, which is a medical intervention intended to treat or alleviate a condition.
No
The device, Cerafix® Dura Substitute, is a resorbable implant for repairing dural defects, not for diagnosing conditions. Its intended use is to act as a dura substitute.
No
The device description clearly states it is a "resorbable implant" and a "porous polymer matrix," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair of dura mater" as a "dura substitute." This is a surgical implant used directly on a patient's tissue.
- Device Description: The description details a "resorbable implant" that is a "porous polymer matrix." This is a physical device for surgical repair.
- Lack of In Vitro Testing: The performance studies focus on mechanical properties, biocompatibility, and animal implantation studies. There is no mention of testing biological samples (like blood, urine, tissue) in vitro to diagnose a condition or provide information about a patient's health status.
- Anatomical Site: The device is used on the "dura mater," which is a tissue within the body. IVDs typically analyze samples taken from the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used in vivo (within the body) for repair.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Thickness, Mass per Area, Tensile Strength, Suture Pull-Out Strength, Burst Strength, Shrink Temperature, Fiber Diameter, and Pore Size. All tests passed acceptance criteria for equivalence or specified values.
Non-Clinical Testing - Biocompatibility: Performed in compliance with ISO 10993. Tests included Cytotoxicity MEM Elution (non-cytotoxic), Guinea Pig Maximization - Sensitization (non-sensitizing), Intracutaneous Irritation Reactivity (non-irritant), Hemolysis Assay (non-hemolytic), Genotoxicity (In Vitro Mouse Lymphoma Assay, In vivo Mouse Micronucleus Assay, Bacterial Mutagenicity Test - Ames Assay - all non-genotoxic/non-mutagenic), Pyrogenicity (non-pyrogenic), Acute Systemic Toxicity (non-toxic), Endotoxin Testing (
§ 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).
0
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
1
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
2
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) |
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
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 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 | 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.
4
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® Dura
Substitute
(subject device) | Ethisorb™ Dura Patch
(predicate device) | DuraGen™ Plus Dural
Regeneration Matrix
(reference device) | Comparison |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 510(k) | K153613 | K991413 | K092388 | N/A |
| Principles of
Operation | 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 with a
running or interrupted
suture application.
Avoid tensioning of
sutures. Suture line
should be 2 mm from
edge of implant. | Device can be cut by
surgeon and placed on
dural defect in either
an onlay or tensionless
suture application.
Implant should be
large enough to
overlap edge of the
remaining dura by at
least one (1)
centimeter. | Equivalent |
| Material of
Construction | Porous polymer matrix | Porous polymer matrix | Bovine collagen matrix | Equivalent to
predicate
device |
| Indications for
Use | 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. | Indicated as an
absorbable, synthetic
implant for bridging
defects of the dura
mater. | Indicated as a dura
substitute for the
repair of dura mater. | Equivalent |
| Size | Variety of Sizes | Variety of Sizes | Variety of Sizes | Equivalent |
| Material
Composition | Porous PGLA / PDO
matrix | Porous PGLA / PDO
matrix | Bovine collagen matrix | Equivalent to
predicate
device |
5
| Surgical
Application
Restrictions | Device does not have
requirement for
specific orientation | On one side the
porous structure of
the VICRYL fleece
allows tissue on-
growth while the PDS
film coating minimizes
leakage of
cerebrospinal fluid. | Device does not have
requirement for
specific orientation | Equivalent to
reference
device |
|-----------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------|
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Equivalent |
| Packaging | Double sterile pack.
Nested pouch
configuration within a
chipboard envelope. | Foil pouch within a
chipboard box | Double sterile pack.
Nested thermoformed
trays with Tyvek lids
within a chipboard
box. | Equivalent to
reference
device |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Equivalent |
| Resorbable | Yes | Yes | Not Applicable | Equivalent to
predicate
device |
| 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.
