The Ventura anesthesia gas delivery machine is designed to deliver a combination of medical gases and volatile anesthetic agents to a breathing system.

Device Description

The DRE Ventura anesthetic machine is a constant flow anesthesia gas delivery system intended for human use. The intended use for the Ventura anesthesia gas delivery machine is for the application of continuous flow anesthesia in a hospital. office based anesthesia settings, induction room or operating room. The units are intended to provide concentrations and flows of anesthesia gases and vapors into a patient breathing system. The anesthesia machine is designed for use by suitably qualified practitioners only. The basic device is commonly referred to as an anesthesia trolley. The Ventura is fitted with facilities to deliver 3 gases – oxygen, nitrous oxide or air. Up to 4 'E' size cylinders can be fitted along with pipeline supplies for all gases. It has a number of drawers for storage. In order to make the unit fully functional, the Ventura can be fitted with FDA cleared equipment, such as: Anesthetic agent vaporizer, specifically Selectatec compatible designs, Carbon dioxide absorber, Gas scavenging system, Ventilator of the complete standalone type. The Ventura has an anti-hypoxic device is built into the oxygen gas control system to enable a safe supply anesthetic gases under varying flow conditions.

AI/ML Overview

The provided text describes a 510(k) summary for the DRE Ventura anesthetic machine, which is a traditional medical device, not an AI/ML-driven one. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria are framed in the context of substantial equivalence to a predicate device, rather than the performance metrics typically associated with AI/ML systems.

Here's an analysis based on the provided text, while acknowledging the limitations for AI-specific questions:

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like the DRE Ventura, acceptance criteria are typically met by demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant performance standards. The document outlines a comparison to the predicate device (Penlon Prima K061102) across various features and ultimately states that the DRE Ventura met all requirements and standards.

Acceptance Criteria Category	DRE Ventura Reported Performance
Indications for Use	Designed to deliver a combination of medical gases and volatile anesthetic agents to a breathing system. (Equivalent to predicate)
Environment of Use	Locations where an anesthesia delivery device may be required. (Equivalent to predicate)
Patient Population	Adult. Not indicated for pediatric populations. (Equivalent to predicate)
Design and Technology	Equivalent design and features; identical technology to the predicate.
Performance and Specifications	Equivalent specifications of performance as the predicate.
Compliance with Standards	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-13, ISO 7767, ASTM F1208-89, ISO 8835-2:2007, ASTM F1343-02, ISO 8835-3:2007, ISO 8835-4:2004, ASTM F1101-90, ISO 8835-5:2004, ISO 5356-1:2004, ASTM F1850-00(2005), ISO 21647:2004+Cor 1:2005. (Many equivalent to predicate)
Materials	Identical to the predicate.
Functional Attributes	Met all requirements.
Performance Tolerances	Met all requirements.
Environmental Conditions	Met all requirements.
Compatibility with Specified Devices	Met all requirements.
Gas Flow and Oxygen Measurement Accuracy	Met performance requirements in compliance with BS EN 60601-2-13:2006, ASTM F1850-00(2005), ISO 21647:2004+Cor 1:2005.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "bench tests" were performed. However, it does not specify any sample size for the test set (e.g., number of machines tested, number of measurement cycles). As this is a physical device rather than an AI/ML system, "data provenance" in the sense of patient data is not applicable. The testing would have been conducted on the device itself under controlled laboratory conditions, likely in the US (where DRE Medical, Inc. is based and seeking FDA clearance).

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 is not applicable to the DRE Ventura. The "ground truth" for a device like this is defined by engineering specifications and compliance with established performance standards (e.g., gas flow rates, oxygen concentration accuracy, alarm functionality). These are typically verified by engineers and technicians with expertise in medical device testing and relevant standards, not clinical "experts" establishing ground truth for diagnostic classifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to the DRE Ventura. Adjudication methods like 2+1 or 3+1 are used in studies where human readers independently interpret data, and discrepancies are resolved. For physical device performance testing, the results are typically quantitative measurements against predefined thresholds, not subjective interpretations requiring adjudication.

