(233 days)
Aesthetic Body Contouring
The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit.
The provided FDA 510(k) summary for the Vitruvian Liposaber pertains to a suction lipoplasty system, which is a physical device used for aesthetic body contouring. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data and comparison of technical specifications, rather than clinical studies involving human patients or AI performance metrics.
Therefore, the requested information regarding AI acceptance criteria, specific study designs (MRMC, standalone), human reader performance improvement, multi-expert ground truth establishment, training and test set sample sizes for AI, and adjudication methods is not applicable to this device and its 510(k) submission.
The document explicitly states: "No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for years. The non-clinical testing details in this submission support the substantial equivalence of the device." This confirms that the approval is based on equivalence to existing, commonly understood devices, not on novel AI performance.
Below is a summary of the acceptance criteria and device performance as demonstrated in this 510(k) in the context of the device's technical specifications and non-clinical testing.
Acceptance Criteria and Reported Device Performance (Non-Clinical) for Vitruvian Liposaber™
The Vitruvian Liposaber™ is a physical medical device (suction lipoplasty system). Its acceptance criteria and performance are demonstrated through comparison to a predicate device and non-clinical testing, as opposed to AI performance metrics.
1. Table of Acceptance Criteria (as implied by comparison to predicate and non-clinical testing) and the Reported Device Performance:
| Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (Subject Device: Vitruvian Liposaber™) |
|---|---|
| Intended Use Equivalence: Aesthetic Body Contouring | Aesthetic Body Contouring (Same as Predicate) |
| User Equivalence: Trained and experienced healthcare professionals | Healthcare professionals completely familiar with use of the device (Same as Predicate) |
| Mechanism of Action Equivalence: Electronic control system designed to reciprocate a cannula in lipoplasty applications. | Electronic control system designed to reciprocate a cannula in lipoplasty applications. (Same as Predicate) |
| Electrical Safety Compliance: Meet IEC 60601-1 standards | Complies with IEC 60601-1:2005 and IEC60601-1-2:2014+A1:2020 (Meets/Updates to applicable standards) |
| Electromagnetic Compatibility (EMC) Compliance: Meet IEC 60601-1-2 standards | Complies with IEC 60601-1-2:2014+A1:2020 (Meets/Updates to applicable standards) |
| Biocompatibility: Intended use compatible materials | Considered biocompatible per ISO 10993-1 |
| Software Verification and Validation: Per IEC 62304/FDA Software Guidance | Verification and validation per IEC 62304/FDA Software Guidance |
| System Functionality - Stroke Rate/RPM Display Accuracy: Accurate display of speed. | Stroke Rate/RPM Display Calibration Validation: Pass |
| System Functionality - Stroke Distance Validation: Cannula reciprocation within specified range. | Stroke Distance Validation: Pass (2.90 mm +/- 0.3mm) (Similar to Predicate 2.8mm ±0.4mm) |
| System Functionality - Dynamic and Static Load Performance: Ability to perform under expected loads. | Dynamic and Static Load Validation: Pass |
| System Functionality - Surface Temperature during Operation: Patient contacting surface temperature within safe limits. | <41°C (Same as Predicate) |
| Cleaning, Disinfection, and Sterilization (CDS): Ability to be cleaned, disinfected, and sterilized to produce a sterile reusable handpiece and cable. | Cleaning/Disinfection: Mild non-abrasive cleaner wipe down in IFU (Similar to predicate's validated wipe down) Sterilization: Autoclavable by end user, steam sterilization (Same as Predicate) Demonstrates process produces a reusable sterile handpiece and cable with a SAL of 10-6 |
| Performance - Speed Range: Within operative range for liposuction. | 3000 - 5000 strokes/min (Different from Predicate's 4000-5000 strokes/min, but deemed not to affect safety/effectiveness as it replaces manual motions) |
| Performance - Duty Cycle: Ability for continuous operation. | Continuous (Different from Predicate's 2 hours continuous use/2 hours rest, but non-clinical testing demonstrates capability) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of an AI test set. Performance was demonstrated through non-clinical engineering tests of the device prototypes, material testing, and comparative analysis to a predicate device.
