(189 days)
Not Found
No
The document describes a wound dressing made of collagen and does not mention any computational or analytical functions that would typically involve AI/ML.
Yes
The device is indicated for the management of various types of wounds, aiming to regenerate dermal tissue, which is a therapeutic function.
No
Explanation: The device is described as a "wound dressing" and a "dermal regeneration template" indicated for the management of various types of wounds, which are therapeutic functions. There is no mention of it being used to analyze or identify medical conditions.
No
The device description clearly states it is a physical wound dressing comprised of collagen microspheres and hydrogel, indicating it is a hardware device, 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 a "wound dressing indicated for the management of wounds." This describes a device applied directly to the body for therapeutic purposes, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a "composite biodegradable wound dressing" that provides a "scaffold for native tissue cellular invasion and capillary growth." This further reinforces its function as a wound treatment, not a diagnostic tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting
The device is a therapeutic wound dressing, not a diagnostic device.
N/A
Intended Use / Indications for Use
DermiSphere™ hDRT hydrogel Dermal Regeneration Template is a wound dressing indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds. This device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
DermiSphere™ hDRT hydrogel Dermal Regeneration Template is an advanced wound dressing comprised of crosslinked bovine collagen microspheres embedded in bovine collagen hydrogel matrix. This composite biodegradable wound dressing provides a scaffold for native tissue cellular invasion and capillary growth.
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)
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate device. The following safety and performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing: A series of biocompatibility testing was performed in accordance with the testing matrix of ISO 10993-1 and an exhaustive extraction chemical characterization was conducted in accordance with ISO 10993-18 to assess the safety of DermiSphere™ hDRT hydrogel Dermal Regeneration Template.
Bench Testing: Product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate. Testing included, but was not limited to, dimensions, drapability, and pyrogenicity.
Conclusions: The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate device. The safety and effectiveness of the subject device has been demonstrated through bench testing, biocompatibility and substantial equivalence comparison to the predicate devices.
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.
Not Found
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
Image /page/0/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.
January 6, 2025
FesariusTherapeutics Inc. % Diana Bordon Sr. Director, Regulatory Affairs, Regenity Biosciences Regenity Biosciences 115 W. Century Rd. Suite 380 Paramus. New Jersey 07652
Re: K241904
Trade/Device Name: DermiSphere™ hDRT Regulatory Class: Unclassified Product Code: KGN Dated: December 6, 2024 Received: December 6, 2024
Dear Diana Bordon:
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/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.
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" (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).
1
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 820.30 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K241904
Device Name
DermiSphere™ hDRT hydrogel Dermal Regeneration Template
Indications for Use (Describe)
DermiSphere™ hDRT hydrogel Dermal Regeneration Template is a wound dressing indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds. This device is intended for one-time use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
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4
| Contact Details | |
|---|---|
| Applicant Name: | FesariusTherapeutics Inc. |
| Applicant Address: | 619 West 54th Street |
| New York NY 10019 United States | |
| Applicant Contact Telephone: | (516) 301-7047 |
| Applicant Contact: | Dr. Yulia Sapir-Lekhovitser |
| Chief Scientific Officer | |
| Date Prepared: | January 04, 2025 |
| Device Name | |
| Device Trade Name: | DermiSphere™ hDRT |
| K241904 | |
| Device Common Name(s): | Dermal Regeneration Template |
| Device Classification Name: | Wound dressing with animal derived materials |
| KGN | |
| Unclassified | |
| Predicate Device | |
| Device Trade Name: | K022127 |
| Avagen Matrix Wound Dressing | |
| Device Classification: | KGN |
| Unclassified |
Device Description Summary
DermiSphere™ hDRT hydrogel Dermal Regeneration Template is an advanced wound dressing comprised of crosslinked bovine collagen microspheres embedded in bovine collagen hydrogel matrix. This composite biodegradable wound dressing provides a scaffold for native tissue cellular invasion and capillary growth.
