(138 days)
No
The device description details a microprocessor-based system using electrochemical measurement principles. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is described as a tool to measure oxygen concentration in an air/oxygen mixture, not to treat a condition or provide therapy.
No
The device measures oxygen concentration in an air/oxygen mixture, providing a quantitative measurement of an external parameter rather than assessing a patient's medical condition or diagnosing a disease.
No
The device description explicitly lists hardware components such as an oxygen sensor, interface cable, analyzer unit, battery, push buttons, and an LCD display. It also mentions testing related to hardware performance and durability.
Based on the provided information, the PM5950 Accu O2 Analyzer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "spot-check or measure oxygen concentration of a delivered air/oxygen mixture." This is a measurement of a gas mixture being delivered to a patient, not a test performed on a biological sample taken from a patient.
- Device Description: The device measures oxygen concentration in a "breathing circuit" using an oxygen sensor. This confirms it's analyzing the gas being delivered, not a biological sample.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing blood, urine, tissue, or any other biological specimen.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health or condition. The PM5950 Accu O2 Analyzer measures the composition of a gas mixture, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.
Product codes (comma separated list FDA assigned to the subject device)
CCL
Device Description
The PM5950 Accu O2 Analyzer measures and displays the amount of oxygen present, percent (%), in an air/oxygen breathing circuit. Oxygen measurement is accomplished by placing an oxygen sensor into a breathing circuit. The sensor employs amperometric electrochemical measurement principles (e.g. galvanic fuel cell; lead oxygen battery). The sensor is a purchased and an existing legally marketed device. The oxygen sensor is connected to the analyzer unit via an interface cable. The analyzer unit is battery powered. The analyzer is microprocessor based and interfaces with user push buttons and a LCD display. User push buttons allow the user to turn the unit on/off and to initiate calibration. The LCD provides indication of the per-cent oxygen measured, low battery indication and calibration required.
The device consists of four basic elements:
- Base Device: The Base Device is a portable / mountable enclosure that houses the device electronic circuitry, a 3 ½" backlight display, membrane keypad, sensor interface jack and 2 AA Alkaline Batteries.
- Extendible Cable: The extendible cable allows connection of the sensor the Base Device. The cable can be extended up to 10 feet from the side of the device.
- Oxygen Sensor W/ Diverter Fitting: The Oxygen sensor is a galvanic fuel cell that generates a voltage output relative to the measured percent oxygen. The Oxygen Sensor (with diverter) is designed to fit industry standard, 15 mm I.D. "T" adaptors.
- Tee Adaptor: The Tee adaptor is used to connect the Oxygen Sensor and Diverter Fitting to an oxygen pathway circuit.
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
The PM5950 Accu O2 Analyzer is intended for use by trained professionals in Hospital, Home Care, Transport, and sub-acute institutions.
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)
The PM5950 Accu O2 Analyzer was tested in compliance with FDA recognized consensus standard ISO 80601-2-55:2011: Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors and meets the requirements of the standard.
Additional certifications include:
- IEC 60601-1:2005-12 Third Edition: Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-6:2013-3.1 Medical Electrical Equipment Part 1 -6: General . Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- IEC 61000-3-2 Edition 3.2:2009: Electromagnetic compatibility (EMC) Part 3-2: . Limits - Limits for harmonic current emissions (equipment input current
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 2, 2018
Precision Medical Inc. James Parker Quality Assurance Manager 300 Held Drive Northampton, Pennsylvania 18067
Re: K173807
Trade/Device Name: PM5950 Accu O2 Oxygen Analyzer Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL Dated: March 12, 2018 Received: March 29, 2018
Dear James Parker:
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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -ഗ
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173807
Device Name PM5950 Accu O2 Analyzer
Indications for Use (Describe)
The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Precision Medical. The words "PRECISION MEDICAL" are written in a serif font, with "PRECISION" in green and "MEDICAL" in black. To the right of the words is a green graphic that resembles a series of angled lines.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
510(k) Summary
Abbreviated 510K
Precision Medical, Inc. PM5950 Accu O2 Analyzer.
