(121 days)
No
The summary describes a microwave device for heating tissue and mentions a software-driven console, but there is no mention of AI, ML, or related concepts like image processing or algorithms that would suggest the use of such technologies for decision-making or analysis.
Yes.
The device is indicated for the treatment of primary axillary hyperhidrosis, which is a medical condition, making it a therapeutic device.
No
The device is indicated for use in the treatment of primary axillary hyperhidrosis and unwanted underarm hair removal, as well as permanent reduction of underarm hair. It is a therapeutic device that delivers microwave energy to heat tissue and destroy sweat glands and hair bulbs, not to diagnose a condition.
No
The device description explicitly states that the miraDry System MD4000 consists of hardware components including a console, handpiece, and bioTip, in addition to being software-driven.
Based on the provided information, the miraDry System MD4000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- miraDry System MD4000 Function: The description clearly states that the miraDry System MD4000 is a microwave device designed to heat tissue in situ (within the body) to treat hyperhidrosis and reduce hair. It directly interacts with the patient's body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, the miraDry System MD4000 is a therapeutic device that applies energy to the body, not an IVD device that analyzes specimens.
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.
Product codes (comma separated list FDA assigned to the subject device)
OUB, NEY, MWY
Device Description
The miraDry System MD4000 is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat glands and hair bulbs reside using a surface contact applicator. The miraDry System MD4000 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 K131162, the miraDry System MD4000 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. The MD4000-PK priming kit is 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
axillae / underarm
Indicated Patient Age Range
Adult subjects
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
The performance for underarm hair reduction was demonstrated in a clinical trial of 56 subjects.
The study was conducted at three private dermatology clinics in the United States.
The primary endpoint of this study was to show >30% reduction (baseline to 3 month, measured by hair counts) in >50% of subjects. There were 42 subjects assessable for this endpoint.
The secondary endpoint was to show >30% reduction (comparing baseline to 12 months photos) to make a claim for permanent axillary hair reduction.
Annotation protocol: Additional analyses used a blinded comparison of baseline to follow-up full-axilla photos by an independent physician reviewer to correctly identify which photo had more hair and score hair reduction at follow-up. Also, a subject assessment of overall satisfaction, odor rating and sweat ratings was determined at the follow-up visits.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Trial
Sample Size: 56 subjects enrolled. 42 subjects assessable for the primary endpoint.
Key Results:
Hair count reduction:
- 3 months: 88.1% (37/42) of subjects with >30% reduction [lower 95% CL: 76.6%]
- 6 months: 97.5% (39/40) of subjects with >30% reduction [lower 95% CL: 88.7%]
- 9 months: 92.1% (35/38) of subjects with >30% reduction [lower 95% CL: 80.8%]
- 12 months: 95.5% (42/44) of subjects with >30% reduction [lower 95% CL: 86.4%]
Average hair count reduction:
- 3 months: 66% [+/- 30%]
- 6 months: 72% [+/- 29%]
- 9 months: 75% [+/- 28%]
- 12 months: 75% [+/- 27%]
Side-by-side axilla review (% of pairs having at least 26-50% reduction):
- 3 months: 74% (63/85)
- 6 months: 78% (65/83)
- 9 months: 78% (66/85)
- 12 months: 89% (83/93)
Patient satisfaction with hair reduction (% of subjects rating "very satisfied" or "somewhat satisfied"):
- 3 months: 81% (38/47)
- 6 months: 70% (31/44)
- 9 months: 68% (30/44)
- 12 months: 70% (33/47)
Odor self-assessment, Mean reduction 10pt scale:
- 3 months: 2.6 +/- 3.0
- 6 months: 2.8 +/- 2.8
- 9 months: 2.5 +/- 2.8
- 12 months: 2.4 +/- 2.7
% of subjects with HDSS reduction to score of 1 or 2:
- 3 months: 92% (23/25)
- 6 months: 96% (25/26)
- 9 months: 96% (24/25)
- 12 months: 89% (25/28)
Both the primary and secondary endpoints were met, since the percentage of patients with hair reduction of at least 30% was significantly higher than 50% at all follow-up timepoints.