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 is not applicable to the DRE Ventura as it is not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to the DRE Ventura as it 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 the DRE Ventura is based on:

Engineering Specifications: The device's design and manufacturing specifications.
Performance Standards: Compliance with recognized national and international standards for anesthesia machines (e.g., ASTM, ISO, IEC). These standards define acceptable ranges for various parameters like gas flow, pressure, oxygen concentration, and safety features.
Functional Verification: Testing that proves the device functions as intended (e.g., anti-hypoxic device activates at correct oxygen levels).

8. The sample size for the training set

This is not applicable as the DRE Ventura is a traditional medical device, not an AI/ML-driven device that undergoes a "training" phase with data.

9. How the ground truth for the training set was established

This is not applicable as the DRE Ventura is a traditional medical device and does not have a "training set" in the context of AI/ML. The "ground truth" (i.e., correct operating parameters and safety features) for such a device is established through engineering design, regulatory standards, and rigorous bench testing against those established criteria.

Summary

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JUL 0 1 2014

510(k) Summary Page 1 of 5 7/1/2014

DRE Medical, Inc.1800 Williamson CourtLouisville, KY 40026 USA	Tel - 502 244 4444Fax - 502 244 0369
Official Contact:	Mike Spencer CEO
Proprietary or Trade Name:	Ventura
Common/Usual Name:	gas-machine, anesthesia
Classification Name/Code:	BSZ - gas-machine, anesthesiaCFR 868.5160Class 2
Device:	DRE Ventura
Predicate Device:	Penlon -Prima K061102

Device Description:

The DRE Ventura anesthetic machine is a constant flow anesthesia gas delivery system intended for human use.

The intended use for the Ventura anesthesia gas delivery machine is for the application of continuous flow anesthesia in a hospital. office based anesthesia settings, induction room or operating room. The units are intended to provide concentrations and flows of anesthesia gases and vapors into a patient breathing system. The anesthesia machine is designed for use by suitably qualified practitioners only.

The basic device is commonly referred to as an anesthesia trolley.

The Ventura is fitted with facilities to deliver 3 gases – oxygen, nitrous oxide or air. Up to 4 'E' size cylinders can be fitted along with pipeline supplies for all gases. It has a number of drawers for storage.

In order to make the unit fully functional, the Ventura can be fitted with FDA cleared equipment, such as:

Anesthetic agent vaporizer, specifically Selectatec compatible designs ●
Carbon dioxide absorber .
. Gas scavenging system
. Ventilator of the complete standalone type

The Ventura has an anti-hypoxic device is built into the oxygen gas control system to enable a safe supply anesthetic gases under varying flow conditions.

Indications for Use: The Ventura anesthesia gas delivery machine is designed to deliver a combination of medical gases and volatile anesthetic agents to a breathing system.

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510(k) Summary Page 2 of 5 7/1/2014

Environment of Use: Locations where an anesthesia delivery device may be required.

Patient Population: Adult, the subject device is not indicated for pediations

Contraindications

There are no known contraindications.

Differences between the proposed and predicate devices:

There are a few differences between the proposed Ventura and the predicate. They include:

Integral oxygen monitor vs. in-line oxygen monitor
- The oxygen monitor has the same features as the add-on but it is just integrated ০ for convenience of the user.
Add of secondary pressure regulator for all gases vs. only for oxygen . No technological differences ୍
Difference ancillary components mounting systems GCX type vs. Modura ●
- o No technological differences

These differences do not pose any significant technological differences nor do they raise any new safety concerns.

Summary of substantial equivalence

The DRE Ventura was compared to the predicate Penlon Prima (K061102) as in the device comparison table below.

