PICO Single Use Negative Pressure Wound Therapy System

K172519 · Smith & Nephew Medical Limited · OMP · Sep 15, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172519
• Device Name: PICO Single Use Negative Pressure Wound Therapy System
• Applicant: Smith & Nephew Medical Limited
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Sep 15, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

Device Story

PICO is a portable, electro-mechanical pump system for negative pressure wound therapy (NPWT). It consists of a pump connected via flexible tubing to a super-absorbent, adhesive dressing, supplemented by fixation strips. The system is sterile and intended for single use. It operates by applying negative pressure to the wound site to remove low to moderate levels of exudate and infectious materials, thereby promoting healing. The device is used in hospital and homecare settings; it is operated by clinicians or patients. The healthcare provider applies the dressing and initiates the pump; the system functions to manage wound exudate, potentially accelerating wound closure and reducing infection risk.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design and technological characteristics to the predicate device, supported by bench testing demonstrating compliance with updated IEC 60601 safety and performance standards.

Technological Characteristics

Portable electro-mechanical suction pump; flexible tubing; super-absorbent adhesive dressing; secondary fixation strips. Single-use, sterile. Compliant with AAMI/ANSI ES60601-1:2005/(R)2012, IEC60601-1-2 Ed 4, IEC60601-1-6 Ed 3.1, and IEC60601-1-11 Ed 2.0.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing by removing low to moderate exudate and infectious materials from chronic, acute, traumatic, subacute, dehisced wounds, partial-thickness burns, ulcers (diabetic/pressure), flaps, grafts, and closed surgical incisions. Suitable for hospital and homecare use.

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

• PICO Single Use Negative Pressure Wound Therapy System (K163387)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

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

September 15. 2017

Smith & Nephew Medical Limited Samantha Neilson Senior Regulatory Affairs Manager, Advanced Wound Management 101 Hessle Road Hull, HU3 2BN GB

Re: K172519

Trade/Device Name: PICO Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: August 18, 2017 Received: August 21, 2017

Dear Samantha Neilson:

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 Actinclude 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 device-

Image /page/0/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol depicts a stylized human figure in profile, with three overlapping heads, representing the department's focus on health and human well-being.

{1}------------------------------------------------

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 (DICE) 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 (DICE) 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 -S3

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

{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)

### K172519

#### Device Name

PICO Single Use Negative Pressure Wound Therapy System

### Indications for Use (Describe)

PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.

Appropriate wound types include:

- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed surgical incisions

PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

{3}------------------------------------------------

# K172519

# SECTION 7: 510(K) SUMMARY

## PICO Single Use Negative Pressure Wound Therapy System

| General Information | |
|------------------------------------|--------------------------------------------------------|
| Submitter Name/Address: | Smith & Nephew Medical Limited |
| | 101 Hessle Road, |
| | Hull |
| | HU3 2BN |
| | United Kingdom |
| Establishment Registration Number: | 8043484 |
| Contact Person: | Samantha Neilson, Senior Regulatory Affairs Manager |
| Phone Number | [phone] |
| Date Prepared: | August 18, 2017 |
| Device Description | |
| Trade Name: | PICO Single Use Negative Pressure Wound Therapy System |
| Common or Usual Name: | Negative Pressure Wound Therapy powered suction pump |
| Classification Name: | Powered suction pump (21 CFR 878.4780) |
| Regulatory Class: | Class II |
| Product Code: | OMP |
| Predicate Device Information | |
| 510(k) Number: | K163387 |
| Device: | PICO Single Use Negative Pressure Wound Therapy System |
| Clearance Date: | April 18, 2017 |

{4}------------------------------------------------

### Device Description

PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use. PICO was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

## Indications for Use

PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.

Appropriate wound types include:

- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns, Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed surgical incisions

PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

## Comparison between New and Predicate Device

The Indications for Use statement of the PICO Single Use Negative Pressure Wound Therapy System is identical to the predicate device. The subject device

{5}------------------------------------------------

and the predicate device are the same. The only difference between the subject device and the predicate device is the compliance against the requirements of IEC60601.

The subject device has been retested to demonstrate compliance with

- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 and . A2:2010/(R)2012
- . IEC60601-1-2 Edition 4 (2014)
- IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: . General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability. (General I (QS/RM))
- IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-. 11: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment. (General II (ES/EMC))

while the predicate device was tested and cleared to the requirements of

- IEC60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) ●
- IEC60601-1-2 Edition 3 (2007) ●
- IEC 60601-1-6: 2010 (Third Edition) Medical electrical equipment Part 1-6: . General requirements for basic safety and essential performance - Collateral standard: Usability)
- IEC 60601-1-11: 2010 (First Edition) General requirements for basic safety . and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

The Instructions for Use and the pump label been updated to reflect a change in test house. The cleared device was tested and certified by CSA Group (Canada)

{6}------------------------------------------------

whilst the subject device was tested and certified by Intertek Testing Service NA, Inc (USA).

## Conclusions

In establishing substantial equivalence to the predicate devices, Smith & Nephew Medical Ltd evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. As there are no design differences between the subject device and the predicate device, PICO Single Use Negative Pressure Wound Therapy System is substantially equivalent to the predicate for the intended use.