(30 days)
Not Found
No
The description focuses on microwave energy delivery and system components, with no mention of AI or ML capabilities.
Yes.
The device is indicated for the treatment of primary axillary hyperhidrosis and may reduce underarm odor when used for this purpose, which are therapeutic uses.
No.
The device is described as a treatment system (microwave device designed to heat tissue) for conditions like primary axillary hyperhidrosis and unwanted underarm hair removal, not for diagnosing them.
No
The device description clearly outlines multiple hardware components including a console, handpiece, and bioTip, in addition to being a microwave device designed to heat tissue. While the console is described as "software-driven," the system as a whole is not software-only.
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 Function: The miraDry System MD4000 is a microwave device that directly treats the body by heating tissue. It is used for therapeutic purposes (treating hyperhidrosis and removing hair) rather than analyzing samples taken from the body.
The description clearly outlines a device that applies energy to the body for treatment, which is characteristic of a therapeutic device, not an IVD.
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 regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
When used with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.
Product codes (comma separated list FDA assigned to the subject device)
NEY, OUB, MWY
Device Description
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:
- MD4000-MC Console: O
- MD4000-HP miraDry Handpiece; and O
- MD4000-BT miraDry bioTip that snaps onto the Handpiece O
The miraDry MD4000 System also includes the following Class I components/accessories:
- MD4000-TS template system, a required component for the miraDry treatment O
- MD4000-PK priming kit; and O
- MD4000-BT-DE demonstration bioTip. O
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 of the Handpiece has a single patient use disposable, the miraDry bioTip, which contacts the underarm skin of 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
Not Found
Intended User / Care Setting
Prescription Use
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)
The Special 510(k) for this device modification to the cleared miraDry System (K160141) utilized Miramar Labs established quality system and design control requirements in accordance with the Quality System Regulation (21 CFR 820).
Miramar Labs Inc. declares conformance to design controls in making this change and utilized the following risk based assessments:
-
- Risk assessment including Hazard Analysis
-
- Complaints incidence and review
-
- Manufacturing environment and process evaluation including bioburden testing and monitoring trends
-
- Instructions for Use
-
- User interface and clinician user feedback
Risk control measures were focused on manufacturing environment, user interface evaluation, and postmarket surveillance and user feedback. No new risks were identified as a result of this change.
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
§ 878.4400 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
March 15, 2018
Miramar Labs, Inc. Cynthia Kada Sr. Director, QA 2790 Walsh Avenue Santa Clara, California 95051
Re: K180396
Trade/Device Name: miraDry System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY, OUB, MWY Dated: February 12, 2018 Received: February 13, 2018
Dear Cynthia Kada:
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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Cynthia Kada
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson -S3
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) K180396
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 regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
When used with the treatment of primary axillary hyperhidrosis, the miraDry System 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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3
2. 510(k) SUMMARY
| 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 |
| Predicate Device | miraDry MD 4000 System K160141 |
| 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: | Cynthia Kada |
| Date: | February 12, 2018 |
4
PURPOSE OF SUBMISSION
The purpose of this Special 510(k) submission is to modify how the treatment bioTip component of the miraDry System is provided to the User. The intended use of the modified device, as described in the labeling, has not changed as a result of this modification.
DEVICE DESCRIPTION
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:
- MD4000-MC Console: O
- MD4000-HP miraDry Handpiece; and O
- MD4000-BT miraDry bioTip that snaps onto the Handpiece O
The miraDry MD4000 System also includes the following Class I components/accessories:
- MD4000-TS template system, a required component for the miraDry treatment O
- MD4000-PK priming kit; and O
- MD4000-BT-DE demonstration bioTip. O
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 of the Handpiece has a single patient use disposable, the miraDry bioTip, which contacts the underarm skin of the patient.
DEVICE MODIFICATION
As described in K160141, the bioTip is disposable and for single patient use, and is provided sterile. The only change to the miraDry MD4000 system cleared under K160141 that is the subject of this Special 510(k) involves supplying the disposable bioTips to the user as clean and non-sterile for single patient use only. The intended use of the modified device, as described in the labeling, has not changed as a result of this modification.