	DRE Ventura	Penlon Prima
	Proposed Device	510(k)- K061102
Indications for Use	The Ventura anesthesia gas delivery machine isdesigned to deliver a combination of medicalgases and volatile anesthetic agents to abreathing system.	The Penlon Prima is designed to deliver acombination of medical gases and volatileanesthetic agents to a breathing system.
Environment of use	Locations where an anesthesia delivery devicemay be required.	Locations where an anesthesia delivery devicemay be required.
Configurations	The trolley may be configured with up to 3different gases, oxygen, nitrous oxide and air	The trolley may be configured with up to 3different gases, oxygen, nitrous oxide and air
Components to be fitted tomake it a complete system	VaporizersVentilatorCarbon Dioxide absorber	VaporizersVentilatorCarbon Dioxide absorber
This components arestandalone 510(k) cleareddevices	Waste Gas Scavenging system (AGSS)Breathing circuitOxygen monitor (built-in)	Waste Gas Scavenging system (AGSS)Breathing circuitOxygen monitor (separate)
Construction	Structural aluminum extrusions, PU moldingsand panels.Aluminum and stainless steel sheet.	Structural aluminum extrusions, PVC moldingsand panels. Aluminum and stainless steel sheet.
Gas supplies	Oxygen, Air and/or Nitrous oxide. Pipelinesupply or cylinder to ISO standards forpressure, purity and non-interchangeableconnections. Inlet 100 micron filters	Oxygen, Air and/or Nitrous oxide. Pipelinesupply or cylinder to ISO standards forpressure, purity and non-interchangeableconnections. Inlet 100 micron filters
Gas flows	O2: 200ml - 10 1/min	O3: 200ml - 10 l/min
	Air: 200ml - 12 l/min	Air: 200ml - 10 l/min
	N2O: 200ml - 10 l/min	N2O: 200ml - 10 1/min
Flowmeter position.	Left Hand Side (LHS) of machine.	LHS of machine.
	Oxygen control on LHS of flowmeter. N2O at	Oxygen control on LHS of flowmeter. N2O
	right extreme position.	at right extreme position.
Flow tubes	Diameter and length indexed.	Diameter and length indexed.
	Oxygen added after all other gasses.	Oxygen added after all other gasses.
Flowmeter illumination.	Yes	Yes
Low oxygen	Yes, Ritchie Whistle system and adjustable 25	Yes, Ritchie Whistle system and adjustable
pressure/concentration	- 100% user set.	30 - 100% user set.
alarms.	Default 25%.	Default 30%.
	Detected with fuel cell.	Detected with fuel cell.
Nitrous cut off system.	Yes, Pressure operated, sprung return cut off	Yes, Pressure operated, sprung return
	spool valve.	cut off spool valve.
Anti Hypoxic system.	Yes, mechanical anti hypoxic link system.	Yes, mechanical anti hypoxic link system.
	Min 23%. Powered by oxygen pressure.	Min 27%. Powered by oxygen pressure.
Air/Nitrous oxide selection	Yes	Yes
switch.
Auxiliary gas drive outlets	Yes, Oxygen and Air	Yes, Oxygen and Air
Cylinder pressure reducer.	Single stage brass pressure regulator c/w	Single stage brass pressure regulator c/w
	pressure relief valve safety system.	pressure relief valve safety system.
Secondary pressure regulator	Yes, all gasses.	Yes, O2 only.
Individual supply pressuregauges	Yes.	Yes.
Internal pipework	Diameter indexed for individual gas supplies	Diameter indexed for individual gassupplies
Low pressure pipework .	Yes, internal	Yes
pressure relief valve at CGO.	/
Vaporizer mounting system.	Selectatec compatible x2.	Selectatec compatible x2.
	Indexed to prevent non-interlock vaporizers	Indexed to prevent non-interlock vaporizers
	being attached	being attached.
02 flush	Yes, front LHS of machine downstream of all	Yes, front LHS of machine downstream of
	other gasses and vapors.	all other gasses and vapors.
Braked castors	Yes	Yes
Ancillary component	GCX type	Modura type
mounting system.
Auxiliary electrical outletsockets.	Yes x4. Independently fused	Yes x4. Independently fused
Oxygen Monitor	Yes integrated	Required add on
Compliance with Standards	ASTM F1208 - 89 Standard Specification for	ASTM F1208 - 89 Standard Specification
	Minimum Performance and Safety	for Minimum Performance and Safety
	Requirements for Anesthesia Breathing	Requirements for Anesthesia Breathing
	Systems.	Systems.
	ISO 8835-2:2007. Inhalational anesthesia	ISO 8835-2:2007. Inhalational anesthesia
	systems -- Part 2: Anesthetic breathing systems	systems -- Part 2: Anaesthetic breathing
		systems

