(57 days)
The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
The PowerX Lipo System consists of three components: electronic controller with software, handpiece, and 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 provided document is a 510(k) Pre-Market Notification for the PowerX Lipo System. It claims substantial equivalence to a predicate device, K110255, also named PowerX Lipo System.
This document describes a medical device (a suction lipoplasty system) rather than an AI/ML-driven diagnostic or prognostic device. Therefore, the typical acceptance criteria and study designs involving AI performance metrics (like sensitivity, specificity, AUC, human-in-the-loop studies, multi-reader multi-case studies, expert consensus for ground truth) as outlined in the prompt are not applicable to this submission.
The "acceptance criteria" for this device are based on its substantial equivalence to a predicate device, meaning it has the same intended use, similar technological characteristics, and safety and effectiveness profiles when tested against applicable non-clinical standards.
Here's how to interpret the provided information in the context of a 510(k) for a medical device:
1. A table of acceptance criteria and the reported device performance:
The "acceptance criteria" here relate to the device meeting performance specifications and safety standards comparable to the predicate device. The document explicitly states:
| Characteristic | Subject Device PowerX Lipo System | Predicate K110255 |
|---|---|---|
| Intended Use | Removal of tissue or fluid from the body | Identical to subject device |
| Operating Frequency | 36kHz Nominal | Identical to subject device |
| Suction Vacuum (max) | 20 inHg at 5,000 ft | Identical to subject device |
| Cannula dimensions | 1-6 mm diameter 7-40 cm length | 2.4 -4.6 mm diameter 17 – 34 cm length |
And also lists compliance with electrical standards:
| Standard | Description | Reported Performance / Compliance |
|---|---|---|
| IEC 60601-1:2005/AM1:2012 | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance | Demonstrated compliance |
| ISO 10079-1:2015 | Medical suction equipment -- Part 1: Electrically powered suction equipment | Demonstrated compliance |
| Cannula deformation resistance | $20°±5°$ and straightening without the shaft exhibiting any fractures, sharp edges, or loss of suction performance | Demonstrated compliance |
| Suction Vacuum (max) | 20 inHg at 5,000 ft | Confirmed performance |
2. Sample size used for the test set and the data provenance:
For this type of device, a "test set" in the AI/ML sense (e.g., a set of medical images) is not applicable. The testing here refers to engineering and bench testing to demonstrate compliance with performance and safety standards. The document does not specify sample sizes for these tests (e.g., how many cannulas were tested for deformation resistance), but often these are done on a representative sample to ensure manufacturing quality and design verification. Data provenance is not specified as it's not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context is established by engineering specifications, international standards (IEC, ISO), and performance testing rather than expert medical interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring adjudication of diagnostic findings.
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:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by engineering specifications, regulatory standards (e.g., IEC 60601-1, ISO 10079-1), and the performance characteristics of the predicate device. For example, a "ground truth" for suction vacuum might be a calibrated pressure gauge reading that matches the specified 20 inHg.
8. The sample size for the training set:
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a standard 510(k) submission for a traditional medical device (suction lipoplasty system). The "acceptance criteria" are met by demonstrating substantial equivalence to a legally marketed predicate device through engineering and non-clinical performance testing against established safety and performance standards. The questions related to AI/ML software performance are not relevant to this specific device submission.
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June 9, 2021
Solta Medical % Manal Morcos Senior Director Regulatory Affairs, Surgical Equipment & Devices Manal Morcos, MS BME, MBA 400 Somerset Corporate Boulevard Bridgewater, New Jersev 08807
Re: K190555
Trade/Device Name: PowerX Lipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Manal Morcos:
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 May 1, 2019. 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/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & 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.
May 1, 2019
Solta Medical % Ms. Marci Halevi Senior Director Regulatory Affairs, Surgical Equipment & Devices 400 Somerset Corporate Boulevard Bridgewater, New Jersey 08807
Re: K190555
Trade/Device Name: PowerX Lipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 5, 2019 Received: March 5, 2019
Dear Ms. Halevi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph A Nielsen
igitally signed by Joseph A. Nielse J: cn=Joseph A. Nielsen, o=FDA -iosenh nielsen@fda hhs go te: 2019.05.01 07:26:32 -04'00
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K190555
Device Name PowerX Lipo System
Indications for Use (Describe)
The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K190555
- General Information Submitter:
Solta Medical Inc. 11720 North Creek Pkwy N., Suite 100 Bothell, WA 98011 Tel: 510-259-5299
Contact Person: Marci Halevi Director, Regulatory Affairs 400 Somerset Corporate Boulevard Bridgewater, New Jersey 08807 Phone: 908-541-8695 Marci.Halevi@bauschhealth.com
Preparation Date: 2. Names
Classification Name
Common Name: CFR References:
Product Codes:
Device Name
PowerX Lipo System System, Suction, Lipoplasty Suction lipoplasty system 21 CFR 878.5040 MUU No performance standards for this device.
April 26, 2019
-
- Predicate Device
Performance Standards:
- Predicate Device
K110255 PowerX Lipo System
-
- Product Description
The subject of this Special 510(k) submission is for the PowerX Lipo System which is substantially equivalent to the predicate PowerX Lipo System.
- Product Description
The PowerX Lipo System consists of three components: electronic controller with software, handpiece, and 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.
-
- Indications for Use
The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
- Indications for Use
-
- Summary of Technological Characteristics
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| Characteristic | Subject DevicePowerX LipoSystem | PredicateK110255 |
|---|---|---|
| Intended Use | Removal of tissueor fluid from thebody | Identical tosubject device |
| OperatingFrequency | 36kHz Nominal | Identical tosubject device |
| Suction Vacuum(max) | 20 inHg at 5,000 ft | Identical to subject device |
| Cannuladimensions | 1-6 mm diameter7-40 cm length | 2.4 -4.6 mm diameter17 – 34 cm length |
The technological characteristics of the PowerX Lipo System are substantially equivalent to those of the predicate device.
-
- Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates the PowerX Lipo System is substantially equivalent to the predicate device.
- Safety and Effectiveness Information
-
- Brief Summary of Nonclinical Tests and Results
Safety tests of the System have demonstrated its compliance with applicable requirements of the following electrical standards:
- Brief Summary of Nonclinical Tests and Results
| IEC 60601-1:2005/AM1:2012 | Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance |
|---|---|
| ISO 10079-1:2015 | Medical suction equipment -- Part 1: Electrically poweredsuction equipment |
| Cannula deformationresistance | $20°±5°$ and straightening without the shaft exhibiting anyfractures, sharp edges, or loss of suction performance |
| Suction Vacuum (max) | 20 inHg at 5,000 ft |
9. Conclusion
The PowerX Lipo System shares the same indications for use, design features, and functional features, and thus is substantially equivalent to, the predicate device.
Non-clinical test results demonstrate that the PowerX Lipo System is substantially equivalent to the predicate device and no new issues of safety or effectiveness have been raised.
§ 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.