Revised 5/1/2018
1. Submitter Information
Submitter: Precision Medical, Inc. 300 Held Drive Northampton, Pa. 18067
Facility Registration #: 2523148
| Contact: | James Parker | |
|---|---|---|
| Quality Assurance Manager | ||
| Tel: | (610)-262-6090 Extensions 2228 | |
| Fax: | (610)-262-6080 | |
| Preparation Date: | 11/17/2017 | Revised Date: 5/1/2018 |
2. Device Name
| Proprietary Name: | Accu O2 |
|---|---|
| Model number: | PM5950 |
| Common Name: | Oxygen Analyzer |
| Classification Name: | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Classification Product Code: | CCL |
| Regulation number: | 868.1720 |
| Regulatory Status: | Class II |
4
3. Predicate Device Equivalence
Precision Medical, Inc. is claiming substantial equivalence;
Primary Predicate Device; Substantial Equivalent:
| Proprietary Name: | MAXO2®+AE |
|---|---|
| Model Number: | R217P72 |
| Manufactured by: | Maxtec |
| 2305 South 1070 West | |
| Salt Lake City, Utah 84119 |
Classification Name: Analyzer, Gas, Oxygen, Gaseous-Phase Premarket Notification #: K040484
Referenced Predicate Device;
| Proprietary Name: | Oxygen Monitor | |
|---|---|---|
| Model Number: | PM5900 | |
| Manufactured by: | Precision Medical Inc. | |
| 300 Held Drive | ||
| Northampton, Pa 18067 |
Classification Name: Analyzer, Gas, Oxygen, Gaseous-Phase
Premarket Notification #: K063096
Image /page/4/Picture/11 description: The image shows the logo for Precision Medical. The words "PRECISION MEDICAL" are written in a serif font, with "PRECISION" in green and "MEDICAL" in black. A green graphic resembling a stylized leaf or feather is placed between the two words. The logo has a clean and professional appearance.
Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
5
510(k): K173807
Image /page/5/Picture/2 description: The image shows the logo for Precision Medical. The words "PRECISION MEDICAL" are written in a serif font, with "PRECISION" in green and "MEDICAL" in black. A green graphic resembling a stylized leaf or feather is placed between the two words. The registered trademark symbol is placed after the word "MEDICAL".
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
4. Device Description (per 21 CFR 807.92)
General Description:
The PM5950 Accu O2 Analyzer measures and displays the amount of oxygen present, percent (%), in an air/oxygen breathing circuit.
Intended Use:
The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.
Indications for Use:
The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.
Contraindication:
The PM5950 Accu O2 Analyzer is not intended to actively monitor oxygen concentration or oxygen gas mixtures while being delivered to a patient. PM5950 Accu O2 Analyzer is not intended for use in a MRI environment.
Intended population \ Environment \ Conditions to be used for:
The PM5950 Accu O2 Analyzer is intended for use by trained professionals in Hospital, Home Care, Transport, and sub-acute institutions.
Prescription:
Caution! US. Federal Law restricts this device to sale by or on the order of a physician.
Principals of Operation:
Oxygen measurement is accomplished by placing an oxygen sensor into a breathing circuit. The sensor employs amperometric electrochemical measurement principles (e.g. galvanic fuel cell; lead oxygen battery). The sensor is a purchased and an existing legally marketed device.
The oxygen sensor is connected to the analyzer unit via an interface cable. The analyzer unit is battery powered. The analyzer is microprocessor based and interfaces with user push buttons and a LCD display. User push buttons allow the user to turn the unit on/off and to initiate calibration. The LCD provides indication of the per-cent oxygen measured, low battery indication and calibration required.
New Technologies/Features:
Neither new technologies nor features are incorporated
Configurations/Variations:
The PM5950 Accu O2 Analyzer will be provided in the configuration submitted; use of the Tee Adaptor is optional. No variations exist.
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Image /page/6/Picture/1 description: The image shows the logo for Precision Medical. The logo is in green and black. The word "PRECISION" is in green, and the word "MEDICAL" is in black. There is a green graphic between the two words.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
Key Functional Elements:
Image /page/6/Figure/5 description: The image shows a Precision Medical oxygen analyzer and its components. The oxygen analyzer has a digital display showing an oxygen concentration of 100.0%. The components include a coiled cable, locking ring, oxygen sensor, diverter fitting, and tee adapter.
The device consists of four basic elements:
- Base Device: The Base Device is a portable / mountable enclosure that houses the device electronic circuitry, a 3 ½" backlight display, membrane keypad, sensor interface jack and 2 AA Alkaline Batteries.
- Extendible Cable: The extendible cable allows connection of the sensor the Base Device. The cable can be extended up to 10 feet from the side of the device.
- Oxygen Sensor W/ Diverter Fitting: The Oxygen sensor is a galvanic fuel cell that generates a voltage output relative to the measured percent oxygen. The Oxygen Sensor (with diverter) is designed to fit industry standard, 15 mm I.D. "T" adaptors.
- Tee Adaptor: The Tee adaptor is used to connect the Oxygen Sensor and Diverter Fitting to an oxygen pathway circuit.
