(104 days)
Aesthetic body contouring
The MicroAire PAL® Aspiration System provides an adjustable vacuum source that drives the suction of tissue during suction-assisted aesthetic body contouring procedures. The PAL Aspiration System features a modular style PAL® Aspiration Pump (ASP-PUMP-120/240) unit with a separate, stackable PAL® Aspiration Pump Console (ASP-UI) which provides organizational modularity and ease of transport within the medical facility. Communication between the units is achieved via the Aspiration Pump Cable (ASP-CBL). The PAL Aspiration Pump utilizes a dual-piston pump as a vacuum source that delivers 0-29 inHg and drives the suction of tissue. The PAL Aspiration Pump also features a multi-socket outlet (MSO) to provide power to up to four devices using the AC Power Cord Jumper Cable (ASP-CORD), eliminating extra power cords for better cable organization. The PAL Aspiration Pump Console is an electronic control system which allows the operator to digitally set and visualize the vacuum level. It also provides the status of basic pump operations, sends the Pump's ON/OFF signal, and provides receptacles for the connection of the Aspiration Pump Cable and optional accessories. The Aspiration Foot Switch (ASP-FOOT) and the 5020 to Aspiration Pump Cable (5020-ASP) are optional accessories which provide the operator with additional Aspiration Pump ON/OFF control options. The PAL Aspiration Pump requires a Biofilter (ASP-FLTR2), which prevents the ingress of vapor particulate into the motor. The Biofilter is a non-sterile filter assembly with vacuum tubing placed on the vacuum inlet. Connection to a system of generic collection canisters (sold separately) is expected for the PAL Aspiration System to function as intended. Additional Vacuum Tubing (ASP-TUBING) can be used to replace existing Biofilter tubing as needed.
The provided text is a 510(k) summary for the MicroAire PAL® Aspiration System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would for AI/ML devices.
Therefore, much of the requested information cannot be found in this type of regulatory submission. The device is a physical suction system, not an AI/ML device, which explains the absence of data related to AI/ML specific criteria.
Here's an analysis based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported device performance in a quantitative manner for specific benchmarks. Instead, it states that "The PAL Aspiration System passed all non-clinical bench testing, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."
It lists several voluntary consensus standards and FDA Guidance documents that the device complies with, which implicitly define the acceptance criteria for various aspects:
| Acceptance Criteria Category (Implied by Compliance) | Reported Device Performance (Implied by "passed all tests") |
|---|---|
| Electrical safety (IEC 60601-1) | Met |
| Electromagnetic Disturbance (IEC 60601-1-2 and IEC 60601-4-2) | Met |
| Essential Performance (IEC 60601-1-6) | Met |
| Software Verification (IEC 62304) | Met |
| Usability testing (IEC 62366-1) | Met |
| Safety testing for electrically powered suction pumps (ISO 10079-1) | Met |
| Vacuum performance | Met specified requirement |
| Free air flow | Met specified requirement |
| Noise | Met specified requirement |
| Reliability | Met specified requirement |
Note on "Maximum Vacuum" and "Maximum Flow Rate": While these are reported as characteristics in Table A, they are presented as comparative figures to the predicate device, not necessarily as acceptance criteria that were quantitatively "met" against a pre-defined threshold.
| Characteristic | Predicate Device Performance | Subject Device Performance |
|---|---|---|
| Maximum Vacuum | 27.5 inHg | 29 inHg |
| Maximum Flow Rate | 6.4 cfm | 2.12 cfm (60L/min) @ 60Hz 1.77 cfm (50L/min) @ 50Hz |
| Sound Level | 50 dB | 56.8 dBA |
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 applicable and not provided. The testing described is non-clinical bench testing of a physical device, not a study involving patient data or a "test set" in the context of AI/ML or clinical trials.
