(107 days)
Not Found
No
The summary describes a microwave device with software control, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the treatment of primary axillary hyperhidrosis, indicating a therapeutic purpose.
No
The device is described as a treatment for primary axillary hyperhidrosis, not for diagnosing it.
No
The device description clearly states that the miraDry System consists of hardware components including a console, handpiece, and bioTip, in addition to being software-driven. It is not solely software.
Based on the provided information, the miraDry System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- miraDry System Function: The miraDry System is a therapeutic device that uses microwave energy to treat a medical condition (primary axillary hyperhidrosis) directly on the patient's body. It does not analyze samples taken from the body.
The description clearly states it's a "microwave device designed to heat tissue" and "delivers microwave energy to the skin." This is a direct treatment method, not an in vitro diagnostic test.
N/A
Intended Use / 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 treating hyperhidrosis related to other body areas or generalized hyperhidrosis.
Product codes (comma separated list FDA assigned to the subject device)
NEY, OUB
Device Description
The miraDry System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the sweat glands reside using a surface contact applicator. The miraDry System consists of: the DTS3000 Console; the miraDry Handpiece; and a disposable, sterile miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover.
The DTS3000 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 console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, that contacts the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axillary (armpit)
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)
Clinical testing showed that the device provides a safe and effective means to treat axillary hyperhidrosis. A randomized, blinded study with 120 subjects with primary axillary hyperhidrosis was conducted. The study primary endpoint was met, which demonstrated a statistically significant difference in sweat reduction efficacy between the treated subjects (n=81) and the subjects that received a sham treatment (n=39). Adverse events were generally mild in severity and all but one (persistent hyperhidrosis on the face) resolved.
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
Miramar Labs, Inc
miraDry System
510(k) Summary JAN 2 8 2011 General Information Trade Name miraDry System Classification 21CFR 878.4400, Electrosurgical cutting and coagulation device and accessories Class II (special controls) Product Code NEY Submitter Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 USA 408-940-8700 Tel: Fax: 408-940-8795 Contact Kathy O'Shaughnessy, PhD VP, Clinical and Regulatory Affairs Date prepared: January 20, 2011
103014
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 treating hyperhidrosis related to other body areas or generalized hyperhidrosis.
Predicate Device
K082819 Miramar Labs' DTS G2 System
Device Description
The miraDry System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the sweat glands reside using a surface contact applicator. The miraDry System consists of: the DTS3000
1
Miramar Labs, Inc
ﺗ ﺗ
miraDry System
Console: the miraDry Handpiece; and a disposable, sterile miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover.
The DTS3000 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 console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, that contacts the patient.
Materials
All materials used in the manufacture of the miraDry System are suitable for this use and have been used in numerous previously cleared products. Patient-contacting materials have been demonstrated to be biocompatible.
Performance Testing
Product and animal testing was conducted to ensure conformance to product specifications, and equivalence to the predicate device. In particular, animal testing demonstrated that thermal zones created with the predicate device were similar to those created with the miraDry System.
The miraDry System has been shown to conform to the applicable requirements of the following:
- IEC 60601-1: (1988 + A1:1991 + A2:1995) Medical Electrical Equipment . Part 1: General Requirements for Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2: (2001+A1:2004) Medical Electrical Equipment Part 1-2: . General Requirements for Safety: Electromagnetic Compatibility
- IEC60601-1-4:2000. Medical Electrical Equipment Part 1-4 General . requirement for safety - Collateral Standard: Programmable electrical medical systems
- IEC60601-1-6:2004. Medical electrical equipment Part 1-6: General . requirements for safety - Collateral Standard: Usability
- IEC 60601-2-2:2006. Medical electrical equipment Part 2-2: Particular . requirements for the safety of High Frequency Surgical Equipment
- IEC 60601-2-6:1984. Medical electrical equipment Part 2: Particular . requirements for the safety of microwave therapy equipment.
Clinical testing showed that the device provides a safe and effective means to treat axillary hyperhidrosis. A randomized, blinded study with 120 subjects with primary axillary hyperhidrosis was conducted. The study primary endpoint was met, which demonstrated a statistically significant difference in sweat
2
K1030/4
reduction efficacy between the treated subjects (n=81) and the subjects that received a sham treatment (n=39). Adverse events were generally mild in severity and all but one (persistent hyperhidrosis on the face) resolved.
Summary of Substantial Equivalence
The miraDry System is substantially equivalent to the predicate product for the following reasons:
-
- The miraDry System has the same intended use as the legally marketed DTS G2 System, i.e., a localized and controlled heating of soft tissue.
-
- The indication for use for the miraDry System is a specific indications for use within the "functional" indications for use for the DTS G2 System that were cleared by FDA, i.e., "The DTS G2 System is indicated for use for coagulation of soft tissue".
-
- The materials used in the miraDry System, the device's methods of manufacturing and overall function are the same as the FDA cleared DTS G2 System.
-
- While the miraDry System has the same intended use and basic technological characteristics as the predicate, the specificity of the miraDry System's indications for use prompted Miramar Labs to conduct a clinical study to ensure that the performance specifications of the device met user needs. On the basis of direct comparison with the predicate device and the results of preclinical and clinical testing, the miraDry System has been demonstrated to be substantially equivalent to the legally marketed DTS G2 System.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Miramar Labs, Inc. % Kathy O'Shaughnessy, Ph.D. Vice President, Clinical and Regulatory Affairs 445 Indio Way Sunnyvale, California 94085
JAN 28 201
Re: K103014
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: OUB, NEY Dated: December 10, 2010 Received: December 13, 2010
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
4
Page 2 - Kathy O'Shaughnessy. Ph.D.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hy. B. rh
for.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1 Indications for Use
510(k) Number (if known):
Device Name:
miraDry System
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.
× Prescription Use (Per 21 CFR 801 Subpart D)
OR Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ander for nxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103014