CELLERATION MIST THERAPY SYSTEM 5.1

K050129 · Celleration, Inc. · NRB · May 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050129
• Device Name: CELLERATION MIST THERAPY SYSTEM 5.1
• Applicant: Celleration, Inc.
• Product Code: NRB · General, Plastic Surgery
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 Therapy System 5.1 is a non-contact, low-energy ultrasound device; utilizes continuous ultrasonic energy to atomize saline; delivers continuous mist to treatment site. Device promotes wound healing through cleansing and maintenance debridement; removes yellow slough, fibrin, tissue exudates, and bacteria. Used in clinical settings; operated by healthcare professionals. Output is a therapeutic mist; healthcare providers use this to facilitate wound bed preparation and healing. Benefits include non-contact debridement and removal of infectious materials.

Clinical Evidence

Supported by preclinical, animal, and human clinical studies. All study results supported the conclusion that the MIST Therapy System promotes wound healing.

Technological Characteristics

Non-contact, low-energy ultrasound device. Operates by atomizing saline into a continuous mist using continuous ultrasonic energy. Class II device (21 CFR 878.4410).

Indications for Use

Indicated for patients requiring wound healing promotion via wound cleansing and maintenance debridement of yellow slough, fibrin, tissue exudates, and bacteria.

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 5.0 (K032378)
• V.A.C. ® ATS™, mini V.A.C.®, V.A.C.® Freedom™ (K032310)
• NeoGen One, Closed Wound Drainage System (K032301)
• Blue Sky Versatile 1 Wound Vacuum System (K042134)

Submission Summary (Full Text)

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## Premarket Notification (510(k)) Summary APPENDIX M:

| Submitted by: | Celleration, Inc.<br>10250 Valley View Road, Suite 137<br>Eden Prairie, Minnesota 55344 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David L. Bremseth, Pharm.D.<br>Vice President, Clinical & Regulatory Affairs<br>Celleration, Inc.<br>952-224-8704 (Phone) |
| Date of Summary: | January 18, 2005 |
| Device Trade Name: | MIST Therapy™ System 5.1 |
| Common or Usual Name: | Ultrasonic Wound Cleaning Device |
| Classification Name: | Low Energy Ultrasound Wound Cleaner (21CFR 878.4410) |
| Predicate Device(s): | MIST Therapy System 5.0 (K032378) V.A.C. ® ATS™, mini V.A.C.®, V.A.C.® Freedom™ (K032310) NeoGen One, Closed Wound Drainage System (K032301) Blue Sky Versatile 1 Wound Vacuum System (K042134) |
| Device Description: | MIST Therapy System is a non-contact, low-energy ultrasound device,<br>which utilizes continuous ultrasonic energy to atomize saline and<br>deliver a continuous mist to the treatment site to promote wound<br>healing. |
| Indication for Use: | The MIST Therapy System produces a low energy ultrasound-<br>generated mist used to promote wound healing through wound<br>cleansing and maintenance debridement by the removal of yellow<br>slough, fibrin, tissue exudates and bacteria. |
| Substantial Equivalence: | The MiST Therapy device under discussion in this application is<br>identical in design, materials, and function to the previously cleared<br>MIST Therapy System (K032378).<br><br>Both the MIST Therapy systems and the Powered Suction Pump<br>predicates use mechanical energy to promote wound healing through<br>means such as the removal of infectious material and other wound<br>exudates.<br><br>Although powered suction pumps use negative pressure to promote<br>healing and MIST Therapy utilizes low energy ultrasound, the<br>performance data provided support the substantially equivalent<br>indication for use for the MIST Therapy System of promoting wound<br>healing. |
| Testing Summary: | MIST Therapy System was subjected to numerous preclinical, animal,<br>and human clinical studies in support of the updated indications for<br>use. All study results supported the conclusion that the MIST Therapy<br>System promotes wound healing. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the image.

MAY 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David L. Bremseth, Pharm.D. Vice President, Clinical & Regulatory Affairs Celleration, Inc. 10250 Valley View Road, Suite 137 Eden Prairie, Minnesota 55344

Re: K050129

K050127
Trade/Device Name: Celleration MIST Therapy™ System 5.1 Regulation Number: 21 CFR 878.4410 Regulation Name: Low energy ultrasound wound cleaner Regulatory Class: II Product Code: NRB Dated: April 13, 2005 Received: April 14, 2005

Dear Dr. Bremseth:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(tr) premainer newited in interests of in indications
referenced above and have determined the device is substantially extentify referenced above and nave uctimated the aerrood predicate devices marketed in interstate for use stated in the enclosure) in tegally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce prior to May 28, 1970, the chaoinen anith the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Feat devices that have been recassince in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to the gentrements for annual registration, listing of general controls provisions of the receiners of aroundbitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See a00ve) into entrols. Existins major regulations affecting your device EDA it may be subject to such additional confrols: "Zhoting might of 898. In addition, FDA can be found in the Code of Federal regentialisms)
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 Please be advised that FDA s issuales of a substainly requirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemmation that Jour as room of rederal agencies. You must
or any Federal statutes and regulations administered by other Federal agencies. You must or any Federal Statutes and regulations administered of each to registration and listing (21
comply with all the Act's requirements, including, but not limited to: registrati comply with all the Act s requirements, meridenting practice requirements as set and CFR Part 807); labeling (21 CFR Part 800); good manaxt 820); and if applicable, the electronic in forth in the quality systems (Q5) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - David L. Bremseth, Pharm.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogh manteeing of substantial equivalence of your device to a legally premarked notification. The PDA miding of basiants. Squar device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac-not on our and with the regulation entitled, Contact the Office of Comphalise as (2 + notification" (21CFR Part 807.97). You may obtain "Misbranding by release to premanor noulties notifican on the Division of Small other general information on your responsionAssistance at its toll-free number (800) 638-204 or Manufacturers, International and Consulter Planetter Pov/cdrl/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koso/29

MIST™ Therapy System 510(k) PreMarket Notification

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## APPENDIX C: Indications For Use Statement [As required by 21 CFR 807.92(c)]

TBD 510(k) Number: Celleration MIST Therapy™ System 5.1 Device Name: The MIST Therapy System produces a low energy ultrasound-Indications For Use: 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision of General, Restorative

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