(25 days)
Not Found
No
The 510(k) summary describes a passive wound dressing made of biodegradable foam and a membrane. There is no mention of any computational or analytical capabilities, let alone AI or ML. The performance studies focus on mechanical properties, not data analysis or algorithmic performance.
Yes
The device is a wound dressing indicated for the management of various types of wounds, which is a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that the NovoSorb™ BTM Wound Dressing is a wound dressing for the management and treatment of various types of wounds. There is no mention of it being used for diagnosis, detection, or monitoring of any medical condition.
No
The device description clearly states it is a physical wound dressing made of foam and membrane, not software.
Based on the provided information, the NovoSorb™ BTM Wound Dressing is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing made of foam and a membrane, designed to be applied to a wound. This is consistent with a medical device for wound care, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NovoSorb™ BTM Wound Dressing does not fit this description.
N/A
Intended Use / Indications for Use
The NovoSorb™ BTM Wound Dressing is indicated for use in the management of wounds including: partial and full thickness wounds, pressure 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, second-degree burns, and skin tears) and draining wounds. The device is for single use only.
Product codes (comma separated list FDA assigned to the subject device)
OSZ, FRO
Device Description
The NovoSorb™ BTM Wound Dressing device is a 2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative water loss during integration of the foam. The adhesive layer and sealing membrane are to be removed and discarded when appropriate leaving only the foam layer to biodegrade in patients.
NovoSorb™ BTM Wound Dressing device is supplied in various sizes, ranging from 4cm² to 800cm². The NovoSorb™ BTM Wound Dressing is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in a white aluminized pouch contained in a cardboard 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: Mechanical testing was performed on the subject device. Results of the tests demonstrate that the mechanical properties of the subject 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.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 15, 2022
PolyNovo Biomaterials Pty Ltd. Ms. Sue Cho Regulatory Affairs Manager Unit 2, 320 Lorimer Street Port Melbourne, Victoria 3207 Australia
Re: K172140
Trade/Device Name: NovoSorb™ BTM Wound Dressing (2cm x 2cm), NovoSorb™ BTM Wound Dressing (10cm x 10cm), NovoSorb™ BTM Wound Dressing (10cm x 20cm), NovoSorb™ BTM Wound Dressing (20cm x 40cm) Regulatory Class: Unclassified Product Code: OSZ
Dear Ms. Sue Cho:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 11, 2017. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. 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
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling three human profiles facing right, arranged in a cascading manner. The symbol is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2017
PolyNovo Biomaterials Pty Ltd Ms. Sue Cho Regulatory Affairs Manager Unit 2, 320 Lorimer Street Port Melbourne, Victoria 3207 Australia
Re: K172140
Trade/Device Name: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2017 Received: July 17, 2017
Dear Ms. Cho:
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. 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 (reporting of medical device
2
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172140
Device Name
NovoSorb BTM Wound Dressing
Indications for Use (Describe)
The NovoSorb™ BTM Wound Dressing is indicated for use in the management of wounds including: partial and full thickness wounds, pressure 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, second-degree burns, and skin tears) and draining wounds. The device is for single use only.
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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Section 6. 510(k) Summary
Date Prepared: 13 July 2017
APPLICANT INFORMATION:
| Applicant/Submitter: | PolyNovo Biomaterials Pty Ltd
2/320 Lorimer Street
Port Melbourne
Victoria, Australia 3207 |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| | Phone: +61 3 8681 4050
Fax: +61 3 8681 4099
Establishment Registration Number: 3007886187 |
| Contact Person: | Sue Cho
Regulatory Affairs Manager
Phone: +61 3 8681 4060
Email: sue.c@polynovo.com |
| Alternate Contact Person: | Joseph DePaolo
Director of Regulatory Affairs
Phone: 508 631 8436
Email: joe.d@polynovo.com |
| | Ivan Jasenko
Regulatory & Quality Systems Manager
Phone: +61 3 8681 4070
Email: ivan.j@polynovo.com |
SUBJECT DEVICE INFORMATION:
| Trade Name: | NovoSorb™ BTM Wound Dressing |
|---|---|
| Device Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
Product Code: FRO
- Product Classification: Unclassified
PREDICATE DEVICE INFORMATION:
Predicate Device: BTM Wound Dressing, K142879
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6.1 Device Description
The NovoSorb™ BTM Wound Dressing device is a 2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative water loss during integration of the foam. The adhesive layer and sealing membrane are to be removed and discarded when appropriate leaving only the foam layer to biodegrade in patients.
NovoSorb™ BTM Wound Dressing device is supplied in various sizes, ranging from 4cm² to 800cm². The NovoSorb™ BTM Wound Dressing is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in a white aluminized pouch contained in a cardboard envelope.
6.2 Indications for Use
The NovoSorb™ BTM Wound Dressing device is indicated for use in the management of wounds including: partial and full thickness wounds, pressure 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. The device is for single use only.
6.3 Technological Characteristics Comparison
The NovoSorb™ BTM Wound Dressing device is a modification of the existing predicate device BTM Wound Dressing, K142879. The predicate and the subject device have the same technological characteristics, however the subject device is supplied to the user fenestrated, thereby removing the need for users to manually fenestrate the device prior to use.
6.4 Non-Clinical Tests
Mechanical testing was performed on the subject device. Results of the tests demonstrate that the mechanical properties of the subject device requirements and that the subject device is substantially equivalent to the predicate device.
6.5 Clinical Tests
No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data.
6.7 Conclusion
PolyNovo believes the modified NovoSorb BTM Wound Dressing device is substantially equivalent to the legally marketed predicate device, BTM Wound Dressing (K142879), because its design and materials used, methods of operation and technological characteristics are either identical or substantially equivalent to the existing marketed predicate. It has the same intended use and maintains the same safety and effectiveness as its premarket cleared predicate device. Any differences that exist between the devices do not affect the intended use or alter the fundamental scientific technology of the device.