- Data Provenance: The data arises from in-house engineering testing, bench testing, and laboratory studies conducted by the manufacturer, Black & Black Surgical, Inc. This is inherent to hardware device approval processes. No patient data (retrospective or prospective) was used for performance validation as no clinical study was conducted. The country of origin of the data is implicitly the USA, where the company is based and the testing would likely have occurred or been commissioned.
3. Number of Experts Used and Qualifications for Ground Truth and 4. Adjudication Method:
- Not applicable. This device is not an AI/software product requiring expert ground truth or adjudication for image interpretation or diagnosis. The "ground truth" for this device's performance is objective measurements from engineering tests (e.g., motor speed, temperature, dimensions, electrical safety compliance) and comparison to established predicate device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- Not applicable. MRMC studies are specific to evaluating AI in diagnostic imaging where human readers interpret cases with and without AI assistance. This device is a surgical instrument.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its "performance" is its mechanical and electrical function.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's approval is based on engineering specifications, compliance with recognized electrical and safety standards (e.g., IEC 60601-1, ISO 10993-1), and documented performance of a legally marketed predicate device. It relies on objective physical measurements and adherence to established regulatory and engineering principles.
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are iterative, informed by design inputs and testing, rather than a data-driven training paradigm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set or ground truth in the AI sense for this device. The design and validation are based on engineering principles, material science, and safety standards.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2024
Black & Black Surgical, Inc. Cynthia Rees Regulatory Manager 5175 South Royal Atlanta Dr. Tucker, Georgia 30084
Re: K240188
Trade/Device Name: Vitruvian LiposaberTM Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: QPB, Dated: January 23, 2024 Received: January 24, 2024
Dear Cynthia Rees:
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.
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"
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(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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, Alicia Hemphill -S
Digitally signed by Alicia Hemphill -S Date: 2024.09.13 18:03:30 -05'00'
Alicia Hemphill, MS 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) K240188
Device Name Vitruvian LiposaberTM
Indications for Use (Describe) Aesthetic Body Contouring
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 SMDA 1990, 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Vitruvian Liposaber™ is provided below.
-
- Submitter Information: Prepared: 12/08/2023
Est. Reg. #: 3006142527
- Submitter Information: Prepared: 12/08/2023
Norman M. Black, CEO, normanblack@blackandblacksurgical.com Black & Black Surgical, Inc. 5175 South Royal Atlanta Dr. Tucker, GA 30084 770-414-4880 T / 770-414-4879 F
Contact Person: Cynthia Rees, Regulatory Manager, crees@blackandblacksurgical.com
2. Device Identification:
Trade/Proprietary Name: Vitruvian Liposaber™ Common/Usual Name: Suction Lipoplasty System Classification Name: System, Suction, Lipoplasty for Removal Regulation Number: 878.5040 Product Code: QPB Device Class: Class II Classification Panel: General & Plastic Surgery
Substantial Equivalence: 3.
The Vitruvian Liposaber™ is substantially equivalent to the devices listed below in terms of use, design, operating principles, materials, and performance.
MicroAire PAL System, K212024
4. Device Description:
The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit.
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The Vitruvian Liposaber is a pre-assembled device consisting of:
Control Unit: Turns device power on and off and is attached to handpiece with a 10 ft cable. The Control Unit includes an interface to allow the user to change the motor speed between 3000 to 5000 RPM at 100 RPM steps and start and stop the cannula motion. The Control Unit is outside the sterile field.
- . Power Operation: 100-240VAC, 50-60Hz, 0.1-0.2A
- . Handpiece: Anodized aluminum body with stainless steel shaft to drive the cannula in a reciprocating motion. The handpiece is a reusable sterile component. The handpiece includes a user interface to allow the user to control the speed between 3000 – 4000 RPM and start and stop the canula motion.
- Display: LED
- Connecting Cable: Connects handpiece to control unit.
- Power Cord: Hospital Grade IEC 60320 .
