MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

K122246 · Celleration, Inc. · NRB · Aug 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122246
• Device Name: MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
• Applicant: Celleration, Inc.
• Product Code: NRB · General, Plastic Surgery
• Decision Date: Aug 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4410
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.

Device Story

MIST 360 Therapy System utilizes low-frequency, low-intensity ultrasound to generate a saline mist. Device consists of a console, transducer, and disposable applicator. Operated by clinicians in clinical settings to treat wounds. Ultrasound energy delivered via mist facilitates wound cleansing and maintenance debridement by removing slough, fibrin, exudates, and bacteria. Non-contact delivery mechanism; promotes wound healing environment. System provides therapeutic benefit through mechanical cleansing action of ultrasound-generated mist.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Low-frequency (40 kHz), low-intensity ultrasound generator. System includes console, transducer, and disposable applicator. Non-contact delivery of saline mist. Operates via electrical energy source. Sterilization of disposables via ethylene oxide.

Indications for Use

Indicated for wound healing via cleansing and maintenance debridement of yellow slough, fibrin, tissue exudates, and bacteria in patients with wounds.

Regulatory Classification

Identification

A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• MIST Therapy System (K042660)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

## Public Health Service

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

AUG 1 3 2012

Celleration, Incorporated % Ms. Kathy Simpson 6231 Bury Drive, Suite 15 Eden Prairie, Minnesota 55346

Re: K122246

Trade/Device Name: MIST® 360° Therapy System Regulation Name: Low Energy Ultrasound Wound Cleaner Regulatory Class: II Product Code: NRB Dated: July 26, 2012 Received: July 27, 2012

Dear Ms. Simpson:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kathy Simpson

forth in the quality systems (OS) 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 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 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.

Sincerely yours,
Mark A. Millman

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

Enclosure

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## Indications for Use

510(k) Number:

Device Name:

Indications for Use:

K122246

MIST® 360° Therapy System

The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.

**Prescription Use**
(Part 21 CFR 801 Subpart D)

AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kane for MM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122246