Who is the manufacturer of Restrata®?

Acera Surgical, Inc. filed the 510(k) submission for Restrata® (K193583).

What is the FDA product code for Restrata®?

QSZ. as a Class U device in the SU panel.

What is the regulatory pathway for Restrata®?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Restrata®?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Restrata®

K193583 · Acera Surgical, Inc. · QSZ · Sep 25, 2020 · SU

Device Facts

Record ID	K193583
Device Name	Restrata®
Applicant	Acera Surgical, Inc.
Product Code	QSZ · SU
Decision Date	Sep 25, 2020
Decision	SESE
Submission Type	Special
Device Class	Class U
Attributes	Therapeutic

Intended 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.

Device Story

Restrata® is a sterile, single-use, absorbable wound matrix; composed of synthetic polyglactin 910 and polydioxanone (PGLA 90:10 / PDO) fibers. Device provides a porous, fibrous scaffold mimicking native extracellular matrix; supports cellular infiltration and vascularization; degrades via hydrolysis. Used in clinical settings for local wound management; applied by healthcare providers. Available in meshed and non-meshed configurations; various sizes. Benefits patient by providing moist environment for natural healing process.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical bench testing (mechanical and biocompatibility) previously submitted for the predicate device (K170300).

Technological Characteristics

Resorbable synthetic polymer matrix; dual-fiber composition of polyglactin 910 and polydioxanone (PGLA 90:10 / PDO). Porous, non-woven structure. Terminally sterilized (SAL 10^-6). Available in meshed and non-meshed configurations. Dimensions range from 14mm disc to 12.5cm x 17.5cm sheets.

Indications for Use

Indicated for management of partial/full thickness wounds, pressure/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Mohs, podiatric, dehisced), trauma wounds (abrasions, 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® Wound Matrix (K170300)

Reference Devices

PriMatrix® Dermal Repair Scaffold (K153690)

Related Devices

K170300 — Restrata Wound Matrix · Acera Surgical, Inc. · Apr 26, 2017
K223725 — Restrata® MiniMatrix · Acera Surgical, Inc. · May 18, 2023
K173544 — Phoenix Wound Matrix · Nanofiber Solutions, Inc. · Mar 2, 2018
K132397 — GORE BIO-A WOUND MATRIX · W. L. Gore & Associates, Inc. · May 7, 2014
K251582 — Redermax Antibacterial Wound Matrix · Beijing Kreate Medical Co., Ltd. · Feb 2, 2026

Submission Summary (Full Text)

{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) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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. {5}------------------------------------------------ #### 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.