(284 days)
No
The summary describes a microwave device for heating tissue and a software-driven console, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for "treatment of primary axillary hyperhidrosis" and "reduction of underarm odor," which are therapeutic applications.
No
The device description and intended use clearly state that the miraDry System MD4000 is a treatment device, delivering microwave energy to heat tissue for the reduction of sweat glands and hair follicles. It does not perform any diagnostic function.
No
The device description explicitly states it is a "microwave device" and includes hardware components such as a console, handpiece, and bioTip. While the console is "software-driven," the device as a whole is a hardware system with integrated software.
Based on the provided information, the miraDry System MD4000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- miraDry System MD4000 Function: The miraDry System MD4000 is a microwave device that directly treats the body by heating tissue to address hyperhidrosis and remove hair. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states treatment of primary axillary hyperhidrosis and hair removal/reduction. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system that delivers energy to the body, not one that processes biological samples.
- Performance Studies: The performance studies evaluate the clinical outcome of the treatment (odor reduction and hair reduction) on the patient's body, not the results of analyzing a biological specimen.
Therefore, the miraDry System MD4000 is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I - IV.
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs reasured at 6. 9 and 12 months after the completion of a treatment regime.
When used for the treatment of primary axillary hyperhidrosis, the miraDry System MD4000 may reduce underarm odor.
Product codes
OUB, NEY, MWY
Device Description
The miraDry MD4000 that is the subject of this 510(k) is identical to the device described and cleared in K150419, except for the proposed labeling changes that resulted in this 510(k) submission.
The miraDry MD4000 System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat and odor glands and hair bulbs reside using a surface contact applicator. The miraDry MD4000 System consists of: the MD4000-MC Console; the MD4000-HP miraDry Handpiece; and a disposable, sterile MD4000-BT miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover.
As described in K150419 and prior submissions, the miraDry MD4000 System also includes Class I components/accessories. The MD4000-TS template system is a required component for the miraDry treatment as well as the MD4000-PK priming kit and the MD4000-BT-DE demonstration bioTip. The MD4000-PK priming kit and the non-sterile "demo" bioTip are required when the system is initially set up at a user facility. Optional accessories include an armrest and disposable ice packs.
The MD4000-MC Console is a software-driven device which contains circuit boards, a microwave generator, integrated vacuum and cooling systems, and an integrated touch-screen user interface.
The non-invasive miraDry Handpiece is specifically designed to deliver microwave energy to the skin at specified frequency and power levels. The proximal end of the Handpiece has a cable bundle and a console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, which contacts the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axillary (underarm)
Indicated Patient Age Range
Adult
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: CLINICAL TESTING. A prospective, split-patient, randomized, single center trial was conducted.
SAMPLE SIZE: Forty adult subjects. One underarm (randomly selected) was treated with the miraDry MD4000 System using the standard miraDry procedure (two treatment sessions 3 months apart). The other underarm was untreated and served as the control.
KEY METRICS: Odor assessments were conducted by four blinded, trained odor assessors, who scored each underarm between 0 (no malodor) and 10 (extremely strong malodor). Patient self-reported odor scores and satisfaction.
KEY RESULTS:
Primary Endpoint: Percentage of subjects with at least a 2 point lower odor score in the treated underarm compared to the untreated underarm (responders) when assessed 1 month after treatment.
- 1 month after treatment: 23/35 (66%)
- 3 months after treatment: 14/36 (39%)
- 6 months after treatment: 13/36 (36%)
*p=0.09, indicating the proportion of subjects experiencing a 2 point difference (between the treated and untreated underarm) was not significantly greater than 50%.
The primary endpoint and a secondary endpoint were not met, since the percentage of patients with at least a 2 point lower score on the treated underarm compared to the untreated underarm was not statistically significant at the three time points. However, the treated underarm was scored as having lower odor at all time points.
Table 2: Average difference in odor in the treated underarm compared to the untreated underarm at all follow-up visits.
- 1 month: 2.84 (±0.73) ; P value
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is composed of three intertwined strands, representing the three branches of government: legislative, executive, and judicial.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
Miramar Labs Incorporated Ms. Kathy O'Shaughnessy Consultant, Regulatory Affairs 2790 Walsh Avenue Santa Clara, California 95051
Re: K160141
Trade/Device Name: miraDrv System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OUB, NEY, MWY Dated: September 19, 2016 Received: September 20, 2016
Dear Ms. O'Shaughnessy:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Jennifer R. Stevenson -A
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
2
Indications for Use
510(k) Number (if known) K160141
Device Name miraDry System
Indications for Use (Describe)
The miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I - IV.
