(63 days)
Penlon - Sigma Elite Vaporizer K942545
No
The device description focuses on standard anesthesia unit components and functionalities, with no mention of AI or ML features. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an "anesthesia unit" intended for "administration of general inhalation anesthesia" and for "providing breathing gas and for either spontaneous ventilation or controlled ventilation of patient lungs." These functions directly involve treating or alleviating a medical condition (anesthesia) and supporting vital physiological functions (breathing), which fall under the definition of a therapeutic device.
No
Anesthesia units are therapeutic devices used to administer gases and control ventilation, not to diagnose medical conditions.
No
The device description clearly outlines numerous hardware components such as flowmeters, pressure gauges, valves, a CO2 absorber, and ports, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "administration of general inhalation anesthesia," "providing breathing gas," and "ventilation of patient lungs." These are all therapeutic and life-support functions performed directly on the patient.
- Device Description: The description details components related to gas delivery, flow control, pressure monitoring, and ventilation circuits. These are characteristic of anesthesia delivery systems, not devices used to examine specimens from the human body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OBA-1™ MRI is intended to provide continuous gas inhalation for patient requiring anesthesia under the direct care and supervision of a trained and qualified practitioner. It provides for oxygen delivery with an anesthetic agent, via the specific vaporizer, of the practitioner's choice. The OBA-1™ MRI is intended for use in an MRI environment of 1.5 tesla or less. It is to be used with an oxygen monitor and other suitable monitors.
The Office Based Anesthesia Unit - OBA-1™ MRI is intended for administration of general inhalation anesthesia using mixtures of achimistration '01 atile anesthetics, and for providing breathing gas and for either spontaneous ventilation or controlled ventilation of patient lungs.
The OBA-1™ MRI can be used in MRI scanner rooms with shielded or unshielded magnets up to 1.5 tesla.
Product codes
73 BSZ
Device Description
The OBA-1™ MRI is an anesthesia unit which includes these features:
- Can be connected to a central pipeline or cylinder oxygen/air source .
- Oxygen flowmeter 0 10 L/min .
- Air flowmeter 0 10 L/min .
- Oxygen and air pipeline pressure gauges 0 100 psi .
- Oxygen Supply Failure Alarm .
- Vaporizer temperature and pressure compensated .
- Oxygen Flush valve ●
- Back Pressure Check valve ●
- Indexed Fresh Gas Common outlet with safety lock .
- Patient Manifold with directional valves inspiratory and expiratory .
- Adjustable APL valve with 19 mm waste gas outlet connection which can be . connected to an active scavenging system
- MRI compatible Airway Pressure Gauge .
- . Oxygen sensor port
- Circuit Pressure monitor and gauge connection ports .
- THERMH2OSORB Sodalime CO2 absorber
- Bag/Ventilator Switch Valve 22 mm breathing bag port and 22 mm ventilator ● hose port
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified practitioner.
Physician office; day surgery center; dental office; MRI environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith - OBA-1™ - K000859, Dräger - Narkomed MRI Anesthesia System K972848
Reference Device(s)
Penlon - Sigma Elite Vaporizer K942545
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Charles A. Smith 811 Starlite Drive Louisville, KY 40207
Non-Confidential Summary of Safety and Effectiveness
July 2001
Charles A. Smith 811 Starlite Drive Louisville, KY 40207 Fax - 502-969-9777 Tel - 502-969-9652 Charles A. Smith Official Contact: OBA-1TM MRI - Office Based Anesthesia Unit MRI Proprietary or Trade Name: Anesthesia gas machine Common/Usual Name: Gas machine, anesthesia Classification Name: Smith - OBA-1™ - K000859 Predicate Devices: Dräger - Narkomed MRI Anesthesia System K972848
TN: Description: -
The OBA-1™ MRI is an anesthesia unit which includes these features:
- Can be connected to a central pipeline or cylinder oxygen/air source .
- Oxygen flowmeter 0 10 L/min .
- Air flowmeter 0 10 L/min .
- Oxygen and air pipeline pressure gauges 0 100 psi .
- Oxygen Supply Failure Alarm .
- Vaporizer temperature and pressure compensated .
- Oxygen Flush valve ●
- Back Pressure Check valve ●
- Indexed Fresh Gas Common outlet with safety lock .
- Patient Manifold with directional valves inspiratory and expiratory .
- Adjustable APL valve with 19 mm waste gas outlet connection which can be . connected to an active scavenging system
- MRI compatible Airway Pressure Gauge .
- . Oxygen sensor port
- Circuit Pressure monitor and gauge connection ports .
