(29 days)
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No
The document describes a passive wound dressing and its intended use with a negative pressure wound therapy system. There is no mention of any computational analysis, algorithms, or learning capabilities.
Yes
The device is a wound dressing used in conjunction with negative pressure wound therapy to promote wound healing by removing excess wound exudate, which constitutes a therapeutic function.
No
The device is a wound dressing used in conjunction with negative pressure wound therapy to promote wound healing by removing exudate. It is not described as being used to diagnose a medical condition.
No
The device description clearly describes a physical wound dressing, a single-use device made of material that permits observation of the wound and has an access port. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a wound dressing used in conjunction with a negative pressure wound therapy system to promote wound healing by removing exudate. This is a therapeutic and wound management function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the dressing (transparency, access port, shapes, sizes) and its function in wound care. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device used for wound treatment and management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Applied Tissue Technologies PWD™ Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Applied Tissue Technologies PWDTM Platform Wound Dressing is a single use device. Its transparency permits the healthcare practitioner to observe the progress of the wound healing without removing the wound dressing. There is an access port to administer negative pressure wound therapy. The PWD is intended to be used for a maximum of 3 days. Therapy duration may be less than indicated if clinical practice or other factors require more frequent dressing changes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: In consideration of design control activities including risk analysis, non-clinical performance testing was conducted to demonstrate that the additional dressing size has the same performance characteristics as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
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July 2, 2019
Applied Tissue Technologies LLC % Michele Lucey Regulatory Affairs Advisor Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K191460
Trade/Device Name: PWD™ Platform Wound Dressing 3" x 5" Oblong Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: Mav 29, 2019 Received: June 3, 2019
Dear Michele Lucey:
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
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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 (OS) 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 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,
Cynthia Chang, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191460
Device Name PWDTM Platform Wound Dressing
Indications for Use (Describe)
The Applied Tissue Technologies PWD™ Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts.
| 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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Special 510(k) Summary Per 21 CFR 807.92
Submitter Information
| Submitters' Name: | Applied Tissue Technologies LLC |
|---|---|
| Address: | 99 Derby Street, Suite 200 |
| Hingham, MA 02043 | |
| Telephone: | 781-366-3848 |
| Contact Person | Michele Lucey |
| 603-748-1374 | |
| Date Prepared | June 27, 2019 |
| Device Trade Name | PWDTM Platform Wound Dressing |
| Classification | Class II |
| Product Code | OMP |
| Regulation Number | 21 CFR 878.4780, Powered Suction Pump |
| Predicate Device | PWDTM Platform Wound Dressing, |
K182409 Intended Use:
The Applied Tissue Technologies PWDTM Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts
Device Description:
The Applied Tissue Technologies PWDTM Platform Wound Dressing is a single use device. Its transparency permits the healthcare practitioner to observe the progress of the wound healing without removing the wound dressing. There is an access port to administer negative pressure wound therapy. The PWD is intended to be used for a maximum of 3 days. Therapy duration may be less than indicated if clinical practice or other factors require more frequent dressing changes.
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The PWD will be marketed in five different shapes and sizes, all having the same intended use. The five sizes are identified as follows.
| PWDTM Platform Wound Dressing | |
|---|---|
| Description | Catalog/REF # |
| 1" Round | AT1070-01 |
| 2" Round | AT1071-01 |
| 3" Round | AT1072-01 |
| 1" x 3" Oblong | AT1073-01 |
| 3" x 5" Oblong | AT1074-01 |
Comparison to Predicate Device(s):
The subject device is the same design as the predicate device. The only difference is the addition of a larger footprint, 3"x5" product variant.
Nonclinical Performance Data:
In consideration of design control activities including risk analysis, non-clinical performance testing was conducted to demonstrate that the additional dressing size has the same performance characteristics as the predicate device.
SE Determination:
Based on the supporting documentation within this premarket notification, the subject device demonstrates substantial equivalence to the listed predicate device.