(128 days)
No
The device description and performance studies focus on the material properties and biological performance of a fish dermal matrix, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of various wounds, including chronic and surgical wounds, which are conditions that require therapeutic intervention for healing and recovery.
No
Explanation: The device description states it is a fish dermal matrix composed of fish collagen, supplied as a sterile sheet for wound management. Its intended use is for the "management of wounds," which implies treatment or healing, not diagnosis. There is no mention of diagnostic capabilities, such as identifying, assessing, or measuring a medical condition.
No
The device description clearly states the device is a "processed fish dermal matrix composed of fish collagen" supplied as a "sterile intact, or meshed sheet," indicating it is a physical biological product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of wounds." This involves applying the device directly to the wound for healing purposes.
- Device Description: The description details a "processed fish dermal matrix" that is applied as a sheet. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic product applied directly to the body for treatment.
N/A
Intended Use / Indications for Use
MariGen Wound Extra is indicated for the management of wounds, including:
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Trauma wounds (second degree burn, abrasions, lacerations, skin tears),
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence),
- Draining wounds.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
The subject device is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in sizes up to 20 x 30 cm. The subject device is obtained from fish skin via standardized controlled GMP manufacturing process and supplied in terminally sterile packaging. The subject device is biocompatible, pliable, and non-cross linked.
The device is intended for single use only.
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
Not Found
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)
The subject device is a size modified version of the predicate device. Both are made from the MariGen Material. Biocompatibility tests and product characterization studies performed on the predicate device fully apply to the subject device as those are identical materials. Present performance data includes data from: elemental impurities and chemical residual analysis.
The subject device is identical to the predicate device apart from being offered in sizes up to 600cm². The subject device does not raise new safety questions for patients. Kerecis's risk-based approach, executed according to EN ISO 14971: Medical devices - Application of risk management to medical devices, shows that all sizes of the modified device are safe for use.
The provided data from biocompatibility testing combined with bench testing and animal studies exhibits product safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
July 10. 2019
Image /page/0/Picture/1 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 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Kerecis Limited Gudmundur Sigurjonsson CEO Eyrargata 2 400 Isafjordur, Iceland
Re: K190528 Trade/Device Name: MariGen Wound Extra Regulatory Class: Unclassified Product Code: KGN Dated: March 29, 2019 Received: April 5, 2019
Dear Gudmundur Sigurjonsson:
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 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)
1
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,
Cynthia Chang 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) K190528
Device Name MariGen Wound Extra
Indications for Use (Describe)
MariGen Wound Extra is indicated for the management of wounds, including:
-
Partial and full-thickness wounds
-
Pressure ulcers
-
Venous ulcers
-
Chronic vascular ulcers
-
Diabetic ulcers
-
Trauma wounds (second degree burn, abrasions, lacerations, skin tears),
-
Surgical wounds (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence),
-
Draining wounds.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary – K190528
SUBMITTER/510K HOLDER
| Company Address: | Kerecis Limited
Eyrargata 2
400 Isafjordur
Iceland |
|------------------|-------------------------------------------------------------|
| Contact Person: | Gudmundur Fertram Sigurjonsson
Executive Chairman |
| Telephone: | 011 354 562 2601 |
| Date Prepared: | February 20th, 2019 |
DEVICE NAME
| Proprietary Name: | MariGen Wound Extra |
|---|---|
| Common/Usual Name: | Collagen, Wound, Dressing |
| Class: | Unclassified |
| Product code: | KGN |
PREDICATE DEVICE
MariGen Wound (K132343), predicate device
SecureMesh (K153364), reference device
DEVICE DESCRIPTION
The subject device is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in sizes up to 20 x 30 cm. The subject device is obtained from fish skin via standardized controlled GMP manufacturing process and supplied in terminally sterile packaging. The subject device is biocompatible, pliable, and non-cross linked.
The device is intended for single use only.
