Avance Y-Connector S
Device Facts
| Record ID | K151872 |
|---|---|
| Device Name | Avance Y-Connector S |
| Applicant | Molnlycke Health Care Us, LLC |
| Product Code | OMP · General, Plastic Surgery |
| Decision Date | Nov 2, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Avance® Y-connector S is intended for use in the Avance® Negative Pressure Wound Therapy (NPWT) system, to connect and allow therapy of multiple wounds simultaneously using one pump. 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.
Device Story
Avance® Y-Connector S is a single-lumen accessory for the Avance® NPWT system; enables connection of multiple dressing kits to a single suction pump. Input: wound exudate/fluids from multiple wound sites. Transformation: provides fluid pathway from two transfer pads to one canister tubing line; allows simultaneous negative pressure application to multiple wounds. Output: fluid transport to pump canister. Used in clinical/home settings; operated by healthcare providers or patients. Benefit: facilitates treatment of large or multiple wounds with one device; promotes healing via fluid removal.
Clinical Evidence
No clinical data was required. Bench testing only: biocompatibility (ISO 10993-5, ISO 10993-10) and internal fluid transport performance testing confirmed functionality with multiple wound models.
Technological Characteristics
Polyurethane/polypropylene single-lumen Y-connector; non-sterile; single-use. Biocompatibility per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Connects Avance® canister tubing to two single-lumen transfer pads.
Indications for Use
Indicated for patients requiring negative pressure wound therapy for chronic, acute, traumatic, sub-acute, dehisced wounds, ulcers (pressure/diabetic), partial-thickness burns, flaps, and grafts; allows simultaneous therapy of multiple wounds using one pump.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2015
Molnlycke Health Care, US LLC Ms. Angela Bunn Director, Regulatory Affairs for the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K151872
Trade/Device Name: Avance® Connector S Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: September 18, 2015 Received: September 21, 2015
Dear Ms. Bunn:
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
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
# 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| <b>Indications for Use</b> |
| Form Approved: OMB No. | 0910-0120 |
|------------------------|--------------------------|
| Expiration Date: | January 31, 2017 |
| | See PRA Statement below. |
| 510(k) Number (if known) | K151872 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Avance Y-Connector S |
| Indications for Use (Describe) | Avance Y-connector S is intended for use in the Avance Negative Pressure Wound Therapy (NPWT) system, to connect and allow therapy of multiple wounds simultaneously by using one pump. 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. |
| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
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## 510(k) SUMMARY OF SAFETY AND EFFICACY
This 510(k) summary of safety and efficacy information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | October 26, 2015 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Mölnlycke Health Care US, LLC<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092<br>Registration number:<br>3004763499<br>Owner/Operator Number:<br>8030877 |
| Official Correspondent: | Angela L. Bunn, RAC<br>Director, Regulatory Affairs of the Americas<br>Tel: 678-250-7930<br>Fax: 678-250-7981<br>e-mail: angela.bunn@Mölnlycke.com |
| Trade/Proprietary Name: | Avance® Y Connector S |
| Common Name: | NPWT Dressing Kits |
| Classification Name: | Powered Suction Pump |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Predicate Device Name(s): | K141847 - Avance® Foam Dressing Kit<br>K142626 - Invia Liberty System with Y-Connector |
### Description of Device:
The subject of this submission is the Avance® Y-Connector S, which is an accessory to the Avance® Negative Pressure Wound Therapy (NPWT) System. It allows connection of multiple dressing kits to one pump in order to accommodate large or multiple wounds. We have classified this device as Class II as it is directly indicated for use with an NPWT Pump which falls under that classification, and the Avance® Y-Connector S forms an integral part of the overall system when multiple wound sites require therapy.
The Avance® Y-connector S is a polyurethane/polypropylene based single lumen Yconnector. It is designed to function with existing Avance® NPWT pumps and dressing kits by connecting the Avance® Canister Tubing to two single lumen transfer pads which
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are applied to the Avance® Foam dressings. Use of the Avance® Y-Connector S allows therapy and transportation of exudate from more than one wound simultaneously using one pump. A maximum of two Avance® Y-Connector S devices may be used to connect three wounds to one pump.
