(116 days)
Not Found
No
The description focuses on the mechanical function of a Y-connector for fluid transport in a negative pressure wound therapy system. There is no mention of any computational analysis, learning, or decision-making processes that would indicate AI/ML.
No.
The device is an accessory (Y-connector) that connects multiple wounds to a single Negative Pressure Wound Therapy (NPWT) pump, which is the therapeutic device. It does not provide therapy itself but facilitates the function of the NPWT system.
No
Explanation: The device is an accessory to a Negative Pressure Wound Therapy (NPWT) system, used to connect multiple wounds to one pump for therapeutic purposes (wound healing via fluid removal). It does not gather information about a patient's health status or diagnose any conditions.
No
The device description clearly states it is a physical Y-connector made of polyurethane/polypropylene, which is a hardware component, not software.
Based on the provided text, the Avance Y-connector S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for connecting and allowing therapy of multiple wounds simultaneously using a negative pressure wound therapy (NPWT) system. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details its function within the NPWT system for transporting exudate from wounds. This is a mechanical function related to wound management, not the analysis of biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or calibrators
- Performing tests on samples outside of the body
The Avance Y-connector S is an accessory to a therapeutic device (NPWT system) used for wound management.
N/A
Intended Use / 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 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.
Product codes
OMP
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
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)
The Avance® Y-Connector S has been evaluated for biocompatibility and for performance within the Avance® NPWT System. The results are as follows:
Biocompatibility Tests:
Cytotoxicity (ISO 10993-5): Under the conditions of the study, the components are not cytotoxic.
Primary Skin Irritation (ISO 10993-10): Under the conditions of the study, the components are not irritants.
ISO Closed Patch Sensitization (ISO 10993-10): Under the conditions of the study, the components are not sensitizers.
Performance Test:
NPWT Functionality (Internal Mölnlycke test method for fluid transport in NPWT): The fluid handling properties of the Avance® NPWT System are sufficient to accommodate the exudate flow rate from large exuding wounds. The test setup included the use of the Avance® Y-Connector S to connect multiple wound models.
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
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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.
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
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
3
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 |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration number: | |
| 3004763499 | |
| Owner/Operator Number: | |
| 8030877 | |
| Official Correspondent: | Angela L. Bunn, RAC |
| Director, Regulatory Affairs of the Americas | |
| Tel: 678-250-7930 | |
| Fax: 678-250-7981 | |
| 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 |
| 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
4
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.
5
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 | ||
| in the Avance® Negative Pressure Wound | |||
| Therapy (NPWT) system, to connect and | |||
| allow therapy of multiple wounds | |||
| simultaneously by using one pump. |
Avance® Y-connector S does not change
the intended use of indications for use of the
Avance® NPWT System, as stated in
K141847. | The Invia Liberty® 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 exudates 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 exudates 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. |
| Product Feature | | | |
| Y Connector | Y connector used to connect more than one
dressing kit to a pump | Y connector used to connect more than one
dressing kit to a pump | N/A |
| Tubing | Same tubing as ViewPad; used to connect to
the tubing of the Avance® Canister | N/A | ViewPad tubing used to connect to the
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
of ISO 10993-5 and ISO 10993-10 | Components meet applicable requirements
of ISO 10993-5 and ISO 10993-10 | Components meet applicable requirements
of ISO 10993 |
6
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 | |
| Guidance | Results Summary | |
| Biocompatibility : | ||
| Cytotoxicity | ISO 10993-5 | Under the conditions of the study, the |
| components are not cytotoxic. | ||
| Primary Skin Irritation | ISO 10993-10 | Under the conditions of the study, the |
| components are not irritants. | ||
| ISO Closed Patch | ||
| Sensitization | ISO 10993-10 | Under the conditions of the study, the |
| components are not sensitizers. | ||
| Performance : | ||
| NPWT Functionality | Internal Mölnlycke test | |
| method for fluid transport in | ||
| NPWT | The fluid handling properties of the Avance® | |
| NPWT System are sufficient to accommodate | ||
| the exudate flow rate from large exuding | ||
| wounds. The test setup included the use of | ||
| the Avance® Y-Connector S to connect | ||
| 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.