(66 days)
Not Found
No
The summary describes an electronic controller with software that controls the motion of a cannula, but there is no mention of AI, ML, or any related concepts. The performance studies focus on standard medical device testing (sterilization, biocompatibility, software testing, etc.), not AI/ML performance metrics.
Yes.
The device is intended for the removal of tissue or fluids from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring, which are therapeutic interventions.
No
The device description clearly states its intended use is for the removal of tissue or fluids during general surgical procedures, specifically suction lipoplasty for aesthetic body contouring. This describes a therapeutic or surgical function, not a diagnostic one (identifying a disease or condition).
No
The device description explicitly states that the system consists of three major components: an electronic Controller with software, an electronic Handpiece, and a reusable, sterilizable Cannula. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Sound Surgical Technologies LLC PowerX Lipo System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a system for physically removing tissue and fluids using a handpiece and cannula, connected to an aspiration source. This is a surgical tool, not a diagnostic test system.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The PowerX Lipo System is a surgical device used for a therapeutic/aesthetic procedure.
N/A
Intended Use / Indications for Use
The Sound Surgical Technologies LLC PowerX Lipo System is intended for the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
Product codes
QPB, MUU
Device Description
The Sound Surgical Technologies LLC (Sound) PowerX Lipo System (PowerX) consists of three major components: (1) an electronic Controller with software, (2) an electronic Handpiece, and (3) a reusable, sterilizable Cannula. The Handpiece is connected to the Controller and to an independent aspiration source. The Controller sends electronic signals to the Handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the Handpiece. The Sound PowerX is a prescription device, and is intended for use by trained medical personnel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel
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)
Performance Testing:
Sterilization: The Sound PowerX Handpiece and Cannulae are not provided sterile, but are sterilized by the user prior to use. The sterilization of the Handpiece and Cannulae was validated in accordance with: ISO 17665-1: 2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Test results indicate that the Sound PowerX complies with the standard.
Biocompatibility: The Sound PowerX Handpiece and Cannulae have patient contact materials and are made from medical grade biocompatible materials. Test results and analyses indicate that the Sound PowerX Handpiece and Cannulae materials comply in accordance with: ISO 10993-1: 2003, Biological evaluation of medical devices – Part 1: Evaluation and testing.
Software Testing: The Sound PowerX contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; and FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. Test results indicate that the Sound PowerX complies with its predetermined specification.
Electrical Safety: Was tested for patient safety in accordance with: IEC 60601-1:1988, Aml: 1991, Am2: 1995, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. Test results indicate that the Sound PowerX complies with the standards.
Electromagnetic Compatibility Testing: Was tested for EMC in accordance with: IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. Test results indicate that the Sound PowerX complies with the Standard.
Performance Testing - Bench: The Sound PowerX was tested for performance in accordance with its predetermined specifications as specified in Section 11, Device Description - Performance Specifications, of this submission. Test results indicate that the Sound PowerX complies with its predetermined specification.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Sound PowerX. The results of these activities demonstrate that the Sound PowerX is safe and effective when used in accordance with its intended use and labeling. Therefore, the Sound PowerX is considered substantially equivalent to the predicate 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
§ 878.5040 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sound Surgical Technologies LLC. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
June 9, 2021
Re: K110255
Trade/Device Name: Sound Surgical Technologies Llc Powerx Lipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Mark Job:
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 April 4, 2011. 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 Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sound Surgical Technologies LLC % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313
APR - 4 2011
Re: K110255
Trade/Device Name: Sound Surgical Technologies LLC PowerX Lipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 18, 2011 Received: March 21, 2011
Dear Mr. Job:
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
2
Page 2 - Mr. Mark Job
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,
Aling B. R. h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K 0255 |
|---|---|
| Device Name: | Sound Surgical Technologies LLC PowerX Lipo System |
| Indications for Use: | The Sound Surgical Technologies LLC PowerX Lipo System is |
| intended for the removal of tissue or fluids from the body during | |
| general surgical procedures including suction lipoplasty for the | |
| purpose of aesthetic body contouring. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kane fan MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110255
4
K 110255
1084
510(k) Summary
y
'APR - 4 2011
| Submission Date: | 13 January 2011 | ||
|---|---|---|---|
| Submitter: | Sound Surgical Technologies LLC | ||
| 357 South McCaslin Boulevard, Suite 100 | |||
| Louisville, CO 80027 | |||
| Submitter and | |||
| Official Contact: | Mr. Stephen C. Smith | ||
| Vice President of RA/QA | |||
| Sound Surgical Technologies LLC | |||
| 357 South McCaslin Boulevard, Suite 100 | |||
| Louisville, CO 80027 | |||
| +1 (720) 240-2970 | |||
| SSmith@soundsurgical.com | |||
| Manufacturing Site: | Sound Surgical Technologies LLC | ||
| 357 South McCaslin Boulevard, Suite 100 | |||
| Louisville, CO 80027 | |||
| Trade Name: | Sound Surgical Technologies LLC PowerX Lipo System | ||
| Common Name: | Power-Assisted Aspiration Cannula System | ||
| Classification Name: | System, Suction, Lipoplasty | ||
| Classification | |||
| Regulation: | 21 CFR §878.5040 | ||
| Product Code: | MUU | ||
| Substantially | |||
| Equivalent Devices: | Sound Model | Predicate 510(k) | |
| Number | Predicate Manufacturer | ||
| and Model | |||
| Sound PowerX | |||
| Lipo System | K012236 | KMI Kolster Methods, Inc. | |
| Store2000 Power Cannula |
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2 of 4
| Device Description: | The Sound Surgical Technologies LLC (Sound) PowerX Lipo System
(PowerX) consists of three major components: (1) an electronic
Controller with software, (2) an electronic Handpiece, and (3) a
reusable, sterilizable Cannula. The Handpiece is connected to the
Controller and to an independent aspiration source. The Controller
sends electronic signals to the Handpiece and thereby controls the
motion of the cannula that is fitted to the distal end of the Handpiece.
