(29 days)
No
The provided text describes a medical device, NovoSorb BTM, which is a wound management product. The description focuses on its physical characteristics, intended use, and materials. There is no mention of "AI", "DNN", "ML", or any form of computational modeling or intelligence within the device's function or design.
Yes
The device is indicated for use in the management of various types of wounds, which is a therapeutic application.
No
The device description indicates that NovoSorb BTM is used for the "management of wounds" and is a "porous, biodegradable, polyurethane foam" that biodegrades in patients. This suggests a therapeutic rather than diagnostic function. There is no mention of the device providing information about a patient's condition or disease state.
No
The device description clearly states it is a "porous, biodegradable, polyurethane foam, adhered to a fenestrated transparent sealing membrane." It is a physical product designed for wound management, not a software application. Verification performance testing describes physical and mechanical properties, not software validation.
No.
The device is a wound dressing / tissue regeneration matrix, and it does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
NovoSorb BTM is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, 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.
Product codes
QSZ
Device Description
The NovoSorb BTM device has been modified to expand the available thickness of the foam component from 2 mm to 2-6 mm. Sizes are limited to a maximum volume of 160 cm³. The device continues to be a porous, biodegradable, polyurethane foam, adhered to a fenestrated transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the foam. The sealing membrane is to be removed and discarded when appropriate, leaving only the foam layer to biodegrade in patients.
NovoSorb BTM is a terminally sterilized, single use device intended for deep partial and full thickness wounds. Each NovoSorb BTM is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.
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
No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data.
Verification performance testing demonstrates that the proposed NovoSorb BTM will consistently meet established functional and performance requirements. These requirements include physical characteristics, mechanical strength, and durability. The same testing protocol used in the predicate was utilized to conduct this verification bench testing. Results of the tests demonstrate that the mechanical properties of the subject device meet the device requirements and that the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
FDA 510(k) Clearance Letter - NovoSorb BTM
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
PolyNovo Biomaterials Pty Ltd
Shruti Dave
Regulatory Affairs Project Manager
2/320 Lorimer Street
Port Melbourne
Melbourne, VIC 3207
Australia
Re: K251567
Trade/Device Name: NovoSorb BTM
Regulatory Class: Unclassified
Product Code: QSZ
Dated: May 6, 2025
Received: May 22, 2025
Dear Shruti Dave:
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).
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2K251567 - Shruti Dave
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 QS 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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3K251567 - Shruti Dave
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251567
Device Name: NovoSorb® BTM
Indications for Use (Describe)
NovoSorb BTM is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) Summary
K251567
Page 1 of 4
Date Summary Prepared: 20 June 2025
APPLICANT INFORMATION:
Applicant/Submitter: PolyNovo Biomaterials Pty Ltd
2/320 Lorimer Street, Port Melbourne
VIC 3207 Australia
Establishment Registration Number: 3007886187
Contact Person: Ms. Shruti Dave
Regulatory Affairs Project manager
Phone: +61 38681 4050
Email: Shruti@polynovo.com
Alternate Contact Person: Mr. Joeseph DePaolo
Senior Director – Regulatory Affairs
Phone: 508 631 8436
Email: Joe.d@polynovo.com
SUBJECT DEVICE INFORMATION:
Trade Name: NovoSorb® BTM
Device Common Name: Wound Dressing
Classification Name: Absorbable Synthetic Wound Dressing
Product code: QSZ
Product Classification: Unclassified
PREDICATE DEVICE INFORMATION:
Predicate Device: NovoSorb BTM, K172140
Reference Device: NovoSorb MTX, K242149
DEVICE DESCRIPTION:
The NovoSorb BTM device has been modified to expand the available thickness of the foam component from 2 mm to 2-6 mm. Sizes are limited to a maximum volume of 160 cm³. The device continues to be a porous, biodegradable, polyurethane foam, adhered to a fenestrated transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the foam. The sealing membrane is to be removed and discarded when appropriate, leaving only the foam layer to biodegrade in patients.
