(84 days)
Not Found
No
The description focuses on the physical mechanism of ultrasound-generated mist and a peristaltic pump, with no mention of AI/ML terms or functionalities.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria," which are therapeutic actions.
No
The device is described as promoting wound healing through wound cleansing and debridement, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly details hardware components including a generator, treatment wand (encasing an ultrasound transducer), and a disposable applicator. It also mentions a peristaltic pump. This is not a software-only device.
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. This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses ultrasound and a fluid mist to treat wounds. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any components or functions related to in vitro testing, such as reagents, sample handling, or analytical measurements of biological markers.
The device is clearly intended for direct application to a patient's wound for therapeutic purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MIST Systems produce 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. The intended use of the MIST Systems is for the delivery of low energy ultrasound via a fluid mist for the promotion of wound healing. It is a prescription use only device.
Product codes
NRB
Device Description
MIST Systems (e.g., UltraMIST System) are low frequency ultrasound devices, which utilize a fluid (e.g., saline) mist to deliver the ultrasound to the treatment site. The atomized fluid allows the treatment to be performed without direct contact to the patient. MIST Systems are made up of a main generator component, treatment wand, and disposable applicator.
MIST Systems deliver low-frequency ultrasound to the treatment site using an atomized fluid mist. The mist is generated from a small, portable system consisting of a generator, a treatment wand (encasing an ultrasound transducer), and a disposable applicator that has been designed to connect to a user-provided fluid source (e.g., IV saline bag). The system provides a flow of fluid (irrigant) to the tissue surface by the use of low frequency, low intensity ultrasound. Only the mist touches the tissue, not the ultrasound radiation surface (horn tip), thus the term "non-contact" ultrasound. The flow of fluid as an irrigant is controlled by a peristaltic pump on the generator unit. The fluid is dispensed onto the ultrasound radiation surface where the mist is generated. The mist is projected by fundamental atomization or nebulization and acoustic streaming or acoustic radiation force respectively.
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)
Testing performed on the subject device to demonstrate Substantial Equivalence:
IEC 60601-1 3rd Ed. General Safety Testing - Testing was performed by Intertek to verify that the change in enclosure material for the Generator and Treatment Wand did not have an adverse effect on the safety or performance of the system. The results of the testing demonstrated that the system with the new material enclosures was as safe, as effective, and performed as well as the predicate device with the previous enclosure materials. The complete test report is included in the submission materials and can be found in VOL_16, Appendix C. Biocompatibility testing, Cytotoxicity – Testing was performed by WuXi AppTec to verify that the change in enclosure material for the Generator and the Treatment Wand did not have an adverse effect on the biocompatibility of the system. Since the Generator and Treatment Wand do not come into contact with a breached or compromised surface, or potential indirect contact with a breached or compromised surface like the Applicator, only Cytotoxicity testing was performed to ensure that the new enclosure materials do not present a new or different biocompatibility issue for the user of the device. The results of the testing demonstrated that the new enclosure materials for the Generator and Treatment wand were as safe, as effective, and performed as well as the previous enclosure material as both were determined to be non-cytotoxic. The complete test report is included in the submission materials and can be found in VOL_15, Appendix B. Consensus standards used in the testing and preparation of this premarket notification may be found in VOL_005, Standards Data Report Forms.
Clinical Studies: NA for this submission.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and an emblem in the center. The emblem is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Alliqua Biomedical, Inc. Kathy Simpson Director. OA/RA 11495 Valley View Road Eden Prairie, Minnesota 55344
Re: K162721
Trade/Device Name: Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator Regulation Number: 21 CFR 878.4410 Regulation Name: Low Energy Ultrasound Wound Cleaner Regulatory Class: Class II Product Code: NRB Dated: November 28, 2016 Received: December 2, 2016
Dear Kathy 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162721
Device Name UltraMIST
Indications for Use (Describe)
MIST Systems produce 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510k Summary
| 510(k) Summary (As required by 21 CFR §807.92) | |
|---|---|
| Submitter | Alliqua BioMedical, Inc. |
| 11495 Valley View Road | |
| Eden Prairie, MN 55344 | |
| Contact Person: | Kathy Simpson |
| Director QA / RA | |
| Telephone: 952-224-8738 | |
| Fax: 952-224-8797 | |
| Email: ksimpson@alliqua.com | |
| Date Prepared: | August 29, 2016 |
| Trade Name of | |
| Device: | UltraMIST™ |
| Common / | |
| Usual Name: | UltraMIST™ |
| Classification | |
| Name: | Low Energy Ultrasound Wound Cleaner |
| Class: II | |
| Regulation: 21 CFR §878.4410 | |
| Product Code: | NRB |
| Manufacturer: | Alliqua BioMedical, Inc. |
