(58 days)
No
The summary describes a device that uses ultrasonic technology for surgical procedures and lipectomy. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The description focuses on the mechanical and electrical aspects of the device.
Yes
The device is used for medical procedures involving the dissection, liquefaction, emulsifying, and aspiration of soft tissues, as well as for aesthetic body contouring involving fatty tissue. These are therapeutic interventions aimed at treating or modifying the body.
No
The device is an instrument for surgical procedures involving the dissection, liquefaction, emulsifying, and aspiration of soft tissues, not for diagnosing conditions.
No
The device description explicitly states it is a physical unit consisting of an ultrasonic generator, infiltration pump, and aspiration pump, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- SONOCA Lipo Function: The description clearly states that the SONOCA Lipo is an instrument used for "ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues" and "liquefaction and aspiration of localized subcutaneous fatty tissue." This is a surgical procedure performed on the body (in vivo), not a test performed on a specimen taken from the body.
- Intended Use: The intended use is for surgical applications in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery, as well as aesthetic body contouring. These are all in-vivo procedures.
Therefore, the SONOCA Lipo is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring.
Product codes
QPB, MUU
Device Description
SONOCA Lipo™ is a modified version of the SONOCA 300 cleared by FDA under K992026 and can be used in two ways:
- As an ultrasonic dissector / aspirator as in the SONOCA 300 to cut, irrigate, and suction at the surgical site and
- As an alternative to conventional Lipectomy because it is a combination of a standard Lipectomy suction device and an Ultrasound assisted Lipectomy for the selective dissection of human fatty tissue.
The SONOCA Lipo™ is not an alternative to conventional surgery but a supplementary tool which provides an advantage for the selective dissection of human tissue.
The advantage of the SONOCA is that the tissue selectivity of the ultrasonically induced cutting effect limits the spectrum to organs with a large proportion of parenchyma in which sustentacular tissue is only minimally developed
During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.
The SONOCA Lipo™ can be trolley mounted or a desktop unit consisting of an ultrasonic generator, an infiltration pump and an aspiration pump. The nodular build of the electronic components allow the unit to function at a high capacity, totally free of electronic maintenance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, localized subcutaneous fatty tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained medical professionals.
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 subject and predicate devices have been designed and tested to pass the following Voluntary Standards: UL 260 1-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:1993 Electromagnetic Compatibility and FGC Part 18 EMC Requirement. The subject device complies with IEC 950 - Safety of Information Technology Equipment, CISPR 22, class A -- Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, IEEE 1003 . - General Pelectrical Safety for medical devices, IEC 601-1 -Electrical Safety for medical devices using RFpower, IEC 601-2-2- Ultrasonic surgical devices, DIN EN 61847.
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
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Soring Gmbh Medizintechnik Carl Alletto Submission Correspondent 1600 Manchester Way Corinth, Texas 76210
June 8, 2021
Re: K052183
Trade/Device Name: Soring Gmbh Sonoca Lipo Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Carl Alletto:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 7, 2005. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510/k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
OCT 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Soring GmbH Medizintechnik c/o Mr. Carl Alletto 1600 Manchester Way Corinth, Texas 76210
Re: K052183
Trade/Device Name: Soring, SONOCA-Lipo Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: August 7, 2005 Received: August 15, 2005
Dear Mr. Alletto:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2-Mr. Carl Alletto
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Barbara Inelund
for
Mark N. Molkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Soring, SONOCA-Lipo
Indications for Use:
The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring.
Typical users of this system are trained medical professionals.
Prescription Use VV (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
Oevbara Bacheupformm
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K052183
4
0C1 7 - 2005
K052183 Page 1/2
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
August 7, 2005
Submitter's Information:
Soring GmbH Medizintechnik Justus-v.Liebig 10 25451 Quickborn Germany
Telephone: 49 4106-5055 Fax: 49 4106-5271 Email: info@soering.com
Trade Name, Common Name, Classification:
| Trade name: | Soring GmbH, Sonoca™-Lipo |
|---|---|
| Common name: | Instrument, Ultrasonic Surgical |
| Classification name: | General and Plastic Surgery |
Predicate Device:
| DEVICE CLASSIFICATION
NAME | PUMP, PORTABLE,
ASPIRATION (MANUAL OR
POWERED) | SYSTEM, SUCTION,
LIPOPLASTY |
|-------------------------------|------------------------------------------------------|---------------------------------------------------------|
| REGULATION NUMBER | 878.4780 | 878.5040 |
| 510(K) NUMBER | K992026 | K041058 |
| DEVICE NAME | SORING GMBH, SONOCA
300 | MISONIX INC. LYSONIX
2000/3000 ULTRASONIC
SURGICA |
| APPLICANT | SORING GMBH | MISONIX, INC. |
| PRODUCT CODE | BTA AND LFL | MUU |
| DECISION DATE | 09/23/1999 | 05/17/2004 |
Device Description:
SONOCA Lipo™ is a modified version of the SONOCA 300 cleared by FDA under K992026 and can be used in two ways:
-
- As an ultrasonic dissector / aspirator as in the SONOCA 300 to cut, irrigate, and suction at the surgical site and
-
- As an alternative to conventional Lipectomy because it is a combination of a standard Lipectomy suction device and an Ultrasound assisted Lipectomy for the selective dissection of human fatty tissue.
5
K052183 page 2/2
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
The SONOCA Lipo™ is not an alternative to conventional surgery but a supplementary tool which provides an advantage for the selective dissection of human tissue.
The advantage of the SONOCA is that the tissue selectivity of the ultrasonically induced cutting effect limits the spectrum to organs with a large proportion of parenchyma in which sustentacular tissue is only minimally developed
During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.
The SONOCA Lipo™ can be trolley mounted or a desktop unit consisting of an ultrasonic generator, an infiltration pump and an aspiration pump. The nodular build of the electronic components allow the unit to function at a high capacity, totally free of electronic maintenance.
Indications for Use:
The SONOCA Lipo™ is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring. Typical users of this system are trained medical professionals.
Performance Data:
The subject and predicate devices have been designed and tested to pass the following Voluntary Standards: UL 260 1-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:1993 Electromagnetic Compatibility and FGC Part 18 EMC Requirement. The subject device complies with IEC 950 - Safety of Information Technology Equipment, CISPR 22, class A -- Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, IEEE 1003 . - General Pelectrical Safety for medical devices, IEC 601-1 -Electrical Safety for medical devices using RFpower, IEC 601-2-2- Ultrasonic surgical devices, DIN EN 61847
Conclusion:
Similar to the predicate devices, the SONOCA Lipo™ does not control any life sustaining functions or services. The new device and the predicate devices share the same conformance to performance standards and both function as Ultrasonic Dissectors. Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.