(277 days)
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.
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.
The provided text is a 510(k) Summary for the Acera Surgical Restrata® wound matrix, seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new medical device is as safe and effective as a legally marketed device and does not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or MRMC studies, as would be expected for an AI/ML powered device.
The "study" in this context is the submission and review process for substantial equivalence (510(k)), which primarily relies on demonstrating that the technological characteristics and performance of the new device are equivalent to a predicate device.
Here's an attempt to answer your questions based on the provided text, while acknowledging that many of your points are not directly addressed because this is not an AI/ML device submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the way one might for a diagnostic performance study. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to the predicate device (Restrata® Wound Matrix K170300) and the reference device (PriMatrix® Dermal Repair Scaffold K153690) across various technological characteristics. The reported device performance is presented as direct equivalence.
| Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (Subject Device - Restrata® K193583) |
|---|---|---|
| Principles of Operation | Equivalent to Predicate Device | Device permits the ingress of cells and soft tissue formation into the defect space / wound bed (Equivalent to Predicate) |
| Material of Construction | Equivalent to Predicate Device (Resorbable synthetic polymer matrix; Dual polymer matrix of PGLA 90:10 / PDO) | Resorbable synthetic polymer matrix; Dual polymer matrix comprised of polyglactin 910 and polydioxanone fibers (PGLA 90:10 / PDO) (Equivalent to Predicate) |
| Material Composition | Equivalent to Predicate Device (Porous, non-woven PGLA:PDO matrix) | Porous, non-woven PGLA:PDO matrix (Equivalent to Predicate) |
| Indications for Use | Equivalent to Predicate Device and Reference Device | Intended for use in the management of wounds including partial/full thickness wounds, pressure sores/ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and draining wounds (Equivalent to Predicate Device) |
| Size | Equivalent to size range of Reference Device | 0.55" disc (14mm disc) up to 5"x7" (12.5cm x 17.5cm) (Equivalent to size range of reference device) |
| Surgical Application Restrictions | Equivalent to Predicate & Reference Devices (No specific orientation requirement) | Device does not have requirement for specific orientation (Equivalent) |
| Sterility | Equivalent to Predicate Device (Sterile, SAL 10-6) | Sterile, SAL 10-6 (Equivalent) |
| Packaging | Equivalent to Predicate Device (Double sterile pack, nested pouch configuration within chipboard envelope) | Double sterile pack; Nested pouch configuration within a chipboard envelope (Equivalent) |
| Pyrogenicity | Equivalent to Predicate Device (Non-pyrogenic) | Non-pyrogenic (Equivalent) |
| Resorbability | Equivalent to Predicate Device (Yes) | Yes (Equivalent) |
| Biocompatibility | Equivalent to Predicate Device (Biocompatible) | Biocompatible (Equivalent) |
| Configurations | Equivalent to Reference Device (Meshed & non-meshed) | Meshed & non-meshed (Equivalent to reference device) |
| Mechanical Properties | Equivalent to Predicate Device (Tensile and suture pullout strength) | No new testing; claims equivalence based on identical components and manufacturing process as predicate. |
| Biocompatibility | Equivalent to Predicate Device | No new testing; claims equivalence based on identical components, manufacturing process, packaging, and sterilization as predicate. |
| Risk Analysis | Conducted and supports substantial equivalence. | Conducted in support of substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of a statistical study for device performance. It refers to the predicate device (Restrata® Wound Matrix K170300) and a reference device (PriMatrix® Dermal Repair Scaffold K153690). The "data" provenance for asserting equivalence comes from prior approvals and testing related to these predicate and reference devices, not new patient data or a specific test set for the subject device. The submission focuses on changes to the predicate device (updated labeling, new smaller size, and meshed design options) and argues these changes do not alter fundamental safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth here is the established safety and effectiveness of the predicate device, as determined by its original 510(k) clearance process. No new expert adjudication for a test set is reported for this specific submission, as it relies on equivalence to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a wound matrix, not an AI/ML-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a wound matrix, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this 510(k) submission, the "ground truth" is that the predicate device is safe and effective. The subject device demonstrates substantial equivalence by showing that its technological characteristics are the same or adequately similar to the predicate, and any differences (like new sizes or meshed configuration) do not raise new questions of safety or effectiveness. This is supported by relying on previously submitted and reviewed non-clinical testing (mechanical, biocompatibility) for the predicate device.