(85 days)
No
The description focuses on the material properties and biological function of a wound matrix, with no mention of AI or ML.
No.
While the device is used in the 'management of wounds' and promotes healing, its description and intended use do not align it with devices typically classified as therapeutic in the sense of actively treating or remediating a condition through external energy, substances, or complex therapeutic mechanisms. It acts as a protective covering and scaffold, aiding natural healing, rather than being a therapeutic intervention itself.
No
Explanation: The device description states that the product is a "Wound Matrix" intended for "management of wounds." It acts as a protective covering and provides a moist environment for healing, and does not mention diagnosis.
No
The device description clearly states it is a "sterile, single use device" and describes its physical properties as a "soft, white, conformable, non-friable, absorbable matrix." This indicates a physical medical device, not a software-only one.
Based on the provided information, the Restrata™ Wound Matrix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- Restrata™ Wound Matrix Function: The description clearly states that the Restrata™ Wound Matrix is a "sterile, single use device intended for use in local management of wounds." It acts as a protective covering and provides a scaffold for healing on the wound itself.
- No Specimen Analysis: There is no mention of the device analyzing any bodily fluids or tissues in vitro. Its function is to directly interact with the wound bed.
Therefore, the Restrata™ Wound Matrix is a medical device used for wound management, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Restrata™ Wound Matrix is intended for use in the management of wounds, including:
Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.
Product codes (comma separated list FDA assigned to the subject device)
QSZ, FRO
Device Description
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur. Restrata™ is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata™ is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues.
Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The subject device has mechanical properties (tensile strength and suture pull-out strength) equivalent or superior to the reference device.
The subject device was also tested against a commercially available wound dressing with the same intended use in a clinically relevant full thickness porcine wound model. Analysis included an assessment of biocompatibility, along with macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology. Test results showed that the subject device had an equivalent wound healing response compared to the control article, and exhibited no adverse tissue responses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
December 15, 2022
Acera Surgical, Inc. % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K170300
Trade/Device Name: Restrata™ Wound Matrix Regulatory Class: Unclassified Product Code: QSZ
Dear Dr. Linda Braddon:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 26, 2017. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human profile in triplicate.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
Acera Surgical, Inc % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highwav, Suite 120 Woodstock, GA 30188
Re: K170300
Trade/Device Name: Restrata Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: January 30, 2017 Received: January 31, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
2
the quality systems (OS) 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Expiration Date: January 31, 2017 |
| 510(k) Number (if known) | See PRA Statement on last page. |
| K170300 | |
| Device Name |
Restrata™ Wound Matrix
Indications for Use (Describe)
Restrata™ Wound Matrix is intended for use in the management of wounds, including:
Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services(301)443-6740 EF
4
510(k) Summary of Safety and Effectiveness 6
Image /page/4/Picture/2 description: The image shows the logo for Acera Surgical. The logo consists of a stylized triangle on the left and the words "ACERA SURGICAL" on the right. The triangle is light green and blue, and the words are light green. The font is sans-serif and modern.
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) Summary for the Acera Surgical Restrata™ Wound Matrix is provided below.
| Date Summary Prepared | April 25, 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 | Restrata™ Wound Matrix |
| Common Name | Wound Dressing |
| Code Classification | FRO, Unclassified |
| Primary Predicate Device | GORE®, BIO-A® Wound Matrix (K132397) |
| Reference Devices | Cook Biotech, Oasis® Wound Matrix (K061711) |
| Acera Surgical, Cerafix® Dura Substitute (K161278) |
5
Device Description
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur. Restrata™ is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata™ is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues.
Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.
Intended Use
Restrata™ Wound Matrix is intended for use in the management of wounds, including:
Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-laser surgery, post-Mohs surgery, podiatric wound dehiscence), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.
Technological Characteristics
The Restrata™ Wound Matrix is composed of a non-woven "fleece" of polymer fibers composed of fully resorbable synthetic polymers. The fibers comprising Restrata™ Wound Matrix are produced from polyglactin 910 (PGLA) and polydiaxonone (PDO), both bioabsorbable polymers utilized in FDA cleared dura substitutes, resorbable sutures, orthopedic implants and other medical devices. Following implantation, both the PGLA and PDO are gradually hydrolyzed and absorbed over time, as new tissue forms in their place.
The subject device, predicate device (GORE® BIO-A® Wound Matrix) and reference device (Oasi® Wound Matrix) are all wound dressings indicated for the management of wounds. The subject device and predicate device are both composed of fully degradable biocompatible polymer materials. The subject device has the same technological characteristics as the predicate device and reference device in terms of principles of operation, intended use, material performance, and biocompatibility.
The subject device is also substantially equivalent to the reference device, Cerafix® Dura Substitute, in terms of design and composition, illustrating its biocompatibility and safety.
