(277 days)
No
The description focuses on the material properties and physical structure of a wound matrix, with no mention of AI or ML capabilities.
Yes
The device is intended for use in the management of various types of wounds, providing a moist environment for healing and a scaffold for cellular infiltration and vascularization, which directly contributes to the treatment and repair of bodily tissues.
No
The device description and intended use clearly state that Restrata® is a wound management device designed to provide a moist environment and scaffold for healing, not to diagnose medical conditions.
No
The device description clearly states it is a sterile, single-use, physical matrix made from synthetic biocompatible materials, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Restrata® is for the "local management of wounds." This involves direct application to the wound bed to support the healing process.
- Device Description: The description details a physical matrix that provides a scaffold for tissue growth and degrades over time. It does not describe any components or processes related to testing samples of human origin (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results. The device's function is entirely focused on supporting the physical healing of the wound.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Restrata® does not perform this function. It is a therapeutic device used to manage wounds.
N/A
Intended Use / Indications for Use
Restrata® 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, dehisced wounds), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.
Product codes
FRO, QSZ
Device Description
Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides 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® is terminally sterilized, in a single use double peel package in a variety of sizes in non-meshed and meshed configurations. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.
The subject device is a modification of the predicate device to include updated product labeling, a change in product size offerings, and a change in product design offerings.
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
Non-Clinical Testing — Mechanical
No new mechanical testing was conducted for this submission. All mechanical testing for the device was submitted as part of the original 510(k) submission for Restrata® Wound Matrix (K170300). The subject device is manufactured using the exact same components and processes as the predicate, it is cut from the same component material, and therefore has mechanical properties (tensile strength and suture pullout strength) equivalent to the predicate device.
Non-Clinical Testing - Biocompatibility
No new biocompatibility testing was conducted for this submission. All biocompatibility testing for the device was submitted as part of the original 510(k) submission for Restrata® Wound Matrix (K170300). The subject device is manufactured using the exact same components and processes as the predicate device, it is cut from the same component material, it is packaged and sterilized in the exact same fashion, and therefore has equivalent biocompatibility.
Risk Analysis
A risk analysis of the design controls was conducted in support of substantial equivalence with the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Restrata® Wound Matrix (K170300)
Reference Device(s)
PriMatrix® Dermal Repair Scaffold (K153690)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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 USA seal. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
December 15, 2022
Acera Surgical, Inc. % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K193583 Trade/Device Name: Restrata® Regulatory Class: Unclassified Product Code: QSZ
Dear 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 September 25, 2020. 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services USA seal on the left and the FDA acronym followed by the full name of the agency on the right. The seal features a stylized eagle emblem, while the FDA text is presented in a clear, sans-serif font, with "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.
September 25, 2020
Acera Surgical, Inc. % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K193583
Trade/Device Name: Restrata® Regulatory Class: Unclassified Product Code: FRO Dated: September 16, 2020 Received: September 17, 2020
Dear Linda 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
2
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Anjana Jain -S
Anjana Jain, Ph.D. Acting 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
Enclosure
3
Indications for Use
510(k) Number (if known) K193583
Device Name
Restrata®
Indications for Use (Describe)
Restrata® 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, dehisced wounds), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.
| 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
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Acera Surgical Restrata® is provided below.
| Date Summary Prepared | 08/25/2020 |
|---|---|
| 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) | |
| Regulatory@SecureBME.com | |
| Trade Name | Restrata® |
| Common Name | Wound Matrix |
| Code -Classification | FRO, Unclassified |
| Predicate Device | Restrata® Wound Matrix (K170300) |
| Reference Device | PriMatrix® Dermal Repair Scaffold (K153690) |
Device Description
Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides 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® is terminally sterilized, in a single use double peel package in a variety of sizes in non-meshed and meshed configurations. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.
The subject device is a modification of the predicate device to include updated product labeling, a change in product size offerings, and a change in product design offerings.
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Indications for Use
Restrata® 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 wounds, dehisced wounds), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.
Technological Characteristics
The subject device has the same technological characteristics as the predicate device in terms of principles of operation, intended use, material performance, biocompatibility, material composition and method of action. The only differences between the subject and predicate device are the new smaller size offering of the subject device and the meshed design offerings of the subject device.
