K Number
K223725
Device Name
Restrata® MiniMatrix
Date Cleared
2023-05-18

(156 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Restrata® MiniMatrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores / ulcers, venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (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.
Device Description
Restrata MiniMatrix is a sterile, single use device intended for the local management of wounds. Restrata MiniMatrix is a form of Restrata Matrix that can be dispersed at the wound site during application. The device is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity similar to native extracellular matrix. Restrata MiniMatrix completely degrades via hydrolysis. The device does not contain any human or animal materials or tissues. Restrata MiniMatrix is supplied in a nested pouch configuration, placed within a shelf-box. The product is terminally sterilized. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.
More Information

No
The device description and performance studies focus on the material properties and wound healing efficacy of a synthetic matrix, with no mention of AI or ML technologies.

Yes
The device is intended for the "management of wounds", which is a therapeutic purpose.

No

Explanation: The device is intended for the management of wounds, not for diagnosis. Its description and performance studies focus on wound healing and local tissue response rather than identifying or characterizing a medical condition.

No

The device description clearly states it is a sterile, single-use device made from synthetic biocompatible materials with a fibrous structure, indicating it is a physical product, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the management of wounds. This involves applying a material directly to a wound to aid in healing.
  • Device Description: The device is a sterile, single-use material applied locally to wounds. It's a physical material designed to support wound healing.
  • Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for something.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic device applied directly to the wound site.

N/A

Intended Use / Indications for Use

Restrata® MiniMatrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores / ulcers, venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (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.

Product codes (comma separated list FDA assigned to the subject device)

QSZ

Device Description

Restrata MiniMatrix is a sterile, single use device intended for the local management of wounds. Restrata MiniMatrix is a form of Restrata Matrix that can be dispersed at the wound site during application. The device is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity similar to native extracellular matrix. Restrata MiniMatrix completely degrades via hydrolysis. The device does not contain any human or animal materials or tissues.

Restrata MiniMatrix is supplied in a nested pouch configuration, placed within a shelf-box. The product is terminally sterilized. 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)

A full thickness porcine wound model was performed. The purpose of this study was to evaluate the local tissue response of the subject device (Restrata MiniMatrix) and show that the device does not cause any delay in the natural wound healing process compared to the predicate/reference devices. Overall, application of the subject device in full thickness wounds showed an equivalent safety and efficacy profile to the comparator devices. The testing data demonstrates comparable wound healing with commercially available devices with the same intended use.

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.

Acera Surgical Inc., Restrata® (K170300, K193583)

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.

ACell Inc., MicroMatrix® (K172399), Aroa Biosurgery Ltd., MyriadTM Particles (K200502)

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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 5, 2023

Acera Surgical, Inc. % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K223725

Trade/Device Name: Restrata® MiniMatrix 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 May 18, 2023. Specifically, FDA is updating this SE Letter as an administrative correction because the issuance date was inadvertently excluded in the original letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Julie Morabito, OHT4: Office of Surgical and Infection Control Devices at (240) 402-3839 or julie.morabito@fda.hhs.gov.

Sincerely,

Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2023.06.05 10:46:42 -04'00'

for Julie A. 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 shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Acera Surgical, Inc. % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K223725

Trade/Device Name: Restrata® MiniMatrix Regulatory Class: Unclassified Product Code: QSZ Dated: April 17, 2023 Received: April 17, 2023

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.

Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Pate: 2023.05.18 08:29:50 -04'00'

for Julie A. 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

Enclosure

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Indications for Use

510(k) Number (if known) K223725

Device Name Restrata® MiniMatrix

Indications for Use (Describe)

Restrata® MiniMatrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores / ulcers, venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (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.

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 K223725 Acera Surgical Restrata® MiniMatrix

DateMay 17, 2023
Submitted byAcera Surgical, Inc.
1650 Des Peres Rd., Suite 120
St. Louis, MO 63131
Phone 844-879-2237
510(k) ContactsSecure BioMed Evaluations
Linda Braddon, Ph.D.
Justin Gracyalny, MSE
7828 Hickory Flat Highway, Suite 120
Woodstock, GA 30188
770-837-2681 (direct)
Regulatory@SecureBME.com
Trade NameRestrata® MiniMatrix
Common NameWound Dressing
Code - ClassificationQSZ
Unclassified
Primary Predicate DeviceAcera Surgical Inc., Restrata® (K170300, K193583)
Reference DevicesACell Inc., MicroMatrix® (K172399)
Aroa Biosurgery Ltd., MyriadTM Particles (K200502)

Device Description

Restrata MiniMatrix is a sterile, single use device intended for the local management of wounds. Restrata MiniMatrix is a form of Restrata Matrix that can be dispersed at the wound site during application. The device is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity similar to native extracellular matrix. Restrata MiniMatrix completely degrades via hydrolysis. The device does not contain any human or animal materials or tissues.

Restrata MiniMatrix is supplied in a nested pouch configuration, placed within a shelf-box. The product is terminally sterilized. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

Indications for Use

Restrata MiniMatrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores / ulcers, venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (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.

5

Technological Characteristics

Restrata MiniMatrix is a form of Restrata Matrix (K170300, K193583) that can be dispersed at the wound site during application. The subject device and predicate device are both indicated for the management of wounds. The subject device is offered in similar packaging and size offerings to those seen in the reference devices (K172399, K200502).

| Characteristic | Subject Device
Acera Surgical Inc.
Restrata® MiniMatrix | Predicate Device
Acera Surgical Inc.
Restrata®
K170300, K193583 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product Code | QSZ | QSZ |
| Device Class | Unclassified | Unclassified |
| Regulation | Unclassified | Unclassified |
| Indications for Use | Restrata MiniMatrix 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 wounds (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 wounds (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. |
| 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. |
| Material of
Construction | Electrospun, resorbable, synthetic dual polymer matrix comprised of polyglactin 910 and polydioxanone fibers (PGLA 90:10 / PDO), which is then milled. | Electrospun, resorbable, synthetic dual polymer matrix comprised of polyglactin 910 and polydioxanone fibers (PGLA 90:10 / PDO). |
| Configuration | Particulate matrix | Meshed & non-meshed matrix |
| Nominal Device Sizes | 100mg
250mg
500mg
1000mg
2000mg | 0.55" disc (14mm disc)
0.5"x1" (1.3cm x 2.5cm)
1"x1" (2.5cm x 2.5cm)
1.5"x2" (3.8cm x 5.0cm)
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) |
| Particle Size |