(111 days)
Not Found
No
The device description and performance studies focus on the mechanical function of tubing, connectors, and a viewpad for negative pressure wound therapy, with no mention of AI or ML capabilities.
Yes.
The device components (tubing, Y-connector, ViewPad) are part of a Negative Pressure Wound Therapy (NPWT) system, which is explicitly indicated to "promote wound healing" by removing fluids, which falls under the definition of a therapeutic device.
No
The device is indicated for promoting wound healing via fluid removal, which is a therapeutic function, not diagnostic.
No
The device description explicitly details physical components (tubing, connectors, viewpad) and bench testing related to their physical performance (fluid transport, pressure delivery, alarm functionality). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Avance NPWT system and its components (tubing, Y-connector, ViewPad) are used to apply negative pressure directly to a wound. Their function is to remove fluids and exudate from the wound site to promote healing.
- Lack of Specimen Analysis: The device does not analyze any biological specimens in vitro (outside the body) to provide diagnostic information. It is a therapeutic device used in vivo (on the body).
The description clearly outlines a system for wound therapy, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications 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 bums, flaps and grafts.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
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.
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
Not Found
Intended User / Care Setting
Not Found
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:
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.
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.
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/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
1
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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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: | October 14, 2016 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Megan Bevill |
| Manager, Regulatory Affairs | |
| Tel: 470-375-0049 | |
| Fax: 678-245-7746 | |
| email: 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
4
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.
5
Technological Characteristics:
| Subject Avance Tubing | ||
|---|---|---|
| Feature | Avance Tubing | Extension Tubing, as cleared within the Venturi Negative Pressure |
| Wound 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 |
| Functionality | ||
| within NPWT | ||
| system | The Avance tubing serves as the connecting link between the | |
| Avance NPWT pump and the Avance dressings, thereby delivering | ||
| negative pressure from the pump to the wound bed and facilitating | ||
| the transport of fluid and exudate from the wound site to the | ||
| canister. | The Extension Tubing connects an NPWT dressing to an NPWT pump, | |
| thereby delivering negative pressure from the pump to the wound bed | ||
| and facilitating the transport of fluid and exudate from the wound site to | ||
| the canister | ||
| 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. | The Talley Venturi system is intended for use for patients with acute or | |
| chronic wounds that may be benefited by the application of negative | ||
| pressure therapy and the potential wound healing effects of removal of | ||
| fluids including wound exudates, irrigation fluids, body fluids, and | ||
| infectious materials. | ||
| Design Features | The Avance Tubing is a single lumen tubing with connectors on | |
| each end to facilitate the assembly of the tubing to a dual lumen | ||
| transfer pad on one end and to the pump's canister on the other | ||
| end. | The Extension Tubing is a single lumen tubing with connectors on each | |
| end to facilitate the assembly of the tubing to a single lumen transfer pad | ||
| on one end and to the pump's canister on the other end. | ||
| Product Offering | Unit item | |
| Kitted with Avance canisters | Unit item | |
| Kitted 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 | ||
|---|---|---|---|---|
| Functionality | ||||
| within NPWT | ||||
| system | The Avance Y-Connector allows connection of multiple Avance | |||
| dressings to one pump in order to accommodate large or multiple | ||||
| wounds. | The Avance Y-Connector S connects and allows therapy of multiple | |||
| wounds simultaneously by using one pump. | ||||
| 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. | 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. | ||||
| Design Features | Dual lumen y-tube with quick connectors on each end to facilitate | |||
| assembly to canister tubing and dual lumen transfer pads; allows | ||||
| therapy of multiple wounds simultaneously using one pump. | Single lumen tubing with y-connector; ends utilize taper fit connectors to | |||
| facilitate 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 | ||
| Functionality | ||||
| within NPWT | ||||
| system | 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 | ||||
| pump tubing for delivery of NPWT and transport of fluids/exudate | ||||
| away from the wound. | 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 pump tubing for | ||||
| delivery of NPWT and transport of fluids/exudate away from the wound. | ||||
| 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. | 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. | ||||
| Design Features | Same design feature as Avance ViewPad (K141847) With | |||
| modifications to the quick connector and slide clamp. | The Avance ViewPad consists of a body with dual lumen tubing and a | |||
| quick 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.
8
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.