(138 days)
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.
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 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, Extendible Cable, Oxygen Sensor W/ Diverter Fitting, and Tee Adaptor.
Here's a breakdown of the acceptance criteria and study information for the Precision Medical Inc. PM5950 Accu O2 Oxygen Analyzer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Technical Specifications & Comparison) | Reported Device Performance (PM5950 Accu O2 Analyzer) |
|---|---|
| Measurement Range 0.0 - 100% Oxygen | 0.0 - 100% Oxygen |
| Resolution 0.1 Increments | 0.1 Increments |
| Total Accuracy $\pm$ 3.0% Actual Oxygen Level over full operating temperature range | $\pm$ 3.0% Actual Oxygen Level over full operating temperature range |
| Drift of Measurement < +/-1% of full scale at constant temperature, pressure and humidity | < +/-1% of full scale at constant temperature, pressure and humidity |
| Response Time 90% of final value in less than 12 seconds at 77°F (25°C) | 90% of final value in less than 12 seconds at 77°F (25°C) |
| Warm-up Time Not required | Not required |
| Low Battery Indication Low battery icon displayed | Low battery icon displayed |
| Operating Temperature 10°C - 45°C (50°F - 113°F) | 10°C - 45°C (50°F - 113°F) |
| Storage Temperature 0°C - 50°C (32°F - 122°F) | 0°C - 50°C (32°F - 122°F) |
| Humidity 0-95% non-condensing | 0-95% non-condensing |
| Ingress of water IPX1 (Drip Proof) | IPX1 (Drip Proof) |
| Electrical Classification Internally powered Medical Electrical equipment | Internally powered Medical Electrical equipment |
| Expected Sensor Life > 1,000,000 O2 % Hours (equivalent to 2 years in typical applications for a similar sensor) | 2-years in typical applications for the Maxtec MAX 13/CAG-13 Galvanic fuel sensor (the same sensor used in the predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for tests related to accuracy, drift, response time, etc. It lists a series of compliance reports and tests performed by Precision Medical Inc. to demonstrate substantial equivalence. These are:
- Ingress of water ISO 80601-2-55 (201.11.6.5)
- Oxygen Analyzer Measurement Accuracy ISO 80601-2-55:2011 (201.12.1.101,102,104)
- Shock & Vibration Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (201.15.3.5.101)
- EMC Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (202.6.2)
- Oxygen Analyzer - Leakage to Atmosphere ISO 80601-2-55:2011 (201.102)
- Operating and Storage Temp
- Operating and Storage Temperature of the PM5950 O2 Analyzer Review
- Software Validation of PM5950
- Effects of Elevation-Barometric Pressure Change
- Drop Test of PM5950 in Shipping Box
- Performance Test
- Process Validation of the PM5950
- Life Expectancy of the Keypad
- Label Durability
- Cleaning and disinfection of ME Equipment of ME Systems
- Compatibility with substances used with ME Equipment
The data provenance is from in-house testing conducted by Precision Medical, Inc. in the USA. The data is prospective in nature, as it was generated specifically for the 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing appears to be primarily engineering and performance verification against specified technical standards and internal criteria, rather than expert-based ground truth establishment for a diagnostic output.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (an oxygen analyzer), testing would likely involve direct measurement against known gas concentrations or calibrated reference instruments, rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI devices where human readers are involved in making diagnoses or assessments. The PM5950 Accu O2 Analyzer is a measurement device for oxygen concentration.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance evaluation was done. The entire suite of tests (accuracy, response time, drift, environmental robustness, software validation, etc.) outlined in section "8. Declarations of Conformity and Summary Reports" represents the standalone performance evaluation of the device itself. The device is designed to provide direct measurements without human interpretation or algorithm modification once calibrated.
7. The Type of Ground Truth Used
The ground truth for the device's performance (e.g., accuracy, response time) would be established using calibrated reference standards and instruments to generate known oxygen concentrations. For other tests (like shock, vibration, ingress of water, EMC), the ground truth is defined by the specific requirements and methodologies of the referenced international and national consensus standards (e.g., ISO 80601-2-55, IEC 60601 series).
