(507 days)
Not Found
No
The summary describes a device that uses high-intensity focused ultrasound (HIFU) for non-invasive fat reduction. 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.
No.
The device is used for aesthetic effect and waist circumference reduction, which are not considered therapeutic medical purposes.
No
The device is described as delivering high intensity focused ultrasound (HIFU) energy to disrupt subcutaneous adipose tissue for non-invasive waist circumference reduction. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it is a "cart-based system" consisting of a base, treatment head, and treatment arm, which are physical hardware components.
Based on the provided information, the LipoSonix system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LipoSonix Function: The LipoSonix system uses high-intensity focused ultrasound (HIFU) energy to physically disrupt subcutaneous adipose tissue for aesthetic purposes (waist circumference reduction). It does not analyze biological samples or provide diagnostic information about a patient's health status.
- Intended Use: The intended use clearly states "non-invasive waist circumference reduction" and "achieve a desired aesthetic effect." This is a therapeutic/aesthetic application, not a diagnostic one.
Therefore, the LipoSonix system falls under the category of a therapeutic or aesthetic 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
OHV
Device Description
The LipoSonix system is a cart-based system intended for non-invasive waist circumference reduction. The LipoSonix system uses ultrasound energy to disrupt subcutaneous adipose tissue (soft tissue). The system consists of a base, a treatment head (which contains the transducer) and a treatment arm in one unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
waist
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)
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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K 100874 1/4
ﺔ
AUG 1 9 2011
510(k) Summary
In accordance with 21 CFR 807.92(c) the following summary of information is provided:
| Date Prepared: | August 18, 2011 |
|---|---|
| Submitter: | Medicis Technologies Corporation |
| 11818 North Creek Parkway North | |
| Bothell, WA 98011 | |
| Contact Person: | Michael A. Hoffman, MPH |
| Vice President - Regulatory Affairs and Quality Systems | |
| Medicis Technologies Corp. | |
| 11818 North Creek Parkway North | |
| Bothell, WA 98011 | |
| Telephone: | 425.420.2135 |
| Facsimile: | 425.420.2335 |
| FR Number: | 21 CFR 878.4590 |
| Product Code: | OHV |
| Classification | |
| Name | Focused Ultrasound for Aesthetic Use |
| Common Name: | Focused Ultrasound Stimulator for Aesthetic Use |
| Trade Name: | LipoSonix® system Model 1 |
| 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): | K072505 Ulthera System, Model 8850-0001 |
Section 5
・・・
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100874 2/4
The LipoSonix system delivers high intensity focused Indications for Use: 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 noninvasive 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 focal depth in the area to be treated.
- · Hernia in the area to be treated.
The LipoSonix system is a cart-based system intended for Device Description: non-invasive waist circumference reduction. The LipoSonix system uses ultrasound energy to disrupt subcutaneous adipose tissue (soft tissue). The system consists of a base, a treatment head (which contains the transducer) and a treatment arm in one unit.
Technology: The LipoSonix system accomplishes its intended use through the use of precisely targeted high intensity focused ultrasound energy that produces thermal coaqulative necrosis and 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 inflammatory response by macrophages that transported the destroyed cells and their contents to the liver via the lymphatic system.
.
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K100874 3/4
Determination of Substantial Equivalence:
1
Summary of Non-Clinical Tests:
The system has been found to conform to the system essential specifications, thermal, electrical, 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
Performance Data:
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.
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The LipoSonix system is substantially equivalent to the Substantial Ulthera™, Inc., Ulthera System, Model 8850-0001 Equivalence: (K072505) device.
The LipoSonix system has the same intended use as the Ulthera system, namely performing a non-invasive treatment to achieve a desired aesthetic effect. The LipoSonix system uses the same technological principles as the Ulthera system, namely HIFU, to thermally coagulate soft tissues which result in the aesthetic affect. The mechanism of action for both devices is essentially the same as well. Coagulated 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 at several different depths within the body.
Therefore, the LipoSonix system is substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medicis Technologies Corp. % Hogan Lovells US LLP Mr. Jonathan S. Kahan Columbia Square 555 Thirteenth Street. NW Washington, District of Columbia 20004
AUG 1 9 2011
Re: K100874
Trade/Device Name: LipoSonix® System Model 1 Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: August 16, 2011 Received: August 16, 2011
Dear Mr. Kahan:
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.
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Page 2 - Mr. Jonathan S. Kahan
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 evenis) (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/ReportalProblem/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,
Mark A. Millerm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K100874
Device Name: LipoSonix® system Model 1
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,
Nest R. Kahlen for n.m.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100874
Section 4 - Indications for Use