4
INTENDED USE
The subject device is indicated for the management of wounds including:
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
- Draining wounds
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
MariGen Wound Extra and the predicate device are made of the same material and share the same functional design, principles of operation, and user safety and efficacy. The subject device is substantially equivalent to the legally marketed predicate device with respect to: Indications for use, material composition, device characteristics, manufacturing processes, packaging material, and shelf life. The subject device performs as well as its predicate device and is offered in a greater variety of sizes, including larger sizes. Both devices can be cut to defect size and shape for better fit. In addition, the subject device shares the same safety as the implantable reference device K153364 SecureMesh, which is made of the same fish skin material (the "MariGen Material"). All devices are fully resorbable and do not require a second intervention for removal.
| Device
Features | Subject Device:
MariGen Wound Extra | Predicate Device:
MariGen Wound | SUBSTANTIAL EQUAIVLENCE |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510(k) Number | K190528 | K132343 | |
| Manufacturer | Kerecis Limited | Kerecis Limited | |
| Product Codes | KGN | KGN | Equivalent |
| Intend. Use | Wound Dressing | Wound Dressing | Equivalent |
| Indications | Management of wounds
including:
- Partial and full-thickness
wounds - Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers | Management of wounds
including: - Partial and full-thickness
wounds - Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers | Equivalent |
Summary Table of Substantial Equivalence
5
| - Diabetic ulcers | - Diabetic ulcers | ||
|---|---|---|---|
| - Trauma wounds (abrasions, | - Trauma wounds (abrasions, | ||
| lacerations, second-degree | lacerations, second-degree | ||
| burns, skin tears) | burns, skin tears) | ||
| - Surgical wounds (donor | - Surgical wounds (donor | ||
| sites/grafts, post-Mohs | sites/grafts, post-Mohs | ||
| surgery, post-laser surgery, | surgery, post-laser surgery, | ||
| podiatric, wound dehiscence) | podiatric, wound dehiscence) | ||
| - Draining wounds | - Draining wounds | ||
| Resource | |||
| origin | Cod Fish skin | Cod Fish skin | Equivalent |
| Tissue | |||
| resource / | |||
| Scaffold base | Identical fish skin tissue | Identical fish skin tissue | Equivalent |
| Nominal sizes | Sized up to | ||
| 20 x 30 cm ( $600 cm²$ ) | 3 x 3.5 cm ( $10.5 cm²$ ) | ||
| 3 x 7 cm ( $21 cm²$ ) | |||
| 7 x 10 cm ( $70 cm²$ ) | Equivalent, | ||
| Subject device has more | |||
| size variety, incl. larger sizes | |||
| Presentation | Solid, fenestrated, or meshed | ||
| lyophilized skin sheet in a peel | |||
| pouch | Solid or meshed lyophilized | ||
| skin sheet in a peel pouch | Equivalent | ||
| Sterilization | Ethylene Oxide SAL 10-6, | ||
| single use only | Ethylene Oxide SAL 10-6, | ||
| single use only | Equivalent | ||
| Shelf life | 3 years | 3 years | Equivalent |
PERFORMANCE DATA
The subject device is a size modified version of the predicate device. Both are made from the MariGen Material. Biocompatibility tests and product characterization studies performed on the predicate device fully apply to the subject device as those are identical materials. Present performance data includes data from: elemental impurities and chemical residual analysis.
The subject device is identical to the predicate device apart from being offered in sizes up to 600cm². The subject device does not raise new safety questions for patients. Kerecis's risk-based approach, executed according to EN ISO 14971: Medical devices - Application of risk management to medical devices, shows that all sizes of the modified device are safe for use.
The provided data from biocompatibility testing combined with bench testing and animal studies exhibits product safety and effectiveness.
CONCLUSION
The subject device is identical to the predicate device apart from being offered in sizes up to 600cm².
6
Based on the data provided within this submission, the subject device is substantially equivalent to the predicate device with regards to intended use and indications for use, technological characteristics including principles of operation, and performance characteristics and device safety.
It is concluded that the subject device is substantially equivalent to the predicate device.