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs reasured at 6. 9 and 12 months after the completion of a treatment regime.
When used for the treatment of primary axillary hyperhidrosis, the miraDry System MD4000 may reduce underarm odor.
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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C)
3
| 1. 510(k) Summary | |
|---|---|
| GENERAL INFORMATION | |
| Classification: | Class II (special controls) |
| Classification No.: | 21 CFR 878.4400 |
| Classification Name: | Electrosurgical cutting and coagulation |
| device and accessories. | |
| Product Code(s): | OUB, NEY, MWY |
| Common Name: | Instrument for Treatment of Hyperhidrosis |
| System, Ablation, Microwave And | |
| Accessories | |
| System, Microwave, Hair Removal | |
| Trade Name: | miraDry MD4000 System |
| Submitter: | Miramar Labs, Inc. |
| 2790 Walsh Avenue | |
| Santa Clara, CA 95051, USA | |
| Tel: 408-940-8700 | |
| Fax: 408-940-8795 | |
| FDA Registration No.: 3008082710 | |
| Contact: | Kathy O'Shaughnessy, PhD |
| VP, Clinical/Regulatory/QA (Consulting) | |
| Date prepared: | 10/27/16 |
INDICATIONS FOR USE
The miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I – IV.
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
When used for the treatment of primary axillary hyperhidrosis, the miraDry System MD4000 may reduce underarm odor.
4
PREDICATE DEVICE
The miraDry MD4000 System (K150419).
DEVICE DESCRIPTION
The miraDry MD4000 that is the subject of this 510(k) is identical to the device described and cleared in K150419, except for the proposed labeling changes that resulted in this 510(k) submission.
The miraDry MD4000 System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat and odor glands and hair bulbs reside using a surface contact applicator. The miraDry MD4000 System consists of: the MD4000-MC Console; the MD4000-HP miraDry Handpiece; and a disposable, sterile MD4000-BT miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover.
As described in K150419 and prior submissions, the miraDry MD4000 System also includes Class I components/accessories. The MD4000-TS template system is a required component for the miraDry treatment as well as the MD4000-PK priming kit and the MD4000-BT-DE demonstration bioTip. The MD4000-PK priming kit and the non-sterile "demo" bioTip are required when the system is initially set up at a user facility. Optional accessories include an armrest and disposable ice packs.
The MD4000-MC Console is a software-driven device which contains circuit boards, a microwave generator, integrated vacuum and cooling systems, and an integrated touch-screen user interface.
The non-invasive miraDry Handpiece is specifically designed to deliver microwave energy to the skin at specified frequency and power levels. The proximal end of the Handpiece has a cable bundle and a console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, which contacts the patient.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
The miraDry MD4000 System described and cleared in 510(k) number K150419 serves as the predicate device for this premarket notification. The miraDry MD4000 System that is the subject of this 510(k) has the same intended use and technological characteristics as the device described and cleared in 510(k) number K150419. Furthermore, there have been no changes in design, material, chemical composition, energy source, or manufacturing process since FDA's clearance of K150419.
5
Substantial Equivalence Comparison Table
| Characteristics | Predicate Device
miraDry MD4000
K150419 | Subject Device
miraDry MD4000 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II |
| Energy Type | Microwave | Microwave |
| Mode of Action | generation of localized heat | generation of localized heat |
| Product Code | NEY, OUB, MWY | NEY, OUB, MWY |
| Indications for Use | The miraDry System MD4000 is
indicated for use in the
treatment of primary axillary
hyperhidrosis plus unwanted
underarm hair removal, and
permanent reduction of
underarm hair of all colors for
Fitzpatrick skin types I - IV.
Permanent hair reduction is
defined as long-term, stable
reduction in the number of
hairs regrowing when
measured at 6, 9 and 12
months after the completion
of a treatment regime. | The miraDry System MD4000 is
indicated for use in the
treatment of primary axillary
hyperhidrosis plus unwanted
underarm hair removal, and
permanent reduction of
underarm hair of all colors for
Fitzpatrick skin types I - IV.
