(457 days)
No
The device description focuses on the material composition and physical properties of a hydrogel wound dressing. There is no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is described as a "wound dressing" intended for the "local management of partial- and full-thickness wounds," which implies a therapeutic purpose of aiding in wound healing and protection.
No
The device description and intended use indicate that this product is a wound dressing designed for the management of superficial wounds, abrasions, minor burns, and various types of ulcers. It is a topical hydrogel matrix that provides a barrier and hydration to the wound. It does not mention any function related to diagnosing a condition or disease.
No
The device is a physical hydrogel matrix supplied in a syringe, clearly describing a hardware component and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a topical wound dressing for the local management of various types of wounds and burns. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the composition and function of the hydrogel matrix as a wound dressing, providing a barrier and donating water to the tissue. It does not mention any function related to analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The anatomical site is "dermal wounds," which are external and treated topically, not internally for diagnostic purposes.
- Performance Studies: The performance studies focus on wound healing in an animal model, demonstrating safety and effectiveness as a wound dressing, not diagnostic accuracy.
- Predicate and Reference Devices: The predicate and reference devices listed are also wound dressings (Collagen Hydrogel, PuraDERM, Excellagen), further supporting the classification as a therapeutic device.
In vitro diagnostics are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease. This device does not fit that definition.
No.
The letter explicitly states: "FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction." This clearly indicates that the device is not authorized under a PCCP.
Intended Use / Indications for Use
OTC: May be used for superficial wounds and abrasions and minor burns.
Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.
Product codes
FRO
Device Description
G4Derm / G4Derm Plus Synthetic Wound Matrix is a sterile, biodegradable hydrogel matrix supplied in a prefilled syringe ready for topical use as primary wound dressing, with or without the use of an optional nozzle. The hydrogel in G4Derm / G4Derm Plus is composed of an aqueous solution of synthetic peptide (≥ 98% sterile water). The device is completely non-animal tissue and non-cellular derived.
G4Derm / G4Derm Plus forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of interwoven fibrils formed from individual peptide monomers. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). This structure also functions as a matrix that holds and donates water to underlying tissue, while providing an effective barrier to cover and protect the wound against the external environment, namely against bacterial penetration.
G4Derm / G4Derm Plus Synthetic Wound Matrix forms a clear, biodegradable hydrogel without expansion in volume. During dressing changes, the unincorporated or unintegrated material may be removed without causing trauma to the underlying tissue by gently flushing / wiping the wound.
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
Rx: Under the supervision of health care professionals
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)
G4Derm / G4Derm Plus is terminally sterilized to achieve a minimum sterility assurance level of 10-6 in accordance with ISO 17665. G4Derm / G4Derm Plus safety and effectiveness is further supported by pre-clinical data including in vivo performance testing in an established porcine wound healing model; biocompatibility testing, as per ISO 10993-1 and consistent with FDA Guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"; clinical data (Human Skin Irritation Test); antibacterial barrier effectiveness testing (in vitro); additional verification and validation activities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 9, 2024
Gel4Med, Inc. Ana Tellechea Senior Product Development Manager 1660 Soldiers Field Rd STE 7 #1063 Brighton, Massachusetts 02135
Re: K222025
Trade/Device Name: G4Derm / G4Derm Plus Synthetic Wound Matrix Regulatory Class: Unclassified Product Code: FRO
Dear Ana Tellechea:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on October 11, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, Yu-Chieh Chiu, yuchieh.chiu@fda.hhs.gov.
Sincerely.
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director for Wound Devices DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2024
Gel4Med, Inc. Ana Tellechea Senior Product Development Manager 1660 Soldiers Field Rd STE 7 #1063 Brighton, Massachusetts 02135
Re: K222025
Trade/Device Name: G4Derm / G4Derm Plus Synthetic Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: June 16, 2023 Received: June 16, 2023
Dear Ana Tellechea:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on October 11, 2023.
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
3
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.
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director for Wound Devices DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K222025
Device Name G4Derm / G4Derm Plus Synthetic Wound Matrix
Indications for Use (Describe)
OTC: May be used for superficial wounds and abrasions and minor burns.
Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.
| 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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5
510(k) Summary- K222025 (As required by 21 CFR 807.92)
6
510(k) Summary
-
- Submitter Information
| Submitter: | Gel4Med, Inc.
1660 Soldiers Field Rd STE 7 #1063
Brighton, MA 02135 |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ana Tellechea, Pharm.D., Ph.D.
Senior Product Development Manager
Email: ana@gelformed.com
Phone: (617) 642-2599 |
| Date Prepared: | October 6, 2023 |
-
- Subject Device
| Name of Device: | G4Derm / G4Derm Plus Synthetic Wound Matrix |
|---|---|
| Common Name: | Wound Dressing |
| Classification Regulation/Class: | Unclassified |
| Product Code: | FRO |
| Panel: | General and Plastic Surgery |
3. Predicate and Reference Devices
Predicate Device:
- . Woun'Dres® Collagen Hydrogel (Coloplast Corporation); K991202
Reference Devices:
4. Device Description
G4Derm / G4Derm Plus Synthetic Wound Matrix is a sterile, biodegradable hydrogel matrix supplied in a prefilled syringe ready for topical use as primary wound dressing, with or without the use of an optional nozzle. The hydrogel in G4Derm / G4Derm Plus is composed of an aqueous solution of synthetic peptide (≥ 98% sterile water). The device is completely non-animal tissue and non-cellular derived.
7
G4Derm / G4Derm Plus forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of interwoven fibrils formed from individual peptide monomers. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). This structure also functions as a matrix that holds and donates water to underlying tissue, while providing an effective barrier to cover and protect the wound against the external environment, namely against bacterial penetration.
G4Derm / G4Derm Plus Synthetic Wound Matrix forms a clear, biodegradable hydrogel without expansion in volume. During dressing changes, the unincorporated or unintegrated material may be removed without causing trauma to the underlying tissue by gently flushing / wiping the wound.
Intended Use and Indications for Use 5.
OTC: May be used for superficial wounds and abrasions and minor burns.
Rx: Under the supervision of health care professionals for the local management of partialand full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partialthickness burns including the management of abrasions and burns associated with dermabrasions and laser resurfacing.
6. Comparison With the Predicate Devices
G4Derm / G4Derm Plus is similar in design, function, mechanism of action, physical properties, and presentation to other wound dressings, including collagen-based devices such as Woun'Dres® Collagen Hydrogel (predicate, K991202) and Excellagen (reference device, K110318), as well as synthetic peptide-based hydrogel materials such as PuraDERM (reference device, K193085).
The intended use of G4Derm / G4Derm Plus and its predicate device is the same. They are intended for local wound management, i.e., to protect the wound and provide a moist wound environment conducive to wound healing. The devices are hydrogels that serve as primary contact wound dressings [via direct topical application] for the management of a variety of wounds, including partial and full thickness wounds, and are intended to be used with a secondary wound dressing.
8
The indications for use for the proposed device are identical to the language from its predicate device. No new indications are proposed.
G4Derm / G4Derm Plus forms a porous hydrogel scaffold that resembles the microarchitecture of endogenous extracellular matrix ("ECM"). G4Derm / G4Derm Plus and its predicate/reference devices form a matrix barrier that fills and conforms to the wound, maintains a moist environment conducive to healing, and covers and protects the wound. The subject device also serves as an antibacterial barrier (based on in vitro testing).
G4Derm / G4Derm Plus is composed of a peptide-based agueous solution, with water being the major component. Woun'Dres is composed of water and collagen, along with skin protectants and a mild preservative, and is also presented as a hydrogel. The minor differences in technological characteristics between G4Derm / G4Derm Plus and its predicates do not present any new questions regarding its safety and effectiveness. The safety and effectiveness of G4Derm / G4Derm Plus is supported by sterility testing, biocompatibility testing, human skin irritation testing, and performance testing including a large animal wound healing model, as well as by additional verification and validation activities.
