(419 days)
Not Found
No
The description focuses on the mechanical function of a negative pressure wound therapy system and does not mention any AI/ML components or capabilities.
Yes
The device is described as creating an environment that "may promote wound healing by removing excess wound exudate" and facilitating "the wound healing process," which are therapeutic actions.
No
The device is a Negative Pressure Wound Therapy (NPWT) system designed to treat wounds by promoting healing through the removal of exudate and creation of a moist environment. It does not provide information about a patient's health status or diagnose a condition.
No
The device description explicitly lists hardware components: PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide negative pressure wound therapy to promote wound healing by removing excess wound exudate. This is a therapeutic intervention applied directly to the wound, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device consists of a dressing, a pump, and a canister. These components are used to apply negative pressure and collect wound fluid, which is a physical treatment process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility. The focus is on the physical treatment of the wound itself.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / 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, 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.
Product codes
OMP
Device Description
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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body surface where wound is present
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and Homecare setting.
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 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 | Description | Reference Standards | Acceptance Criteria | Results |
|---|---|---|---|---|
| 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 health care 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Pressure |
| System | |
| 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 Pressure |
| Wound 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,
4
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 | Reference | ||
| Standards | Acceptance Criteria | Results | ||
| 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 | Simulated Use | N/A | System must | Pass |
5
| Performance Test Summary | ||||
|---|---|---|---|---|
| Test Name | Description | Reference | ||
| Standards | Acceptance Criteria | Results | ||
| Throughput | ||||
| Properties | ||||
| Under | ||||
| Negative | ||||
| Pressure | testing using various | |||
| exudate types to | ||||
| confirm acceptable | ||||
| fluid flow when | ||||
| connected to the | ||||
| Pump and Canister | ||||
| system | demonstrate the | |||
| ability to remove | ||||
| exudates of various | ||||
| types from the wound | ||||
| bed | ||||
| 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 health care 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 |
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:
6
| Substantial Equivalence Comparison Chart | ||||
|---|---|---|---|---|
| Feature / | ||||
| Specification | PWD™ Platform | |||
| Wound Dressing | ||||
| Negative Pressure | ||||
| System | PICO 7 Single | |||
| Use Negative | ||||
| Pressure Wound | ||||
| Therapy System | PWDTM | |||
| Platform Wound | ||||
| Dressing | Comparison | |||
| Regulatory | ||||
| Clearance/ | ||||
| Approval | ||||
| Reference | N/A | Primary | ||
| K172005 | Secondary | |||
| K191460 | N/A | |||
| Product Code | OMP | OMP | OMP | Same |
| Regulation | ||||
| Number | 21 CFR 878.4780 | 21 CFR | ||
| 878.4780 | 21 CFR 878.4780 | Same | ||
| Regulation Name | Powered Suction | |||
| Pump | Powered Suction | |||
| Pump | Powered Suction | |||
| Pump | Same | |||
| Anatomical | ||||
| location | Body surface where | |||
| wound is present | Body surface where | |||
| wound is present | Body surface | |||
| where wound is | ||||
| present | 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. | The Negative | |||
| Pressure Wound | ||||
| Therapy System is | ||||
| suitable for use in | ||||
| both hospital and | ||||
| homecare settings. | Same | |||
| 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 | PICO 7 is | |||
| indicated for | ||||
| patients who would | ||||
| benefit from a | ||||
| suction device | ||||
| (Negative Pressure | ||||
| Wound Therapy) as | ||||
| it may promote | ||||
| wound healing via | ||||
| removal of low to | ||||
| moderate levels of | ||||
| exudate and | ||||
| infectious | ||||
| materials. | ||||
| Appropriate wound | ||||
| types include: | ||||
| Chronic | ||||
| Acute | ||||
| Traumatic | ||||
| Subacute and | ||||
| dehisced wounds | 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 |
7
| Substantial Equivalence Comparison Chart | |||||||
|---|---|---|---|---|---|---|---|
| Feature / | |||||||
| Specification | PWD™ Platform | ||||||
| Wound Dressing | |||||||
| Negative Pressure | |||||||
| System | PICO 7 Single | ||||||
| Use Negative | |||||||
| Pressure Wound | |||||||
| Therapy System | PWDTM | ||||||
| Platform Wound | |||||||
| Dressing | Comparison | ||||||
| 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, | |||||||
| grafts and closed | |||||||
| surgical incisions. | |||||||
