(227 days)
Not Found
No
The summary describes a standard negative pressure wound therapy system with a pump, canister, and dressings. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on biocompatibility, bench testing, software validation (to IEC 62304), electromagnetic compatibility, electrical safety, and human factors, none of which indicate AI/ML components.
Yes
The device is indicated for wound management via the application of negative pressure wound therapy, and it promotes wound healing.
No
Explanation: The Avance Solo NPWT System is designed for wound management through the application of negative pressure wound therapy and removal of exudate, infectious material. Its intended use is to promote wound healing as a therapy, not to provide diagnostic information about a patient's condition.
No
The device description explicitly lists multiple hardware components: Avance Solo Pump, Avance Solo Canister, Avance Solo Border Dressing, and Avance Solo Foam. The software validation mentioned is for the software controlling these hardware components, not a standalone software device.
Based on the provided information, the Avance Solo NPWT System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "wound management via the application of negative pressure wound therapy" and "removal of exudate, infectious material." This describes a therapeutic intervention applied directly to the patient's body, not a test performed on samples taken from the body.
- Device Description: The components described (pump, canister, dressing, foam) are all designed to apply negative pressure to a wound and manage wound exudate. None of these components are used for analyzing biological samples.
- Performance Studies: The performance studies focus on the device's ability to transport fluid, maintain pressure, safety, and usability. There are no studies related to the analysis of biological samples or diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Avance Solo NPWT System does not perform this function.
N/A
Intended Use / Indications for Use
The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.
Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts.
Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam which together form a system for wound management via the application of negative pressure wound therapy.
- . Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications
- . Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate
- . Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips
- . Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds
Avance Solo NPWT System maintains negative pressure nominally at -125 mmHg to the wound and enables exudate management by absorption and evaporation in Avance Solo Border Dressing. Excess exudate is collected in Avance Solo Canister 50 ml.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare professionals for therapy on patients in healthcare facilities and home care settings.
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)
Non-Clinical Testing:
(Biocompatibility) The subject devices have been evaluated in accordance with ISO 10993-1 and have been shown to meet the criteria for the relevant endpoints, based on the characterization of contact with respect to nature and duration. The results meet the relevant ISO 10993-XX criteria for their intended use. The endpoints included cytotoxicity, sensitization, acute systemic toxicity, materialmediated pyrogenicity, subacute/subchronic toxicity, implantation, and genotoxicity.
(Bench testing) Bench testing has been performed to demonstrate that the Avance Solo NPWT System is capable of effectively transporting fluid away from the wound and that pressure is delivered in accordance with the pump settings. Test setups addressed both low (0.6 g/cm²/24 hours) and moderately (1.1 g/cm²/24 hours) exuding wounds, with and without wound filler. In addition, alarm functionality, device lifetime, and pressure safety mechanism testing was conducted. The subject Avance Solo NPWT System performed as intended in the test setups, and all predefined acceptance criteria were met.
(Software validation) Software validation has been conducted in accordance with IEC 62304:2006 + A1:2015.
(Electromagnetic compatibility and electrical safety testing)
The Avance Solo NPWT System has been shown to comply with the relevant medical electrical equipment standards:
- AAMI ES 60601-1: 2005 +A2 +A1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: 2014, Medical electrical equipment: General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
- . IEC 60601-1-6: 2010 + A1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8: 2006 + A1:2012. Medical electrical equipment -- Part 1-8: General requirements . for basic safety and essential performance -- Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems
- . IEC 60601-1-11: 2015. Medical electrical equipment: General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
(Human factors/usability) Summative usability testing has been performed with the two identified user qroups (healthcare professionals and patients/lay persons).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
PICO Single Use NPWT System (K163387), ActiVAC Therapy Unit (K120033)
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.
Not Found
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).
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2021
Molnlycke Health Care US, LLC Megan Bevill Manager, Regulatory Affairs 5445 Triangle Parkwav Suite 400 Peachtree Corners, Georgia 30092
Re: K203369
Trade/Device Name: Avance Solo Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: Mav 28, 2021 Received: June 1, 2021
Dear Megan Bevill:
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
1
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,
Lixin Liu, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203369
Device Name
Avance Solo Negative Pressure Wound Therapy (NPWT) System
Indications for Use (Describe)
The Avance Solo NPWT System is indicated for patients who would management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.
Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulch as diabetic, venous or pressure). surgically closed incisions. flaps. and grafts.
Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.
| 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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3
510(k) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | June 30, 2021 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC |
| 5445 Triangle Parkway, Suite 400 | |
| Peachtree Corners, GA 30092 | |
| Registration Number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Megan Bevill |
| Manager, Regulatory Affairs | |
| Tel: 770-547-9196 | |
| email: megan.bevill@molnlycke.com | |
| Trade/Proprietary Names: | Avance Solo Negative Pressure Wound Therapy (NPWT) |
| System | |
| Regulation Name: | Negative Pressure Wound Therapy Powered Suction Pump |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Predicate Device Name(s): | PICO Single Use NPWT System (K163387) |
| ActiVAC Therapy Unit (K120033) |
Description of Device:
Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam which together form a system for wound management via the application of negative pressure wound therapy.
- . Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications
- . Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate
- . Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips
- . Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds
Avance Solo NPWT System maintains negative pressure nominally at -125 mmHg to the wound and enables exudate management by absorption and evaporation in Avance Solo Border Dressing. Excess exudate is collected in Avance Solo Canister 50 ml.
Avance Solo NPWT System is intended for adults.
4
Intended Use/Indication for Use:
The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.
Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts.
Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.
5
Technological Characteristics:
| Feature | Avance Solo NPWT System | PICO Single Use NPWT System | ActiVAC Therapy Unit | Substantial Equivalence
Comments (comparison
to primary predicate
unless otherwise stated) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
clearance | K203369 (subject device) | K163387 | K120033 | NA |
| Rationale for
inclusion | Subject of submission | Primary predicate device | Secondary predicate device | NA |
| Manufacturer | Mölnlycke Health Care | Smith & Nephew Medical Inc. | KCI USA, Inc. | NA |
| Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 | 21 CFR 878.4780 | Same |
| Class name | Negative Pressure Wound Therapy
Powered Suction Pump | Negative Pressure Wound Therapy
Powered Suction Pump | Negative Pressure Wound Therapy
Powered Suction Pump | Same |
| Class | II | II | II | Same |
| Product Name | Avance Solo NPWT System | PICO Single Use NPWT System | ActiVAC Therapy Unit | NA |
| Product code | OMP | OMP | OMP | Same |
| Indication for
use/Intended
use | The Avance Solo NPWT System is
indicated for patients who would
benefit from wound management
via the application of negative
pressure wound therapy,
particularly as the device may
promote wound healing through the
removal of exudate, infectious
material.
Avance Solo NPWT System is
indicated for removal of low to
moderate amounts of exudates
from chronic, acute, traumatic,
subacute and dehisced wounds,
ulcers (such as diabetic, venous or
pressure), surgically closed
incisions, flaps, and grafts.
Avance Solo NPWT System is
intended for use by healthcare
professionals for therapy on
patients in healthcare facilities and
home care settings. | PICO 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
- 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 hospital
and homecare setting. | The ActiVAC NPWT System is an
integrated wound management
system for use in acute, extended
and home care settings.
When used on open wound, it is
intended to create an environment
that promotes wound healing by
secondary or tertiary (delayed
primary) intention by preparing the
wound bed for closure, reducing
edema, promoting granulation
tissue formation and perfusion, and
by removing exudate and infectious
material. Open wound types
includes: chronic, acute, traumatic,
subacute and dehisced wounds,
partial thickness burns, ulcers
(such as diabetic, pressure, or
venous insufficiency), flaps and
grafts.