The subject device has the same characteristics as the predicate and reference device as follows:
6
| Characteristic | Restrata™ Wound
Matrix
(subject device) | GORE® BIO-A® Wound
Matrix (K132397)
(predicate device) | Cook Biotech, Oasis®
Wound Matrix
(K061711)
(reference device) | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K170300 | K132397 | K061711 | N/A |
| Principles of
Operation | Device serves to
protect a wound and
facilitate a moist
environment for
natural healing to
occur by forming a
physical barrier over
the wound bed and
providing a scaffold for
cellular infiltration and
vascularization before
completely degrading
via hydrolysis. | Device serves to
protect a wound and
facilitate a moist
environment for
natural healing to
occur by forming a
physical barrier over
the wound bed and
providing a scaffold for
cellular infiltration and
vascularization before
completely degrading
via hydrolysis. | Provides physical
scaffold for wound
repair. | Equivalent to
predicate
device |
| Material of
Construction | Resorbable synthetic
polymer matrix
Dual polymer matrix
comprised of
polyglactin 910 and
polydioxanone fibers
(PGLA 90:10 / PDO) | Resorbable synthetic
polymer matrix
Copolymer matrix
comprised of
polyglycolic acid and
trimethylene
carbonate (PGA:TMC) | Minimally processed
Porcine SIS
Animal-derived,
extracellular matrix | Although
resorbable
polymers used
are different,
the biocompat
-ibility,
performance
and safety are
equivalent to
predicate |
| Intended Use | Restrata™ Wound
Matrix is intended for
use in the
management of
wounds. | The GORE® BIO-A®B
Wound Matrix is
intended for use in the
management of
wounds. | Oasis® Wound Matrix
is indicated for the
management of
wounds. | Equivalent to
predicate
device |
| Size | 2.5cm x 2.5cm (1"x1")
2.5cm x 7.5cm (1"x3")
5.0cm x 5.0cm (2"x2")
7.5cm x 7.5cm (3"x3")
10.0cm x 12.5cm (4"x5")
12.5cm x 17.5cm (5"x7") | 7.0cm x 10.0cm
8.0cm x 8.0cm
9.0cm x 15.0cm
10.0cm x 30.0cm
20.0cm x 20.0cm
20.0cm x 30.0cm | 3.0cm x 3.5cm
3.0cm x 7.0cm | Equivalent to
range set by
predicate and
reference
device |
| Material
Composition | Porous, non-woven
PGLA:PDO matrix | Porous, non-woven
PGA:TMC matrix | Bovine collagen matrix | Equivalent to
predicate
device |
| Surgical
Application
Restrictions | Device does not have
requirement for
specific orientation | Device does not have
requirement for
specific orientation | Device does not have
requirement for
specific orientation | Equivalent to
predicate
device |
| Sterility | Sterile, SAL 10-6 | Sterile | Sterile | Equivalent |
| Packaging | Double sterile pack.
Nested pouch
configuration within a
chipboard envelope. | Unknown | Double sterile pack.
Nested pouch within a
chipboard unit 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 |
7
The following technological differences exist between the subject and predicate devices:
- . Although the subject device and predicate device are both manufactured from resorbable polymers, the subject device is composed of PGLA and PDO fibers, while the predicate device is composed from PGA and TMC fibers.
Although the polymers differ between the subject device and predicate device, both sets of polymers have a long-standing track record in medical device applications, including use in dural substitutes, resorbable sutures, orthopedic implants, and other medical devices. Each of the polymers were proven fully biocompatible, including; non-pyrogenic, non-genotoxic, non-hemolytic, and nonmutagenic. Both the subject device and predicate device are porous, non-woven matrices that serve to protect a wound and facilitate a moist environment for natural healing to occur by forming a physical barrier over the wound bed and providing a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. So, despite the difference in polymer composition, the subject device is equivalent in function, indication for use, product code, environment of use, and principles of operation to the predicate device.
Performance Data
The subject device has mechanical properties (tensile strength and suture pull-out strength) equivalent or superior to the reference device.
The subject device was also tested against a commercially available wound dressing with the same intended use in a clinically relevant full thickness porcine wound model. Analysis included an assessment of biocompatibility, along with macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology. Test results showed that the subject device had an equivalent wound healing response compared to the control article, and exhibited no adverse tissue responses.
Conclusions
The subject device and the predicate device were initially compared based on product code and intended use and found to be equivalent. Next, the subject device, predicate device, and reference device underwent non-clinical evaluation that confirms equivalence in the intended use of each device, biocompatibility, safety, efficacy, environment of use, and the principles of operation. Therefore, the subject device demonstrates substantial equivalence to the predicate and reference devices.