The Avelle™ NPWT System is indicated for use on patients that would benefit from a Negative Pressure Wound Therapy (NPWT) device as it may promote wound healing via removal of exudate and infectious materials from low to moderately exuding wound, such as:

· Chronic Wounds e.g. Leg ulcers
· Acute Wounds
· Subacute and dehisced wounds
Traumatic wounds
· Flaps & Grafts
· Surgically closed incision sites

Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.

Device Description

The Avelle Negative Pressure Wound Therapy (NPWT) System consists of:

a disposable battery powered pump
absorbent wound dressing which is connected to the pump via tubing and luer-lock fittings
adhesive fixation strips

The Avelle System is intended for single-patient use.

The Avelle pump is disposable, portable and battery-powered. The internal software of the pump limits the use to 30 days. The pump requires 3 AAA lithium batteries to operate. Testing shows that the 3 batteries will power the pump for a minimum of 15.6 days based on testing. A total of 6 AAA lithium batteries (2 sets) are provided with the pump which will power the device for its entire 30-day lifetime. The disposable battery-powered pump unit is attached to the dressing via the supplied tubing and luer-lock fittings.

The Avelle dressing is comprised of gelling fiber (Hydrofiber®) to absorb wound exudate with negative pressure applied indirectly to the dressing via the Avelle pump. The dressing is applied to the wound and secured around its periphery via its adhesive border and adhesive fixation strips are applied to ensure an adequate seal. The dressing's adhesive surface is protected by a split release liner system comprising of 2 or 3 sections of Low Density Polyethylene (LDPE) release liner (depending on dressing size), which are removed prior to dressing application.

The pump is turned on to apply and maintain a nominal negative pressure of -80mmHg to the dressing. The pump will draw excess wound exudate and infectious materials away from the wound bed and into the Hydrofiber® layers as demonstrated in a simulated use test with a moderately exuding flow of 82 mL over 3 days and a second simulated use test with a low exuding flow of 102 mL over 7 days.

The system will deliver up to 30 days' single patient use for the pump component, and up to 7 days' wear time for the dressing. Each dressing may be used for up to 7 days but may require more frequent changes due to clinical situations. After 30 days of use the pump must be discarded and treatment must be stopped.

The pump unit is provided non-sterile. The Absorbing Dressing (with adhesive fixation strips) is provided sterile via ethylene oxide (EtO) sterilization.

AI/ML Overview

This document, a 510(k) summary for the AVELLE Negative Pressure Wound Therapy System, describes non-clinical performance testing rather than clinical studies with human participants. Therefore, many of the requested elements for clinical study data (such as sample size for test sets, ground truth establishment for test sets, expert qualifications, adjudication methods, and MRMC studies) are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes that "The AVELLE NPWT meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device." Specific quantitative acceptance criteria are not provided in this summary, but the successful completion of the listed tests implies that the device met their pre-defined criteria.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Overall Design	Met design inputs/specs	Met requirements
Sterilization	Met design inputs/specs	Met requirements (Absorbing Dressing is provided sterile via ethylene oxide (EtO) sterilization)
Biocompatibility	Met design inputs/specs	Met requirements
Electrical Safety	Met design inputs/specs	Met requirements
Peel testing (dressing)	Met design inputs/specs	Successfully completed
Peel testing (fixation strips)	Met design inputs/specs	Successfully completed
Bacterial Barrier testing	Met design inputs/specs	Successfully completed
Viral penetration testing	Met design inputs/specs	Successfully completed
Distribution of Negative pressure	Met design inputs/specs	Successfully completed; nominal negative pressure of -80mmHg applied
Absorption assessment	Met design inputs/specs	Successfully completed; system draws excess wound exudate and infectious materials away from wound bed and into Hydrofiber® layers
Fluid Retention testing	Met design inputs/specs	Successfully completed
Moisture Vapor Transmission Rate	Met design inputs/specs	Successfully completed
Pump performance & alarm testing	Met design inputs/specs	Successfully completed; pump powers for a minimum of 15.6 days with 3 AAA lithium batteries, total 30-day lifetime with 6 batteries (2 sets).
Assessing Waterproofness	Met design inputs/specs	Successfully completed
Rucking Test	Met design inputs/specs	Successfully completed
Simulated Use Testing	Met design inputs/specs	Successfully completed: demonstrated removal of exudate and infectious materials with a moderately exuding flow of 82 mL over 3 days and a low exuding flow of 102 mL over 7 days.
Human Factors/Usability Testing	Met design inputs/specs	Successfully completed
Software Documentation	Met FDA guidance	Assembled according to recommendations in "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). Software Level of Concern determined to be Moderate.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each non-clinical test. The tests are "bench testing" and "simulated use tests," meaning they were conducted in a laboratory setting, not on human patients. The data provenance is ConvaTec Limited (the applicant).

