(89 days)
No
The summary describes a resorbable implant for dural repair and does not mention any AI or ML components or functionalities.
Yes
The device is a dura substitute for the repair of dura mater, which is a therapeutic intervention.
No
The device is a resorbable implant for repairing dural defects and does not diagnose conditions.
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, not software.
Based on the provided information, the Cerafix Dura Substitute is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of dura mater in the human body. This is a surgical implant used in vivo (within a living organism).
- Device Description: The description details a resorbable implant for surgical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. The Cerafix Dura Substitute is a surgical implant used in vivo.
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 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.
Product codes
GXQ
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
K040888 DuraMatrix™ Collagen Dura Substitute Membrane
Reference Device(s)
K153613, K161278 Cerafix® Dura Substitute
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
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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) |
|---|
| ------------------------------------------------- |
| Transactional Use (Per 31 CFR 990.3, Subject to Change) | For The Institution (Per 31 CFR 990.3, Subject to Change) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
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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.
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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.