The Sound PowerX is a prescription device, and is intended for use by
trained medical personnel. | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use: | The Sound Surgical PowerX Lipo System is intended for the removal
of tissue or fluids from the body during general surgical procedures
including suction lipoplasty for the purpose of aesthetic body
contouring. | |
| Technology Comparison: | The Sound PowerX employs the same technological characteristics as
the predicate device with a few minor differences: | |
| | Predicate Device | Sound PowerX Lipo System |
| | Stepper motor in handpiece | Brushless DC motor in handpiece |
| | Direct drive cannula | Motor/gearbox drive arrangement |
| | Suction path through motor
shaft | Suction path offset from motor axis |
| | Graphical user interface | Seven-segment LED display user
interface |
| | Membrane switches/buttons | Rotary switches and knobs |
| Performance Testing: | | |
| Sterilization | The Sound PowerX Controller is not sterilized or sterilizable, and
therefore this section does not apply to the Controller. | |
| | The Sound PowerX Handpiece and Cannulae are not provided sterile,
but are sterilized by the user prior to use. The sterilization of the
Handpiece and Cannulae was validated in accordance with: | |
| | • ISO 17665-1: 2006, Sterilization of health care products - Moist
heat - Part 1: Requirements for the development, validation and
routine control of a sterilization process for medical devices. | |
| | Test results indicate that the Sound PowerX complies with the standard. | |
| Biocompatibility | The Sound PowerX Controller has no patient contact materials, and
therefore this section does not apply to the Controller.
The Sound PowerX Handpiece and Cannulae have patient contact
materials and are made from medical grade biocompatible materials.
Test results and analyses indicate that the Sound PowerX Handpiece
and Cannulae materials comply in accordance with:
ISO 10993-1: 2003, Biological evaluation of medical devices – Part
1: Evaluation and testing. | |
| Software Testing | The Sound PowerX contains MODERATE level of concern software.
Software was designed and developed according to a robust software
development process, and was rigorously verified and validated.
Software information is provided in accordance with:
FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; andFDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02.Test results indicate that the Sound PowerX complies with its
predetermined specification. | |
| Electrical Safety | The Sound PowerX was tested for patient safety in accordance with:
IEC 60601-1:1988, Aml: 1991, Am2: 1995, Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance.IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8:
General requirements for safety – Collateral standard: General
requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systemsTest results indicate that the Sound PowerX complies with the
standards. | |
| Electromagnetic
Compatibility Testing | The Sound PowerX was tested for EMC in accordance with:
IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:
General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests.Test results indicate that the Sound PowerX complies with the
Standard. | |
| Performance Testing
- Bench | The Sound PowerX was tested for performance in accordance with its
predetermined specifications as specified in Section 11, Device
Description - Performance Specifications, of this submission. | |
| | Test results indicate that the Sound PowerX complies with its
predetermined specification. | |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of the Sound PowerX. The
results of these activities demonstrate that the Sound PowerX is safe
and effective when used in accordance with its intended use and
labeling. | |
| | Therefore, the Sound PowerX is considered substantially equivalent to
the predicate device. | |
.
り
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K 110255
3.F4
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ાન વિદ્યાર તેમ જ દિવેલા ગુજરાત રાજ્યના દિવસાય ખેતી ખેત
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