The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.

This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

Device Description

The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the MINISCAV™ device, based on the provided document:

The document describes a 510(k) premarket notification for the MINISCAV™ waste gas evacuation apparatus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical efficacy studies in the same way a PMA would. Therefore, the "study" mentioned here refers primarily to the non-clinical testing performed to show the device meets its performance specifications and is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format for each performance aspect. Instead, it describes various tests and what they demonstrated. I've extracted the implied criteria and the reported performance from the "Non-Clinical Testing Summary" and "Technology, Construction, Performance" sections.

Acceptance Criteria Category	Specific Criterion / Requirement	Reported Device Performance
Electrical Safety	Compliance with AAMI/ANSI/ES60601-1 standard.	Demonstrated compliance with AAMI/ANSI/ES60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 standard.	Demonstrated compliance with IEC 60601-1-2.
Durability - Continuous Running	Maintain specifications for at least 10,000 hours of continuous running.	Continuous running demonstrated the vacuum pump stays within its specifications for at least 10,000 hours.
Durability - Real-time Unit Life	Meet performance specifications after 2 years of use.	Real-time testing of the complete unit supports that the device meets its performance specifications after 2 years use.
Vacuum and Flow - Constant Vacuum	Provide a constant vacuum of <= 90 mmHg.	Testing demonstrates that the device provides a constant vacuum of <= 90 mmHg.
Vacuum and Flow - Flow Rate	Provide a constant flow rate of 42 Lpm +/- 5 Lpm, sufficient for scavenging.	Testing demonstrates that the device provides a constant Flow rate of 42 Lpm +/- 5 Lpm, which has been deemed sufficient for scavenging waste gases from nitrous oxide / oxygen delivery equipment.
Vacuum and Flow - Tubing Length	Determine the maximum length of exhaust tubing.	Testing to determine maximum length of exhaust tubing was performed (specific length not provided in this summary but implies successful determination).
Leakage	No leaks and meet performance specifications after 2 years.	Testing demonstrates that after 2 years the unit has no leaks and meets its performance specifications.
Oxygen Rich Environment	Compliance with IEC 60601-1 section 11.2.2 requirements (e.g., related to oxygen build-up).	Risk analysis of critical components, oxygen build-up in housing, and construction/separation of housing/components support compliance to IEC 60601-1 section 11.2.2, clause 1.b(3).
Compatibility	Compatibility with specified analgesia systems (Porter, Accutron, Nitronox).	Demonstrated compatibility with Porter, Accutron, and Nitronox analgesia systems.
Risk Mitigation (Vacuum Failure)	Validate ability to expel gases at specified vacuum pressures, mitigating risks from vacuum failure.	The device validates the ability to expel gases at specified vacuum pressures, mitigating risks associated with failure to vacuum (as stated in the "Technology, Construction, Performance" section comparing it to the Dundas predicate). This implies it meets the functional requirement for safe gas evacuation.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in terms of a number of devices tested for each non-clinical test. It mentions "continuous running," "real-time testing of the complete unit," and "testing demonstrates" but doesn't give precise quantities like "n=X devices were tested." This is common for this type of non-clinical device testing, where the focus is on design verification and validation rather than statistical sampling of many units.
Data Provenance: Not explicitly stated, but given it's a device manufactured by Sedation Systems LLC in Florida, the non-clinical testing was likely conducted in the USA or by a contracted lab. The document does not indicate if the data is retrospective or prospective; for non-clinical lab testing, this distinction is less relevant than for clinical studies. It's direct testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

This information is not applicable and not provided in the document.

The "test set" here refers to the physical MINISCAV™ devices (or prototypes/components) undergoing non-clinical validation. There isn't a "ground truth" established by experts in the context of an AI/human-in-the-loop study. The "ground truth" for the performance specifications is determined by established engineering standards (e.g., AAMI/ANSI/ES60601-1, IEC 60601-1-2) and the manufacturer's own design specifications, which are then validated through objective measurements (e.g., pressure gauges, flow meters, electrical testers, timers).

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or expert review processes, especially for establishing ground truth for diagnostic AI, which is not the nature of this submission. The non-clinical tests involve objective measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for diagnostic medical devices, especially those using AI, to compare the performance of human readers with and without AI assistance on a set of clinical cases. The MINISCAV™ is a waste gas evacuation apparatus, a piece of mechanical/electrical equipment, not a diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable.

