(111 days)
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness bums, flaps and grafts.
The subject Avance Tubing serves as the connecting link between the Avance NPWT pump and the Avance dressings, thereby delivering negative pressure wound therapy from the pump to the wound bed and facilitating the transport of fluid and exudate from the wound site to the canister. It consists of a 1.5 m length of tubing with connectors on each end to facilitate connection to other components of the Avance NPWT System.
The subject Avance Y-Connector allows connection of multiple Avance dressings to one Avance pump in order to accommodate large or multiple wounds. It consists of y-tubing with connectors on all ends to facilitate connection to other components of the Avance NPWT System. A maximum of one Avance Y-Connector may be used to connect up to two large dressing kits to a single pump.
The subject Avance ViewPad used in conjunction with the Avance dressings; it is placed on top of the wound cover (film), connected to the wound filler via a hole cut in the wound cover, and then connected to the Avance NPWT pump tubing for delivery of NPWT and transport of fluids and exudate away from the wound. The subject Avance ViewPad is similar to the existing ViewPad component of the Avance Foam Dressing Kits (K141847), with the exception of a green colorant that has been added to the connector and a modification to the design of the slide clamp.
This document describes the premarket notification for Avance Tubing, Avance Y-Connector, and Avance ViewPad, which are components of a Negative Pressure Wound Therapy (NPWT) system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the devices were evaluated through non-clinical bench testing. The general acceptance criteria were that the devices "performed as intended in the test setups, and all predefined acceptance criteria were met." Specific quantitative acceptance criteria are not explicitly detailed in this summary, but the reported performance is that they met all such criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device does not negatively affect fluid transport by the NPWT system | Performed as intended; fluid transport maintained |
| Pressure is delivered in accordance with pump settings | Performed as intended; pressure delivery maintained |
| Alarm functionality of the NPWT pump is maintained | Performed as intended; alarm functionality maintained |
| Biocompatibility (cytotoxicity, sensitization, irritation) | Non-cytotoxic, non-sensitizing, non-irritating (meets ISO 10993 criteria) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample size (number of devices or test runs) for the non-clinical bench testing. It only states that "Bench testing has been performed."
- Data Provenance: The testing was conducted as part of the premarket notification for the devices by the manufacturer, Mölnlycke Health Care. It is considered prospective data generated specifically for regulatory submission. The country of origin for the data is not explicitly stated, but the manufacturer is Mölnlycke Health Care, US LLC, located in Norcross, Georgia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable as the studies conducted were non-clinical bench tests, not clinical studies involving expert interpretation of medical data or ground truth established by medical professionals. The "ground truth" here refers to the functional performance of the device against engineering specifications and industry standards.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies conducted were non-clinical bench tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same cases to arrive at a consensus for ground truth. In bench testing, performance is measured objectively against predefined engineering specifications.
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:
This information is not applicable. The submission is for components of a Negative Pressure Wound Therapy system, which are physical medical devices, not an AI or computer-aided diagnostic (CAD) system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the submitted devices are physical medical device components, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing was based on predefined engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and functional performance requirements. These requirements dictated that the device should:
- Not negatively affect fluid transport.
- Deliver pressure according to pump settings.
- Maintain alarm functionality.
- Meet biocompatibility criteria (non-cytotoxic, non-sensitizing, non-irritating).
8. The Sample Size for the Training Set:
This information is not applicable. The tested devices are physical components, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for these physical devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2016
Molnlycke Health Care, Us LLC Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway Suite 500 Norcross, Georgia 30092
Re: K161797
Trade/Device Name: Avance Tubing, Avance Y-connector, Avance Viewpad Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 19, 2016 Received: September 21, 2016
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K161797
Device Name
Avance Tubing, Avance Y-Connector, and Avance View Pad
Indications for Use (Describe)
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness bums, flaps and grafts.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
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510(k) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | October 14, 2016 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877 |
| Official Correspondent: | Megan BevillManager, Regulatory AffairsTel: 470-375-0049Fax: 678-245-7746email: megan.bevill@molnlycke.com |
| Trade/Proprietary Names: | Avance® Tubing, Avance® Y-Connector, and Avance®ViewPad™ |
| Common Name: | NPWT System Components |
| Regulation Name: | Powered Suction Pump |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Predicate Device Information: | Venturi Negative Pressure Wound Therapy System (K080897)Avance® Y-Connector S (K151872)Avance® Foam Dressing Kits (K141847) |
Reason for 510(k) Submission:
This premarket notification has been prepared to obtain clearance for the following line additions to Mölnlycke's Avance Negative Pressure Wound Therapy (NPWT) System: Avance Tubing, Avance Y-Connector, and Avance ViewPad.