5
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 with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
The miraDry MD4000 System described and cleared in 510(k) number K160141 serves as the predicate device for this premarket notification. The miraDry MD4000 System that is the subject of this Special 510(k) has the same technological characteristics and intended use as the device described and cleared in 510(k) number K160141. Furthermore, there have been no changes in design, component materials, chemical composition, or energy source, since FDA's clearance of K160141.
Therefore, the miraDry System MD4000 remains substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act except for one characteristic: the condition of use of the bioTips. This difference is rendered inconsequential by the "single patient use" and disposable nature of the bioTips that eliminates the risk of cross contamination between patients. Summarized in the substantial equivalence tables below are the key technological characteristics and indications for use of the miraDry System compared to the predicate device identified in this Special 510(k).
| Characteristics
miraDry
System | Predicate Device
miraDry MD4000
K160141 | Modified Device
miraDry MD4000 | Comparison |
|--------------------------------------|-----------------------------------------------|-----------------------------------|------------|
| Device Class | II | II | Same |
| Energy Type | Microwave | Microwave | Same |
| Mode of Action | Generation of localized
heat | Generation of localized
heat | Same |
| Product Code | NEY, OUB, MWY | NEY, OUB, MWY | Same |
| miraDry System Substantial Equivalence Comparison Table | |||
|---|---|---|---|
6
| Characteristics
miraDry
System | Predicate Device
miraDry MD4000
K160141 | Modified Device
miraDry MD4000 | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 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. | 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. | Same |
| | 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. | 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. | Same |
| | When used with the
treatment of primary
axillary hyperhidrosis, the
miraDry System may
reduce underarm odor. | When used with the
treatment of primary
axillary hyperhidrosis, the
miraDry System may
reduce underarm odor. | Same |
| 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 | Same |
| 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 | Same |
| Key
Components | Console, Handpiece,
disposable bioTip | Console, Handpiece,
disposable bioTip | Same |
| Console Control
Mechanism | Electronic user interface | Electronic user interface | Same |
| Coolant usage | Delivers cooling to the
skin surface | Delivers cooling to the
skin surface | Same |
| Characteristics
of bioTip | Predicate Device
miraDry MD4000
K160141 | Modified Device
miraDry MD4000 | Comparison |
| Materials | Polyurethane,
Thermoplastic
Elastomer (TPE),
Polycarbonate | Polyurethane,
Thermoplastic
Elastomer (TPE),
Polycarbonate | Same |
| Biocompatible | Yes | Yes | Same |
| Packaging
Configuration | Thermo-formed (PETG)
plastic tray with Tyvek
lid | Thermo-formed (PETG)
plastic tray with Tyvek
lid | Same |
| Treatment
Condition | Sterile | Clean, non-sterile | Change to how it
is provided |
| Condition of Use | Single patient use,
disposable | Single patient use,
disposable | Same |
7
miraDry System bioTip Component Substantial Equivalence Comparison Table
SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES
The Special 510(k) for this device modification to the cleared miraDry System (K160141) utilized Miramar Labs established quality system and design control requirements in accordance with the Quality System Regulation (21 CFR 820).
Miramar Labs Inc. declares conformance to design controls in making this change and utilized the following risk based assessments:
-
- Risk assessment including Hazard Analysis
-
- Complaints incidence and review
-
- Manufacturing environment and process evaluation including bioburden testing and monitoring trends
-
- Instructions for Use
-
- User interface and clinician user feedback
Risk control measures were focused on manufacturing environment, user interface evaluation, and postmarket surveillance and user feedback. No new risks were identified as a result of this change.
CONCLUSION
Based on all information in this Special 510(k), the miraDry MD4000 System and accessories is substantially equivalent to the identified predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. The safety and effectiveness of the device modification are reasonably assured with no new or increased risks justifying 510(k) clearance.