Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator

K162721 · Alliqua Biomedical, Inc. · NRB · Dec 22, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K162721
• Device Name: Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
• Applicant: Alliqua Biomedical, Inc.
• Product Code: NRB · General, Plastic Surgery
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4410
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

UltraMIST System is a low-frequency, low-intensity ultrasound device for wound care. It consists of a generator, treatment wand, and disposable applicator. The system uses a user-provided fluid source (e.g., IV saline) to create an atomized mist. A peristaltic pump on the generator controls fluid flow to the ultrasound radiation surface (titanium alloy horn tip), where fundamental atomization and acoustic streaming generate the mist. The mist is applied to the wound site; the radiation surface does not contact the patient. The device is used in clinical settings by healthcare providers to cleanse wounds and perform maintenance debridement. By removing slough, fibrin, exudates, and bacteria, the device promotes wound healing. The generator includes a microprocessor to manage treatment variables, including duration based on the treatment area.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including IEC 60601-1 3rd Ed. general safety testing and cytotoxicity biocompatibility testing.

Technological Characteristics

Low-frequency (40 ± 1 kHz) ultrasound generator; 100-240VAC input. Radiation surface: 0.390 in. diameter, TI-6AL-4V titanium alloy. Enclosure: Geon HC 8210 (Rigid PVC, V-0 flammability). Fluid delivery: Peristaltic pump. Connectivity: Standalone. Sterilization: Gamma radiation for applicators. Software: Microprocessor-controlled with algorithm-based treatment duration.

Indications for Use

Indicated for promoting wound healing through wound cleansing and maintenance debridement by the removal 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

• UltraMIST System (K140782)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## 510k Summary

