(104 days)
No
The description focuses on basic electronic control and digital display functionalities, with no mention of AI or ML terms or capabilities.
No
The device delivers gases for sedation, but it does not directly treat a disease or condition. It is a component of a sedation system.
No
The device is a flowmeter for delivering a mixture of nitrous oxide and oxygen, which is a therapeutic function, not a diagnostic one. It displays information about gas percentages and flow, but this data is used for controlling the delivery of gases, not for diagnosing a medical condition.
No
The device description explicitly states it is a modification of a physical flowmeter with the addition of an electronically controlled digital display and associated electronics, and the performance studies include hardware verification and validation. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering a mixture of nitrous oxide and oxygen gases for sedation. This is a therapeutic/anesthetic application, not a diagnostic one performed on in vitro samples.
- Device Description: The device is a flowmeter that controls and displays gas flow. It does not interact with biological samples or perform diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information about a patient's health status.
The device is clearly intended for use in a clinical setting for administering gases to a patient, which falls under the category of medical devices used for treatment or anesthesia, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Digital MXR-D Flowmeter is intended for use in nitrous oxide/oxygen sedation systems for the delivery of a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.
Product codes
BSZ
Device Description
The proposed Digital MXR-D Flowmeter is a modification of the MXR 2000 Flowmeter that was cleared for marketing in the U.S. as K923781. The major modification to the MXR 2000 Flowmeter to produce the proposed Digital MXR-D Flowmeter is the addition of an electronically controlled digital display to the control panel of the cabinet mount version. The electronics incorporated in the Digital MXR-D Flowmeter function as follows:
- Turn flow and clectronics on/off and display start-up information .
- Display nitrous oxide (N2O) percentage and total flow .
- Display information and instructions (i.e. fault conditions and error codes)
- Provide an audible signal for certain fault conditions.
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
Not Found
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)
Testing conducted to evaluate the functional performance and safety of the proposed Digital MXR-D Flowmeter includes software and hardware verification and validation and electrical safety and electromagnetic compatibility. The test results confirm that the proposed Digital MXR-D Flowmeter performs within established specifications and is safe and effective for use as a dental analgesia gas machine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Porter Instrument Co. MXR 2000 Flowmeter (K923781), Digital Ultra Analgesia Gas Machine (K052335), Matrx Digital MDM™, RA (K945722)
Reference Device(s)
Not Found
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).
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510(k) Summary for Digital MXR-D Flowmeter
NOV - 9 2006
1. SPONSOR
Parker Hannifin Corporation Porter Instrument Division 245 Township Line Rd. P.O. Box 907 Hatfield, PA 19440-0907
Contact Person: Stephen Loeffler Telephone: 215-723-4000
Date Prepared October 17, 2006
2. DEVICE NAME
Proprietary Name: Digital MXR-D Flowmeter Common/Usual Name: Flowmeter Classification Name: Analgesia gas machine
3. PREDICATE DEVICES
- Porter Instrument Co. MXR 2000 Flowmeter (K923781) .
- Digital Ultra Analgesia Gas Machine (K052335) .
- Matrx Digital MDM™, RA (K945722) .
4. DEVICE DESCRIPTION
The proposed Digital MXR-D Flowmeter is a modification of the MXR 2000 Flowmeter that was cleared for marketing in the U.S. as K923781. The major modification to the MXR 2000 Flowmeter to produce the proposed Digital MXR-D Flowmeter is the addition of an electronically controlled digital display to the control panel of the cabinet mount version. The electronics incorporated in the Digital MXR-D Flowmeter function as follows:
- Turn flow and clectronics on/off and display start-up information .
1
- Display nitrous oxide (N2O) percentage and total flow .
- . Display information and instructions (i.e. fault conditions and error codes)
- . Provide an audible signal for certain fault conditions.
5. INTENDED USE
The Digital MXR-D Flowmeter is intended for use in nitrous oxide/oxygen sedation systems for the delivery of a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Digital MXR-D Flowmeter and the predicate Digital Ultra Analgesia Gas Machine and the Matrx Digital MDM™, RA all incorporate a control panel that includes a digital display for setting device parameters including flow rate and concentration. The major difference between the proposed Digital MXR-D Flowmeter and the predicate Digital Ultra Analgesia Gas Machine and the Matrx Digital MDM™, RA devices is that these predicate devices provide electronic control of flow rate and concentration from the control panel.
The modifications to the predicate MXR 2000 Flowmeter that was implemented to produce the proposed Digital MXR-D Flowmeter is limited to the addition of the necessary hardware and software to support a digital display with the features identified in the bulleted list (see Section 4 of this summary). The proposed modification does not include electronic control of N2O percentage and flow rate. Like the predicate MXR 2000 Flowmeter, control of N2O percentage and total flow rate is mechanical in the proposed device, using the control knobs on the front of the Control Panel.
7. PERFORMANCE TESTING
Testing conducted to evaluate the functional performance and safety of the proposed Digital MXR-D Flowmeter includes software and hardware verification and validation and electrical safety and electromagnetic compatibility. The test results confirm that the proposed Digital MXR-D Flowmeter performs within established specifications and is safe and effective for use as a dental analgesia gas machine.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing strength and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Porter Instrument Company, Limited C/O Cynthia J. M. Nolte, Ph.D., RAC Senior Staff Consultant Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
NOV - 9 2006
Re: K062155
Trade/Device Name: Digital MXR-D Flowmeter Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Ancsthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: October 17, 2006 Received: October 18, 2006
Dear Dr. Nolte:
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 - Dr. Nolte
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 your 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutta Y. Mckau MD.
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
Enclosure
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510(k) Number (if known): K062155
Device Name: Digital MXR-D Flowmeter
Indications For Use:
The Digital MXR-D Flowmeter is intended for use in nitrous oxide/oxygen sedation systems for the delivery of a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Srita Y. Michael Davis
u of Anaschesiblogy, General Hospitz i on Control, Dental Devices