8. The Sample Size for the Training Set
This information is not applicable/not provided. The PM5950 Accu O2 Analyzer is a hardware-based measurement device that relies on a galvanic fuel cell sensor and a microprocessor. It does not appear to utilize machine learning or AI models that require a "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering verification.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above (no AI/ML training set).
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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);
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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
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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 |
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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: | Maxtec2305 South 1070 WestSalt 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
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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 KeyImage: [Power Key Symbol] | The Power Key turns the Oxygen Analyzer ON and OFF. |
| Calibration KeyImage: [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)
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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% of full scale at constant temperature, pressure and humidity |
| Response Time: | 90% of final value in less than 12 seconds at 77°F (25°C) |
| Warm-up Time: | Not required |
| Low Battery Indication: | Low battery icon displayed |
| Patient Contact: | None |
| Classifications: | |
| Protection against electric shock: Internally powered equipment | |
| Protection against water: IPX1 (Drip Proof) | |
| Mode of Operation: | Continuous |
| Sterilization: | Non-Sterile Device |
| Flammable anesthetic mixture: | Not suitable for use in presence of a flammable anestheticmixture |
| Sensor Specifications: | |
| Sensor Type: | Galvanic oxygen sensor; Precision Medical PN 504877 |
| Expected Sensor Life: | > 1,000,000 O2 % Hours |
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5. Difference in technology from MAXO2®+AE R217P72 (Predicate) to PM5950 Accu O2 Analyzer
| Technicaldifference | MAXO2®+AE(Primary Predicate)K040484 | PM5900 OxygenMonitor(Reference Predicate)K063096 | PM5950 Accu O2AnalyzerK173807 |
|---|---|---|---|
| Intended Use | The MAXO2+ isintended as a tool foruse by qualifiedpersonnel to spot-checkor measure oxygenconcentration of adelivered air/oxygenmixture. The MAXO 2+is not intended for usein continuousmonitoring of oxygendelivery to a patient. | The oxygen monitorprovides continuous,direct monitoring ofoxygen mixtures in awide variety of medicalapplications such asanesthesiology [e.g.anesthesia machines],respiratory devices [e.g.respirators, ventilators,pediatric incubators], andoxygen therapy [e.g.,oxygen tents]. Theoxygen monitor is to beused by trainedhealthcare professionalsunder the supervision, oron the order, of aphysician in a hospital [orother clinical setting. ThePrecision Medical, Inc.oxygen monitor is notintended for transportuse. This device is not anoxygen supply source. | The PM5950 Accu O2Analyzer is intended as atool for use by qualifiedpersonnel to spot-checkor measure oxygenconcentration of adelivered air/oxygenmixture. The PM5950Accu O2 Analyzer is notintended for use incontinuous monitoring ofoxygen delivery to patient. |
| Calibration | After the device isturned on it willautomatically calibrateto room air. The displayshould be stable andreading 20.9%. | The device requiresmanual calibration | The device requiresmanual calibration. |
PRECISION®
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
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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 < 16A per phase)
- . IEC 61000-3-3 Edition 2.0: 2008: Electromagnetic compatibility (EMC) – Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in low-voltage supply systems, for equipment with rated current < 16A per phase and not subject to conditional connection
- IEC 61000-4-2 Edition 2.0 2008-12: Electromagnetic compatibility (EMC) Part 4-2: . Testing and measurement techniques - Electrostatic discharge immunity test
- IEC 61000-4-3 Edition 3.2: 2010-04: Electromagnetic compatibility (EMC) Part 4-3: . Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
- IEC 61000-4-4 Edition 2.1: 2011-03: Electromagnetic compatibility (EMC) Part 4-4: . Testing and measurement techniques – Electrical fast transient/burst immunity test
- IEC 61000-4-5 Edition 2.0: 2005-11: Electromagnetic compatibility (EMC) Part 4-5: . Testing and measurement techniques - Surge immunity test
- IEC 61000-4-6 Edition 4.0: 2013-10: Electromagnetic compatibility (EMC) Part 4-6: ● Testing and measurement techniques - Immunity to conducted disturbances, induced by radio frequency fields.