The subject device has the same characteristics as the predicate device as follows:
| Characteristic | Restrata®
(subject device) | Restrata® Wound
Matrix
K170300
(Predicate device) | PriMatrix® Dermal
Repair Scaffold
K153690
(Reference device) | Comparison |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 510(k) | K193583 | K170300 | K153690 | N/A |
| Principles of
Operation | Device permits the
ingress of cells and soft
tissue formation into the
defect space / wound
bed | Device permits the
ingress of cells and soft
tissue formation into the
defect space / wound
bed | Device permits the
ingress of cells | 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
Dual polymer matrix
comprised of polyglactin
910 and polydioxanone
fibers (PGLA 90:10 /
PDO) | An acellular dermal
tissue matrix derived
from fetal bovine
dermis | Equivalent to
Predicate
Device |
| Material
Composition | Porous, non-woven
PGLA:PDO matrix | Porous, non-woven
PGLA:PDO matrix | An acellular dermal
tissue matrix derived
from fetal bovine
dermis | Equivalent to
Predicate
Device |
| Characteristic | Restrata®
(subject device) | Restrata® Wound
Matrix
K170300
(Predicate device) | PriMatrix® Dermal
Repair Scaffold
K153690
(Reference device) | Comparison |
| Indications for
Use | Restrata® is intended for
use in the management
of wounds, including:
Partial and full thickness
wounds, pressure sores
/ ulcers, venous ulcers,
diabetic ulcers, chronic
vascular ulcers, tunneled
/ undermined wounds,
surgical wound (e.g.,
donor site / grafts, post-
laser surgery, post-Mohs
surgery, podiatric
wounds, dehisced
wounds), trauma
wounds (e.g., abrasions,
lacerations, partial
thickness burns, skin
tears), and draining
wounds. | Restrata® is intended for
use in the management
of wounds, including:
Partial and full thickness
wounds, pressure sores
/ ulcers, venous ulcers,
diabetic ulcers, chronic
vascular ulcers, tunneled
/ undermined wounds,
surgical wound (e.g.,
donor site / grafts, post-
laser surgery, post-Mohs
surgery, podiatric
wounds, dehisced
wounds), trauma
wounds (e.g., abrasions,
lacerations, partial
thickness burns, skin
tears), and draining
wounds. | PriMatrix is intended
for the management
of wounds that
include:
Partial and full thickness wounds Pressure, diabetic, and venous ulcers Second-degree burns Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence Trauma wounds – abrasions, lacerations and skin tears Tunneled/undermined wounds Draining wounds | Equivalent to
Predicate
Device |
| Size | 0.55" disc (14mm disc)
1"x1" (2.5cm x 2.5cm)
1"x2" (2.5cm x 5.0cm)
1"x3" (2.5cm x 7.5cm)
2"x2" (5.0cm x 5.0cm)
3"x3" (7.5cm x 7.5cm)
4"x5" (10.0cm x 12.5cm)
5"x7" (12.5cm x 17.5cm) | 1"x1" (2.5cm x 2.5cm)
1"x2" (2.5cm x 5.0cm)
1"x3" (2.5cm x 7.5cm)
2"x2" (5.0cm x 5.0cm)
3"x3" (7.5cm x 7.5cm)
4"x5" (10.0cm x 12.5cm)
5"x7" (12.5cm x 17.5cm) | 0.2cm x 26.5cm
14mm disc
18mm disc
2cm x 2cm
3cm x 3cm
4cm x 4cm
5cm x 5cm
6cm x 6cm
8cm x 8cm
8cm x 12cm
10cm x 12cm
10cm x 25cm
20cm x 25cm | Equivalent to
size range of
reference
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 |
| 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
peel packages | Equivalent |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Equivalent |
| Characteristic | Restrata®
(subject device) | Restrata® Wound
Matrix
K170300
(Predicate device) | PriMatrix® Dermal
Repair Scaffold
K153690
(Reference device) | Comparison |
| Resorbable | Yes | Yes | Yes | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent |
| Configurations | Meshed & non-meshed | Non-meshed | Meshed & non-
meshed | Equivalent to
reference
device |
6
7
The function, physical appearance, indication, product code, use environment, and principles of operation of Restrata® are exactly the same as the predicate, Restrata® Wound Matrix.
Non-Clinical Testing — Mechanical
No new mechanical testing was conducted for this submission. All mechanical testing for the device was submitted as part of the original 510(k) submission for Restrata® Wound Matrix (K170300). The subject device is manufactured using the exact same components and processes as the predicate, it is cut from the same component material, and therefore has mechanical properties (tensile strength and suture pullout strength) equivalent to the predicate device.
Non-Clinical Testing - Biocompatibility
No new biocompatibility testing was conducted for this submission. All biocompatibility testing for the device was submitted as part of the original 510(k) submission for Restrata® Wound Matrix (K170300). The subject device is manufactured using the exact same components and processes as the predicate device, it is cut from the same component material, it is packaged and sterilized in the exact same fashion, and therefore has equivalent biocompatibility.
Risk Analysis
A risk analysis of the design controls was conducted in support of substantial equivalence with the predicate device.
Conclusions
The subject device and the predicate device underwent 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 device.