(89 days)
To be used in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.
The Accutron Digital Ultra Analgesia Gas Machine precisely meters oxygen and nitrous oxide medical gases for conscious sedation of patients in dental offices and hospitals. With the device, the attending physician or dentist is able to set both the percentage of nitrous oxide and the total flow to a desired level of sedation and flow. The Digital Ultra Analgesia Gas Machine has been designed with built in safety features that prevent the level of oxygen gas from falling below 30% of total flow, mechanical features that prevent the mix-up of gases, and fail-safe features to prevent the flow of nitrous oxide in the absence of oxygen gas.
The provided text describes a 510(k) premarket notification for the Accutron Digital Ultra Analgesia Gas Machine. This type of submission is for medical devices, not for AI/ML-based diagnostic or prognostic algorithms. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance metrics is not applicable to this document.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on safety and effectiveness, primarily through compliance with recognized voluntary standards and good manufacturing practices. It does not contain information about studies proving the device meets specific performance criteria in the way an AI algorithm would be evaluated.
Here's an attempt to answer the questions based only on the provided text, noting its limitations for AI-specific queries:
1-5, 7-9: Not Applicable (N/A) for this device and document type.
This submission is for a medical device (analgesia gas machine) that is not an AI/ML diagnostic or prognostic algorithm. Therefore, the concepts of acceptance criteria for AI performance, clinical study design for AI efficacy, expert ground truth adjudication for AI, MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for AI are not applicable to this 510(k) submission.
The "acceptance criteria" for this device are implicitly tied to compliance with the listed voluntary standards and the demonstration of substantial equivalence to predicate devices in terms of safety and intended use. The "study" proving it meets these "criteria" is the documentation provided to the FDA demonstrating this compliance and equivalence, which is reviewed by the FDA.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is Not Applicable as the device is a physical gas machine, not an algorithm.
Summary of Device and Regulatory Submission:
The Accutron Digital Ultra Analgesia Gas Machine meters oxygen and nitrous oxide for conscious sedation. Key safety features include preventing oxygen from falling below 30% of total flow, mechanical prevention of gas mix-ups, and fail-safe features to stop nitrous oxide flow without oxygen.
The 510(k) submission (K052335) seeks to demonstrate substantial equivalence to predicate devices (K970163: Technical Medical Products Model 20 Alpha MX / Model 30 Ultra PC by Accutron Inc.; K945722: Matrx MDM, RA by Matrx Medical, Inc.). This equivalence is supported by adherence to various voluntary standards:
- EN 60601-1 / IEC 60601-1: "Medical Electrical Equipment - Part 1 : General Requirements for Safety"
- EN 60601-1-2 / IEC 60601-1-2: "Medical electrical equipment -- Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests"
- ISO 5356-1: "Anesthetic and respiratory equipment -- conical connectors"
- ASTM F1054-01: "Standard specification for conical fittings"
- CGA C-9:1988: "Standard color marking of compressed gas containers for medical use"
- CGA V-5:2000: "Diameter-Index Safety System (non-interchangeable low-pressure connections for medical gas applications)"
- ADA Recommendations: Designed to meet recommendations of the American Dental Association.
The "study" referenced in the prompt (though not a clinical study in the AI sense) is the comprehensive product design and risk management program, which aimed to eliminate or mitigate known health hazards, ensuring the device is "safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices."
The FDA's review of the 510(k) documentation determined substantial equivalence, allowing the device to be marketed.
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Accutron, Inc. Digital Ultra Analgesia Gas Machine NOV 2 3 2005 510(k) Number: K 052335
Date: Page 1 of 2
510(k) Summary
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Applicant
Accutron, Inc. 1733 West Parkside Lane Phoenix, AZ, 85027 USA
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 700 Ave., Golden, CO 80401 USA
Date Prepared
August 24, 2005
Trade Name of Device
Accutron Digital Ultra Analgesia Gas Machine
Classification Name
Gas-Machine, Anesthesia
510(k) Classification
21CFR§868.5160 Product Code: BSZ
Device Description
The Accutron Digital Ultra Analgesia Gas Machine precisely meters oxygen and nitrous oxide medical gases for conscious sedation of patients in dental offices and hospitals. With the device, the attending physician or dentist is able to set both the percentage of nitrous oxide and the total flow to a desired level of sedation and flow.
The Digital Ultra Analgesia Gas Machine has been designed with built in safety features that prevent the level of oxygen gas from falling below 30% of total flow, mechanical features that prevent the mix-up of gases, and fail-safe features to prevent the flow of nitrous oxide in the absence of oxygen gas.
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Accutron, Inc.
Digital Ultra Analgesia Gas Machine
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| Date: | |
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Intended Use
The Digital Ultra Analgesia Gas Machine is intended for use in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.
Predicate Devices
K970163 Technical Medical Products Model 20 Alpha MX / Model 30 Ultra PC manufactured by Accutron Inc., Phoenix AZ.
K945722 Matrx MDM, RA manufactured by Matrx Medical, Inc., Orchard Park, New York.
Voluntary Standards
EN 60601-1 / IEC 60601-1, "Medical Electrical Equipment - Part 1 : General Requirements for Safety"
EN 60601-1-2 / IEC 60601-1-2, "Medical electrical equipment -- Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests"
ISO 5356-1, "Anesthetic and respiratory equipment -- conical connectors"
ASTM F1054-01, "Standard specification for conical fittings"
CGA C-9:1988, "Standard color marking of compressed gas containers for medical use"
CGA V-5:2000, "Diameter-Index Safety System (non-interchangeable low pressure connections for medical gas applications)"
ADA Recommendations
The Accutron Digital Ultra Analgesia Gas Machine has been designed to meet the recommendations of the American Dental Association.
Risk Management
This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program.
The user must be qualified in conscious sedation procedures, and must be familiar with all labeling and instructions for use associated with the device.
Accutron Inc. believes that the Digital Ultra Analgesia Gas Machine is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling birds in flight or flowing lines, stacked on top of each other.
NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Accutron, Incorporated C/O Mr. Robert N. Clark President & Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Avenue Golden, Colorado 80401-4604
Re: K052335
Trade/Device Name: Accutron Digital Ultra Analgesia Gas Machine Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: November 14, 2005 Received: November 15, 2005
Dear Mr. Clark:
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.
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Page 2 - Mr. Clark
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K052335
Accutron Digital Ultra Analgesia Gas Machine Device Name:
Indications For Use:
To be used in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cucy Syllom
on Sim-Old on of Anesthesiology, General Hospital, . Collion Control, Dental Devices
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Page 1 of 1
K052335/S1 Page 5 of 205
§ 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).