- IEC 61000-4-8 Edition 2.0: 2009-09: Electromagnetic compatibility (EMC) Part 4-8: ● Testing and measurement techniques - Power frequency magnetic field immunity test
- IEC 61000-4-11Edition 2.0: 2004-03: Electromagnetic compatibility (EMC) Part 4-11: . Testing and measurement techniques –Voltage dips, short interruptions and voltage variations immunity test
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Image /page/11/Picture/1 description: The image shows the logo for Precision Medical. The word "PRECISION" is in a bold, green, sans-serif font. To the right of the word "PRECISION" is a green graphic that resembles blades of grass. To the right of the graphic is the word "MEDICAL" in a black, serif font.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
Table of Comparisons to Predicate Device 7.
| R217P72MAXO2®+AE(Primary Predicate)K040484 | PM5900Oxygen Monitor(Referenced Predicate)K063096 | PM5950Accu O2 Analyzer | |
|---|---|---|---|
| Specifications | |||
| Weight (device only) | 0.4 lbs. (170g) | 1.11 lbs (0.50 kg) | 0.33 Lbs. (150g) |
| Dimensions (inches): | |||
| Length | 1.5" | 1.72" | 1.3" |
| Height | 4.0" | 5.44" | 4.0" |
| Width | 3.0" | 3.56" | 2.9" |
| Electrical Requirements | 2, AA Alkalinebatteries (2 x 1.5Volts) | 4, AA Alkaline batteries(4 x 1.5 Volts) | 2, AA Alkaline batteries(2 x 1.5 Volts) |
| Operating temp range | 15°C - 40°C(59°F - 104°F) | 10°C - 45°C(50°F - 113°F) | 10°C - 45°C(50°F- 113°F) |
| Storage temp range | -15°C - 50°C(5°F - 122°F) | -15°C- 50°C(5°F - 122°F) | -0°C- 50°C(32°F - 122°F) |
| Humidity | 0 - 95% non-condensing | 0 - 95% non-condensing | 0 - 95% non-condensing |
| Mode of Operation: | Continuous | Continuous | Continuous |
| Electrical Classification: | Internally poweredMedical Electricalequipment | Internally poweredMedical Electricalequipment | Internally poweredMedical Electricalequipment |
| Protection against water: | IPX1 | IPX1 | IPX1 |
| Measurement Range: | 0.0 - 100.0% | 0.0 - 100.0% | 0.0 - 100.0% |
| Resolution: | 0.1 Increments | 0.1 Increments | 0.1 Increments |
| Total Accuracy: | $\pm$ 3% Actual OxygenLevel over fulloperating temperaturerange | $\pm$ 3% Actual OxygenLevel over fulloperating temperaturerange | $\pm$ 3% Actual OxygenLevel over fulloperating temperaturerange |
| Specifications | R217P72MAXO2®+AE(Primary Predicate)K040484 | PM5900Oxygen Monitor(Referenced Predicate)K063096 | PM5950Accu O2 Analyzer |
| Response Time: | 90% of final value inapproximately 15seconds at 23°C | 90% of final value inless than 12 seconds at77°F (25°C) | 90% of final value inless than 12 seconds at77°F (25°C) |
| Warm-up Time: | none required | none required | none required |
| Low Battery Indication: | Low battery icondisplayed on graphicsscreen | Low battery icondisplayed on graphicsscreen | Low battery icondisplayed on graphicsscreen |
| Interface | Two buttonOn\Off, Cal | Two buttonOn\Off, Cal | Two buttonOn\Off, Cal |
| Sensor Type | Maxtec MAX 13/CAG-13Galvanic fuel sensor(0-100%) | Maxtec MAX 13/CAG-13Galvanic fuel sensor(0-100%) | Maxtec MAX 13/CAG-13Galvanic fuel sensor(0-100%) |
| Sensor Life | 2-years in typicalapplications | 2-years in typicalapplications | 2-years in typicalapplications |
| Drift of Measurement: | < +/-1% of full scale atconstant temperature,pressure and humidity | < +/-1% of full scale atconstant temperature,pressure and humidity | < +/-1% of full scale atconstant temperature,pressure and humidity |
| Alarms | None | high/low alarms,respective flashing redLEDs and graphics,68db audible alarm @1 meter | None |
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Image /page/12/Picture/1 description: The image shows the logo for Precision Medical. The word "PRECISION" is in green, block letters. To the right of the word "PRECISION" is a green graphic that looks like blades of grass. To the right of the graphic is the word "MEDICAL" in black, block letters.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090
Fax: 610-262-6080
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Image /page/13/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.
