(113 days)
No
The 510(k) summary describes a line addition (a larger dressing size) to an existing negative pressure wound therapy system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The focus is on the physical components and fluid transport capabilities of the system.
Yes
The device is indicated for promoting wound healing, which is a therapeutic benefit.
No
The device is described as a suction device (negative pressure wound therapy) intended to promote wound healing by removing fluids. It does not mention any diagnostic capabilities.
No
The device description explicitly states that the subject of the notification is a "line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL." It lists physical components like "Avance ViewPad, Avance Foam (green), Avance Transparent Film," which are hardware components of a negative pressure wound therapy system. The performance studies also describe bench testing of the physical dressing kit's ability to transport fluid and deliver pressure. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies negative pressure to a wound to remove fluids and promote healing. This is a therapeutic intervention applied directly to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a negative pressure wound therapy system with associated dressings. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the Avance NPWT system and its associated products, including the Avance Foam Dressing Kit - XL, fall under the category of therapeutic medical devices, not IVDs.
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 burns, flaps and grafts.
Product codes
OMP
Device Description
The subject of this premarket notification is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large.
The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847:
- Avance ViewPad
- Avance Foam (green)
- . Avance Transparent Film
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
Bench testing has been performed to demonstrate that the line addition to the Avance NPWT System does not negatively affect the ability of the NPWT system to transport fluid away from the wound and that pressure is delivered in accordance with the pump settings. The subject Avance Foam Dressing Kit - XL performed as intended in the test setups, and all predefined acceptance criteria were met. No clinical data was required to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Avance® Foam Dressing Kits (K141847)
Reference Device(s)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Molnlycke Health Care, Us LLC Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K161935
Trade/Device Name: Avance Foam Dressing Kit - XL Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 13, 2016 Received: July 14, 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 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.
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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
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K161935
Device Name Avance Foam Dressing Kit - XL
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 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ |
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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: | July 13, 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 Foam Dressing Kit - XL |
| Common Name: | NPWT Dressing Kit |
| Regulation Name: | Powered Suction Pump |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Predicate Device Information: | Avance® Foam Dressing Kits (K141847) |
Reason for 510(k) Submission:
This premarket notification has been prepared to obtain clearance for the following line addition to Mölnlycke's Avance Negative Pressure Wound Therapy (NPWT) System: Avance Foam Dressing Kit -XL.
Description of Devices:
The subject of this premarket notification is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large.
The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847:
- Avance ViewPad
- Avance Foam (green)
- . Avance Transparent Film
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
4
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:
| Feature | Avance Foam Dressing Kits - XL | 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 | The Avance Foam Dressing Kit - XL contains all | |
| dressing components necessary to administer | ||
| NPWT using foam as a wound filler material. | The Avance Foam Dressing Kits contain all dressing | |
| components necessary to administer NPWT using | ||
| foam as a wound filler material. | ||
| 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. | ||
| Dressing kit components | ● Avance ViewPad (I pc) | |
| ● Avance Foam, XL (2 pcs) | ||
| ● Avance Transparent Film (6 pcs) | (size L: largest size of comparable K141847 kit) | |
| ● Avance ViewPad (1 pc) | ||
| ● Avance Foam, L (1 pc) | ||
| ● Avance Transparent Film (2 pc) | ||
| Single use or Reusable | Single use | Single use |
| Sterility | EtO | EtO |
All technological differences between the subject and peen accounted 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 device has been evaluated in accordance with ISO 10993 and has been shown to be biocompatible for the intended use.
Bench testing has been performed to demonstrate that the line addition to the Avance NPWT System does not negatively affect the ability of the NPWT system to transport fluid away from the wound and that pressure is delivered in accordance with the pump settings. The subject Avance Foam Dressing Kit - XL 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.