The Office Based Anesthesia Unit - OBA-1™ MRI is intended for administration of general inhalation anesthesia using mixtures of volatile 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.

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.

AI/ML Overview

The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a clinical trial or performance testing with quantitative metrics.

Instead, the submission for the Charles A. Smith OBA-1™ MRI Anesthesia Unit (K012446) is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness or specific quantitative performance against acceptance criteria.

The "study" or justification for equivalence is a comparison of attributes between the proposed device and predicate devices.

Here's a breakdown based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria or reported performance in a quantitative, metrics-based table. Instead, it offers a qualitative comparison table to establish substantial equivalence.

Attribute	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (OBA-1 MRI)
Intended to provide anesthesia delivery in office or outpatient setting and MRI scanning rooms	Yes (as per predicate devices)	Yes
Can be connected to central pipeline systems or cylinder yokes with regulators	Yes (as per predicate devices)	Yes
Two gas flowmeters; 1 (oxygen) 1 (air)	Yes (as per predicate devices)	Yes
Utilizes standard flowmeters	Yes (as per predicate devices)	Yes
Utilizes a disposable CO2 absorber canister	Yes (as per predicate devices)	Yes
Has directional valves (inspiratory/ expiratory)	Yes (as per predicate devices)	Yes
Incorporates standard 510(k) cleared vaporizers	Yes (as per predicate devices)	Yes
Has an APL valve with gas scavenging	Yes (as per predicate devices)	Yes
Manual ventilation via a breathing bag or automatic ventilation with ventilator	Yes (as per predicate devices)	Yes
Has oxygen monitoring port	Yes (as per predicate devices)	Yes
Has patient pressure monitoring port	Yes (as per predicate devices)	Yes
Connects to standard anesthesia breathing circuits	Yes (as per predicate devices)	Yes
Has oxygen flush valve	Yes (as per predicate devices)	Yes
Materials are standard for use in anesthesia gas machines	Yes (as per predicate devices)	Yes
Provided clean, non-sterile	Yes (as per predicate devices)	Yes
Can be cleaned and disinfected	Yes (as per predicate devices)	Yes
Performance Standards / Specifications	None applicable under Section 514	None applicable under Section 514

Note: The "acceptance criteria" for a 510(k) submission are implicitly demonstrating that the new device shares the same fundamental scientific technology, indications for use, and technological characteristics as the predicate device(s), and does not raise different questions of safety and effectiveness.

Regarding the "Study" that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the substantive equivalence comparison presented in the document, primarily the comparison table and the statement "There are no functional differences between the proposed device and the legally marketed predicate device."

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

Sample Size: Not applicable. This is not a study involving patient data or a test set in the traditional sense of a clinical trial. It's a technical and functional comparison.
Data Provenance: Not applicable for a test set. The data provenance refers to the specifications and characteristics of the device itself and its predicate devices.

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

Not applicable. There is no "test set" and no "ground truth" derived from expert consensus on patient data described here. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices based on their prior clearance or pre-amendment status.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication process for a test set is described.

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:

No. This device is an anesthesia machine, not an AI-assisted diagnostic tool. Therefore, an MRMC study is completely irrelevant.

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

No. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices (e.g., Smith OBA-1™ K000859, Dräger Narkomed MRI Anesthesia System K972848, Penlon Sigma Elite Vaporizer K942545, etc.) based on their prior clearance or legal marketing status. The applicant is asserting that the new device is fundamentally similar enough to these predicates to leverage their "ground truth" of known safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This is not a machine learning or AI device.

In summary: K012446 is a 510(k) submission for an anesthesia machine, which relies on demonstrating substantial equivalence to pre-existing devices. It does not involve patient studies, AI algorithms, or the kind of acceptance criteria and performance evaluation typically seen in diagnostic device clearances or clinical trials. The "proof" is the detailed comparison of features and intended use against legally marketed predicate devices.

Summary

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K012446

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

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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 Valvewith APL Valve	preamendment

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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 deviceOBA-1 MRI	Predicate Devicesare listed under eachattribute
Design (continued)
Connects to standard anesthesiabreathing circuits	Yes	1, 5
Has oxygen flush valve	Yes	1,3
Materials
Materials are standard for usein 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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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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トランドアイドストースレディースストーストーストーストーストースーパースーパースーパースーパースーパースーパースーパース

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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

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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

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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)

Over-the-counter use

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).