(66 days)
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.
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.
The provided document is a 510(k) summary for the Sound Surgical Technologies LLC PowerX Lipo System. It describes the device, its intended use, and various performance tests conducted to demonstrate its safety and effectiveness. However, it does not include information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic accuracy, which is typically what such a request implies.
The "Performance Testing" section states that "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." However, Section 11 is not provided in the snippet, so the specific performance specifications are unknown.
The document does provide information on acceptance criteria and testing for aspects like sterilization, biocompatibility, software validation, electrical safety, and electromagnetic compatibility. This is generally summarized as compliance with recognized standards.
Here's a breakdown of the information that can be extracted from the provided text, and significant gaps where information related to diagnostic accuracy would typically be found:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, specific performance specifications for the device's primary function (tissue/fluid removal) are not detailed in the provided excerpt beyond a general statement of compliance. The other "performance" criteria relate to general medical device safety and functionality.
| Acceptance Criteria Category | Specific Criterion (if given) | Reported Device Performance |
|---|---|---|
| Primary Device Performance | Predetermined specifications (not detailed in this document) | Complies with its predetermined specification (as stated in "Performance Testing - Bench") |
| Sterilization | Compliance with ISO 17665-1: 2006 (Moist heat sterilization for medical devices) | Complies with the standard |
| Biocompatibility | Compliance with ISO 10993-1: 2003 (Biological evaluation of medical devices) | Complies in accordance with the standard |
| Software Testing | Compliance with FDA guidance for software in medical devices (May 11, 2005) and general principles of software validation (Jan 11, 2002). Predetermined specification. | Robust software development, rigorously verified and validated. Complies with its predetermined specification. |
| Electrical Safety | Compliance with IEC 60601-1:1988, Aml: 1991, Am2: 1995 (General requirements for basic safety and essential performance) and IEC 60601-1-8: 2006 (Alarm systems) | Complies with the standards |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2007 (Requirements and tests) | Complies with the Standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document for any of the performance tests. The document refers to "test results" but does not detail the nature of these tests in terms of sample size or data provenance that would be typical for a diagnostic accuracy study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The device is a "Suction lipoplasty system" meant for "removal of tissue or fluids," not a diagnostic device that relies on expert interpretation of output to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for the same reasons as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. The device is not a diagnostic AI system, and therefore, MRMC studies and AI assistance metrics are not relevant to its evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided as it is not a diagnostic algorithm. The device itself is standalone in its mechanical/electronic function, but this question typically refers to the performance of a diagnostic algorithm in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of diagnostic "ground truth." The "ground truth" for the device's technical performance would be its ability to meet its engineering specifications (e.g., proper motor function, suction power, sterilization efficacy), which are implicitly based on established engineering principles and medical device standards.
8. The sample size for the training set
This information is not applicable/not provided. This question typically refers to the development of machine learning algorithms. The device's software is stated to be designed and developed "according to a robust software development process" and "rigorously verified and validated," implying standard software engineering practices rather than machine learning training sets.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
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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
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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
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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
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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 isintended for the removal of tissue or fluids from the body duringgeneral surgical procedures including suction lipoplasty for thepurpose 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
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K 110255
1084
510(k) Summary
y
'APR - 4 2011
| Submission Date: | 13 January 2011 | ||
|---|---|---|---|
| Submitter: | Sound Surgical Technologies LLC357 South McCaslin Boulevard, Suite 100Louisville, CO 80027 | ||
| Submitter andOfficial Contact: | Mr. Stephen C. SmithVice President of RA/QASound Surgical Technologies LLC357 South McCaslin Boulevard, Suite 100Louisville, CO 80027+1 (720) 240-2970SSmith@soundsurgical.com | ||
| Manufacturing Site: | Sound Surgical Technologies LLC357 South McCaslin Boulevard, Suite 100Louisville, CO 80027 | ||
| Trade Name: | Sound Surgical Technologies LLC PowerX Lipo System | ||
| Common Name: | Power-Assisted Aspiration Cannula System | ||
| Classification Name: | System, Suction, Lipoplasty | ||
| ClassificationRegulation: | 21 CFR §878.5040 | ||
| Product Code: | MUU | ||
| SubstantiallyEquivalent Devices: | Sound Model | Predicate 510(k)Number | Predicate Manufacturerand Model |
| Sound PowerXLipo System | K012236 | KMI Kolster Methods, Inc.Store2000 Power Cannula |
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| Device Description: | The Sound Surgical Technologies LLC (Sound) PowerX Lipo System(PowerX) consists of three major components: (1) an electronicController with software, (2) an electronic Handpiece, and (3) areusable, sterilizable Cannula. The Handpiece is connected to theController and to an independent aspiration source. The Controllersends electronic signals to the Handpiece and thereby controls themotion 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 bytrained medical personnel. | |
|---|---|---|
| Intended Use: | The Sound Surgical PowerX Lipo System is intended for the removalof tissue or fluids from the body during general surgical proceduresincluding suction lipoplasty for the purpose of aesthetic bodycontouring. | |
| Technology Comparison: | The Sound PowerX employs the same technological characteristics asthe 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 motorshaft | Suction path offset from motor axis | |
| Graphical user interface | Seven-segment LED display userinterface | |
| Membrane switches/buttons | Rotary switches and knobs | |
| Performance Testing: | ||
| Sterilization | The Sound PowerX Controller is not sterilized or sterilizable, andtherefore 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 theHandpiece and Cannulae was validated in accordance with: | ||
| • ISO 17665-1: 2006, Sterilization of health care products - Moistheat - Part 1: Requirements for the development, validation androutine 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, andtherefore this section does not apply to the Controller.The Sound PowerX Handpiece and Cannulae have patient contactmaterials and are made from medical grade biocompatible materials.Test results and analyses indicate that the Sound PowerX Handpieceand Cannulae materials comply in accordance with:ISO 10993-1: 2003, Biological evaluation of medical devices – Part1: Evaluation and testing. | |
| Software Testing | The Sound PowerX contains MODERATE level of concern software.Software was designed and developed according to a robust softwaredevelopment process, and was rigorously verified and validated.Software information is provided in accordance with:FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05; andFDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02.Test results indicate that the Sound PowerX complies with itspredetermined specification. | |
| Electrical Safety | The Sound PowerX was tested for patient safety in accordance with:IEC 60601-1:1988, Aml: 1991, Am2: 1995, Medical electricalequipment - Part 1: General requirements for basic safety andessential performance.IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8:General requirements for safety – Collateral standard: Generalrequirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systemsTest results indicate that the Sound PowerX complies with thestandards. | |
| ElectromagneticCompatibility 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 theStandard. | |
| Performance Testing- Bench | The Sound PowerX was tested for performance in accordance with itspredetermined specifications as specified in Section 11, DeviceDescription - Performance Specifications, of this submission. | |
| Test results indicate that the Sound PowerX complies with itspredetermined specification. | ||
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the Sound PowerX. Theresults of these activities demonstrate that the Sound PowerX is safeand effective when used in accordance with its intended use andlabeling. | |
| Therefore, the Sound PowerX is considered substantially equivalent tothe predicate device. |
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K 110255
3.F4
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ાન વિદ્યાર તેમ જ દિવેલા ગુજરાત રાજ્યના દિવસાય ખેતી ખેત
ﮯ ﻧ
§ 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.