(188 days)
PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.
PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin.
The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel.
PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM").
The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip.
The provided FDA 510(k) document for PuraDerm Gel (K193085) does not describe an acceptance criterion or a study that proves the device meets an acceptance criterion.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that does not require premarket approval. This is achieved by showing that the device has the same intended use and the same technological characteristics as the predicate, or that differences in technological characteristics do not raise different questions of safety and effectiveness.
Here's why the requested information isn't present:
- No new performance data: The document explicitly states: "Because there is no change to the device, source material, or manufacturing compared to the predicate K143058, the existing biocompatibility, sterilization, and shelf life information from K143058 fully applies. GLP pyrogenicity testing showed that the device is considered to be nonpyrogenic. New performance testing was not necessary to support the additional indications or the updates to the IFU."
- Focus on equivalence: The entire "Substantial Equivalence Discussion" (Section 6) and "Conclusions" (Section 8) are dedicated to comparing the proposed device with the predicates based on their characteristics and indications for use, rather than presenting results from a new performance study against defined acceptance criteria.
Therefore, I cannot populate the requested table and details because the provided text explicitly states that new performance testing was not done and thus no acceptance criteria or study results for K193085 are discussed.
The document essentially leverages the prior clearance (K143058) for its technical characteristics and expands its indications based on equivalence to another predicate (K991202) for those specific indications.
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May 11, 2020
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3-D Matrix, Inc. % Stephen Rhodes Principal Streamline Regulatory 3502 Dundee Driveway Chevy Chase, Maryland 20815
Re: K193085
Trade/Device Name: PuraDERM Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 9, 2020 Received: April 9, 2020
Dear Stephen Rhodes:
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 medical devices and radiation-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, Ph.D. For 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) K193085
Device Name PuraDerm Gel
Indications for Use (Describe)
PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below.
SUBMITTER 1.
3-D Matrix, Inc. 250 First Ave., Suite 205 Needham, MA 02494
Contact Person: Lisa Spirio, PhD Phone: 617-875-6204 Email: lisa@puramatrix.com
Prepared By: Stephen P. Rhodes, Streamline Regulatory, stephen.rhodes@streamlineregulatory.com Date Prepared: May 7, 2020
2. SUBJECT DEVICE
Name of Device: PuraDerm Gel Common Name: Wound Dressing Classification Regulation/Class: Unclassified Product Code: FRO Panel: General and Plastic Surgery
PREDICATE DEVICE 3.
Predicate Devices: PuraDerm Gel (K143058) and Woun'Dres (K991202)
DEVICE DESCRIPTION 4.
Description
PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin.
The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel.
PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore
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sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM").
The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip. This same delivery system was previously cleared by FDA in K143058, and there have been no changes to the delivery system for PuraDerm Gel since K143058.
5. INDICATION FOR USE
PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.
SUBSTANTIAL EQUIVALENCE DISCUSSION 6.
As shown in the table below, the technical characteristics of the PuraDerm Gel are identical to the predicate (K143058). Additionally, the Woun'Dres predicate (K991202) is provided for comparison of the indications for use.
| Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| 510(k) Number | K193085 | K143058 | K991202 |
| Applicant | 3-D Matrix | 3-D Matrix | Coloplast Corp |
| Trade name | PuraDerm Gel | PuraDerm Gel | Woun'Dres Collagen Hydrogel |
| ClassificationRegulation | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | MGQ |
| Indications forUse | PuraDerm Gel is indicatedfor the hydration andmanagement of partial andfull thickness wounds, suchas pressure sores, legulcers, diabetic ulcers,surgical wounds, andabrasions and burnsassociated withdermabrasion and laserresurfacing. | PuraDerm Gel is usedfor the management ofpartial and fullthickness wounds,such as pressure sores,leg ulcers, diabeticulcers, and surgicalwounds. | May be used for superficialwounds and abrasions and minorburns. Use under the supervision ofhealth care professions for thelocal management of partial- andfull-thickness wounds includingpressure, and diabetic ulcers; lowerextremity ulcers including those ofvenous, arterial and mixedetiology; surgical wounds; first-and second-degree burns includingmanagement of abrasions andburns associated withdermabrasion and laserresurfacing. |
Table 1: Device Comparison Table
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| Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Contraindications | Do not use on patients witha known sensitivity to thegel or any of itscomponents.Do not use on third degreeburns. | Do not use on patientswith a knownsensitivity to the gel orany of its components.Do not use on thirddegree burns. | Do not use on third-degree burns. |
| Single use | Yes | Yes | No |
| Amount used | At physician's discretion,fill wound to the level ofthe surrounding skin | At physician'sdiscretion, fill woundto the level of thesurrounding skin | At physician's discretion, fillwound to the level of thesurrounding skin |
| Capable of absorbing exudate | Yes (may be used for mildexudate) | Yes (may be used formild exudate) | Yes (minimal to moderate exudate) |
| Duration of continuous wear | Recommended maximumof 7 days | Recommendedmaximum of 7 days | Minimum dressing change 3 timesper week [2-3 day maximumcontinuous wear] |
| Sterilized | Yes | Yes | Unknown |
| Labeled sterile | Yes | Yes | No |
| Preservative free | Yes | Yes | No |
| Appearance | Clear, viscous gel | Clear, viscous gel | Clear amorphous gel |
The indications for use for PuraDerm Gel has the following modifications from the predicate K143058):
- "Used" has been replaced with "indicated" to more accurately reflect the indications.
- . "Management" has been replaced with "hydration and management" to more completely describe the intended use of the hydrogel.
- . "Abrasions and burns associated with dermabrasion and laser resurfacing" has been added to the indications for use. These additional indications were included in the predicate K991202 Coloplast Corporation's Woun'Dres Collagen Hydrogel, which was one of the predicate devices for the original PuraDerm Gel predicate (K143058).
The first two modifications to the predicate indications for use improve the accuracy of the indications and do not affect the intended use of the device. The additional indications of dermabrasion and laser resurfacing do not raise different questions of safety and effectiveness. In fact, the Woun'Dres predicate (K991202) for PuraDerm Gel (K143058) included these identical indications. Therefore, the modifications to the indications for use do not affect the intended use of the device, which is to hydrate and manage wounds.
Additionally, the technological characteristics of the new and predicate device are identical. There have been no design modifications to PuraDerm Gel since it was cleared in K143058.
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7. PERFORMANCE DATA
Because there is no change to the device, source material, or manufacturing compared to the predicate K143058, the existing biocompatibility, sterilization, and shelf life information from K143058 fully applies. GLP pyrogenicity testing showed that the device is considered to be nonpyrogenic.
New performance testing was not necessary to support the additional indications or the updates to the IFU.
CONCLUSIONS 8.
In conclusion, PuraDerm Gel is substantially equivalent to the predicate devices (K143058 and K991202).
N/A