DRE VENTURA
Device Facts
| Record ID | K132903 |
|---|---|
| Device Name | DRE VENTURA |
| Applicant | Dre Medical, Inc. |
| Product Code | BSZ · Anesthesiology |
| Decision Date | Jul 1, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5160 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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. 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.
Device Story
DRE Ventura is a constant flow anesthesia gas delivery system (anesthesia trolley) for human use. It delivers oxygen, nitrous oxide, and air to a patient breathing system. The device features an integrated oxygen monitor, mechanical anti-hypoxic link system, and pressure-operated nitrous oxide cut-off valve. It is designed for use by qualified practitioners in clinical settings. The system is modular, allowing for the attachment of FDA-cleared components including anesthetic agent vaporizers (Selectatec compatible), carbon dioxide absorbers, gas scavenging systems, and standalone ventilators. The healthcare provider operates the gas controls and monitors the integrated oxygen levels to manage anesthesia delivery. The device ensures safe gas concentrations and flows, supporting patient stability during surgical procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included functional attributes, performance tolerances, environmental conditions, and compatibility with specified devices. Performance verification confirmed compliance with BS EN 60601-2-13, ASTM F1850, and ISO 21647 regarding gas flow and oxygen measurement accuracy.
Technological Characteristics
Anesthesia trolley constructed of structural aluminum extrusions, PU moldings, and stainless steel. Features mechanical anti-hypoxic link system, pressure-operated nitrous oxide cut-off, and integrated oxygen fuel cell monitor. Gas supply via pipeline or cylinders with 100-micron inlet filters. Connectivity includes auxiliary electrical outlets. Complies with ASTM F1208, ISO 8835-2/3/4/5, ISO 5356-1/2, and IEC 60601-1/1-2/2-13.
Indications for Use
Indicated for adult patients requiring continuous flow anesthesia delivery in hospital, office-based, induction, or operating room settings. Not indicated for pediatric populations.
Regulatory Classification
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. 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).
Predicate Devices
- Penlon Prima (K061102)
Submission Summary (Full Text)
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JUL 0 1 2014
#### 510(k) Summary Page 1 of 5 7/1/2014
| DRE Medical, Inc.<br>1800 Williamson Court<br>Louisville, KY 40026 USA | Tel - 502 244 4444<br>Fax - 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, anesthesia<br>CFR 868.5160<br>Class 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 is<br>designed to deliver a combination of medical<br>gases and volatile anesthetic agents to a<br>breathing system. | The Penlon Prima is designed to deliver a<br>combination of medical gases and volatile<br>anesthetic agents to a breathing system. |
| Environment of use | Locations where an anesthesia delivery device<br>may be required. | Locations where an anesthesia delivery device<br>may be required. |
| Configurations | The trolley may be configured with up to 3<br>different gases, oxygen, nitrous oxide and air | The trolley may be configured with up to 3<br>different gases, oxygen, nitrous oxide and air |
| Components to be fitted to<br>make it a complete system | Vaporizers<br>Ventilator<br>Carbon Dioxide absorber | Vaporizers<br>Ventilator<br>Carbon Dioxide absorber |
| This components are<br>standalone 510(k) cleared<br>devices | Waste Gas Scavenging system (AGSS)<br>Breathing circuit<br>Oxygen monitor (built-in) | Waste Gas Scavenging system (AGSS)<br>Breathing circuit<br>Oxygen monitor (separate) |
| Construction | Structural aluminum extrusions, PU moldings<br>and panels.<br>Aluminum and stainless steel sheet. | Structural aluminum extrusions, PVC moldings<br>and panels. Aluminum and stainless steel sheet. |
| Gas supplies | Oxygen, Air and/or Nitrous oxide. Pipeline<br>supply or cylinder to ISO standards for<br>pressure, purity and non-interchangeable<br>connections. Inlet 100 micron filters | Oxygen, Air and/or Nitrous oxide. Pipeline<br>supply or cylinder to ISO standards for<br>pressure, purity and non-interchangeable<br>connections. 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 pressure<br>gauges | Yes. | Yes. |
| Internal pipework | Diameter indexed for individual gas supplies | Diameter indexed for individual gas<br>supplies |
| 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 outlet<br>sockets. | 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 anesthesia<br>systems -- Part 3: Transfer and receiving<br>systems of active anaesthetic gas scavenging<br>systems | ISO 8835-3:2007. Inhalational anesthesia<br>systems -- Part 3: Transfer and receiving<br>systems of active anaesthetic gas scavenging<br>systems | |
| ISO 8835-4:2004. Inhalational anesthesia<br>systems -- Part 4: Anaesthetic vapor delivery<br>devices | ISO 8835-4:2004. Inhalational anesthesia<br>systems -- Part 4: Anaesthetic vapor<br>delivery devices | |
| ASTM F1101 - 90 (Reapproved 2003).<br>Standard Specification for Ventilators Intended<br>for Use During Anesthesia<br>ISO 8835-5:2004. Inhalational anesthesia<br>systems -- Part 5: Anaesthetic ventilators | ASTM F1101 - 90 (Reapproved 2003).<br>Standard Specification for Ventilators<br>Intended for Use During Anesthesia<br>ISO 8835-5:2004. Inhalational anesthesia<br>systems -- Part 5: Anaesthetic ventilators | |
| ISO 5356-1:2004. Anaesthetic and respiratory<br>equipment -- Conical connectors -- Part 1:<br>Cones and sockets. Part 1 refers to the<br>connections on the breathing circuit. These<br>connections are not generally used on the<br>machine but they mate with ISO 5356-2:2006.<br>Anaesthetic and respiratory equipment --<br>Conical connectors -- Part 2: Screw-threaded<br>weight-bearing connectors, which are on the<br>anaesthetic machine. (Dimensional standards) | ISO 5356-1:2004, Anaesthetic and<br>respiratory equipment -- Conical connectors<br>-- Part 1: Cones and sockets. Part 1 refers to<br>the connections on the breathing circuit.<br>These connections are not generally used on<br>the machine but they mate with ISO 5356-<br>2:2006. Anaesthetic and respiratory<br>equipment -- Conical connectors -- Part 2:<br>Screw-threaded weight-bearing connectors,<br>which are on the anaesthetic machine.<br>(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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# 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 Devic…