Adverse Events: All subjects experienced at least one (1) treatment-related adverse event (AE), 99% (324/326) of all AEs were rated as mild in severity. Most common were localized edema (55%), tingling or numbness in the treatment area (30%), vacuum acquisition marks (29%), bumps or lumps under the skin (29%) or discomfort or tenderness in the treatment area (26%). One patient experienced unilateral ulnar neuropathy that was improving but not completely resolved at study exit.
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.
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
§ 878.4400 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. The logo is simple and professional, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Miramar Labs Incorporated Dr. Kathy O'Shaughnessy, Ph.D. Vice President, Clinical/Regulatory/Quality Assurance 2790 Walsh Avenue Santa Clara, California 95051
Re: K150419
Trade/Device Name: MiraDry System MD4000 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: May 5, 2015 Received: May 6, 2015
Dear Dr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Kathy O'Shaughnessy, Ph.D.
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.
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" (21CFR 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 yours.
Jennifer R. Stevenson -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
2
Indications for Use
510(k) Number (if known) K150419
Device Name miraDry System MD4000
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.
| 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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3
| 5. 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 | |
| Trade Name: | System, Microwave, Hair Removal |
| miraDry System MD4000 | |
| 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/Quality | |
| Date prepared: | 06/16/15 |
INTENDED 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.
4
PREDICATE DEVICES
The miraDry System MD4000 (K131162).
REFERENCE DEVICE
The Microwave Delivery System Model MMC-330 (K991456).
DEVICE DESCRIPTION
The miraDry System MD4000 is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat glands and hair bulbs reside using a surface contact applicator. The miraDry System MD4000 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 K131162, the miraDry System MD4000 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. The MD4000-PK priming kit is 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 System MD4000 with the revised, expanded indication to include underarm hair removal is substantially equivalent to the miraDry System MD4000 as previously cleared for sweat reduction. The subject and predicate device have the same fundamental technology, design, and method of usage. A comparison of the two devices is shown in Table 1 below.
5
| Characteristics | Predicate Device
miraDry MD4000 | Subject Device
miraDry MD4000 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K131162 | K150419 |
| Device Class | II | II |
| Energy Type | Microwave | Microwave |
| Mode of Action | generation of localized heat | generation of localized heat |
| Product Code | NEY, OUB | NEY, OUB, MWY |
| Indications for Use | The miraDry System is indicated for
use in the treatment of primary
axillary hyperhidrosis.
Note: The miraDry System is not
indicated for use in the treatment of
hyperhidrosis related to other body
areas or generalized hyperhidrosis. | 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. |
| Function | Heat absorption by tissue located at
the dermal- hypodermal interface
where the axillary sweat glands
reside | Heat absorption by tissue located
at the dermal- hypodermal interface
where the axillary sweat 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 |
| Table 1. Substantial Equivalence Comparison Table. | ||
|---|---|---|
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 System MD4000, cleared under K131162).
6
CLINICAL TESTING
The safety and effectiveness of the clinical application of the miraDry System MD4000 for sweat reduction was demonstrated in prior clinical studies. The performance for underarm hair reduction was demonstrated in a clinical trial of 56 subjects.
The primary objective of this study was to quantify hair reduction in the axillae after treatment(s) with the miraDry System MD4000. The study device was used in the same manner as the commercially available technique cleared by the FDA for the treatment of primary axillary hyperhidrosis, as described in the User Manual.
The study was conducted at three private dermatology clinics in the United States. The study was initiated at the first site in September of 2012. Adult subjects seeking hair reduction in the axillae were considered for enrollment. Subjects were treated with the miraDry System MD4000 using the standard miraDry procedure in one or two treatment sessions 3 months apart.