Intended Use
DermiSphere™ hDRT hydrogel Dermal Regeneration Template is a wound dressing indicated for the management of wounds including: partial and full-thickness wounds, pressure 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, skin tears) and draining wounds. This device is intended for one-time use.
Technological Comparison
The subject device, DermiSphere™ hDRT hydrogel Dermal Template, has the same intended use, indications, principals of operation, basic design and performance as the predicate device, Avagen Wound Dressing (K022127). The subject and predicate devices have very similar technological characteristics. The predicate device is a porous matrix comprised of crosslinked Type I collagen derived from bovine Achilles tendon, with the fractional addition of glycosaminoglycan (GAG). In contrast, the subject device is a hydrogel matrix comprised of Type I collagen derived from bovine dermis only and a crosslinked subcomponent (collagen spheres). Both resulting devices are comprised of a collagenous matrix that provides a scaffold for cellular invasion and capillary growth. Both devices consist primarily of Type I bovine collagen. Together, the material differences between the subject device and predicate are not significant and support substantially equivalent modes of action for their shared ise.
5
Based on the testing performed, including biocompatibility assessment, biocompatibility testing, and functional performance testing, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate device. A comparison of the subject device to the predicate device is provided in the following table.
| Feature | Subject Device - K241904 | Predicate Device - K022127 |
|---|---|---|
| Indications for | ||
| Use Statement | DermiSphere™ hDRT hydrogel Dermal | |
| Regeneration Template is a wound dressing | ||
| 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, skin tears) and | ||
| draining wounds. The device is intended for | ||
| one-time use. | Avagen Wound Dressing 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, skin tears) and draining | ||
| wounds. The device is intended for one-time | ||
| use. | ||
| Device | ||
| Description | DermiSphere™ hDRT hydrogel Dermal | |
| Regeneration Template is an advanced | ||
| wound dressing comprised of crosslinked | ||
| bovine collagen microspheres embedded in | ||
| bovine collagen hydrogel matrix. This | ||
| composite biodegradable wound dressing | ||
| provides a scaffold for native tissue cellular | ||
| invasion and capillary growth. | Avagen Wound Dressing is an advanced | |
| wound dressing composed of a porous | ||
| matrix of cross-linked bovine tendon | ||
| collagen and glycosaminoglycan. The | ||
| biodegradable matrix provides a scaffold for | ||
| cellular invasion and capillary growth. | ||
| Material | ||
| Composition | Type I bovine collagen | Type I bovine collagen |
| Glycosaminoglycan (GAG) | ||
| Animal Tissue | ||
| Source | Bovine Dermis | Bovine Tendon (collagen) |
| Shark Cartilage (GAG) | ||
| Crosslinking | Material component (microspheres) | |
| crosslinked | Full product crosslinked | |
| Collagen Stability | Adequate stability to support cellular | |
| integration and vascularization | Adequate stability to support cellular | |
| integration and vascularization | ||
| Drapability | $7.88 \pm 0.21$ mm | $8.97 \pm 1.62$ mm* |
| Product Sizes | 4 cm x 5 cm | |
| 10 cm x 12 cm | 10 cm x 12.5 cm | |
| 10 cm x 25 cm | ||
| 20 cm x 25 cm | ||
| Sterile | Sterile, SAL 10-6 using irradiation | Sterile, SAL 10-6 using irradiation |
- The values are derived by Fesarius testing
Non-Clinical and/or Clinical Tests Summary & Conclusions
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate device. The following safety and performance data are provided in support of the substantial equivalence determination.
6
Biocompatibility Testing
A series of biocompatibility testing was performed in accordance with the testing matrix of ISO 10993-1 and an exhaustive extraction chemical characterization was conducted in accordance with ISO 10993-18 to assess the safety of DermiSphere™ hDRT hydrogel Dermal Regeneration Template.
Bench Testing
Product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate. Testing included, but was not limited to, dimensions, drapability, and pyrogenicity.
Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate device. The safety and effectiveness of the subject device has been demonstrated through bench testing, biocompatibility and substantial equivalence comparison to the predicate devices.