(118 days)
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.
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.
The provided text describes a Premarket Notification (510(k)) Summary for the MIST Therapy™ System 5.1, seeking clearance from the FDA. This summary focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study with quantified metrics.
Therefore, many of the requested details about acceptance criteria, specific study results, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in the provided document, as the 510(k) approval process for this type of device often relies on demonstrating equivalence through design, materials, and function, supported by a summary of clinical evidence rather than a de novo performance study with pre-defined acceptance criteria.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with numerical targets are provided in the document. The "Testing Summary" broadly states that "All study results supported the conclusion that the MIST Therapy System promotes wound healing." This is a qualitative statement of performance rather than a specific quantitative metric against an acceptance criterion.
| Acceptance Criteria (Not explicitly stated as criteria) | Reported Device Performance |
|---|---|
| Promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria. | "All study results supported the conclusion that the MIST Therapy System promotes wound healing." |
| Substantial Equivalence to predicate devices (K032378, K032310, K032301, K042134) in design, materials, function, and indication for use. | The device is described as "identical in design, materials, and function to the previously cleared MIST Therapy System (K032378)." Performance data was provided to support the "substantially equivalent indication for use" compared to other predicate devices as well. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "numerous preclinical, animal, and human clinical studies" but does not provide details on sample sizes for these studies.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable and not specified. The studies mentioned relate to wound healing, which would likely involve clinical assessments by healthcare professionals, but the document does not detail how "ground truth" was established, nor the number or qualifications of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ultrasonic wound cleaning device, not an AI-assisted diagnostic or imaging tool. Therefore, MRMC studies and "human readers with/without AI assistance" are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device used for treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "Testing Summary" refers to "preclinical, animal, and human clinical studies." For human clinical studies, "wound healing" would likely be assessed through observable clinical outcomes (e.g., wound size reduction, removal of slough/fibrin/exudates, reduction of bacteria). The specific methods for establishing this "ground truth" (e.g., specific clinical assessments, photographic evidence, microbial cultures) are not detailed.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Premarket Notification (510(k)) Summary APPENDIX M:
| Submitted by: | Celleration, Inc.10250 Valley View Road, Suite 137Eden Prairie, Minnesota 55344 |
|---|---|
| Contact Person: | David L. Bremseth, Pharm.D.Vice President, Clinical & Regulatory AffairsCelleration, 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 anddeliver a continuous mist to the treatment site to promote woundhealing. |
| Indication for Use: | The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through woundcleansing and maintenance debridement by the removal of yellowslough, fibrin, tissue exudates and bacteria. |
| Substantial Equivalence: | The MiST Therapy device under discussion in this application isidentical in design, materials, and function to the previously clearedMIST Therapy System (K032378).Both the MIST Therapy systems and the Powered Suction Pumppredicates use mechanical energy to promote wound healing throughmeans such as the removal of infectious material and other woundexudates.Although powered suction pumps use negative pressure to promotehealing and MIST Therapy utilizes low energy ultrasound, theperformance data provided support the substantially equivalentindication for use for the MIST Therapy System of promoting woundhealing. |
| Testing Summary: | MIST Therapy System was subjected to numerous preclinical, animal,and human clinical studies in support of the updated indications foruse. All study results supported the conclusion that the MIST TherapySystem 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
Page 1 of __
Ko. Sol 29
§ 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.