Pa 18067
Tel: 610-262-6090
Fax: 610-262-6080
8. Declarations of Conformity and Summary Reports
The following list is high level summary of the tests that were used to demonstrate substantial equivalence.
IEC 60601-1 3rd + A1 (60601_1k) Report CB_PM5950
IEC 60601-1-2 EMC Test Report_PM5950
IEC 60601-1-6 _ IEC 62366 COMPLIANCE Report_PM5950
ISO 80601-2-55 2011 Compliance Report PM5950
IEC 60068-2-27& 64 Shock & Vibration Test_PM5950
ISO 14971 Risk Management File PM5950_101617
The following list is a summary of the tests performed by Precision Medical Inc. that were used to demonstrate substantial equivalence.
| 811-1 | Ingress of water ISO 80601-2-55 (201.11.6.5) |
|---|---|
| 811-2 | Oxygen Analyzer Measurement Accuracy ISO 80601-2-55:2011(201.12.1.101,102,104) |
| 811-3 | Shock & Vibration Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011(201.15.3.5.101) |
| 811-4 | EMC Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (202.6.2) |
| 811-6 | Oxygen Analyzer - Leakage to Atmosphere ISO 80601-2-55:2011 (201.102) |
| 811-7 | Operating and Storage Temp |
| 811-7A | Operating and Storage Temperature of the PM5950 O2 Analyzer Review |
| 811-8 | Software Validation of PM5950 |
| 811-10 | Effects of Elevation-Barometric Pressure Change |
| 811-11 | Drop Test of PM5950 in Shipping Box |
| 811-12 | Performance Test |
| 811-13 | Process Validation of the PM5950 |
| 811-15 | Life Expectancy of the Keypad |
| 811-16 | Label Durability |
| 811-17 | Cleaning and disinfection of ME Equipment of ME Systems |
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Image /page/14/Picture/1 description: The image features the logo for "Precision Medical." The word "PRECISION" is written in a bold, green font, followed by a stylized green graphic that resembles a series of angled lines. To the right of the graphic, the word "MEDICAL" is written in a thinner, black font, with the registered trademark symbol (®) next to it. The overall design is clean and professional, suggesting a company in the healthcare or medical industry.
300 Held Drive Northampton, Pa 18067 USA
Tel: 610-262-6090 Fax: 610-262-6080
811-18 Compatibility with substances used with ME Equipment
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for PM5950 Oxygen Analyzer was considered to be "Moderate" because a failure of the Device Software could result in Minor Injury to a patient, and a malfunction of a latent design flaw in the Device Software may lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
9. Conclusions
Precision Medical's PM5950 Accu O2 Analyzer operates in the same manner as the Primary Predicate Device: MAXO2+AE. The Referenced Predicate Device, Precision Medical PM5900, is only presented to indicate no new technologies or features have been developed or incorporated. Compliance testing indicates the technical specifications presented have been achieved. The PM5950 Accu O2 Analyzer has the same Intended/Indicated use as the Primary Predicate Device. Precision Medical's PM5950 Accu O2 Analyzer has the same therapeutic use. Precision Medical's PM5950 Accu O2 Analyzer is substantially equivalent to the Primary Predicate Device.
The Precision Medical PM5900 Oxygen Monitor was used a reference predicate device as the same applied consensus standard was used for compliance testing (ISO 80601-2-55:2011). The significant difference between the Precision Medical, Inc PM5900 Oxygen Monitor and PM5950 Accu O2 Analyzer is that the Oxygen Monitor may be used to continuously monitor and contains alarms.
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.
In summary, Precision Medical, Inc had demonstrated that the Precision Medical, Inc PM5950 Accu O2 Analyzer is as safe and as effective as the predicate device. The combined non-clinical testing and analysis of results provides assurance that the device meets the specifications and is as safe, as effective, and performs as well as or better than the legally marketed predicate MAXO2+AE device..
§ 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).