(118 days)
Not Found
No
The summary describes a physical device that uses ultrasound to create a mist for wound healing. There is no mention of AI, ML, image processing, or any data-driven decision-making process.
Yes
The device is used to promote wound healing, which is a therapeutic purpose.
No
The device is described as a therapy system used to promote wound healing through cleansing and debridement, not to diagnose a condition.
No
The device description explicitly states it is a "non-contact, low-energy ultrasound device," indicating it includes hardware components for generating and delivering the ultrasound mist.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to promote wound healing through wound cleansing and maintenance debridement by removing various substances from the wound. This is a therapeutic action performed directly on the patient's body.
- Device Description: The device description confirms it's a non-contact ultrasound device that delivers a mist to the treatment site. This is a physical treatment applied externally.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, tissue) to diagnose a disease or condition. IVDs are specifically designed for in vitro (outside the body) diagnostic testing.
The device is clearly intended for therapeutic use in wound care, not for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
N RB
Device Description
MIST Therapy System is a non-contact, low-energy ultrasound device, which utilizes continuous ultrasonic energy to atomize saline and deliver a continuous mist to the treatment site to promote wound healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MIST Therapy System was subjected to numerous preclinical, animal, and human clinical studies in support of the updated indications for use. All study results supported the conclusion that the MIST Therapy System promotes wound healing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4410 Low energy ultrasound wound cleaner.
(a)
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.(b)
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.
0
Premarket Notification (510(k)) Summary APPENDIX M:
| Submitted by: | Celleration, Inc.
10250 Valley View Road, Suite 137
Eden Prairie, Minnesota 55344 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David L. Bremseth, Pharm.D.
Vice President, Clinical & Regulatory Affairs
Celleration, Inc.
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,
which utilizes continuous ultrasonic energy to atomize saline and
deliver a continuous mist to the treatment site to promote wound
healing. |
| Indication for 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. |
| Substantial Equivalence: | The MiST Therapy device under discussion in this application is
identical in design, materials, and function to the previously cleared
MIST Therapy System (K032378).
Both the MIST Therapy systems and the Powered Suction Pump
predicates use mechanical energy to promote wound healing through
means such as the removal of infectious material and other wound
exudates.
Although powered suction pumps use negative pressure to promote
healing and MIST Therapy utilizes low energy ultrasound, the
performance data provided support the substantially equivalent
indication for use for the MIST Therapy System of promoting wound
healing. |
| Testing Summary: | MIST Therapy System was subjected to numerous preclinical, animal,
and human clinical studies in support of the updated indications for
use. All study results supported the conclusion that the MIST Therapy
System promotes wound healing. |
:
1
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
2
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
3
Koso/29
MIST™ Therapy System 510(k) PreMarket Notification
Page 35 of 45
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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