| 11495 Valley View Road | |
| Eden Prairie, MN 55344 | |
| Establishment | |
| Registration: | 3004580659 |
| Predicate | |
| Device(s): | K140782, UltraMIST® System |
| Manufacturer: Alliqua BioMedical, Inc. | |
| Device | |
| Description: | MIST Systems (e.g., UltraMIST System) are low frequency ultrasound |
| devices, which utilize a fluid (e.g., saline) mist to deliver the ultrasound to | |
| the treatment site. The atomized fluid allows the treatment to be performed | |
| without direct contact to the patient. MIST Systems are made up of a main | |
| generator component, treatment wand, and disposable applicator. |
MIST Systems deliver low-frequency ultrasound to the treatment site using
an atomized fluid mist. The mist is generated from a small, portable system
consisting of a generator, a treatment wand (encasing an ultrasound
transducer), and a disposable applicator that has been designed to connect
to a user-provided fluid source (e.g., IV saline bag). The system provides a
flow of fluid (irrigant) to the tissue surface by the use of low frequency, low
intensity ultrasound. Only the mist touches the tissue, not the ultrasound
radiation surface (horn tip), thus the term "non-contact" ultrasound. The flow
of fluid as an irrigant is controlled by a peristaltic pump on the generator
unit. The fluid is dispensed onto the ultrasound radiation surface where the
mist is generated. The mist is projected by fundamental atomization or
nebulization and acoustic streaming or acoustic radiation force respectively. |
| Intended Use: | The intended use of the MIST Systems is for the delivery of low energy
ultrasound via a fluid mist for the promotion of wound healing. It is a
prescription use only device. |
| | The overall target market for MIST Systems is the advanced wound care |
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| | market. There have been no changes to the intended use of the subject of
this submission. | | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for
Use | MIST Systems produce 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. | | |
| Summary of
Technical
Comparisons: | A summary of the technical components of the subject device and the
predicate UltraMIST System are presented in the Table below: | | |
| | Technical
Component | UltraMIST System | Subject
Device |
| | Control of Fluid Flow | Clamp on tubing line to stop
and start fluid flow for priming
purposes.
Peristaltic pump used to
provide consistent flow | Same |
| | Enclosures | Injection molded PC/ABS
polymer and compound
curvature | Geon HC
8210, Rigid
Polyvinyl
Cyholride,
Flammability
rated V-0 |
| | Supply Voltage and
Current | 100-240VAC Universal input | Same |
| | Input Frequency | 50-60Hz Universal input | Same |
| | Rated Power | 100 watts (fuse limited) | Same |
| | Distal Displacement of
Radiation Surface | $65 \pm 10$ microns | Same |
| | Acoustic Frequency | $40 \pm 1$ kHz | Same |
| | Radiation Surface
Diameter and Material | 0.390 in. $\pm$ 0.001 in.
Titanium alloy (TI-6AL-4V) | Same |
| | Single patient Use
Disposable Applicator | Injection molded PC/ABS
polymer and compound
curvature | Same |
| | Packaging and
Labeling | System: Non-sterile, reusable
Applicator: Sterile per ISO
11607 | Same |
| | Method of Sterilization | Gamma radiation | Same |
| | Shelf Life / Product Life
Cycle | System: 5 years
Applicator: 3 years | Same |
| | Mode of Exudate and
Bacterial Removal | Atomized mist
Acoustic and fluid stream
delivery / washout | Same |
| | Microprocessor | Yes | Same |
| | Patient contact | None - fluid contact only via
atomized mist | Same |
| | Treatment variables | Treatment duration based on
area to be treated (algorithm) | Same |
| | - Generator v0.8 | current out of range narrower
than original MIST System | modified to
be equivalent
to that of the
original MIST
System |
| Performance
Data - Non-
Clinical Testing: | Testing performed on the subject device to demonstrate Substantial
Equivalence:
IEC 60601-1 3rd Ed. General Safety Testing -Testing was performed by
Intertek to verify that the change in enclosure material for the Generator
and Treatment Wand did not have an adverse effect on the safety or
performance of the system. The results of the testing demonstrated that
the system with the new material enclosures was as safe, as effective,
and performed as well as the predicate device with the previous
enclosure materials. The complete test report is included in the
submission materials and can be found in VOL_16, Appendix C. Biocompatibility testing, Cytotoxicity – Testing was performed by WuXi
AppTec to verify that the change in enclosure material for the Generator
and the Treatment Wand did not have an adverse effect on the
biocompatibility of the system. Since the Generator and Treatment
Wand do not come into contact with a breached or compromised
surface, or potential indirect contact with a breached or compromised
surface like the Applicator, only Cytotoxicity testing was performed to
ensure that the new enclosure materials do not present a new or
different biocompatibility issue for the user of the device. The results of
the testing demonstrated that the new enclosure materials for the
Generator and Treatment wand were as safe, as effective, and
performed as well as the previous enclosure material as both were
determined to be non-cytotoxic. The complete test report is included in
the submission materials and can be found in VOL_15, Appendix B. Consensus standards used in the testing and preparation of this
premarket notification may be found in VOL_005, Standards Data
Report Forms. | | |
| Clinical Studies: | NA for this submission. | | |
| Conclusions: | The modifications made to the subject device are substantially equivalent to
its predicate, the UltraMIST System. | | |
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