| 510(k) Summary (As required by 21 CFR §807.92) | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Alliqua BioMedical, Inc.<br>11495 Valley View Road<br>Eden Prairie, MN 55344 |
| Contact Person: | Kathy Simpson<br>Director QA / RA<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 29, 2016 |
| Trade Name of<br>Device: | UltraMIST™ |
| Common /<br>Usual Name: | UltraMIST™ |
| Classification<br>Name: | Low Energy Ultrasound Wound Cleaner<br>Class: II<br>Regulation: 21 CFR §878.4410 |
| Product Code: | NRB |
| Manufacturer: | Alliqua BioMedical, Inc.<br>11495 Valley View Road<br>Eden Prairie, MN 55344 |
| Establishment<br>Registration: | 3004580659 |
| Predicate<br>Device(s): | K140782, UltraMIST® System<br>Manufacturer: Alliqua BioMedical, Inc. |
| Device<br>Description: | MIST Systems (e.g., UltraMIST System) are low frequency ultrasound<br>devices, which utilize a fluid (e.g., saline) mist to deliver the ultrasound to<br>the treatment site. The atomized fluid allows the treatment to be performed<br>without direct contact to the patient. MIST Systems are made up of a main<br>generator component, treatment wand, and disposable applicator.<br><br>MIST Systems deliver low-frequency ultrasound to the treatment site using<br>an atomized fluid mist. The mist is generated from a small, portable system<br>consisting of a generator, a treatment wand (encasing an ultrasound<br>transducer), and a disposable applicator that has been designed to connect<br>to a user-provided fluid source (e.g., IV saline bag). The system provides a<br>flow of fluid (irrigant) to the tissue surface by the use of low frequency, low<br>intensity ultrasound. Only the mist touches the tissue, not the ultrasound<br>radiation surface (horn tip), thus the term "non-contact" ultrasound. The flow<br>of fluid as an irrigant is controlled by a peristaltic pump on the generator<br>unit. The fluid is dispensed onto the ultrasound radiation surface where the<br>mist is generated. The mist is projected by fundamental atomization or<br>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<br>ultrasound via a fluid mist for the promotion of wound healing. It is a<br>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<br>this submission. | | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for<br>Use | MIST Systems produce a low energy ultrasound generated mist used<br>to promote wound healing through wound cleansing and maintenance<br>debridement by the removal of yellow slough, fibrin, tissue exudates<br>and bacteria. | | |
| Summary of<br>Technical<br>Comparisons: | A summary of the technical components of the subject device and the<br>predicate UltraMIST System are presented in the Table below: | | |
| | Technical<br>Component | UltraMIST System | Subject<br>Device |
| | Control of Fluid Flow | Clamp on tubing line to stop<br>and start fluid flow for priming<br>purposes.<br>Peristaltic pump used to<br>provide consistent flow | Same |
| | Enclosures | Injection molded PC/ABS<br>polymer and compound<br>curvature | Geon HC<br>8210, Rigid<br>Polyvinyl<br>Cyholride,<br>Flammability<br>rated V-0 |
| | Supply Voltage and<br>Current | 100-240VAC Universal input | Same |
| | Input Frequency | 50-60Hz Universal input | Same |
| | Rated Power | 100 watts (fuse limited) | Same |
| | Distal Displacement of<br>Radiation Surface | $65 \pm 10$ microns | Same |
| | Acoustic Frequency | $40 \pm 1$ kHz | Same |
| | Radiation Surface<br>Diameter and Material | 0.390 in. $\pm$ 0.001 in.<br>Titanium alloy (TI-6AL-4V) | Same |
| | Single patient Use<br>Disposable Applicator | Injection molded PC/ABS<br>polymer and compound<br>curvature | Same |
| | Packaging and<br>Labeling | System: Non-sterile, reusable<br>Applicator: Sterile per ISO<br>11607 | Same |
| | Method of Sterilization | Gamma radiation | Same |
| | Shelf Life / Product Life<br>Cycle | System: 5 years<br>Applicator: 3 years | Same |
| | Mode of Exudate and<br>Bacterial Removal | Atomized mist<br>Acoustic and fluid stream<br>delivery / washout | Same |
| | Microprocessor | Yes | Same |
| | Patient contact | None - fluid contact only via<br>atomized mist | Same |
| | Treatment variables | Treatment duration based on<br>area to be treated (algorithm) | Same |
| | - Generator v0.8 | current out of range narrower<br>than original MIST System | modified to<br>be equivalent<br>to that of the<br>original MIST<br>System |
| Performance<br>Data - Non-<br>Clinical Testing: | Testing performed on the subject device to demonstrate Substantial<br>Equivalence:<br>IEC 60601-1 3rd Ed. General Safety Testing -Testing was performed by<br>Intertek to verify that the change in enclosure material for the Generator<br>and Treatment Wand did not have an adverse effect on the safety or<br>performance of the system. The results of the testing demonstrated that<br>the system with the new material enclosures was as safe, as effective,<br>and performed as well as the predicate device with the previous<br>enclosure materials. The complete test report is included in the<br>submission materials and can be found in VOL_16, Appendix C. Biocompatibility testing, Cytotoxicity – Testing was performed by WuXi<br>AppTec to verify that the change in enclosure material for the Generator<br>and the Treatment Wand did not have an adverse effect on the<br>biocompatibility of the system. Since the Generator and Treatment<br>Wand do not come into contact with a breached or compromised<br>surface, or potential indirect contact with a breached or compromised<br>surface like the Applicator, only Cytotoxicity testing was performed to<br>ensure that the new enclosure materials do not present a new or<br>different biocompatibility issue for the user of the device. The results of<br>the testing demonstrated that the new enclosure materials for the<br>Generator and Treatment wand were as safe, as effective, and<br>performed as well as the previous enclosure material as both were<br>determined to be non-cytotoxic. The complete test report is included in<br>the submission materials and can be found in VOL_15, Appendix B. Consensus standards used in the testing and preparation of this<br>premarket notification may be found in VOL_005, Standards Data<br>Report Forms. | | |
| Clinical Studies: | NA for this submission. | | |
| Conclusions: | The modifications made to the subject device are substantially equivalent to<br>its predicate, the UltraMIST System. | | |

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