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 and not provided. As above, there is no "test set" requiring expert-established ground truth in the context of this device's non-clinical bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 and not provided. The device is a suction lipoplasty system, not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The device is a physical system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided. For non-clinical bench testing, the "ground truth" would be established by validated measurement equipment and adherence to engineering specifications and international standards.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for this type of device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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December 30, 2024
MicroAire Surgical Instruments, LLC Heather Crilly Senior Regulatory Affairs Specialist 3590 Grand Forks Blvd. Charlottesville, Virginia 22911
Re: K242804
Trade/Device Name: PAL® Aspiration System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB Dated: September 17, 2024 Received: December 5, 2024
Dear Heather Crilly:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely, Digitally signed by Alicia Alicia Hemphill Hemphill -S Date: 2024.12.30 20:29:46 -2 -06'00' Alicia L. Hemphill, M.S.
Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242804
Device Name PAL® Aspiration System
Indications for Use (Describe)
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
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for MicroAire PAL Aspiration System is provided below:
1. Submitter
MicroAire® Surgical Instruments, LLC. 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 USA
2. Primary Contact Person
Heather Crilly Senior Regulatory Affairs Specialist MicroAire® Surgical Instruments, LLC Phone: (434) 975-8024 Fax: (434) 975-4144 Email: heather.crilly@microaire.com
3. Date Prepared
August 30, 2024
4. Device Identification
| Trade/Proprietary Name: | PAL® Aspiration System |
|---|---|
| Common/Usual Name: | Aspiration System |
| Regulation Number: | 21 CFR 878.5040 |
| Regulation Name: | Suction lipoplasty system |
| Regulatory Class: | Class II |
| Product Code: | QPB |
| Classification Panel: | General and Plastic Surgery Device |
5. Predicate Device
Primary Predicate
Device name: K161722, Black & Black Surgical, Inc. Vitruvian Ultimate Aspirator This predicate has not been subjected to a design-related recall.
6. Device Description
The MicroAire PAL® Aspiration System provides an adjustable vacuum source that drives the suction of tissue during suction-assisted aesthetic body contouring procedures.
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The PAL Aspiration System features a modular style PAL® Aspiration Pump (ASP-PUMP-120/240) unit with a separate, stackable PAL® Aspiration Pump Console (ASP-UI) which provides organizational modularity and ease of transport within the medical facility. Communication between the units is achieved via the Aspiration Pump Cable (ASP-CBL).
The PAL Aspiration Pump utilizes a dual-piston pump as a vacuum source that delivers 0-29 inHg and drives the suction of tissue. The PAL Aspiration Pump also features a multi-socket outlet (MSO) to provide power to up to four devices using the AC Power Cord Jumper Cable (ASP-CORD), eliminating extra power cords for better cable organization.
The PAL Aspiration Pump Console is an electronic control system which allows the operator to digitally set and visualize the vacuum level. It also provides the status of basic pump operations, sends the Pump's ON/OFF signal, and provides receptacles for the connection of the Aspiration Pump Cable and optional accessories.
The Aspiration Foot Switch (ASP-FOOT) and the 5020 to Aspiration Pump Cable (5020-ASP) are optional accessories which provide the operator with additional Aspiration Pump ON/OFF control options.
The PAL Aspiration Pump requires a Biofilter (ASP-FLTR2), which prevents the ingress of vapor particulate into the motor. The Biofilter is a non-sterile filter assembly with vacuum tubing placed on the vacuum inlet. Connection to a system of generic collection canisters (sold separately) is expected for the PAL Aspiration System to function as intended. Additional Vacuum Tubing (ASP-TUBING) can be used to replace existing Biofilter tubing as needed.
7. Indications for Use Statement
Aesthetic body contouring.
8. Substantial Equivalence Comparison
The following Table A compares the subject device MicroAire Surgical PAL® Aspiration System with the predicate device Black & Black Surgical Vitruvian Ultimate Aspirator (K161722) with respect to indications for use, mechanisms of operation, technological characteristics, and performance testing forming the basis for the determination of substantial equivalence. The differences in the subject device as compared to the predicate device do not raise any new questions of safety or effectiveness.
