(41 days)
K100874, LipoSonix® system Model 1
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No
The document describes a device that uses high-intensity focused ultrasound (HIFU) for fat disruption. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The predicate device is also the same technology, suggesting no significant technological shift towards AI/ML.
No
The device is described as providing a "non-invasive approach to achieve a desired aesthetic effect" and "non-invasive waist circumference reduction," indicating an aesthetic rather than therapeutic purpose.
No
The device is intended for non-invasive waist circumference reduction and disruption of subcutaneous adipose tissue, which are aesthetic and therapeutic effects, not diagnostic.
No
The device description explicitly states it is a "cart-based medical device" consisting of a cart, handpiece, and user interface display, indicating it includes significant hardware components beyond just software.
Based on the provided information, the LipoSonix system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The LipoSonix system's intended use is to disrupt subcutaneous adipose tissue in vivo (within the body) using ultrasound energy for aesthetic purposes (waist circumference reduction).
- The device description confirms it's a cart-based medical device that applies energy directly to the body.
Therefore, the LipoSonix system is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.
The LipoSonix system is specifically indicated for non-invasive waist circumference reduction.
Product codes (comma separated list FDA assigned to the subject device)
OHV
Device Description
The LipoSonix system is a cart-based medical device intended for non-invasive disruption of subcutaneous adipose tissue (SAT) by employing ultrasound energy. The system consists of a cart, a detachable handpiece and a user interface display in one unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Waist circumference (subcutaneous adipose tissue)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LipoSonix system was evaluated in a multicenter, randomized study. Treatment with the LipoSonix system was shown to be superior to a sham control in reducing waist circumference, meeting the pre-specified primary endpoint of the study. The 59 J/cm² treatment group demonstrated a 1.01 cm greater waist circumference reduction as compared to sham. The least square (LS) mean change from baseline to 12 weeks of the waist circumference in the same 59 J/cm2 group was -2.44 cm. On average, the mean change in waist circumference of approximately 2.55 cm (1 inch) compared to baseline that was demonstrated in the 59 J/cm2 treatment group. This could equal one dress or pant size.
The safety of treatment with the LipoSonix system was assessed through 24 weeks post-treatment. The AEs resulting from treatment with the LipoSonix system during this study were mostly mild, short-lived in duration, and resolved without incident. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the investigational device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
1.01 cm greater waist circumference reduction
least square (LS) mean change from baseline to 12 weeks of the waist circumference in the same 59 J/cm2 group was -2.44 cm
mean change in waist circumference of approximately 2.55 cm (1 inch) compared to baseline
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.
K100874, LipoSonix® system Model 1
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.
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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).
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§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
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LipoSonix® system Model 2 Special 510(k) Premarket Notification Medicis Technologies Corporation
510(k) Summary
In accordance with 21 CFR 807.92(c) the following summary of information is provided:
| Date Prepared: | September 8, 2011 |
|---|---|
| Submitter: | Medicis Technologies Corporation |
| 11818 North Creek Parkway North | |
| Bothell, WA 98011 USA | |
| Contact Person: | Michael A. Hoffman, MPH |
| Vice President - Regulatory Affairs and Quality Systems | |
| Medicis Technologies Corp. | |
| 11818 North Creek Parkway North | |
| Bothell, WA 98011 USA | |
| Telephone: | 425.420.2135 |
| Facsimile: | 425.420.2335 |
| FR Number: | 21 CFR 878.4590 |
| Product Code: | OHV |
| Classification Name | Focused Ultrasound Stimulator System for Aesthetic Use |
| Common Name: | Focused Ultrasound Stimulator System for Aesthetic Use |
| Trade Name: | LipoSonix® system Model 2 |
| Regulatory Class: | Class II |
| Classification | |
| Advisory | |
| Committee: | Division of General, Restorative and Neurological |
| Devices; General Surgery Devices Branch | |
| Special Controls: | Class II Special Controls Guidance Document: Focused |
| Ultrasound Stimulator System for Aesthetic Use (July 20, |
-
|
| Predicate Device(s): | K100874, LipoSonix® system Model 1 |
| Intended
Use/Indications for
Use: | The LipoSonix system delivers high intensity focused
ultrasound (HIFU) energy that can disrupt subcutaneous
adipose tissue (SAT) to provide a non-invasive approach
to achieve a desired aesthetic effect.