Permanent hair reduction is
defined as long-term, stable
reduction in the number of
hairs regrowing when
measured at 6, 9 and 12
months after the completion of
a treatment regime. |
| | | When used for the treatment
of primary axillary
hyperhidrosis, the miraDry
System MD4000 may reduce
underarm odor. |
| Function | Heat absorption by tissue
located at the dermal-
hypodermal interface where
the axillary sweat (wetness
and odor) glands and hair
bulbs reside | Heat absorption by tissue
located at the dermal-
hypodermal interface where
the axillary sweat (wetness
and odor) glands and hair
bulbs reside |
| Overall System structure | microwave source/amplifier,
coolant supply system,
operator interface, and
microwave, electrical and
coolant lines that connect to
the applicator | microwave source/amplifier,
coolant supply system,
operator interface, and
microwave, electrical and
coolant lines that connect to
the applicator |
| Key Components | Console, handpiece,
disposable applicator tip | Console, handpiece,
disposable applicator tip |
| Console Control
Mechanism | Electronic user interface | Electronic user interface |
| Coolant usage | Delivers cooling to the skin
surface | Delivers cooling to the skin
surface |
NON-CLINICAL TESTING
There was no additional non-clinical testing that was completed, as the device being used is the same as the cleared device (miraDry MD4000 System, cleared under K150419).
6
CLINICAL TESTING
In support of this 510(k), a prospective, split-patient, randomized, single center trial was conducted. Forty adult subjects with high underarm odor were enrolled. Subjects were treated in one underarm (randomly selected) with the miraDry MD4000 System using the standard miraDry procedure, which at the time of the study was two treatment sessions 3 months apart. The other underarm was untreated and served as the control.
The odor assessments were conducted by four blinded, trained odor assessors, where each assessor qave a score to each underarm between 0 (no malodor) and 10 (extremely strong malodor). Scores for each underarm were obtained by averaging the scores from the four judges. Patients also self-reported their odor scores and rated their satisfaction with the procedure. The mean subject age was 49 years; 63% of the subjects were female and 57% were African American, with the remainder Caucasian.
| Study Design | Prospective, split-patient, randomized, single center trial |
|---|---|
| Sample Size | 40 patients – one underarm treated, one underarm untreated |
| Odor | |
| Assessment | |
| Method | Panel of 4 blinded, trained odor assessors; each underarm rated |
| on a scale of 0 (none, no malodor) to 10 (extremely strong | |
| malodor) and averaged | |
| Principal | |
| Eligibility | |
| Criteria | Score of at least 5 in each underarm; less than a 2 point difference between underarms Willing to comply with washout period instructions prior to each odor assessment Willing to receive the miraDry treatments and available for the follow-up period |
| Follow-ups | 1 month, 3 months and 6 months after last treatment |
| Endpoints | Primary: |
| Percentage of the subjects that scored at least a 2 point lower | |
| odor score in the treated underarm compared to the untreated | |
| underarm (responders) when assessed 1 month after treatment |
Secondary: Statistically significant difference in % of subjects with at least a 2 point drop in underarm odor score in the treated underarm compared to the untreated underarm at 3 and 6 months. Average difference in odor in the treated underarm compared to the untreated underarm at all follow-up visits. Patient-rated satisfaction scores on odor specific questions, as measured at the follow-up visits that are 1, 3 and 6 months post final treatment |
The study design and results are summarized in the table below.
7
| Effectiveness | The results for the responder analysis are shown in the table below | ||||
|---|---|---|---|---|---|
| results | for the subjects that attended the study visits. | ||||
| Table 1: Percentage of subjects with at least 2 point lower odor | |||||
| score in the treated underarm compared to the untreated | |||||
| underarm | |||||
| # of | Percentage of subjects with at | ||||
| Evaluable | least 2 point lower odor score in | ||||
| subjects | the treated underarm compared | ||||
| to the untreated underarm 1 | |||||
| month after treatment. | |||||
| 1 month after | 35 | 23/35 (66%)* | |||
| treatment | |||||
| 3 months after | 36 | 14/36 | |||
| (39%) | |||||
| treatment | |||||
| 6 months after | |||||
| treatment | 36 | 13/36 | |||
| (36%) | |||||
| *p=0.09, indicating the proportion of subjects experiencing a 2 | |||||
| point difference (between the treated and untreated underarm) | |||||
| was not significantly greater than 50%. | |||||
| The primary endpoint and a secondary endpoint were not met, | |||||
| since the percentage of patients with at least a 2 point lower | |||||
| score on the treated underarm compared to the untreated | |||||
| underarm was not statistically significant at the three time points. | |||||
| However, the treated underarm was scored as having lower odor | |||||
| at all time points. | |||||
| Table 2: Average difference in odor in the treated underarm | |||||
| compared to the untreated underarm at all follow-up visits. | |||||
| Average difference in odor | P value | ||||
| between the treated and | |||||
| untreated underarm (± | |||||
| 95%CI) | |||||
| 1 month | 2.84 (±0.73) |