3. Number of experts used to establish the ground truth for the test set and their qualifications

Not applicable. These were non-clinical, bench and simulated use tests, not diagnostic studies requiring expert review for ground truth.

4. Adjudication method for the test set

Not applicable for non-clinical bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (NPWT system), not an AI-powered diagnostic tool, and no MRMC study was conducted or mentioned. The document explicitly states "Clinical Data is not included in this 510(k)."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is a physical system (pump, dressing, tubing), not an algorithm-only device. "Standalone" performance would refer to the device's functional operation, which was assessed through the various bench and simulated use tests.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods, and industry standards for material properties, sterility, performance, and safety. For example, bacterial barrier testing would have a known standard for barrier effectiveness as its "ground truth."

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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October 19, 2018

ConvaTec Limited Justin Lovelace Senior Regulatory Affairs Specialist First Avenue Deeside, CH5 2NU Gb

Re: K180205

Trade/Device Name: AVELLE Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 14, 2018 Received: September 17, 2018

Dear Justin Lovelace:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

for

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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) K180205

Device Name

Avelle™ Negative Pressure Wound Therapy System

Indications for Use (Describe)

· Chronic Wounds e.g. Leg ulcers
· Acute Wounds
· Subacute and dehisced wounds
Traumatic wounds
· Flaps & Grafts
· Surgically closed incision sites

Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K180205 - 510(k) Summary

Device:	Avelle Negative Pressure Wound Therapy System
Applicant:	ConvaTec Limited
Contact:	Justin LovelaceSenior Regulatory Affairs SpecialistTelephone: 1-336-542-4745Email: Justin.Lovelace@convatec.com
Date:	October 18, 2018
Trade Name:	Avelle Negative Pressure Wound Therapy System
Classification Name:	Powered Suction Pump (21 CFR 878.4780)
Device Class:	Class II
Product Code:	OMP

Predicate Device Information

Predicate Device	510(k) number	Clearance Date
PICO Single UseNegative PressureWound TherapySystem	K151436	01/28/2016

Device Description:

The Avelle Negative Pressure Wound Therapy (NPWT) System consists of:

a disposable battery powered pump ।
absorbent wound dressing which is connected to the pump via tubing and luer-lock fittings
adhesive fixation strips

The Avelle System is intended for single-patient use.

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for its entire 30-day lifetime. The disposable battery-powered pump unit is attached to the dressing via the supplied tubing and luer-lock fittings.

The pump unit is provided non-sterile. The Absorbing Dressing (with adhesive fixation strips) is provided sterile via ethylene oxide (EtO) sterilization.

Indications for Use

Chronic Wounds e.g. Leg ulcers
Acute Wounds
Subacute and dehisced wounds
Traumatic wounds
Flaps & Grafts
Surgically closed incision sites

Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.

Clinical Data Clinical Data is not included in this 510(k).

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Non-Clinical Performance Data

The AVELLE NPWT is subject to a number of non-clinical performance tests. The AVELLE NPWT meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.

The list below summarizes the bench testing undertaken and successfully completed for the AVELLE NPWT system:

Peel testing of the dressing
Peel testing of the adhesive fixation strips ●
Bacterial Barrier testing
Viral penetration testing
Distribution of Negative pressure across the dressing
Absorption assessment of dressing ●
Fluid Retention testing
Moisture Vapor Transmission Rate assessment of dressing
Pump performance and alarm testing
Assessing Waterproofness
Rucking Test of the adhesive strips
Simulated Use Testing
. Human Factors/Usability Testing

The software documentation in this submission has been assembled according to the recommendations in the FDA document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. The software Level of Concern has been evaluated and determined to be Moderate, and appropriate documentation included, as recommended by the cited FDA guidance.

Conclusions

In establishing substantial equivalence to the predicate device, ConvaTec evaluated the indications for use, materials, technology, product specifications, and performance of the device and determined the subject device is substantially equivalent to the predicate. The differences do not raise different questions of safety or effectiveness.

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.