Restrata® MiniMatrix

K223725 · Acera Surgical, Inc. · QSZ · May 18, 2023 · SU

Device Facts

• Record ID: K223725
• Device Name: Restrata® MiniMatrix
• Applicant: Acera Surgical, Inc.
• Product Code: QSZ · SU
• Decision Date: May 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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 Story

Restrata® MiniMatrix is a sterile, single-use, resorbable wound dressing designed for local wound management. It consists of a milled, particulate matrix made from electrospun synthetic polyglactin 910 and polydioxanone (PGLA 90:10 / PDO) fibers. The device is applied to the wound site, where its high-porosity, fibrous structure mimics native extracellular matrix to facilitate cell ingress and soft tissue formation. It degrades completely via hydrolysis. The device is intended for clinical use by healthcare professionals. It provides a scaffold for tissue repair, potentially benefiting patients by supporting natural wound healing processes in various chronic and acute wound types.

Clinical Evidence

No human clinical data. Evidence includes bench testing (biocompatibility per ISO 10993-1, sterilization validation per ISO 11137-2) and a comparative full-thickness porcine wound healing study. The animal study demonstrated that the subject device does not delay natural wound healing and shows an equivalent safety and efficacy profile compared to the predicate and reference devices.

Technological Characteristics

Electrospun, resorbable, synthetic dual polymer matrix (polyglactin 910 and polydioxanone fibers, PGLA 90:10 / PDO). Particulate configuration with particle size <3.15mm. Sterile (SAL 10^-6), single-use, biocompatible, non-pyrogenic. Resorption via hydrolysis. No human or animal tissues.

Indications for Use

Indicated for management of partial and full thickness wounds, pressure sores, venous/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-laser/Mohs, podiatric, dehisced), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Regulatory Classification

Identification

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Predicate Devices

• Restrata® (K170300, K193583)

Reference Devices

• MicroMatrix® (K172399)
• MyriadTM Particles (K200502)

Submission Summary (Full Text)

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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 [phone] or [e-mail].

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

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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

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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 ([e-mail]) or phone [phone] 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)

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|--------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### 510(k) Summary K223725 Acera Surgical Restrata® MiniMatrix

| Date | May 17, 2023 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Acera Surgical, Inc.<br>1650 Des Peres Rd., Suite 120<br>St. Louis, MO 63131<br>Phone [phone] |
| 510(k) Contacts | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>Justin Gracyalny, MSE<br>7828 Hickory Flat Highway, Suite 120<br>Woodstock, GA 30188<br>770-837-2681 (direct)<br>[e-mail] |
| Trade Name | Restrata® MiniMatrix |
| Common Name | Wound Dressing |
| Code - Classification | QSZ<br>Unclassified |
| Primary Predicate Device | Acera Surgical Inc., Restrata® (K170300, K193583) |
| Reference Devices | ACell Inc., MicroMatrix® (K172399)<br>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.

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## 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<br>Acera Surgical Inc.<br>Restrata® MiniMatrix | Predicate Device<br>Acera Surgical Inc.<br>Restrata®<br>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<br>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<br>250mg<br>500mg<br>1000mg<br>2000mg | 0.55" disc (14mm disc)<br>0.5"x1" (1.3cm x 2.5cm)<br>1"x1" (2.5cm x 2.5cm)<br>1.5"x2" (3.8cm x 5.0cm)<br>1"x2" (2.5cm x 5.0cm)<br>1"x3" (2.5cm x 7.5cm)<br>2"x2" (5.0cm x 5.0cm)<br>3"x3" (7.5cm x 7.5cm)<br>4"x5" (10.0cm x 12.5cm)<br>5"x7" (12.5cm x 17.5cm) |
| Particle Size | <3.15mm | Not applicable |
| Single Use | Yes | Yes |
| Prescription Use | Yes | Yes |
| Resorbable | Yes | Yes |
| Biocompatibility | Biocompatible | Biocompatible |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic |
| Endotoxin | <20 EU/Device | <20 EU/Device |
| Characteristic | Subject Device<br>Acera Surgical Inc.<br>Restrata® MiniMatrix | Predicate Device<br>Acera Surgical Inc.<br>Restrata®<br>K170300, K193583 |
| Sterilization | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| Surgical Application<br>Restrictions | Device does not have requirement for<br>specific orientation. | Device does not have requirement for<br>specific orientation. |
| Packaging | Double sterile pack. Nested pouch<br>configuration within a chipboard unit<br>box. | Double sterile pack. Nested pouch<br>configuration within a chipboard unit<br>box or envelope. |

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## Non-Clinical Testing

Due to the fact that the subject device is made from the exact same component material as the predicate device, pre-existing data pertaining to the predicate device materials are applicable to the subject device. To support the change in device configuration, the subject device particle size was characterized using established imaging techniques, and an evaluation of residual heavy metals was performed. Additionally, a comparative porcine wound healing animal model supports equivalent wound healing performance between the subject, predicate, and reference (K172399) devices.

A biocompatibility evaluation was conducted in accordance with ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the FDA Guidance Document "Use of International Standard ISO 10993-1. The results of the testing adequately address biocompatibility for the subject device and its intended use. Additionally, a sterilization validation was conducted in accordance with ISO 11137-2 "Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose" and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" to a sterility Assurance Level (SAL) of 1x10 . All test method acceptance criteria were met.

## Wound Healing Study

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.

## Conclusion

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 device.