Description of Devices:
The subject Avance Tubing serves as the connecting link between the Avance NPWT pump and the Avance dressings, thereby delivering negative pressure wound therapy from the pump to the wound bed and facilitating the transport of fluid and exudate from the wound site to the canister. It consists of a 1.5 m length of tubing with connectors on each end to facilitate connection to other components of the Avance NPWT System.
The subject Avance Y-Connector allows connection of multiple Avance dressings to one Avance pump in order to accommodate large or multiple wounds. It consists of y-tubing with connectors on all ends to facilitate connection to other components of the Avance NPWT System. A maximum of one Avance Y-Connector may be used to connect up to two large dressing kits to a single pump.
The subject Avance ViewPad used in conjunction with the Avance dressings; it is placed on top of the wound cover (film), connected to the wound filler via a hole cut in the wound cover, and then connected to
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the Avance NPWT pump tubing for delivery of NPWT and transport of fluids and exudate away from the wound. The subject Avance ViewPad is similar to the existing ViewPad component of the Avance Foam Dressing Kits (K141847), with the exception of a green colorant that has been added to the connector and a modification to the design of the slide clamp.
Indication for Use:
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
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Technological Characteristics:
| Subject Avance Tubing | ||
|---|---|---|
| Feature | Avance Tubing | Extension Tubing, as cleared within the Venturi Negative PressureWound Therapy System |
| 510(k)clearance | Subject device | K080897 |
| Manufacturer | Mölnlycke Health Care | Talley Medical |
| Common name | Canister tubing for NPWT system | Canister tubing for NPWT system |
| Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 |
| Class name | Powered Suction Pump | Powered Suction Pump |
| Class | II | II |
| Product code | OMP | OMP |
| Functionalitywithin NPWTsystem | The Avance tubing serves as the connecting link between theAvance NPWT pump and the Avance dressings, thereby deliveringnegative pressure from the pump to the wound bed and facilitatingthe transport of fluid and exudate from the wound site to thecanister. | The Extension Tubing connects an NPWT dressing to an NPWT pump,thereby delivering negative pressure from the pump to the wound bedand facilitating the transport of fluid and exudate from the wound site tothe canister |
| Indication foruse | The Avance NPWT system, with associated products, are indicatedfor patients who would benefit from a suction device (negativepressure wound therapy), as it may promote wound healing via theremoval of fluids, including irrigation and body fluids, woundexudate and infectious materials. Examples of appropriate woundtypes include: chronic, acute, traumatic, sub-acute and dehiscedwounds, ulcers (such as pressure or diabetic), partial-thicknessburns, flaps and grafts. | The Talley Venturi system is intended for use for patients with acute orchronic wounds that may be benefited by the application of negativepressure therapy and the potential wound healing effects of removal offluids including wound exudates, irrigation fluids, body fluids, andinfectious materials. |
| Design Features | The Avance Tubing is a single lumen tubing with connectors oneach end to facilitate the assembly of the tubing to a dual lumentransfer pad on one end and to the pump's canister on the otherend. | The Extension Tubing is a single lumen tubing with connectors on eachend to facilitate the assembly of the tubing to a single lumen transfer padon one end and to the pump's canister on the other end. |
| Product Offering | Unit itemKitted with Avance canisters | Unit itemKitted with Venturi canisters |
| Single Use | Y | Y |
| Sterility | EtO | NS |
| Subject Avance Y-Connector | ||
| Feature | Avance Y-Connector | Avance Y-Connector S |
| 510(k)clearance | Subject device | K151872 |
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care |
| Common name | Y-connector for NPWT system | Y-connector for NPWT system |
| Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 |
| Class name | Powered Suction Pump | Powered Suction Pump |
| Class | II | II |
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| Product code | OMP | OMP | ||
|---|---|---|---|---|
| Functionalitywithin NPWTsystem | The Avance Y-Connector allows connection of multiple Avancedressings to one pump in order to accommodate large or multiplewounds. | The Avance Y-Connector S connects and allows therapy of multiplewounds simultaneously by using one pump. | ||