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Table A
Comparison to Predicate
| Characteristic | Predicate DeviceVitruvian Ultimate Aspirator, K161722 | Subject DeviceMicroAire, TBD | Device Comparison |
|---|---|---|---|
| CLASSIFICATION & INDICATIONS | |||
| FDA Classification | Class II | Class II | Same |
| FDA Product Code | QPB | QPB | Same |
| FDA Classification Name | Suction Lipoplasty System | Suction Lipoplasty System | Same |
| Indications for Use | Aesthetic body contouring | Aesthetic body contouring | Same |
| Intended Use | Aesthetic body contouring | Aesthetic body contouring | Same |
| SUMMARY OF PHYSICAL CHARACTERISTICS | |||
| Housing | Powder Coated Steel | Powder Coated Steel | Same |
| Dimensions | LxWxH: 18"x18"x38" | ASP-PUMP-XXX (LxWxH):18.5"x15.8"x13.5"ASP-UI (LxWxH):14.0"x12.1"x5.2" | Similar |
| Weight | 100 lb | Pump = 67 lbControl = 10 lb | Similar |
| IV Pole for Solutions | IV Pole + Mount | None | Different |
| Filter Port | Yes | Yes | Same |
| SUMMARY OF TECHNOLOGICAL CHARACTERISTICS | |||
| Pump Type | Two-cylinder piston | Two-cylinder piston | Same |
| AC Power input | 120V, 60Hz230V, 50Hz | 115V, 60Hz (ASP-PUMP-120)230V, 50Hz (ASP-PUMP-240) | Similar |
| Display | Vacuum gauge w/ LED color graphic readout.Displays the current vacuum pressure in graphical (for inHg and mmHg) and digital (for inHg) format. | Non-touchscreen LCD digital readout of vacuum pressure (inHg and mmHg), target vacuum pressure settings, and Biofilter operational hours; as well as Information Signals to inform the user when to change the Biofilter, motor overtemp condition, and if the Pump is not functioning. | Different |
| Pressure Control | Knob to control vacuum | Knob to control vacuum and optional programmable membrane switches on Pump Control interface to preset/user defined values | Different |
| Footswitch | Dual activated air powered | Dual electric powered | Different |
| Remote WiredActivation | N/A | Remote wired ON/OFF vacuumPump activation throughMicroAire 5020 Console(component of Reference DevicePAL System, K212024). | Different |
| Safety Features(overflow valve) | Manual (canister) | Internal catch-can with fluidsensor cutoff | Similar |
| Filter Size | 0.3 Micron | 0.22 Micron | Similar |
| Maximum Vacuum | 27.5 inHg | 29 inHg | Different; see referencedevice comparison inTable B |
| Maximum FlowRate | 6.4 cfm | 2.12 cfm (60L/min) @ 60Hz1.77 cfm (50L/min) @ 50Hz | Different |
| Sound Level | 50 dB | 56.8 dBA | Similar |
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9. Performance Data
Non-clinical testing was performed to verify and validate the design of the PAL® Aspiration System against specified design requirements and to assure conformance with applicable recognized national consensus standards and FDA Guidance documents. The PAL Aspiration System passed all non-clinical bench testing, supporting its safety and effectiveness, and its substantial equivalence to the predicate device.
The PAL Aspiration System complies with all applicable voluntary consensus standards and FDA Guidance documents for electrical safety, electromagnetic compatibility, and safety of electrically powered suction pumps:
- . Electrical safety testing per IEC 60601-1
- . Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 and IEC 60601-4-2
Rev B
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- Essential Performance per IEC 60601-1-6
- . Software Verification per IEC 62304
- . Usability testing per IEC 62366-1
- . Safety testing for electrically powered suction pumps per ISO 10079-1
- . Bench Testing demonstrated that the specifications for vacuum performance, free air flow, noise, and reliability were met.
10. Clinical Performance Data
The PAL Aspiration System has not been the subject of clinical testing.
11. Conclusion
The Black & Black Vitruvian Ultimate Aspirator (K161722) and the MicroAire PAL® Aspiration System share the same Indications for Use, Intended Use, and similar overall technical and functional capabilities, and therefore the PAL Aspiration System demonstrates substantially equivalence to the predicate device.
§ 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.