Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a wound dressing and its use with a negative pressure wound therapy system. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.

Therapeutic

No
The device is a wound dressing that works with an NPWT system to remove wound exudate and promote healing, but it is not a therapeutic device itself.

Diagnostic

No

The device is a wound dressing used with negative pressure wound therapy to promote healing by removing exudate and allowing observation of the wound. It is not described as diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical wound dressing, a single-use device with transparency and an access port, intended for use with a negative pressure wound therapy system. It is not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Applied Tissue Technologies PWD™ Platform Wound Dressing is a wound dressing used in conjunction with a negative pressure wound therapy system. Its function is to create an environment that promotes wound healing by removing excess wound exudate. It is applied directly to the wound on the patient's body.
Lack of In Vitro Testing: The description clearly states the device is used on the wound itself and the performance studies focus on physical characteristics (vapor transmission, pressure maintenance, exudate removal) and biocompatibility, not on analyzing samples taken from the body.

Therefore, based on the intended use, device description, and performance studies, this device is a therapeutic device used for wound management, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

OMP

Device Description

The Applied Tissue Technologies PWD™ 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.

The PWD will be marketed in four different shapes and sizes, all having the same intended use. The four sizes are identified as follows.
1" Round
2" Round
3" Round
1" x 3" Oblong

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wounds (exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts)

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)

Bench testing of the PWD™ Platform Wound Dressing was performed to evaluate device vapor transmission characteristics, ability to maintain negative pressure, and the ability to remove exudate. Biocompatibility testing was conducted according to the ISO 10993 standard series. Test results of all nonclinical testing were acceptable and demonstrate that the subject device is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Medela Ag Invia Foam Dressing Kit, K170088

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 11, 2019

Applied Tissue Technologies LLC % Michele Lucey Regulatory Affairs Manager Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255

Re: K182409

Trade/Device Name: Applied Tissue Technologies PWD™ Platform Wound Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: December 7, 2018 Received: December 12, 2018

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kimberly Ferlin -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) K182409

Device Name

Applied Tissue Technologies PWD™ 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

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
Telephone:	603-748-1374
Date Prepared:	January 11, 2019
Device Trade Name:	Applied Tissue Technologies
PWD™ Platform Wound Dressing
Classification:	Class II
Product Code(s):	OMP
Regulation Number(s):	21 CFR 878-4780 Powered Suction Pump
Predicate Device:	Medela Ag Invia Foam Dressing Kit,
K170088

Intended 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.

Device Description/Technological Characteristics:

The Applied Tissue Technologies PWD™ 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.

4

The PWD will be marketed in four different shapes and sizes, all having the same intended use. The four 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

Performance Data:

Bench testing of the PWD™ Platform Wound Dressing was performed to evaluate device vapor transmission characteristics, ability to maintain negative pressure, and the ability to remove exudate. Biocompatibility testing was conducted according to the ISO 10993 standard series. Test results of all nonclinical testing were acceptable and demonstrate that the subject device is substantially equivalent to the predicate device

Substantial Equivalence:

The following chart provides the evidence to support the claim for substantial equivalence:

Substantial Equivalence Comparison Chart
Feature / Specification	PWDTM
Platform Wound
Dressing	Invia Foam Dressing Kit
(Medela Ag,)	Comparison
Regulatory Clearance/
Approval Reference	K182409	K170088	N/A
Product Code	OMP	OMP	Same
Regulation Number	21 CFR 878.4780	21 CFR 878.4780	Same
Regulation Name	Powered Suction Pump
(accessory)	Powered Suction Pump
(accessory)	Same
Where used
(environment)	The Negative Pressure
Wound Therapy System
is suitable for use in both
hospital and homecare
settings.	The Negative Pressure
Wound Therapy System is
suitable for use in
both hospital and
homecare settings.	Same
Maximum Duration of
a single dressing	72 Hours	72 Hours	Same
Negative Pressure to
the wound surface
requirements in mmHg	80 mmHg (nominal)
+/- 20mmHG to the
wound surface	125 mmHg to the wound
surface	This constitutes a
nominal
recommended
setting, pump
settings range
from -40 to -175.
This difference
in recommended
nominal setting.
Substantial Equivalence Comparison Chart
Feature / Specification	PWDTM
Platform Wound
Dressing	Invia Foam Dressing Kit
(Medela Ag,)	Comparison
			does not range
new questions of
safety.
Multiple Shapes for
Wound Sizes up to
400cc (Surface Area x
depth)	400cc	240 - 2700c	PWD is within
the range of the
predicate
device.
Dressing
Configuration	Clear polyurethane
embossed occlusive drape
with tubing	Clear polyurethane
occlusive drape dressing
with foam insert negative
pressure/instillation tubing –
dressing is cut to size	Similar
materials and
configuration,
the PWD uses a
embossed layer
to allow for
fluid transfer,
the predicate
uses a
foam. This
difference does
not raise new
questions of
safety.
Access Port	For attachment to the
negative pressure pump.
For removal of fluids.	For attachment to the
negative pressure pump.
For removal of fluids	Same.
Collection Pack	The PWD tubing is
connected to the Medela
Invia Motion
canister/tubing set during
negative pressure wound
therapy for collection of
fluids. The fluids are
removed from the wound
site and secured within
the cannister.	The Invia Foam Dressing
Tubing is connected to the
Medela Invia Motion
canister/tubing set during
negative pressure wound
therapy for collection of
fluids. The fluids are
removed from the wound
site and secured within the
cannister	Same.
Pump	To be used with the
Medela Invia®
Motion™ Negative
Pressure Wound
Therapy System	To be used with the Medela
Invia® Motion™ Negative
Pressure Wound Therapy
System	Same
How Supplied	PWD is Sterile Single
Use Only	Dressing is Sterile
Single Use Only	Same
Substantial Equivalence Comparison Chart
Feature / Specification	PWDTM
Platform Wound
Dressing	Invia Foam Dressing Kit
(Medela Ag,)	Comparison
Tissue Contact
Materials	Polymers and Adhesive	Polymers Adhesive and
dressing	Similar,
differences do
not introduce
new questions of
safety
Additives - antimicrobial,
animal origin	No	No	Same
Sterilization	Eto	Eto	Same

5

6

The PWD™ Platform Wound Dressing is substantially equivalent to the predicate device, the Invia Foam Dressing Kit (K170088) and does not raise different questions of safety and effectiveness.