2-2
1
Non-Confidential Summary of Safety and Effectiveness
July 2001
- THERMH2OSORB Sodalime CO2 absorber �
- Bag/Ventilator Switch Valve 22 mm breathing bag port and 22 mm ventilator ● hose port
- The OBA-1™ MRI is intended to provide continuous gas 1. Intended use inhalation for patient requiring anesthesia under the direct care and supervision of a trained and qualified practitioner. It provides for oxygen delivery with an anesthetic agent, via the specific vaporizer, of the practitioner's choice. The OBA-1™ MRI is intended for use in an MRI environment of 1.5 tesla or less. It is to be used with an oxygen monitor and other suitable monitors. Physician office; day surgery center; dental office; MRI 2. Environment of Use environment
- Patients requiring general anesthesia by inhalation 3.Patient Population -
The following comparison table details the primary attributes of the intended device and legally marketed predicate devices. The most significant attributes have been listed.
A glossary of the predicate devices:
| Company | Model | 510(k) status |
|---|---|---|
| 1. Smith | OBA-1™ | K000859 |
| 2. Penlon | Sigma Elite Vaporizer | K942545 |
| 3. Clippard | Oxygen Flush valve | exempt |
| One way check valve | exempt | |
| 4. Anesthesia Associates | MRI Airway pressure gauge | preamendment |
| Bag/Ventilator Switch Valve | ||
| with APL Valve | preamendment |
2
Non-Confidential Summary of Safety and Effectiveness
July 2001
| Attribute | Proposed device OBA-1 MRI | Predicate Devices are listed under each attribute |
|---|---|---|
| Intended to provide anesthesia delivery in office or outpatient setting and MRI scanning rooms | Yes | 1 |
| Can be connected to central pipeline systems or cylinder yokes with regulators | Yes | 1 |
| Two gas flowmeters; 1 (oxygen) 1 (air) | Yes | 1 |
| Utilizes standard flowmeters | Yes | 1, 6 |
| Utilizes a disposable CO2 absorber canister | Yes | 1, 5 |
| Has directional valves (inspiratory/ expiratory) | Yes | 1 |
| Incorporates standard 510(k) cleared vaporizers | Yes | 1, 2 |
| Has an APL valve with gas scavenging | Yes | 1, 4 |
| Manual ventilation via a breathing bag or automatic ventilation with ventilator | Yes | 1 |
| Has oxygen monitoring port | Yes | 1 |
| Has patient pressure monitoring port | Yes | 1 |
| Attribute | Proposed device | |
| OBA-1 MRI | Predicate Devices | |
| are listed under each | ||
| attribute | ||
| Design (continued) | ||
| Connects to standard anesthesia | ||
| breathing circuits | Yes | 1, 5 |
| Has oxygen flush valve | Yes | 1,3 |
| Materials | ||
| Materials are standard for use | ||
| in anesthesia gas machines | Yes | 1, 2, 3, 4, 5, 6 |
| Packaging | ||
| Provided clean, non-sterile | Yes | 1,5 |
| Can be cleaned and disinfected | Yes | 1,4 |
| Performance Standards / Specifications | ||
| None applicable under Section 514 | Yes | 1, 2, 3, 4, 5, 6 |
| Differences Between Other Legally Marketed Predicate Devices |
.
:
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3
Non-Confidential Summary of Safety and Effectiveness
July 2001
There are no functional differences between the proposed device and the legally marketed predicate device.
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:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure with its wings spread.
OCT - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Charles A. Smith 811 Starlite Drive Louisville, KY 40207
Re: K012446
OBA-A™ MRI Anesthesia Machine Regulation Number: 868.5160 Regulation Name: Gas Machine For Anesthesia Regulatory Class: II (two) Product Code: 73 BSZ Dated: September 11, 2001 Received: September 14, 2001
Dear Mr. Smith:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
5
Page 2 - Mr. Charles A. Smith
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 607); laboring (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogain maing of substantial equivalence of your device to a legally premarket notincation: "The PDF intellig sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific ad roo for in vitro diagnostic devices), please contact the Office of additionally 21 CF ICT at 607.10 for terming for questions on the promotion and advertising of Compinance at (301) 594-1910. office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation chiticou, "Nilocranaing of esponsibilities under the Act may be obtained from the Outer general information tween the mational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
N.G. Hull
ames E. Dillard Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number:
KO12446 ______________________________________________________________________________________________________________________________________________________________________ (To be assigned)
Device Name:
Office Based Anesthesia Machine - OBA-1™M MRI
Intended Use :
The Office Based Anesthesia Unit - OBA-1™ MRI is intended for administration of general inhalation anesthesia using mixtures of achimistration '01 atile anesthetics, and for providing breathing gas and for either spontaneous ventilation or controlled ventilation of patient lungs.
The OBA-1™ MRI can be used in MRI scanner rooms with shielded or unshielded magnets up to 1.5 tesla.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number R012446
Prescription Use v (Per CFR 801.109)
or
Over-the-counter use