	ASTM F1343 - 02. Standard Specification for	ASTM F1343 - 02. Standard Specification
	Anesthetic Gas Scavenging Systems-Transfer	for Anesthetic Gas Scavenging Systems-

and Receiving Systems	Transfer and Receiving Systems
ISO 8835-3:2007. Inhalational anesthesiasystems -- Part 3: Transfer and receivingsystems of active anaesthetic gas scavengingsystems	ISO 8835-3:2007. Inhalational anesthesiasystems -- Part 3: Transfer and receivingsystems of active anaesthetic gas scavengingsystems
ISO 8835-4:2004. Inhalational anesthesiasystems -- Part 4: Anaesthetic vapor deliverydevices	ISO 8835-4:2004. Inhalational anesthesiasystems -- Part 4: Anaesthetic vapordelivery devices
ASTM F1101 - 90 (Reapproved 2003).Standard Specification for Ventilators Intendedfor Use During AnesthesiaISO 8835-5:2004. Inhalational anesthesiasystems -- Part 5: Anaesthetic ventilators	ASTM F1101 - 90 (Reapproved 2003).Standard Specification for VentilatorsIntended for Use During AnesthesiaISO 8835-5:2004. Inhalational anesthesiasystems -- Part 5: Anaesthetic ventilators
ISO 5356-1:2004. Anaesthetic and respiratoryequipment -- Conical connectors -- Part 1:Cones and sockets. Part 1 refers to theconnections on the breathing circuit. Theseconnections are not generally used on themachine but they mate with ISO 5356-2:2006.Anaesthetic and respiratory equipment --Conical connectors -- Part 2: Screw-threadedweight-bearing connectors, which are on theanaesthetic machine. (Dimensional standards)	ISO 5356-1:2004, Anaesthetic andrespiratory equipment -- Conical connectors-- Part 1: Cones and sockets. Part 1 refers tothe connections on the breathing circuit.These connections are not generally used onthe machine but they mate with ISO 5356-2:2006. Anaesthetic and respiratoryequipment -- Conical connectors -- Part 2:Screw-threaded weight-bearing connectors,which are on the anaesthetic machine.(Dimensional standards)

· Device Comparison Table

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510(k) Summary

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510(k) Summary Page 4 of 5 7/1/2014

Indications - Equivalent indications

Prescriptive - The DRE Ventura is prescriptive as is the predicate.

Design and Technology - The DRE Ventura has equivalent design and features as the predicate and has the identical technology to the predicate.

Performance and Specifications - The DRE Ventura has equivalent specifications of performance as the predicate.

Compliance with standards – The DRE Ventura and predicate device declare compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-13. Additionally, the Ventura complies with ISO 7767

Materials - Materials used are identical to the predicate.

Environment of Use - Same

Patient Population – Adult. The subject device is not indicated for pediatric populations

Performance Testing

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510(k) Summary Page 5 of 5 7/1/2014

We have performed bench tests and found that the DRE Ventura met all requirements specifications and applicable standards requirements and was found to be equivalent in comparison to the predicate. Testing includes:

Functional Attributes
. Performance Tolerances
Environmental Conditions ●
Compatibility with specified devices .
. A variety of performance requirements related to gas flow and oxygen measurement accuracy in compliance with the following performance standards:
- BS EN 60601-2-13:2006 (IEC 60601-2-13) Medical electrical equipment. Particular requirements for the safety and essential performance of anaesthetic systems.
- . ASTM F 1850 ASTM F1850-00(2005) Particular Requirements for Anesthesia Workstations and Their Components.
- 트 ISO 21647:2004+Cor 1:2005 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas Monitors

Conclusion

The DRE Ventura is substantially equivalent to the predicate Penlon Prima (K061102) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 1, 2014

DRE Medical, Inc. c/o Paul Dryden Regulatory Consultant 1800 Williamson Court Louisville, KY 40026

Re: K132903

Trade/Device Name: DRE Ventura Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: May 29, 2014 Received: May 30, 2014

Dear Mr. 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. Ilsting 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

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Page 2 - Mr. Dryden

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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

. Tejasbri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Cliaical Deputy Director DAGRID/ODE/CDRH FOR が、 Section of the county of

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on fast page.

510(k) Number (if known) K132903

Device Name DRE Ventura

Indications for Use (Describe)

The Ventura anesthesia gas delivery machine is deliver a combination of medical gases and volatile anesthetic agents to a breathing system.

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

2 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)

Todd D. Courtney -S 2014.07.01 10:15:43 -04'00'

FORM FDA 3881 (9/13)

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Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).