SNAP WOUND CARE SYSTEM

K112341 · Spiracur, Inc. · OKO · Aug 29, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112341
• Device Name: SNAP WOUND CARE SYSTEM
• Applicant: Spiracur, Inc.
• Product Code: OKO · General, Plastic Surgery
• Decision Date: Aug 29, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4683
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.

Device Story

SNaP Wound Care System is non-powered, portable, single-use suction device for negative pressure wound therapy (NPWT). Device utilizes dedicated constant-force springs to mechanically generate negative pressure gradient; removes excess exudates, infectious material, and tissue debris from wound site. Used in conjunction with SNaP Dressing Kit, which incorporates hydrophobic polyurethane foam. System intended for wound management; promotes healing by maintaining negative pressure. Operated by clinicians or patients in various care settings. Output is physical removal of wound fluids; healthcare providers monitor wound status and exudate collection to guide treatment. Benefits include active wound treatment via portable, non-electric mechanism.

Clinical Evidence

Bench testing only. Evaluation included assessment of negative pressure delivery performance compared to the predicate device and biocompatibility testing.

Technological Characteristics

Non-powered, portable, single-use suction apparatus. Materials include hydrophobic polyurethane foam in the dressing kit. Principle of operation: constant-force springs for mechanical negative pressure generation. No electronic components or software.

Indications for Use

Indicated for patients requiring suction for wound healing; applicable to chronic, acute, traumatic, subacute, dehisced wounds, partial-thickness burns, ulcers (diabetic/pressure), surgically closed incisions, flaps, and grafts.

Regulatory Classification

Identification

A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• SNaP® Wound Care System (K111393)

Submission Summary (Full Text)

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

SPIRACUR INC.

SNaP® WOUND CARE SY: SPECIAL 510(k) PREMARKET NOTIFICATION

# SECTION 6 510(k) SUMMARY

#### 510(k) Notification K (234) AUG 2 9 2011

## GENERAL INFORMATION

# Applicant:

Spiracur Inc. 1180 Bordeaux Drive Sunnyvale, CA 94089 U.S.A. Phone: [phone] Fax:

## Contact Person:

Sarah L. Canio Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: [phone] ext. 109 Fax: [phone] Email: [e-mail]

Date Prepared: August 12, 2011

# Classification:

21 CFR§878.4683, Class II

#### Product Code:

OKO

Trade Name: SNaP® Wound Care System

#### Generic/Common Name:

Non-powered suction apparatus device intended for negative pressure wound therapy

Predicate Device: SNaP® Wound Care System (K111393)

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

SPIRACUR INC.

K 112341 Page 2/3

NaP® WOUND CARE SYSTEM SPECIAL 510(k) PREMARKET NOTIFICATION

#### SECTION 6 510(k) SUMMARY

#### Intended Use:

The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.

# Product Description:

The SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP Wound Care System is designed to provide active wound treatment through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts. The SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient.

The SNaP Wound Care System is used in conjunction with the SNaP Dressing Kit.

# Substantial Equivalence:

This Special 510(k) premarket notification is for the SNaP Wound Care System, which is a modified version of the cleared SNaP Wound Care System (K111393). The minor design modification implemented to develop the modified SNaP System includes a change to the SNaP Dressing Kit to incorporate the use of a hydrophobic polyurethane foam. There have been no changes to the other components of the SNaP System as a result of this design change. The design modifications outlined in this Special 510(k) premarket notification do not (1) affect the intended use or (2) alter the fundamental scientific technology of the device. The modified SNaP System shares the same intended use, the same technological characteristics and the same principles of operation as the predicate device. The modified SNaP System and the cleared SNaP System (K111393) are both non-powered, portable, single-use suction devices intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids and infectious materials. Both systems utilize dedicated constant-force springs to mechanically generate the negative pressure gradient. Any differences between the devices do not raise any new issues of safety or effectiveness.

{2}------------------------------------------------

Spiracur Inc.

## SECTION 6 510(k) Summary

SPECIAL 510(k) PREMARKET NOTIFICATION

# Testing in Support of Substantial Equivalence Determination:

The SNaP Wound Care System and its components were evaluated to ensure conformance to design specifications. The testing performed includes:

- Bench testing conducted on the modified SNaP Wound Care System to assess the . ability to deliver negative pressure wound therapy comparable to the predicate device (K111393)
- Biocompatibility testing .

# Summary:

The SNaP Wound Care System is substantially equivalent to the predicate device.

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

Spiracur, Inc. % Experien Group, LLC Ms. Sarah Canio 755 N. Mathilda Avenue Sunnyvale, California 94085

AUG 29 2011

Re: K112341

Trade/Device Name: SNaP® Wound Care System Regulation Number: 21 CFR 878.4683 Regulation Name: Non-Powered suction apparatus device intended for negative pressure wound therapy Regulatory Class: II Product Code: OKO Dated: August 12, 2011 Received: August 15, 2011

Dear Ms. Canio:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in addesice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorement date of the Medical Device Amendments, or to Conninered prilly to May 20, 1978, the econdance 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 r ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls proficions of wactice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Ticase note: "CDree books and 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 If your device to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 i that FDA has made a determination that your device complies with other requirements of the Act

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

Page 2 - Ms. Sarah Canio

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Paul 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely vours.

fo

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SPIRACUR INC.

## SECTION 5 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Klo

Device Name: SNaP® Wound Care System

# Indications For Use:

The SNaP® Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Knoeffer MXM

Division Si (Division of Surgical, Orthoped and Restorative Devices

510(k) Number K112341