Avance Abdominal Dressing Kit

K161939 · Molnlycke Health Care Us, LLC · OXJ · Nov 17, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161939
• Device Name: Avance Abdominal Dressing Kit
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: OXJ · General, Plastic Surgery
• Decision Date: Nov 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.

Device Story

Dressing kit for open abdominal wounds; used with Avance Max NPWT pump. Components: ViewPad, abdominal foam, transparent film, organ contact layer. Applied in operating theatre by clinicians in acute hospital settings (trauma, general/plastic surgery). System applies negative pressure to transport fluid away from wound; facilitates temporary bridging of abdominal wall openings. Benefits: supports wound management in complex cases requiring repeat access or where primary closure is unachievable.

Clinical Evidence

No clinical data was required to support substantial equivalence. Bench testing performed to verify fluid transport capability within the NPWT system; all predefined acceptance criteria met.

Technological Characteristics

Single-use, EtO-sterilized NPWT dressing kit. Components include foam, film, organ contact layer, and ViewPad. Operates as part of the Avance Max NPWT system for fluid transport. Materials evaluated per ISO 10993-1.

Indications for Use

Indicated for patients with open abdominal wounds with exposed viscera and organs, including abdominal compartment syndrome, where primary closure is not possible or repeat abdominal entries are required.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Avance Abdominal Dressing Kit (K130852)

Reference Devices

• Avance Foam Dressing Kits (K141847)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

Molnlycke Health Care Us, LLC Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K161939

Trade/Device Name: Avance Abdominal Dressing Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Mesh, Surgical, Non-Absorbable, Large Abdominal Regulatory Class: Class II Product Codes: OXJ, OMP Dated: October 14, 2016 Received: October 17, 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 (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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R.

# Stevenson -A

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) K161939

Device Name Avance Abdominal Dressing Kit

#### Indications for Use (Describe)

The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> 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: | November 16, 2016 |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Mölnlycke Health Care US, LLC<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092<br>Registration number: 3004763499<br>Owner/Operator Number: 8030877 |
| Official Correspondent: | Megan Bevill<br>Manager, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Trade/Proprietary Names: | Avance Abdominal Dressing Kit |
| Common Name: | NPWT Dressing Kit |
| Regulation Name: | Surgical Mesh |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.3300 |
| Product Code: | OXJ, OMP |
| Predicate Device Information:<br>Reference Device Information: | Avance Abdominal Dressing Kit (K130852)<br>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 Abdominal Dressing Kit.

#### Description of Device:

The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.

#### Indication for Use:

The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.

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# Technological Characteristics:

| Feature | Avance Abdominal Dressing Kit | Avance Abdominal Dressing Kit |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) clearance | Subject device | K130852 |
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care |
| Common name | NPWT Dressing Kit | NPWT Dressing Kit |
| Regulation | 21 CFR 878.3300 | 21 CFR 878.3300 |
| Class name | Mesh, Surgical, Non-Absorbable, Large Abdominal<br>Wall Defects | Mesh, Surgical, Non-Absorbable, Large Abdominal<br>Wall Defects |
| Class | II | II |
| Product code | OXJ, OMP | OXJ, OMP |
| Functionality within NPWT system | The Avance Abdominal Dressing Kit contains all<br>components necessary to dress an abdominal<br>wound in preparation for administering NPWT. | The Avance Abdominal Dressing Kit contains all<br>components necessary to dress an abdominal<br>wound in preparation for administering NPWT. |
| Indication for use | The Avance Foam Abdominal Dressing Kit is<br>indicated for temporary bridging of abdominal wall<br>openings where primary closure is not possible<br>and/or repeat abdominal entries may be required.<br>Its intended use is with patients who have open<br>abdominal wounds with exposed viscera and<br>organs, and including but not limited to patients with<br>abdominal compartment syndrome. It is intended<br>for use in acute hospital settings (trauma, general<br>and plastic surgery wards) and should ideally be<br>applied in the operating theatre. The dressing kit is<br>intended for use together with the Avance Max<br>NPWT pump and its accessories. | The Avance Foam Abdominal Dressing Kit is<br>indicated for temporary bridging of abdominal wall<br>openings where primary closure is not possible<br>and/or repeat abdominal entries may be required.<br>Its intended use is with patients who have open<br>abdominal wounds with exposed viscera and<br>organs, and including but not limited to patients with<br>abdominal compartment syndrome. |
| Dressing kit components | ● Avance ViewPad (1 pc)<br>● Avance Abdominal Foam (2 pcs)<br>● Avance Transparent Film (4 pcs)<br>● Avance Organ Contact Layer (1 pc) | ● Avance Transfer Pad (I pc)<br>● Avance Abdominal Foam (2 pcs)<br>● Avance Film with Safetac technology (4 pcs)<br>● Avance Organ Contact Layer (1 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 10993-1 and have been shown to meet the criteria for their 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. The subject Avance Abdominal Dressing Kit performed as intended in the test setup, and all predefined acceptance criteria were met.

## Clinical Data:

No clinical data was required to support substantial equivalence.

#### Conclusion:

The subject device is substantially equivalent to the predicate and reference devices with respect to design, technological characteristics, intended use, and conformance to standard requirements.