- . Motor: DC
- ട. Indications for Use: Aesthetic Body Contouring
-
- Comparison to Predicate
Control Unit Comparison Chart
| Item | Predicate Device | Subject Device | Similarity |
|---|---|---|---|
| Device name | MicroAire PAL System | Vitruvian Liposaber | N/A |
| Device Manufacturer | MicroAire Surgical Instruments, LLC | Black & Black Surgical, Inc. | N/A |
| 510(k) Reference | K212024 | K240188 | N/A |
| Image | Image: MicroAire PAL System | Image: Vitruvian Liposaber | N/A |
| FDA Product Code | QPB | QPB | Same |
| FDA Classification | System, Suction, Lipoplasty forRemoval | System, Suction, Lipoplasty forRemoval | Same |
| FDA Regulation # | 21 CFR 878.5040 Class II | 21 CFR 878.5040 Class II | Same |
| Indication for Use /Intended Use | For Aesthetic body contouring. | Aesthetic body contouring. | Same |
| Device Overview | |||
| User | Only trained and experiencedhealthcare providers/professionalsshould use this medical equipment. | Should only be handled andoperated by healthcareprofessionals completely familiarwith use of the device. | Same |
| Mechanism of Action | MicroAire power assisted liposuctionis an electronic control systemdesigned to reciprocate a cannula inlipoplasty applications. | The Vitruvian Liposaber is anelectronic control systemdesigned to reciprocate acannula in lipoplasty applications. | Same |
| Item | Predicate Device | Subject Device | Similarity |
| Display | The color touch screen displayprovides an intuitive graphical userinterface that allows users to viewsystem status and set parameterswith a touch of the screen. | LED Display of the speed of themotor in stroke per minute (RPM) | Similar |
| Speed Control | Touch screen Handpiece | Control Unit Buttons Handpiece | Similar |
| Physical Characteristics | |||
| Dimensions | 304.8 mm x 355.6 mm x152.4 mm | 168 mm x 125 mm x 185 mm | Different - Dimensionalphysical characteristics do notaffect the safety andeffectiveness of thedevice. |
| Weight | 6.35 kg | 1.7 kg | Different - Weight variancerelated to physicalcharacteristics does not affectthe safety and effectivenessof the device. |
| Display | Color Touchscreen Display | LED Display | Similar |
| AC Powered | 100 VAC - 240 VAC, 50/60 Hz | 100-240 VAC, 50/60Hz | Same |
| Number of AttachableDevices | Two (2) Handpieces | One (1) Handpiece | Different - A singlehandpiece connects to theVitruvian Liposaber System toperform liposuctionprocedures only. Thisdifference does not affectSafety and effectiveness dueto the mode of operation. |
| Safety and Performance Testing | |||
| ElectricalSafetyTests Passed | IEC/EN 60601-1-2:2014IEC 60601-1:2005IEC 60601-1-6:2013IEC 62366: 2015 | IEC60601-1-2:2014+A1:2020AAMI ES 60601-1:2005IEC 60601-1-6:2010 AMD1:2013IEC 62366:2007 A1: 2014 | Same |
| Performance | 4000 - 5000 strokes/min. | 3000 - 5000 strokes/min. | Different - This differencedoes not affect Safety andeffectiveness due to themode of operation. Thedevice is intended to replacethe same manual motionsmade by the physician duringa liposuction procedure. |
| Reuse | |||
| Cleaning/Disinfecting | Validated germicidal wipe downmethod in IFU | Mild non-abrasive cleaner wipedown in IFU | Similar |
| Operating Environment | |||
| Temperature | 15°C to +24°C | 0 deg C to + 40 deg C | Similar |
| Item | Predicate Device | Subject Device | Similarity |
| Humidity | 20%-60% | <80% | Similar |
| Handpiece Comparison | |||
| Item | Predicate Device | Subject Device | Similarity |
| Device name | PAL-650 Handpiece and 5006-PALCable | Vitruvian Liposaber Handpieceand Cable | N/A |
| Device Manufacturer | MicroAire Surgical Instruments, LLC | Black & Black Surgical, Inc. | N/A |
| Device Overview | |||
| Image | Image: PAL-650 Handpiece | Image: Vitruvian Liposaber Handpiece | N/A |
| User | Use of this device is limited to thosephysicians who, by means of formalprofessional training or sanctionedcontinuing medical education(including supervised operativeexperience), have attainedproficiency in suction Lipoplasty. | Use of this device is limited tothose physicians who, by meansof formal professional training orsanctioned continuing medicaleducation (including supervisedoperative experience), haveattained proficiency in suctionLipoplasty. | Same |