### Intended Use/Indication for Use:
The Avance® Y-connector S is intended for use in the Avance® Negative Pressure Wound Therapy (NPWT) system, to connect and allow therapy of multiple wounds simultaneously using one pump. 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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# Predicate Device Comparison Table
| Predicate Device Comparison | | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Avance® Y-Connector S | Invia Liberty NPWT System with Y connector | Avance® Foam Dressing Kits with ViewPad |
| 510(k) Clearance | Subject of Submission | K142626 | K141847 |
| Manufacturer | Mölnlycke Health Care | Medela | Mölnlycke Health Care |
| Common Name | NPWT Dressing Kits | NPWT Dressing Kits | NPWT Dressing Kits |
| Classification # | 21 CFR 878.4780 | 21 CFR 878.4780 | 21 CFR 878.4780 |
| Class Name | Powered Suction Pump | Powered Suction Pump | Powered Suction Pump |
| Class | II | II | II |
| Product Code | OMP | OMP | OMP |
| Indication For Use/Intended Use | Avance® Y-connector S is intended for use<br>in the Avance® Negative Pressure Wound<br>Therapy (NPWT) system, to connect and<br>allow therapy of multiple wounds<br>simultaneously by using one pump.<br><br>Avance® Y-connector S does not change<br>the intended use of indications for use of the<br>Avance® NPWT System, as stated in<br>K141847. | The Invia Liberty® NPWT system, with<br>associated products are indicated for patients<br>who would benefit from a suction device<br>(negative pressure wound therapy), as it may<br>promote wound healing via the removal of<br>fluids, including irrigation and body fluids,<br>wound exudates and infectious materials.<br>Examples of appropriate wound types<br>include: chronic, acute, traumatic, sub-acute<br>and dehisced wounds, ulcers (such as<br>pressure or diabetic), partial-thickness<br>burns, flaps and grafts. | The Avance® NPWT system, with<br>associated products are indicated for patients<br>who would benefit from a suction device<br>(negative pressure wound therapy), as it may<br>promote wound healing via the removal of<br>fluids, including irrigation and body fluids,<br>wound exudates and infectious materials.<br>Examples of appropriate wound types<br>include: chronic, acute, traumatic, sub-acute<br>and dehisced wounds, ulcers (such as<br>pressure or diabetic), partial-thickness<br>burns, flaps and grafts. |
| Product Feature | | | |
| Y Connector | Y connector used to connect more than one<br>dressing kit to a pump | Y connector used to connect more than one<br>dressing kit to a pump | N/A |
| Tubing | Same tubing as ViewPad; used to connect to<br>the tubing of the Avance® Canister | N/A | ViewPad tubing used to connect to the<br>tubing of the Avance Canister |
| Single Use | Yes | Yes | Yes |
| Non-sterile | Yes | Not known | N/A (no Y Connector component) |
| Biocompatibility | Components meet applicable requirements<br>of ISO 10993-5 and ISO 10993-10 | Components meet applicable requirements<br>of ISO 10993-5 and ISO 10993-10 | Components meet applicable requirements<br>of ISO 10993 |
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#### Summary of Performance Testing
The Avance® Y-Connector S has been evaluated for biocompatibility and for performance within the Avance® NPWT System. The results are as follows.
| Test Data Summary: Avance® Y-Connector S | | |
|------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Standard/Test/FDA<br>Guidance | Results Summary |
| Biocompatibility : | | |
| Cytotoxicity | ISO 10993-5 | Under the conditions of the study, the<br>components are not cytotoxic. |
| Primary Skin Irritation | ISO 10993-10 | Under the conditions of the study, the<br>components are not irritants. |
| ISO Closed Patch<br>Sensitization | ISO 10993-10 | Under the conditions of the study, the<br>components are not sensitizers. |
| Performance : | | |
| NPWT Functionality | Internal Mölnlycke test<br>method for fluid transport in<br>NPWT | The fluid handling properties of the Avance®<br>NPWT System are sufficient to accommodate<br>the exudate flow rate from large exuding<br>wounds. The test setup included the use of<br>the Avance® Y-Connector S to connect<br>multiple wound models. |
### Clinical Testing:
No clinical data was required.
#### Conclusion:
Based on the information presented in this submission, it can be concluded that the Avance® Y-Connector S is substantially equivalent to the predicate device identified with respect to intended use, design and technological characteristics.