6
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 Criteria
Results |
|--------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Thickness | Comparison of Cerafix® Dura
Substitute thickness to other dura
substitutes on the market | Equivalent to Predicate
or Reference Device
PASS |
| Mass per Area | Comparison of Cerafix® Dura
Substitute mass per area to other
dura substitutes on the market | Equivalent to Predicate
or Reference Device
PASS |
| Tensile Strength | Comparison of Cerafix® Dura
Substitute tensile strength to other
dura substitutes on the market | Equivalent to Predicate
or Reference Device
PASS |
| Suture Pull-Out Strength | Comparison of Cerafix® Dura
Substitute suture pull-out strength to
other dura substitutes on the market | Equivalent to Predicate
or Reference Device
PASS |
| Burst Strength | Comparison of Cerafix® Dura
Substitute burst strength to other
dura substitutes on the market | Equivalent to Predicate
or Reference Device; and
burst strength greater than anticipated
intracranial pressures
PASS |
| Shrink Temperature | Evaluation of Cerafix® Dura
Substitute stability at various
temperatures | Show stability at applicable
temperatures
PASS |
| Fiber Diameter | Evaluation of Cerafix® Dura
Substitute fiber diameter via SEM | Meets Final Device Specification
PASS |
| Pore Size | Evaluation of Cerafix® Dura
Substitute pore size via SEM | Meets Final Device Specification
PASS |
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 Elution | |
| According to ISO 10993-5 Biological evaluation of medical | |
| devices: Part 5 Tests for In vitro Cytotoxicity | Cell culture treated with test sample |
| exhibited no reactivity. Therefore, non- | |
| cytotoxic. | |
| Guinea Pig Maximization - Sensitization | |
| According to ISO 10993-10 Biological evaluation of medical | |
| devices: Part 10 Tests for irritation and delayed hypersensitivity | Albino guinea pigs treated with test sample |
| did not elicit a sensitization response. | |
| Therefore, non-irritant. | |
| Intracutaneous Irritation Reactivity | |
| According to ISO 10993-10 Biological evaluation of medical | |
| devices: Part 10 Tests for irritation and delayed hypersensitivity | Rabbits treated with test samples were |
| non-irritating. Therefore, non-irritant. | |
| Hemolysis Assay | |
| According to ASTM F756-08 | |
| FDA Consensus Standard Number 2-154 | Rabbit blood treated with test samples was |
| found to be non-hemolytic. |
7
| Biocompatibility Tests | Results |
|---|---|
| Genotoxicity | |
| In Vitro Mouse Lymphoma Assay | |
| ISO 10993-3:2003 | Cell culture with mouse lymphoma cells in |
| the presence of trifluorothymidine | |
| exhibited a mean mutant frequency | |
| equivalent to the negative control | |
| Therefore, non-genotoxic. | |
| Genotoxicity | |
| In vivo Mouse Micronucleus Assay | |
| ISO 10993-3:2003 | Adult CD-1 mice treated with test sample |
| were considered non-mutagenic | |
| Genotoxicity | |
| Bacterial Mutagenicity Test - Ames Assay | |
| ISO 10993-3:2003 | Salmonella typhimurium histidine |
| auxotrophs and E. coli were considered | |
| non-mutagenic | |
| Pyrogenicity | |
| Materials Mediated Rabbit Pyrogen Test | Albino rabbits treated with test samples |
| exhibited a negative response. | |
| Therefore, non-pyrogenic. | |
| Acute Systemic Toxicity | |
| ISO 10993-11 | Albino mice treated with test samples were |
| considered non-toxic. | |
| Endotoxin Testing | Less than 2.15 EU/device. Non-pyrogenic. |
| Subchronic Toxicity | |
| 90 day animal study | Rabbits treated with test samples for 90 |
| days show the device to be non-toxic. | |
| Chronic Toxicity | |
| 180 day animal study | Rabbits treated with test samples for 180 |
| days 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.