| Indication foruse | The Avance NPWT system, with associated products, are indicatedfor patients who would benefit from a suction device (negativepressure wound therapy), as it may promote wound healing via theremoval of fluids, including irrigation and body fluids, woundexudate and infectious materials. Examples of appropriate woundtypes include: chronic, acute, traumatic, sub-acute and dehiscedwounds, ulcers (such as pressure or diabetic), partial-thicknessburns, flaps and grafts. | The Avance NPWT system, with associated products, are indicated forpatients who would benefit from a suction device (negative pressurewound therapy), as it may promote wound healing via the removal offluids, including irrigation and body fluids, wound exudate and infectiousmaterials. Examples of appropriate wound types include: chronic, acute,traumatic, sub-acute and dehisced wounds, ulcers (such as pressure ordiabetic), partial-thickness burns, flaps and grafts. | ||
| Design Features | Dual lumen y-tube with quick connectors on each end to facilitateassembly to canister tubing and dual lumen transfer pads; allowstherapy of multiple wounds simultaneously using one pump. | Single lumen tubing with y-connector; ends utilize taper fit connectors tofacilitate assembly to canister tubing and single lumen transfer pads;allows therapy of multiple wounds simultaneously using one pump. | ||
| Single Use | Y | Y | ||
| Sterility | EtO | NS | ||
| Subject Avance ViewPad | ||||
| Feature | Avance ViewPad | Avance ViewPad, as cleared within the Avance Foam Dressing Kits | ||
| 510(k)clearance | Subject device | K141847 | ||
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | ||
| Common name | Dressing kit component for NPWT system | Dressing kit component for NPWT system | ||
| Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 | ||
| Class name | Powered Suction Pump | Powered Suction Pump | ||
| Class | II | II | ||
| Product code | OMP | OMP | ||
| Functionalitywithin NPWTsystem | Placed on top of the wound cover (film), connected to the woundfiller via a hole cut in the wound cover, and then connected to thepump tubing for delivery of NPWT and transport of fluids/exudateaway from the wound. | Placed on top of the wound cover (film), connected to the wound filler viaa hole cut in the wound cover, and then connected to the pump tubing fordelivery of NPWT and transport of fluids/exudate away from the wound. | ||
| Indication foruse | The Avance NPWT system, with associated products, are indicatedfor patients who would benefit from a suction device (negativepressure wound therapy), as it may promote wound healing via theremoval of fluids, including irrigation and body fluids, woundexudate and infectious materials. Examples of appropriate woundtypes include: chronic, acute, traumatic, sub-acute and dehiscedwounds, ulcers (such as pressure or diabetic), partial-thicknessburns, flaps and grafts. | The Avance NPWT system, with associated products, are indicated forpatients who would benefit from a suction device (negative pressurewound therapy), as it may promote wound healing via the removal offluids, including irrigation and body fluids, wound exudate and infectiousmaterials. Examples of appropriate wound types include: chronic, acute,traumatic, sub-acute and dehisced wounds, ulcers (such as pressure ordiabetic), partial-thickness burns, flaps and grafts. | ||
| Design Features | Same design feature as Avance ViewPad (K141847) Withmodifications to the quick connector and slide clamp. | The Avance ViewPad consists of a body with dual lumen tubing and aquick connector to facilitate connection to the canister tubing.Incorporates a slide clamp to block tubing during dressing changes. | ||
| Product Offering | Unit item | Unit item |
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| Kitted in Avance Foam Dressing Kits | Kitted in Avance Foam Dressing Kits | |
|---|---|---|
| Single Use | Y | Y |
| Sterility | EtO | EtO |
All technological differences between the subject and producted for within the submission through detailed device comparisons, nonclinical testing, and other means. Technological differences have been shown to raise of safety or effectiveness.
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Non-Clinical Testing:
The subject devices have been evaluated in accordance with ISO 10993 and have been shown to be non-cytotoxic, non-sensitizing, and non-irritating. The results meet the ISO 10993 criteria for their intended use.
Bench testing has been performed to demonstrate that the line additions to the Avance NPWT System do not negatively affect the ability of the NPWT system to transport fluid away from the wound, that pressure is delivered in accordance with the pump settings, and that the alarm functionality of the NPWT pump is maintained. The subject Avance Tubing, Avance Y-Connector, and Avance ViewPad performed as intended in the test setups, and all predefined acceptance criteria were met.
Clinical Data:
No clinical data was required to support substantial equivalence.
Conclusion:
The subject devices are substantially equivalent to the predicate and reference devices with respect to design, technological characteristics, intended use, and conformance to standard requirements.
§ 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.