NovoSorb BTM is a terminally sterilized, single use device intended for deep partial and full thickness wounds. Each NovoSorb BTM is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch
Page 6
K251567
Page 2 of 4
together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.
INDICATIONS FOR USE
The NovoSorb BTM is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, 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.
TECHNOLOGICAL CHARACTERISTICS
The proposed NovoSorb BTM device is the same as the previously cleared predicate NovoSorb BTM (K172140) in terms of physical and material properties, maximum volume of 160 cm³ of the foam, manufacturing, indications for use, environment of use, packaging, shelf life, and sterilization. Like the predicate device, the proposed device consists of a fenestrated sealing membrane adhered to the foam; constructed from the same synthetic biodegradable polyurethane material using the same manufacturing process. In both the proposed device and the predicate device, the foam provides a scaffold for cellular infiltration and vascularization. The foam permits the ingress of cells and soft tissue formation in the defect space/wound bed.
The properties of the foam component, including average pore size, porosity, and density, remain unchanged compared to both predicate devices. Additionally, the proposed device is sterilized using gamma radiation at a dose of 25–40 kGy, achieving a sterility assurance level (SAL) of 10⁻⁶, which is consistent with both predicate devices. The proposed NovoSorb BTM device also offers the same range of foam thicknesses (2 mm to 6 mm) as the secondary predicate, NovoSorb MTX (K242149), ensuring similarity in structural characteristics.
The subject device has the same characteristics as the predicate device as follows:
| Characteristic | NovoSorb BTM (subject device) | NovoSorb BTM K173544 (predicate device) | NovoSorb MTX K242149 (reference predicate) | Comparison |
|---|---|---|---|---|
| Product Code | QSZ | QSZ | QSZ | Same |
| Device Class | Unclassified | Unclassified | Unclassified | Same |
| Indication for Use | Indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post- | Indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery post- | Indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, tunneled/undermined wounds, surgical wounds (donor | Same as Predicate Device |
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K251567
Page 3 of 4
| Characteristic | NovoSorb BTM (subject device) | NovoSorb BTM K173544 (predicate device) | NovoSorb MTX K242149 (reference predicate) | Comparison |
|---|---|---|---|---|
| laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. | laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. | 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. | ||
| Materials of Construction | Polyurethane | Polyurethane | Polyurethane | Same |
| Physical Structure | Foam with fenestrated sealing membrane | Foam with fenestrated sealing membrane | Foam only | Same as Predicate Device |
| Size Range | L x W x T limited to a volume of 160 cm³ | L x W x T limited to a volume of 160 cm³ | L x W x T limited to a volume of 160 cm³ | Same |
| Thickness | 2-6 mm | 2 mm | 2-6 mm | Same as Reference Device |
| Sealing Membrane | Yes | Yes | No | Same as Predicate Device |
| Packaging | polymer pouch within an aluminized envelope | polymer pouch within an aluminized envelope | polymer pouch within an aluminized envelope | Same |
| Sterilization | Gamma | Gamma | Gamma | Same |
| Single Use | Yes | Yes | Yes | Same |
NON-CLINICAL TESTS
Verification performance testing demonstrates that the proposed NovoSorb BTM will consistently meet established functional and performance requirements. These requirements include physical characteristics, mechanical strength, and durability. The same testing protocol used in the predicate was utilized to conduct this verification bench testing. Results of the tests demonstrate that the mechanical properties of the subject device meet the device requirements and that the subject device is substantially equivalent to the predicate device.
CLINICAL TESTS
No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data.
CONCLUSION
PolyNovo believes the modified NovoSorb BTM device is substantially equivalent to the legally marketed predicate devices NovoSorb BTM (K172140) and NovoSorb MTX
Page 8
K251567
Page 4 of 4
(K242149), because no differences in technological characteristics exist between different foam thicknesses as there is no change to the foam density for different foam thicknesses. It has the same intended use and maintains the same safety and effectiveness as its previously cleared predicate devices. Any difference that exists between the devices do not affect the intended use or alter the fundamental scientific technology of the device.