The LipoSonix system is specifically indicated for non-invasive waist circumference reduction |
| Contraindications: | A patient is ineligible for treatment with the LipoSonix system if any of the following criteria are met:
The patient is a female who is pregnant, may be pregnant, or is lactating. Female patients of child bearing age should have a negative pregnancy test before being treated with the LipoSonix system. The patient has less than 1.0 cm of adipose tissue thickness beyond the selected treatment focal depth in the area to be treated. Hernia in the area to be treated. |
| Device Description: | The LipoSonix system is a cart-based medical device intended for non-invasive disruption of subcutaneous adipose tissue (SAT) by employing ultrasound energy. The system consists of a cart, a detachable handpiece and a user interface display in one unit. |
| Technology: | The LipoSonix system accomplishes its intended use through the use of precisely targeted high intensity focused ultrasound energy that produces a thermal cellular disruption in the subcutaneous adipose tissue (soft tissue). This thermal energy also causes collagen to contract. Thus creating a dual tissue response. The destroyed adipose tissue is subsequently cleared via an |
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K112626 pg 2 of 4
LipoSonix® system Model 2 Special 510(k) Premarket Notification Medicis Technologies Corporation
lymphatic system.
inflammatory response by macrophages that transported the destroyed cells and their contents to the liver via the
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LipoSonix® system Model 2 Special 510(k) Premarket Notification Medicis Technologies Corporation
Summary of Non-Clinical Tests: Determination of
The system has been found to conform to the system Substantial essential specifications, thermal. electrical. Equivalence: electromagnetic and mechanical safety, and has been found to conform to FDA consensus, medical device safety standards and international harmonized standards.
The following risks as identified in the FDA special control quidance document entitled, "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" have been addressed.
- Thermal Injury from Focused Ultrasound Exposure . (Thermal Damage)
- Mechanical Injury from Focused Ultrasound Exposure .
- (Cavitation or other Mechanical Damage) .
- . Ocular Injury
- Electrical Shock
- Inflammation/Foreign Body Response ●
- Use Error ●
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K112626 pg 4 of 4
LipoSonix® system Model 2 Special 510(k) Premarket Notification
The LipoSonix system was evaluated in a multicenter, Performance Data: randomized study. Treatment with the LipoSonix system was shown to be superior to a sham control in reducing waist circumference, meeting the pre-specified primary endpoint of the study. The 59 J/cm² treatment group demonstrated a 1.01 cm greater waist circumference reduction as compared to sham. The least square (LS) mean change from baseline to 12 weeks of the waist circumference in the same 59 J/cm2 group was -2.44 cm. On average, the mean change in waist circumference of approximately 2.55 cm (1 inch) compared to baseline that was demonstrated in the 59 J/cm2 treatment group. This could equal one dress or pant size.
The safety of treatment with the LipoSonix system was assessed through 24 weeks post-treatment. The AEs resulting from treatment with the LipoSonix system during this study were mostly mild, short-lived in duration, and resolved without incident. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the investigational device.
The LipoSonix system is substantially equivalent to the Substantial LipoSonix system Model1 (K100874) device. Equivalence:
The LipoSonix system Model 2 has the same intended use as the Model 1 system, namely performing a noninvasive treatment to achieve a desired aesthetic effect. Both systems use the same technological principles, namely HIFU, to thermally disrupt soft tissues which result in the aesthetic affect. The mechanism of action for both devices is essentially the same as well. Disrupted soft tissue is removed by normal healing processes of the body resulting in an aesthetic affect. Both devices can deliver more than one energy dose.
Therefore, the LipoSonix system Model 2 is substantially equivalent to the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Medicis Technologies Corporation % Michael A. Hoffman, MPH Vice President - Regulatory Affairs and Quality Systems 11818 North Creek Parkway North Bothell, Washington 98011
Re: K112626
Trade/Device Name: LipoSonix® System Model 2 Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: October 04, 2011 Received: October 04, 2011
Dear Mr. Hoffman:
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, Orug, 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 musicading.
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 tan 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.
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Page 2 - Michael A. Hoffman, MPH
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 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,
Evin L. Keith
For Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): This Submission
Device Name: LipoSonix® system Model 2
Indications For Use:
The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.
The LipoSonix system is specifically indicated for non-invasive waist circumference reduction.
Prescription Use
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
NilkRedden for mkm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K112626
Section 18 - Indications for Use