When used on closed surgical
incision, they are also intended to
manage the environment of
surgical incisions that continue to | Minor differences in
formatting with no impact
on substantial
equivalence; primary
predicate device does not
explicitly include venous
ulcers in indicated wound
types, but secondary
predicate does |
| | | | drain following sutured or stapled
closure by maintaining a closed
environment and removing
exudates via the application of
negative pressure wound therapy. | |
| Use
environment | Healthcare facilities and home care
setting | Hospital and homecare setting | Hospital and homecare setting | Same |
| System
components | Pump
Canister
Border dressing with fixation strips
Foam | Pump
Border dressing with fixation strips
Foam | Pump
Canister
Transfer port
Cover film
Foam | Avance Solo NPWT
System utilizes both the
exudate
absorption/evaporation
properties of the border
dressing as well as a
canister for collection of
excess exudate. PICO
Single Use NPWT System
handles exudate only
through
absorption/evaporation in
the border dressing (i.e., it
does not utilize a
canister). In both
systems, most of the
wound fluids are handled
through evaporation
through the dressing; the
Avance Solo Canister
serves as a backup for
excess exudate. Despite
this difference, both
systems are capable of
delivering effective
negative pressure wound
therapy and removing
excess wound exudate
and are therefore
substantially equivalent. |
| Performance
specification | -125 mmHg (nominal) | -80 mmHg (nominal) | -125 mmHg (nominal) (default
setting) | Preclinical and clinical
literature suggests that
delivery of negative
pressure within the range
of -50mmHg to -150 |
| | | | | mmHg induces safe and
effective NPWT. Because
both the Avance Solo
NPWT System and PICO
Single Use NPWT System
are specified to deliver
negative pressure within
the clinically acceptable
range, the performance
specification difference
does not impact
substantial equivalence. |
| Pump useful
life | 14 days | 7 days | NA (multiple patient use) | Differences in useful life
do not impact substantial
equivalence; the total time
of treatment is not
determined by the lifetime
of the pumps, as
continued therapy with
either system can be
provided by connecting a
new pump. |
| Pump power
source | Two AA Lithium batteries | Two AA Lithium batteries | Battery and AC powered | Same as primary
predicate |
| Sterility | System components are supplied
sterile; sterilization is achieved by
EtO | System components are supplied
sterile; sterilization is achieved by
EtO | Pump is not supplied sterile
Canister has a sterile fluid path;
sterilization is achieved by radiation
Transfer port, cover film, and foam
are supplied sterile; sterilization is
achieved by radiation | Same as primary
predicate |
6
7
8
Non-Clinical Testing:
(Biocompatibility) The subject devices have been evaluated in accordance with ISO 10993-1 and have been shown to meet the criteria for the relevant endpoints, based on the characterization of contact with respect to nature and duration. The results meet the relevant ISO 10993-XX criteria for their intended use. The endpoints included cytotoxicity, sensitization, acute systemic toxicity, materialmediated pyrogenicity, subacute/subchronic toxicity, implantation, and genotoxicity.
(Bench testing) Bench testing has been performed to demonstrate that the Avance Solo NPWT System is capable of effectively transporting fluid away from the wound and that pressure is delivered in accordance with the pump settings. Test setups addressed both low (0.6 g/cm²/24 hours) and moderately (1.1 g/cm²/24 hours) exuding wounds, with and without wound filler. In addition, alarm functionality, device lifetime, and pressure safety mechanism testing was conducted. The subject Avance Solo NPWT System performed as intended in the test setups, and all predefined acceptance criteria were met.
(Software validation) Software validation has been conducted in accordance with IEC 62304:2006 + A1:2015.
(Electromagnetic compatibility and electrical safety testing)
The Avance Solo NPWT System has been shown to comply with the relevant medical electrical equipment standards:
- AAMI ES 60601-1: 2005 +A2 +A1, Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance
- . IEC 60601-1-2: 2014, Medical electrical equipment: General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
- . IEC 60601-1-6: 2010 + A1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8: 2006 + A1:2012. Medical electrical equipment -- Part 1-8: General requirements . for basic safety and essential performance -- Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems
- . IEC 60601-1-11: 2015. Medical electrical equipment: General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
(Human factors/usability) Summative usability testing has been performed with the two identified user qroups (healthcare professionals and patients/lay persons).
Clinical Data:
No clinical data was provided to support substantial equivalence.
Conclusion:
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics as well as performance and electrical safety testing. The Avance Solo NPWT System is as safe and effective, and performs as well as the predicate devices.