(419 days)
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions.
PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System consists of the PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump and the Wound exudate canister. The system provides a negative pressure wound dressing therapy in a moist environment to facilitate the wound healing process. The dressing has an access port through which fluids can be drawn from the wound site. The same port can also be utilized to administer negative pressure wound therapy using the negative pressure pump if required. The negative pressure pump is used with a collection cannister to collect the exudate. The PWD Platform Wound Dressing is supplied in five different shapes and sizes, all having the same intended use.
The provided document describes the PWD™ Platform Wound Dressing Negative Pressure System and its substantial equivalence to predicate devices, focusing on performance data from bench testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Description | Reference Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Water Vapor Transmission Rate | Measures the passage of water vapor through the membrane/adhesive barrier | ASTM 1249 | Must be at least equivalent to commercially available NPWT dressing | Pass |
| Exudate Throughput Properties Under Negative Pressure | Simulated Use testing using various exudate types to confirm acceptable fluid flow when connected to the Pump and Canister system | N/A | System must demonstrate the ability to remove exudates of various types from the wound bed | Pass |
| Maintenance of Negative Pressure | Simulated use testing from under moist conditions to demonstrate maintenance of negative pressure | NA | The PWD must maintain negative pressure at the wound bed for the test duration | Pass |
| Usability | Usability testing for both healthcare and home use environments | NA | Users must demonstrate the ability to correctly use the device | Pass |
| Electrical Safety | Complies with applicable safety standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Requirements for electrical safety per the applicable safety standards is met | Pass |
| Electro-magnetic Compatibility | Complies with applicable safety standards | Complies with IEC 60601-2-3 | Requirements for electromagnetic compatibility per the applicable safety standards is met | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that the performance data was generated through "Bench testing" for various characteristics. This type of testing typically uses laboratory samples of the device components or simulated systems rather than human subjects or a clinical test set.
- Sample Size for Test Set: Not specified, but implied to be laboratory samples of device components.
- Data Provenance: Not applicable in the context of clinical data. The data is from laboratory bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For bench testing, ground truth is typically established by engineering specifications, validated test methods, and compliance with industry standards, rather than expert clinicians.
4. Adjudication Method for the Test Set:
- This information is not applicable as the described tests are bench tests, not clinical studies requiring adjudication of output from human readers or an algorithm.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) premarket notification process based on substantial equivalence to predicate devices and bench testing. There is no mention of a clinical trial involving human readers or a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical device (Negative Pressure Wound Therapy System), not an AI algorithm. The performance evaluation focuses on the physical and functional aspects of the system.
7. The Type of Ground Truth Used:
- The ground truth for the bench tests appears to be based on engineering specifications, established industry standards (e.g., ASTM, IEC), and the functional requirements for a negative pressure wound therapy system. For instance, "ability to remove exudates of various types from the wound bed" and "maintain negative pressure at the wound bed for the test duration" serve as the functional ground truths.
8. The Sample Size for the Training Set:
- Not applicable. This document describes the testing of a physical medical device. There is no mention of an AI component requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no AI component or training set mentioned, this information is not relevant to the provided document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
September 21, 2022
Applied Tissue Technologies LLC % Ms. Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye HIll Landing Newbury, New Hampshire 03255
Re: K212359
Trade/Device Name: PWD Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 19, 2022 Received: August 23, 2022
Dear Ms. 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
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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 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 (QS) 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 medical devices and radiation-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,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K212359
Device Name
PWD™ Platform Wound Dressing Negative Pressure System
Indications for Use (Describe)
The Applied Tissue Technologies PWD™ Platform Wound Dressing Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions.
PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
| 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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K212359 Traditional 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: | Ms. Michele Lucey |
| President, Lakeshore Medical Device Consulting LLC | |
| Address | 128 Blye Hill Landing, |
| Newbury, NH 03255 | |
| Telephone | 603-748-1374 |
| lucey_m@msn.com | |
| Date Prepared: | September 20, 2022 |
| Device Trade Name: | PWD™ Platform Wound Dressing Negative PressureSystem |
| Classification: | Class II |
| Product Code(s): | OMP |
| Regulation Number(s): | 21 CFR 878-4780 Powered Suction Pump |
| Predicate Device (Primary): | PICO 7 Single Use Negative PressureWound Therapy System K172005 |
| Predicate Device (Secondary) | PWD™ Platform Wound Device K191460 |
Indications for Use:
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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,
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K212359
traumatic, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies). flaps, grafts and closed surgical incisions.
PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
Device Description/Technological Characteristics:
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System consists of the PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump and the Wound exudate canister. The system provides a negative pressure wound dressing therapy in a moist environment to facilitate the wound healing process. The dressing has an access port through which fluids can be drawn from the wound site. The same port can also be utilized to administer negative pressure wound therapy using the negative pressure pump if required. The negative pressure pump is used with a collection cannister to collect the exudate. The PWD Platform Wound Dressing is supplied in five different shapes and sizes, all having the same intended use. The five sizes are identified as follows.
| PWD TM Platform Wound Device Dressing Sizes | |
|---|---|
| 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 |
Performance Data:
Bench testing of the PWD™ Platform Wound Dressing Negative Pressure System was performed to evaluate device vapor transmission characteristics, ability to maintain negative pressure, and the ability to remove exudate. Biocompatibility testing was conducted on the dressing component according to the ISO 10993 standard series. The Pump and the Cannister are not tissue contacting. Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use. A summary of the Non-clinical Bench tests is provided in the following Table:
| Performance Test Summary | ||||
|---|---|---|---|---|
| Test Name | Description | ReferenceStandards | Acceptance Criteria | Results |
| Water VaporTransmissionRate | Measures thepassage of watervapor through themembrane/adhesivebarrier | ASTM 1249 | Must be at leastequivalent tocommerciallyavailable NPWTdressing | Pass |
| Exudate | Simulated Use | N/A | System must | Pass |
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| Performance Test Summary | ||||
|---|---|---|---|---|
| Test Name | Description | ReferenceStandards | Acceptance Criteria | Results |
| ThroughputPropertiesUnderNegativePressure | testing using variousexudate types toconfirm acceptablefluid flow whenconnected to thePump and Canistersystem | demonstrate theability to removeexudates of varioustypes from the woundbed | ||
| Maintenance ofNegativePressure | Simulated use testingfrom under moistconditions todemonstratemaintenance ofnegative pressure | NA | The PWD mustmaintain negativepressure at the woundbed for the testduration | Pass |
| Usability | Usability testing forboth health care andhome useenvironments | NA | Users mustdemonstrate theability to correctly usethe device | Pass |
| ElectricalSafety | Complies withapplicable safetystandards | IEC 60601-1, IEC60601-1-2,IEC 60601-1-11 | Requirements forelectrical safety perthe applicable safetystandards is met | Pass |
| Electro-magneticCompatibility | Complies withapplicable safetystandards | Complieswith IEC60601-2-3 | Requirements forelectromagneticcompatibility per theapplicable safetystandards is met | Pass |
Substantial Equivalence:
The Indications for Use statement for the PWD™ Platform Wound Dressing Negative Pressure System is the same as the PICO 7 Single Use Negative Pressure Wound Therapy System.
The following table provides the evidence to further support the claim for substantial equivalence:
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| Substantial Equivalence Comparison Chart | ||||
|---|---|---|---|---|
| Feature /Specification | PWD™ PlatformWound DressingNegative PressureSystem | PICO 7 SingleUse NegativePressure WoundTherapy System | PWDTMPlatform WoundDressing | Comparison |
| RegulatoryClearance/ApprovalReference | N/A | PrimaryK172005 | SecondaryK191460 | N/A |
| Product Code | OMP | OMP | OMP | Same |
| RegulationNumber | 21 CFR 878.4780 | 21 CFR878.4780 | 21 CFR 878.4780 | Same |
| Regulation Name | Powered SuctionPump | Powered SuctionPump | Powered SuctionPump | Same |
| Anatomicallocation | Body surface wherewound is present | Body surface wherewound is present | Body surfacewhere wound ispresent | Same |
| Where used(environment) | The Negative PressureWound Therapy Systemis suitable for use inboth hospital andhomecaresettings. | The NegativePressure WoundTherapy System issuitable for use inboth hospitaland homecaresettings. | The NegativePressure WoundTherapy System issuitable for use inboth hospital andhomecare settings. | Same |
| Indicationsfor Use | The Applied TissueTechnologies PWD™Platform WoundDressing NegativePressure Systemcomprised of the;PWD™ Dressing,PWD™ NegativePressure WoundTherapy Pump, and thePWD™ WoundExudate Canister isindicated in patientswho would benefit froma suction device(Negative PressureWound Therapy) as itcreates an environmentthat may promotewound healing byremoving excess wound | PICO 7 isindicated forpatients who wouldbenefit from asuction device(Negative PressureWound Therapy) asit may promotewound healing viaremoval of low tomoderate levels ofexudate andinfectiousmaterials.Appropriate woundtypes include:ChronicAcuteTraumaticSubacute anddehisced wounds | The AppliedTissueTechnologiesPWDTM PlatformWound Dressing isintended to beused inconjunction withthe Invia MotionNegative PressureWound Therapy(NPWT) systemand is indicated inpatients whowould benefitfrom a suctiondevice (NPWT) asit creates anenvironment thatmay promotewound healing by |