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Image /page/7/Picture/1 description: The image shows the logo for Precision Medical. The logo is in green and black. The word "PRECISION" is in green, and the word "MEDICAL" is in black.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
The device User interface
| ITEM NAME | DESCRIPTION |
|---|---|
| Power Key | |
| Image: [Power Key Symbol] | The Power Key turns the Oxygen Analyzer ON and OFF. |
| Calibration Key | |
| Image: [Calibration Key Symbol] | Pressing the Calibration Key calibrates the Oxygen Analyzer with air or oxygen. |
| Image: [Calibration Symbol] | Calibration Symbol - The calibration symbol is located on the display and is timed to activate when a calibration is necessary, or when a calibration is being conducted. |
| Image: [Low Battery Symbol] | Low Battery Symbol - The low battery indicator is located on the top of the display and is only activated when the voltage on the batteries is below a normal operating level. |
| Image: [Invalid Reading Symbol] | Invalid Reading Symbol - failed sensor, failed cable , invalid calibration |
| 100.0 % | Oxygen Concentration Reading. (0.0 to 100.0 %) |
Technical Specifications
Base Device Specifications
Dimensions: (Analyzer without cable and sensor attached):
| Depth: | 1.30" (3.32 cm) |
|---|---|
| Width: | 2.90" (7.30 cm) |
| Height: | 4.00" (10.23 cm) |
| Cable Length: | 10 ft. (3.05m) (fully extended) |
Weight:
Device Weight: 0.35 lbs (5.60 oz / 0.15 kg)
8
Image /page/8/Picture/1 description: The image shows the logo for Precision Medical. The logo is in green and black. The word "PRECISION" is in green, and the word "MEDICAL" is in black. There is a green graphic between the two words.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
(Includes: analyzer, sensor, batteries and cable)
| Operating Conditions: | |
|---|---|
| Temperature: | 50°F - 113°F (10°C - 45°C) |
| Altitude: | Sea Level to 8000 feet |
| Humidity: | 0-95% non-condensing |
| Storage Conditions: | |
| Temperature: | 5°F - 122°F (0°C - 50°C) |
| Humidity: | 0 - 95% non-condensing |
| Mode of Operation: | Continuous |
| Electrical Classification: | Internally powered Medical Electrical equipment |
| Diverter Fitting: | Fits industry standard, 15 mm “T” adapter |
| Measurement Range: | 0.0 - 100% Oxygen |
| Resolution: | 0.1 % |
| Total Accuracy: | $\pm$ 3.0% Actual Oxygen Level over full operating temperature range |
| Drift of Measurement: | 1,000,000 O2 % Hours |
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5. Difference in technology from MAXO2®+AE R217P72 (Predicate) to PM5950 Accu O2 Analyzer
| Technical
difference | MAXO2®+AE
(Primary Predicate)
K040484 | PM5900 Oxygen
Monitor
(Reference Predicate)
K063096 | PM5950 Accu O2
Analyzer
K173807 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The MAXO2+ is
intended as a tool for
use by qualified
personnel to spot-check
or measure oxygen
concentration of a
delivered air/oxygen
mixture. The MAXO 2+
is not intended for use
in continuous
monitoring of oxygen
delivery to a patient. | The oxygen monitor
provides continuous,
direct monitoring of
oxygen mixtures in a
wide variety of medical
applications such as
anesthesiology [e.g.
anesthesia machines],
respiratory devices [e.g.
respirators, ventilators,
pediatric incubators], and
oxygen therapy [e.g.,
oxygen tents]. The
oxygen monitor is to be
used by trained
healthcare professionals
under the supervision, or
on the order, of a
physician in a hospital [or
other clinical setting. The
Precision Medical, Inc.
oxygen monitor is not
intended for transport
use. This device is not an
oxygen supply source. | The PM5950 Accu O2
Analyzer is intended as a
tool for use by qualified
personnel to spot-check
or measure oxygen
concentration of a
delivered air/oxygen
mixture. The PM5950
Accu O2 Analyzer is not
intended for use in
continuous monitoring of
oxygen delivery to patient. |
| Calibration | After the device is
turned on it will
automatically calibrate
to room air. The display
should be stable and
reading 20.9%. | The device requires
manual calibration | The device requires
manual calibration. |
PRECISION®
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
10
Abbreviated 510k for PM5950 Accu O2 Analyzer Model # PM5950
510(k): K173807
Image /page/10/Picture/2 description: The image shows the logo for Precision Medical. The word "PRECISION" is in green, and the word "MEDICAL" is in black. There is a green graphic between the two words. The logo also includes the registered trademark symbol.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
6. Certifications
The PM5950 Accu O2 Analyzer was tested in compliance with FDA recognized consensus standard ISO 80601-2-55:2011: Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors and meets the requirements of the standard.
- IEC 60601-1:2005-12 Third Edition: Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-6:2013-3.1 Medical Electrical Equipment Part 1 -6: General . Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- IEC 61000-3-2 Edition 3.2:2009: Electromagnetic compatibility (EMC) Part 3-2: . Limits - Limits for harmonic current emissions (equipment input current