9
| Table 1: Substantial Equivalence Comparison G4Derm Plus vs Predicate Device | |||
|---|---|---|---|
| | SUBJECT DEVICE | PREDICATE DEVICE | SUBJECT VS
PREDICATE
COMPARISON | REFERENCE DEVICE 1 | REFERENCE DEVICE 2 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Regulatory Information | | | |
| Trade Name | G4Derm/G4Derm Plus
Synthetic Wound Matrix | Woun'Dres® Collagen
Hydrogel Wound
Dressing | | Excellagen | PuraDERM Gel |
| Applicant | Gel4Med | Coloplast | | Tissue Repair Company | 3D Matrix |
| 510(k)
Number(s) | K222025 | K991202 | | K110318 | K193085; K143058 |
| OTC or Prescription
(per 21 CFR801.109) | OTC and Prescription | OTC and Prescription | Same as predicate
device. | Prescription | OTC and Prescription |
| Intended Use | Local management of
wounds.
Direct topical application to
dermal wounds. | Local management of
wounds. Direct topical
application to dermal wounds. | Same as predicate
device. | Local management of
wounds.
Direct topical application to
dermal wounds. | Local management of
wounds.
Direct topical application
to dermal wounds. |
| Indications for Use | OTC: May be used for
superficial wounds and
abrasions and minor burns.
Rx: Under the supervision of
health care professionals for
the local management of
partial- and full- thickness
wounds including pressure,
and diabetic ulcers; lower
extremity ulcers including
those of venous, arterial, and
mixed etiology; surgical
wounds; first- degree and
partial- thickness burns
including management of
abrasions and burns
associated with
dermabrasions and laser
resurfacing. | OTC: May be used for
superficial wounds and
abrasions and minor burns.
Rx: Under the supervision of
health care professionals for
the local management of
partial- and full- thickness
wounds including pressure,
and diabetic ulcers; lower
extremity ulcers including
those of venous, arterial,
and mixed etiology; surgical
wounds; first- and second-
degree burns including
management of abrasions
and burns associated with
dermabrasions and laser
resurfacing. | Same as predicate
device. | OTC: N/A
Rx: Excellagen is indicated
for the management of
wounds including partial
and full thickness wounds,
pressure ulcers, venous
ulcers, diabetic ulcers,
chronic vascular ulcers,
tunneled/undermined
wounds, surgical wounds
(donor sites/grafts, post-
Moh's surgery, post- laser
surgery, podiatric, wound
dehiscence), trauma
wounds (abrasions,
lacerations, second- degree
burns, and skin tears) and
draining wounds. | OTC: PuraDERM is used
for the management of
minor cuts, minor
abrasions, minor wounds,
and minor burns (1st
degree burns).
Rx: PuraDERM Gel is
indicated for the hydration
and management of partial
and full-thickness wounds,
such as pressure sores,
leg ulcers, diabetic ulcers,
and surgical wounds, and
abrasions and burns
associated with
dermabrasion and laser
resurfacing. |
| | SUBJECT DEVICE | PREDICATE DEVICE | SUBJECT VS
PREDICATE
COMPARISON | REFERENCE DEVICE 1 | REFERENCE DEVICE 2 |
| | | | Technological Characteristics | | |
| Form | Hydrogel | Hydrogel | Same as predicate
device. | Hydrogel | Hydrogel |
| Single Use | Yes | No | Different but does not
affect safety and
effectiveness.
Reference devices 1
and 2 are included to
support technological
characteristics. | Yes | Yes |
| Product Application | Apply directly to the clean
wound and fill wound to the
level of the surrounding skin. | Apply directly to the clean
wound and fill wound to the
level of the surrounding skin. | Same as predicate
device. | Apply directly to clean
wound and fill wound to the
level of the surrounding
skin. | Apply directly to clean
wound and fill wound to the
level of the surrounding
skin. |
| Frequency of
Application | Change dressing and reapply
product as needed. | Change dressing and reapply
product as needed.
Recommended minimum
dressing changes 3 times per
week. | Similar to predicate
device.
Animal performance
testing data supports SE
Reference devices 1 and
2 are included to
support technological
characteristics. | Change dressing as
needed and reapply
product at once per week
intervals. | Change dressing and
reapply product as needed.
Recommended maximum
continuous wear of 7 days. |
| Labeled Sterile | Yes | No | Different but does not
affect safety and
effectiveness.