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| Substantial Equivalence Comparison Chart | |||||||
|---|---|---|---|---|---|---|---|
| Feature /Specification | PWD™ PlatformWound DressingNegative PressureSystem | PICO 7 SingleUse NegativePressure WoundTherapy System | PWDTMPlatform WoundDressing | Comparison | |||
| exudate. The AppliedTissue TechnologiesPlatform WoundDressing is appropriatefor use on the followingwounds: exudating,chronic, acute,traumatic, sub-acuteand dehisced wounds,partial thickness burns,ulcers (such as diabetic,pressure and venousinsufficiencies), flaps,grafts and closedsurgical incisions.PWD NegativePressure WoundTherapy System aresuitable for use both ina hospital and homecaresetting. | Partial-thicknessburns, Ulcers (suchas diabetic orpressure)Flaps and graftsClosed surgicalincisionsPICO Single UseNegative PressureWound TherapySystem is suitablefor usein both a hospitaland homecaresetting. | removing excesswound exudate.The AppliedTissueTechnologiesPlatform WoundDressing isappropriate foruse on thefollowingwounds:exudating,chronic, acute,traumatic, sub-acute anddehisced wounds,partial-thicknessburns, ulcers(such as: diabetic,pressure andvenousinsufficiencies),flaps and grafts | |||||
| MaximumDuration ofa single dressing | 7 Days | 7 Days | 3 Days | Same as theprimarypredicate | |||
| NegativePressure to thewound surfacerequirements inmmHg | Fixed setting at -80mmHg (nominal) to thewound surface | Fixed setting at -80mmHg to the woundsurface | -80 mmHg | Same | |||
| Multiple DressingShapes for WoundSizes (area = L xW) | 1-3" Round1 x 3" Oblong3 x 5" Oblong | 10 x 20 cm to 25 x25 cm | 1-3" Round1 x 3" Oblong3 x 5" Oblong | PWD issmaller thanthe predicatefor overalldimensions.The dressingis sized forthe wound |
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| Substantial Equivalence Comparison Chart | ||||
|---|---|---|---|---|
| Feature /Specification | PWD™ PlatformWound DressingNegative PressureSystem | PICO 7 SingleUse NegativePressure WoundTherapy System | PWD™Platform WoundDressing | Comparison |
| size. Same asthe SecondaryPredicate | ||||
| DressingConfiguration | Clear polyurethaneembossed occlusivedrape with negativepressure/instillationtubing | Clear polyurethaneocclusive drapedressing with foamor gauze filler,negativepressure/instillationtubing - filler is cutto size | Clearpolyurethaneembossedocclusive drapewith negativepressure/instillation tubing | Same as thesecondarypredicate |
| Access Port | For attachment to thenegative pressure pump.For removal of fluids. | For attachment to thenegative pressurepump. For removalof fluids | For attachment tothe negativepressure pump.For removal offluids. | Same |
| Collection Pack | The dressing tubing isconnected to thecanister/tubing setduring negative pressurewound therapy forcollection of fluids. Thefluids are removed fromthe wound site andsecured within thecannister withoutrequiring additionaldressing changes | No Cannister, relieson dressing changesfor removal ofexudate, frequencydependent on thelevel of exudate | The dressingtubing isconnected to thecanister/tubing setduring negativepressure woundtherapy forcollection offluids. The fluidsare removed fromthe wound siteand securedwithin thecannister withoutrequiringadditionaldressing changes | Same as thesecondarypredicate. |
| Pump | PWD™ NegativePressure WoundTherapy Pump | PICO 7 | NA | Same |
| Pump Type | Custom designed pumpcontrolled by amicroprocessor | Custom designedpump controlled bya microprocessor | NA | Same |
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| Substantial Equivalence Comparison Chart | |||||||
|---|---|---|---|---|---|---|---|
| Feature /Specification | PWD™ PlatformWound DressingNegative PressureSystem | PICO 7 SingleUse NegativePressure WoundTherapy System | PWD™Platform WoundDressing | Comparison | |||
| How Supplied | PWD Dressing issupplied Sterile SingleUse Only. The pumpand cannister aresupplied non-sterilesingle use only | The system issupplied sterile,single use only | PWD Dressing issupplied SterileSingle Use Only. | The PWDpump andcannister aresuppliednonsterile –similar toother systemswith the sameintended use.Thisdifferencedoes not raisenew questionsof safety. | |||
| TissueContactMaterials | Polymers and Adhesive | Polymers andAdhesive | Polymers andAdhesive | Same as thesecondarypredicate | |||
| Additives -antimicrobial,animal origin | No | No | No | Same | |||
| Sterilization | Eto at an SAL 10-6 | Eto | Eto at an SAL 10-6 | Same. | |||
| Electrical SafetyTesting | Complies with IEC60601-1, IEC 60601-1-2, IEC 60601-1-11 | Complies with IEC60601-1, IEC 60601-1-2, IEC 60601-1-11 | NA | Same | |||
| ElectromagneticCompatibility | Complies with IEC60601-2-3 | Complies with IEC60601-2-3 | NA | Same | |||
| MR Safety | Pump is MR Unsafe | Pump is MR Unsafe | NA | Same |
Conclusion:
When considering design, feature, materials, and performance characteristics the PWD™
PNegPlatform Wound Dressing Negative Pressure System is substantially equivalent to the predicate device, the PICO 7 Single Use Negative Pressure Wound Therapy System K172005
§ 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.