The MINISCAV™ is a physical medical device (vacuum pump), not an algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate. Its operation is standalone in the sense that it mechanically performs its function without a human intervening in its internal mechanism once activated, but it is operated by a human in a clinical setting.

7. Type of Ground Truth Used

As discussed in point 3, the "ground truth" here is based on engineering and performance specifications derived from international standards (AAMI/ANSI/ES60601-1, IEC 60601-1-2) and the functional requirements for waste gas scavenging. This is objectively measurable data from physical testing, not expert consensus on clinical cases, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable.

This device does not involve a "training set" in the context of machine learning or AI. The MINISCAV™ is a designed and engineered product, not a system that is "trained" on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

As there is no training set for an AI/ML algorithm, there is no ground truth established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or movement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 5, 2017

Sedation Systems LLC % Paul Dryden Consultant, Promedic LLC 2471 McMullen Booth Rd., Ste. 316 Clearwater, Florida 33759

Re: K160950

Trade/Device Name: MINISCAVTM Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: Class II Product Code: CBN, BTA Dated: April 27, 2017 Received: May 1, 2017

Dear Paul Dryden:

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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K160950

Device Name

MINISCAVTM

Indications for Use (Describe)

This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (8/14)

Page 1 of 1

EF PSC Publishing Services (301) 443-6740

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Sedation Systems LLC 2471 McMullen Booth Rd., Suite 316 Clearwater, FL 33759

Tel – 888-959-5288

Official Contact:	S. Michael Bender, Managing Member
Proprietary or Trade Name:	MINISCAV™
Common/Usual Name:	Apparatus, Gas Scavenging
Classification Name /Product Classification	Apparatus, Gas ScavengingCBN, 21CFR 868.5430, Class II
Predicate Devices:	G. Dundas, Active Waste Gas Scavenger System, K11093Medela, Dominant Flex Suction Pumps, K150134

Device Description:

Indications for Use:

The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures of nitrous oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.

This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

Feature	PredicateG. DundasActive Waste GasScavenger SystemK110930	PredicateMedelaDominant FlexSuction PumpsK150134	ProposedMINISCAVTM
Product Classification	CBNCFR 868.5430Gas scavengingapparatusClass II	BTACFR 878.4780Powered suction pumpClass II	CBNCFR 868.5430Gas scavenging apparatusClass II
Indications for Use	The Waste GasScavenger is designedfor use with vacuum(suction) waste gasdisposal systems withanesthesia machinesand heart/lung bypass	The Dominant FlexSuction Pump isindicated for vacuumextraction, aestheticbody contouring,aspiration duringflexible endoscopy, and	The MINISCAVTM wastegas evacuation apparatusis intended to removepatients' exhaled wastegases during procedureswhere analgesia isadministered to a patient

Table 1 Substantial equivalence Comparison to Predicates

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510(k) Summary 5-May-17

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	machines.	aspiration and removalof surgical fluids, tissue(including bone), gases,bodily fluids orinfectious materialsfrom wounds or from apatient's airway orrespiratory supportsystem either duringsurgery or at the beside.	via inspiration ofmixtures of nitrous oxideand oxygen from anitrous oxide / oxygendelivery device. Notintended for use withflammable anestheticgases.This device is intendedfor professional use onlyin healthcare facilities,clinics, and physician anddentist offices.
Environment of Use	Healthcare facilities,clinics and physicianand dentist offices.	Healthcare facilitiesand clinics
Used with flammableanesthetic gases	No	No	No
Requires a vacuumsource	Yes, connects to anyvacuum sourceCentral supply / wall /Portable pump	Portable vacuum source	Portable vacuum sourceto connect to a waste gasscavenging apparatus tosupply the vacuum source
Means of connection	A flexible vacuum hosefrom the device to thevacuum source	Connects a flexiblehose from this pump toany device requiring avacuum source, i.e., gasscavenging apparatus	Connects a flexible hosefrom this pump to a gasscavenging apparatus
Fittings	19 mmHose barb for vacuum	Hose barb for vacuum	19 mmHose barb for vacuum
Vacuum pressuresFlow rate	Can accept a range ofapplied vacuum as it norange limit specified	Up to -700 mmHg	90 mmHg42 Lpm +/- 5 LpmConnects to a nitrousoxide/ oxygen flowmeterexhaust port
Technology	Passive device whichrequires connection to avacuum source	Piston / cylinder designPortable	Diaphragm designPortable

Substantial Equivalence Discussion -

Table 1 above compares the key features of the proposed MINISCA V™ with the identified predicate and reference to demonstrate that the proposed device can be found to be substantially equivalent.