Reference devices 1 and
2 are included to
support technological
characteristics. | Yes | Yes |
| Presentation | Supplied sterile in single use
syringe for direct
administration to the wound.
Sterile applicator/ nozzle is
also provided and may be
used if desired. | Supplied non-sterile in
multiple use tubes for direct
administration to the wound. | Different. Differences
were evaluated by
biocompatibility and
performance testing and
support SE. Reference
devices 1 and 2 are
included to support
technological
characteristics. | Supplied sterile in single
use syringe for direct
administration to the
wound. Sterile flexible
applicator is also provided. | Supplied sterile in single-
use syringe for direct
administration to the
wound. Provided applicator
nozzle may be used if
desired. |
| Shelf-Life | 12 months (1 year) | 2 years | Similar to predicate
device. | 3 years | 3 years |
| | SUBJECT DEVICE | PREDICATE DEVICE | SUBJECT VS
PREDICATE
COMPARISON | REFERENCE DEVICE 1 | REFERENCE DEVICE 2 |
| Storage | Store at +2°C to +30°C
(+36°F to +86°F)
Do not freeze.
Avoid excessive heat. | Not Specified (room
temperature) | Similar to predicate
device. | Store at 36°- 46°F / 2 -
8°C.
Avoid freezing. | Store in a refrigerator (+2°C
to +8°C / +35.6°F
to +46.4°F).
Do not Freeze. |
| Safety and Performance Testing | | | | | |
| Biological
Evaluation | Performed. Biocompatibility
Testing in accordance with
ISO 10993-1
demonstrated safety of the
device for its intended use
[management of wounds].
Clinical (human skin
irritation) testing confirmed
safety. | Performed. Biocompatibility
Testing demonstrated safety of
the device for its intended use
[management of wounds]. | Similar. No new or
different questions of
safety were raised
when compared to the
predicate device. | Performed. Biocompatibility
Testing in accordance with
ISO 10993-1 demonstrated
safety of the device for its
intended use [management
of wounds]. | Performed. Biocompatibility
Testing in accordance with
ISO 10993-1
demonstrated safety of the
device for its intended use
[management of wounds]. |
| Animal Performance
Testing | Performed. GLP pre- clinical
performance testing in
wound healing animal model
demonstrated substantial
equivalence regarding safety
and effectiveness when
compared to the predicate
devices. | Unknown | Similar. Animal
performance testing
demonstrated that the
subject device is safe
and effective under
the proposed
conditions of use for
its intended use [local
management of
wounds] and
substantial
equivalence to its
predicate device. | Unknown | Performed. GLP pre-
clinical performance testing
in wound healing animal
model demonstrated
substantial equivalence
regarding safety and
effectiveness when
compared to the predicate
devices. |
10
11
12
7. Safety and Performance Data
G4Derm / G4Derm Plus is terminally sterilized to achieve a minimum sterility assurance level of 10° in accordance with ISO 17665. G4Derm / G4Derm Plus safety and effectiveness is further supported by pre-clinical data including in vivo performance testing in an established porcine wound healing model; biocompatibility testing, as per ISO 10993-1 and consistent with FDA Guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"; clinical data (Human Skin Irritation Test); antibacterial barrier effectiveness testing (in vitro); additional verification and validation activities.
8. Substantial Equivalence Discussion and Conclusion
G4Derm / G4Derm Plus Synthetic Wound Matrix is substantially equivalent in intended use, indications for use, device design, function, physical properties, principles of operation, instructions for use, biocompatibility, safety, and performance to the predicate device. The technological differences between G4Derm / G4DermPlus and the predicate are minor and do not raise any new or different questions regarding its safety and effectiveness. Any differences in the technological characteristics of the subject device when compared to the predicate have been successfully evaluated using appropriate scientific methods. Safety and performance evaluation including sterility testing, shelf-life testing, biocompatibility testing, animal performance testing, and additional verification and validation activities confirmed that the subject device is as safe, as effective, and performs as well as the predicate device for its intended use and indications for use.
In conclusion, the evaluation of G4Derm / G4Derm Plus Synthetic Wound Matrix has determined it to be substantially equivalent to the previously cleared predicate devices.