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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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
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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
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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 (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
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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 BlvdSt. Louis, MO 63132Phone 844-879-2237 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681 (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® WoundMatrixK170300(Predicate device) | PriMatrix® DermalRepair ScaffoldK153690(Reference device) | Comparison |
|---|---|---|---|---|
| 510(k) | K193583 | K170300 | K153690 | N/A |
| Principles ofOperation | Device permits theingress of cells and softtissue formation into thedefect space / woundbed | Device permits theingress of cells and softtissue formation into thedefect space / woundbed | Device permits theingress of cells | Equivalent toPredicateDevice |
| Material ofConstruction | Resorbable syntheticpolymer matrixDual polymer matrixcomprised of polyglactin910 and polydioxanonefibers (PGLA 90:10 /PDO) | Resorbable syntheticpolymer matrixDual polymer matrixcomprised of polyglactin910 and polydioxanonefibers (PGLA 90:10 /PDO) | An acellular dermaltissue matrix derivedfrom fetal bovinedermis | Equivalent toPredicateDevice |
| MaterialComposition | Porous, non-wovenPGLA:PDO matrix | Porous, non-wovenPGLA:PDO matrix | An acellular dermaltissue matrix derivedfrom fetal bovinedermis | Equivalent toPredicateDevice |
| Characteristic | Restrata®(subject device) | Restrata® WoundMatrixK170300(Predicate device) | PriMatrix® DermalRepair ScaffoldK153690(Reference device) | Comparison |
| Indications forUse | Restrata® is intended foruse in the managementof wounds, including:Partial and full thicknesswounds, pressure sores/ ulcers, venous ulcers,diabetic ulcers, chronicvascular ulcers, tunneled/ undermined wounds,surgical wound (e.g.,donor site / grafts, post-laser surgery, post-Mohssurgery, podiatricwounds, dehiscedwounds), traumawounds (e.g., abrasions,lacerations, partialthickness burns, skintears), and drainingwounds. | Restrata® is intended foruse in the managementof wounds, including:Partial and full thicknesswounds, pressure sores/ ulcers, venous ulcers,diabetic ulcers, chronicvascular ulcers, tunneled/ undermined wounds,surgical wound (e.g.,donor site / grafts, post-laser surgery, post-Mohssurgery, podiatricwounds, dehiscedwounds), traumawounds (e.g., abrasions,lacerations, partialthickness burns, skintears), and drainingwounds. | PriMatrix is intendedfor the managementof wounds thatinclude: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 toPredicateDevice |
| 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 26.5cm14mm disc18mm disc2cm x 2cm3cm x 3cm4cm x 4cm5cm x 5cm6cm x 6cm8cm x 8cm8cm x 12cm10cm x 12cm10cm x 25cm20cm x 25cm | Equivalent tosize range ofreferencedevice |
| SurgicalApplicationRestrictions | Device does not haverequirement for specificorientation | Device does not haverequirement for specificorientation | Device does not haverequirement forspecific orientation | Equivalent |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile | Equivalent |
| Packaging | Double sterile pack.Nested pouchconfiguration within achipboard envelope | Double sterile pack.Nested pouchconfiguration within achipboard envelope | Doublepeel packages | Equivalent |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Equivalent |
| Characteristic | Restrata®(subject device) | Restrata® WoundMatrixK170300(Predicate device) | PriMatrix® DermalRepair ScaffoldK153690(Reference device) | Comparison |
| Resorbable | Yes | Yes | Yes | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent |
| Configurations | Meshed & non-meshed | Non-meshed | Meshed & non-meshed | Equivalent toreferencedevice |
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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.
N/A