Fifty-six subjects were enrolled in the study. The mean age was 33 years; 80% of the subjects were female and 88% were Caucasian. The majority of the subjects were of Fitzpatrick skin type I-IV. 23% (13/56) of the subjects completed only one treatment session; 5 of these 13 subjects declined a second session due to adverse events. The primary endpoint of this study was to show >30% reduction (baseline to 3 month, measured by hair counts) in >50% of subjects. There were 42 subjects assessable for this endpoint. The secondary endpoint was to show >30% reduction (comparing baseline to 12 months photos) to make a claim for permanent axillary hair reduction. Additional analyses used a blinded comparison of baseline to follow-up full-axilla photos by an independent physician reviewer to correctly identify which photo had more hair and score hair reduction at follow-up. Also, a subject assessment of overall satisfaction, odor rating and sweat ratings was determined at the follow-up visits. A summary of the results is presented in Table 2 below.
7
| Efficacy measure | Follow-up visit time from the last treatment session | |||
|---|---|---|---|---|
| 3 months | 6 month | 9 month | 12 month | |
| Hair count: | ||||
| % of subjects with >30% | ||||
| reduction [lower 95% CL] | Primary: | |||
| 88.1% (37/42) | ||||
| [76.6%] | 97.5% (39/40) | |||
| [88.7%] | 92.1% (35/38) | |||
| [80.8%] | Secondary: | |||
| 95.5% (42/44) | ||||
| [86.4%] | ||||
| Hair count: | ||||
| Average reduction [std] | ||||
| Light hair subgroup (n) | 66% [± 30%] | |||
| 66% (n=12) | 72% [± 29%] | 75% [± 28%] | 75% [± 27%] | |
| 72% (n=13) | ||||
| Side-by-side axilla review: | ||||
| % of pairs having at least | ||||
| 26-50% reduction | 74% (63/85) | 78% (65/83) | 78% (66/85) | 89% (83/93) |
| Patient satisfaction with hair | ||||
| reduction: % of subjects | ||||
| rating "very satisfied" or | ||||
| "somewhat satisfied" | 81% | |||
| (38/47) | 70% | |||
| (31/44) | 68% | |||
| (30/44) | 70% | |||
| (33/47) | ||||
| Odor self-assessment, Mean | ||||
| reduction 10pt scale | 2.6 ± 3.0 | 2.8 ± 2.8 | 2.5 ± 2.8 | 2.4 ± 2.7 |
| % of subjects with HDSS | ||||
| reduction to score of 1 or 2 | 92% | |||
| (23/25) | 96% | |||
| (25/26) | 96% | |||
| (24/25) | 89% | |||
| (25/28) |
2: Summary of Efficacy Results
Both the primary and secondary endpoints were met, since the percentage of patients with hair reduction of at least 30% was significantly higher than 50% at all follow-up timepoints.
All subjects experienced at least one (1) treatment-related adverse event (AE), 99% (324/326) of all AE's were rated as mild in severity. Many subjects experienced the expected mild transient post-treatment effects; the most common were localized edema (55%), tingling or numbness in the treatment area (30%), vacuum acquisition marks (29%), bumps or lumps under the skin (29%) or discomfort or tenderness in the treatment area (26%). Other rarer treatment effects affecting more than the treatment area were noted in 18% of subjects (10/56), 75% of which were rated as mild. These included numbness or tingling in the arms (n=6 events); more extensive swelling in the adjacent area (e.g. arms) (n=4 events); and bruising outside the treatment area (n=2 events). One patient experienced unilateral ulnar neuropathy that was improving but not completely resolved at study exit. The types, rates and severity of the reported AE's are substantially equivalent to those from the predicate device (MD4000-MC with the hyperhidrosis indication, K131162).
The modification to the Indications for Use statement has not altered the fundamental technology of the miraDry System MD4000.
8
CONCLUSION
As described in this 510(k) Summary, Miramar Labs Inc. considers the miraDry System MD4000 to be substantially equivalent to the predicate device.