| Mechanism of Action | The PAL-650 is a powered surgicalinstrument that reciprocates acannula used in liposuctionprocedures. | The Vitruvian Liposaberhandpiece is a powered surgicalinstrument that reciprocates acannula used in liposuctionprocedures. | Same |
| TechnologyOverview | The reciprocating output shaft of thehandpiece drives the cannulathrough a stroke distance of 2.8 mm(±0.4 mm) at a rate of 4,000 to 5,000strokes/minute. | The reciprocating output shaft ofthe handpiece drives the cannulathrough a stroke distance of 2.90mm (+/- 0.3mm) at a rate of3,000 to 5,000 strokes/minute. | Similar |
| Physical Characteristics | |||
| Dimensions | 25 mm x 38 mm x 250 mm (width xthickness x length) [45.5 mm x 250mm ~ equivalent diameter x lengthenvelope] | 30 mm x 40 mm x 250mm (WxHxD) | Similar |
| Weight | 0.5 kg (Handpiece) | 0.8 kg (Handpiece and Cable) | Similar |
| 0.28 kg (Cable) | |||
| Power Source | Console, detachable cable. | Console, detachable cable. | Same |
| Performance | |||
| Duty Cycle | Duty cycle of 2 hours continuoususe/ 2 hours. | Continuous | Different - non-clinicalperformance testdemonstrates ability toperform continuously.Difference does not raise newissues of safety andperformance. |
| Item | Predicate Device | Subject Device | Similarity |
| Patient ContactingSurface Temperatureduring Operation | <41°C | <41°C | Same |
| Reuse | |||
| Cleaning | ManualAutomated | Manual | Similar |
| Sterilization | Handpiece and cable areAutoclavable by end user, steamsterilization | Handpiece and cable areAutoclavable by end user, steamsterilization | Same |
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7. Non-Clinical Performance Data
To demonstrate substantial equivalence of the Vitruvian Liposaber System to the predicate device, Black & Black Surgical completed the following non-clinical tests. The results confirm the design inputs and performance specifications for the device are met. The Vitruvian Liposaber System was tested according to the internal design requirements, national standards, and international standards referenced below, supporting that the device is substantial equivalence to the predicate device.
- Biological evaluation per ISO 10993 – 1: The Vitruvian Liposaber instrument cable was considered biocompatible for the intended use.
- -Electrical safety testing per IEC 60601-1 – the Vitruvian Liposaber System was found to comply with the requirements of the electrical safety standard.
- -Electromagnetic Compatibility testing per IEC 60601-1-2: The Vitruvian Liposaber System demonstrated compliance to complied with the requirements of IEC 60601-1-2
- -Software verification and validation per IEC 62304/FDA Software Guidance
- -Functionality Verification Testing
- Stroke Rate/RPM Display Calibration Validation Pass O
- O Stroke Distance Validation - Pass
- Dynamic and Static Load Validation Pass O
- Surface Temperature Validation Pass O
- -Cleaning, Disinfection and Sterilization demonstrate the process produces a reusable sterile handpiece and cable with a SAL of 10-6
8. Clinical Performance Data
No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for years. The non- clinical testing details in this submission support the substantial equivalence of the device.
Statement of Substantial Equivalence
The Vitruvian Liposaber System, the subject device, has the same intended use and similar technological characteristics have been compared and contrasted with the predicate device. Nonclinical testing demonstrates the Vitruvian Liposaber System is substantially equivalent to the predicate device. Therefore, with the same intended use, similar technology and performance, the Vitruvian Liposaber System is substantially equivalent 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.