Indications for Use -

While the indications for use are not identical to that of the predicate device (K110930), the subject device and Dundas predicate are intended to remove waste gases from anesthesia gas machine system..

Discussion - The MINISCAV™ is one part of a waste gas scavenging system. The parts include: (1) a scavenger to titrate exhaust gas flow from the patient circuit, which is connected to (2) a vacuum source. This device is intended to scavenge gas, which the same as the intended use of the predicate Dundas scavenger.

Technology, Construction, Performance -

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The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases. The Dundas scavenger (K110930) is a flowmeter that titrates exhaust flow with wall-supplied vacuum sources. While the Dundas scavenger does not supply the vacuum, both the MINISCAV and Dundas devices validate the ability to expel gases at specified vacuum pressures, mitigating risks associated with failure to vacuum. Therefore, the MINISCAV™ does not raise different concerns of safety or effectiveness for substantial equivalence.

The Medela Dominant Flex Suction Pump (K150134) is pump with an adjustable vacuum flow as high as -700 mmHg. The Medela includes indications to remove gases from respiratory support svstems, which the MINISCAV also performs by providing vacuum via a separate gas scavenger, Therefore, both devices are validated for vacuum specifications. Although different technologies (vacuum range -700mmHg compared to -90mmHg) exist, these differences do not raise different questions of safety and effectiveness.

Environment of Use -

The environments of use are similar to the predicate Medela Dominant Flex Suction Pump (K150134) and the Dundas Active Waste Gas Scavenger System (K110930).

Discussion - As the environments of use are similar to the predicate they should be considered substantially equivalent.

Non-Clinical Testing Summary -

We performed testing which evaluated:

AAMI/ANSI/ES60601-1 for electrical safety ●
IEC 60601-1-2 for EMC ●
Durability ●
- o Continuous running demonstrated that the vacuum pump stays within its specifications for at least 10,000 hours
- Real-time testing of the complete unit supports that the device meets its O performance specifications after 2 years use
. Vacuum and Flow testing
- Testing demonstrates that the device provides a constant vacuum of <=90 mmHg o at a constant Flow rate of 42 Lpm +/- 5 Lpm which has been deemed sufficient for scavenging waste gases from nitrous oxide / oxygen delivery equipment
- Determination of maximum length of exhaust tubing о
Leakage
- Testing demonstrates that after 2 years the unit has no leaks and meets its O performance specifications
Evaluation in an Oxygen Rich Environment per IEC 60601-1 section 11.2.2. .
- Risk Analysis of critical components, oxygen build-up in housing, and o construction and separation of the housing and components support compliance to IEC 60601-1 section 11.2.2, clause 1.b(3).
. Compatibility
- o with Porter, Accutron, and Nitronox analgesia systems.

Discussion of Differences –

The differences between the proposed device and the predicate are:

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MINISCAV™ is intended to scavenge waste gases, which is similar to the Dundas ● Active Waste Gas Scavenger System (K110930).
. While the intended uses are similar, the Dundas device (K110930) must be connected to a vacuum source (such as the MINISCAVTM) to operate.
Limitation of vacuum. While the Medela Dominant Flex Suction Pump (K150134) has a ● higher vacuum, for connection to a waste gas scavenger, the vacuum pressure is much lower and within the performance specifications of the proposed device.
- o This lower vacuum range is appropriate for the intended use of scavenging gases.

These differences still allow one to find the subject device substantially equivalent to the predicate devices for the proposed indications for use.

Substantial Equivalence Conclusion -

Based upon the presented information the sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate device are substantially equivalent.

Regulation Number and Section

§ 868.5430 Gas-scavenging apparatus.

(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).