| PWD Negative | |||||||
| Pressure Wound | |||||||
| Therapy System are | |||||||
| suitable for use both in | |||||||
| a hospital and homecare | |||||||
| setting. | Partial-thickness | ||||||
| burns, Ulcers (such | |||||||
| as diabetic or | |||||||
| pressure) | |||||||
| Flaps and grafts | |||||||
| Closed surgical | |||||||
| incisions | |||||||
| PICO Single Use | |||||||
| Negative Pressure | |||||||
| Wound Therapy | |||||||
| System is suitable | |||||||
| for use | |||||||
| in both a hospital | |||||||
| and homecare | |||||||
| setting. | 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 | |||||||
| Maximum | |||||||
| Duration of | |||||||
| a single dressing | 7 Days | 7 Days | 3 Days | Same as the | |||
| primary | |||||||
| predicate | |||||||
| Negative | |||||||
| Pressure to the | |||||||
| wound surface | |||||||
| requirements in | |||||||
| mmHg | Fixed setting at -80 | ||||||
| mmHg (nominal) to the | |||||||
| wound surface | Fixed setting at -80 | ||||||
| mmHg to the wound | |||||||
| surface | -80 mmHg | Same | |||||
| Multiple Dressing | |||||||
| Shapes for Wound | |||||||
| Sizes (area = L x | |||||||
| W) | 1-3" Round | ||||||
| 1 x 3" Oblong | |||||||
| 3 x 5" Oblong | 10 x 20 cm to 25 x | ||||||
| 25 cm | 1-3" Round | ||||||
| 1 x 3" Oblong | |||||||
| 3 x 5" Oblong | PWD is | ||||||
| smaller than | |||||||
| the predicate | |||||||
| for overall | |||||||
| dimensions. | |||||||
| The dressing | |||||||
| is sized for | |||||||
| the wound |
8
| Substantial Equivalence Comparison Chart | ||||
|---|---|---|---|---|
| Feature / | ||||
| Specification | PWD™ Platform | |||
| Wound Dressing | ||||
| Negative Pressure | ||||
| System | PICO 7 Single | |||
| Use Negative | ||||
| Pressure Wound | ||||
| Therapy System | PWD™ | |||
| Platform Wound | ||||
| Dressing | Comparison | |||
| size. Same as | ||||
| the Secondary | ||||
| Predicate | ||||
| Dressing | ||||
| Configura | ||||
| tion | Clear polyurethane | |||
| embossed occlusive | ||||
| drape with negative | ||||
| pressure/instillation | ||||
| tubing | Clear polyurethane | |||
| occlusive drape | ||||
| dressing with foam | ||||
| or gauze filler, | ||||
| negative | ||||
| pressure/instillation | ||||
| tubing - filler is cut | ||||
| to size | Clear | |||
| polyurethane | ||||
| embossed | ||||
| occlusive drape | ||||
| with negative | ||||
| pressure/instillat | ||||
| ion tubing | Same as the | |||
| secondary | ||||
| predicate | ||||
| Access Port | For attachment to the | |||
| negative pressure pump. | ||||
| For removal of fluids. | 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 dressing tubing is | |||
| connected to the | ||||
| 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 without | ||||
| requiring additional | ||||
| dressing changes | No Cannister, relies | |||
| on dressing changes | ||||
| for removal of | ||||
| exudate, frequency | ||||
| dependent on the | ||||
| level of exudate | The dressing | |||
| tubing is | ||||
| connected to the | ||||
| 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 without | ||||
| requiring | ||||
| additional | ||||
| dressing changes | Same as the | |||
| secondary | ||||
| predicate. | ||||
| Pump | PWD™ Negative | |||
| Pressure Wound | ||||
| Therapy Pump | PICO 7 | NA | Same | |
| Pump Type | Custom designed pump | |||
| controlled by a | ||||
| microprocessor | Custom designed | |||
| pump controlled by | ||||
| a microprocessor | NA | Same |
9
| Substantial Equivalence Comparison Chart | |||||||
|---|---|---|---|---|---|---|---|
| Feature / | |||||||
| Specification | PWD™ Platform | ||||||
| Wound Dressing | |||||||
| Negative Pressure | |||||||
| System | PICO 7 Single | ||||||
| Use Negative | |||||||
| Pressure Wound | |||||||
| Therapy System | PWD™ | ||||||
| Platform Wound | |||||||
| Dressing | Comparison | ||||||
| How Supplied | PWD Dressing is | ||||||
| supplied Sterile Single | |||||||
| Use Only. The pump | |||||||
| and cannister are | |||||||
| supplied non-sterile | |||||||
| single use only | The system is | ||||||
| supplied sterile, | |||||||
| single use only | PWD Dressing is | ||||||
| supplied Sterile | |||||||
| Single Use Only. | The PWD | ||||||
| pump and | |||||||
| cannister are | |||||||
| supplied | |||||||
| nonsterile – | |||||||
| similar to | |||||||
| other systems | |||||||
| with the same | |||||||
| intended use. | |||||||
| This | |||||||
| difference | |||||||
| does not raise | |||||||
| new questions | |||||||
| of safety. | |||||||
| Tissue | |||||||
| Contact | |||||||
| Materials | Polymers and Adhesive | Polymers and | |||||
| Adhesive | Polymers and | ||||||
| Adhesive | Same as the | ||||||
| secondary | |||||||
| predicate | |||||||
| Additives - | |||||||
| antimicrobial, | |||||||
| animal origin | No | No | No | Same | |||
| Sterilization | Eto at an SAL 10-6 | Eto | Eto at an SAL 10-6 | Same. | |||
| Electrical Safety | |||||||
| Testing | Complies with IEC | ||||||
| 60601-1, IEC 60601-1- | |||||||
| 2, IEC 60601-1-11 | Complies with IEC | ||||||
| 60601-1, IEC 60601- | |||||||
| 1-2, IEC 60601-1-11 | NA | Same | |||||
| Electromagnetic | |||||||
| Compatibility | Complies with IEC | ||||||
| 60601-2-3 | Complies with IEC | ||||||
| 60601-2-3 | 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