(321 days)
The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).
The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card. The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected. The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable. The connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor. The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
Here's a breakdown of the acceptance criteria and study information for the Dolphin Medical Voyager Pulse Oximeter, based on the provided text:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (ARMs) | Reported Device Performance (ARMs) |
|---|---|---|
| Adult/Pediatric (> 30 kg) SpO2 | < 2.0% | < 2.0% |
| Pediatric (< 30 kg) SpO2 | < 2.2% | < 2.2% |
| Neonate SpO2 | < 3.5% | < 3.5% |
Note: ARMs (Accuracy, Root Mean Square) is a measure of the statistical accuracy of the pulse oximeter readings compared to reference values.
Study Details
1. Sample sized used for the test set and the data provenance:
* Sample Size: 14 volunteers.
* Data Provenance: Prospective, clinical data collected at the VA Hospital of Wisconsin - Milwaukee (USA).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not explicitly stated. However, the study was conducted under the direction of Dr. Philip Clifford, MD, implying medical expertise was involved in the clinical validation, including potentially obtaining functional SaO2 values.
3. Adjudication method for the test set:
* Not explicitly mentioned. The text states "Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpOz values to functional SaO2 values," suggesting direct comparison to a reference standard rather than multi-reader adjudication as typically seen in image-based diagnostics.
4. 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 type of study (MRMC) is not relevant for a pulse oximeter, which is a standalone device measuring physiological parameters, not interpreting images or clinical cases requiring human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes. The study assessed the accuracy of the Dolphin Medical Voyager Pulse Oximeter itself by comparing its readings (SpO2 values) to a reference standard (functional SaO2 values) during breathe-down protocols. This is a standalone performance evaluation.
6. The type of ground truth used:
* Physiological Ground Truth: Functional SaO2 values, likely obtained through co-oximetry, which is considered the gold standard for measuring arterial oxygen saturation. The breathe-down protocol specifically generated a range of SaO2 values for comparison.
7. The sample size for the training set:
* Not specified. The document describes the clinical validation study (test set) but does not provide details on any separate training set used for the device's development or internal calibration.
8. How the ground truth for the training set was established:
* Not specified, as details about a training set are not provided. However, generally, for pulse oximeters, initial calibration and development would also rely on comparisons to known physiological oxygen saturation levels, often from similar breathe-down studies or controlled laboratory settings.
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7 2002 NOV
KC14218
November 6, 2002
Summary of Safety and Effectiveness Information for the Dolphin Medical Voyager Pulse Subject: Oximeter and Accessories Dolphin Medical Voyager Pulse Oximeter and Accessories Proprietary: Common: Oximeter Oximeter Class II - 21 CFR 870.2700 - 74 DQA Classification:
The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card.
The Dolphin Medical Voyager Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):
- Dolphin Medical Stand Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036. .
- QRS Diagnostic Spiroxcard Diagnostic Spirometer and Pulse Oximeter #K001995. .
The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected.
The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable.
The connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor.
The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
The Dolphin Medical Voyager Pulse Oximeter and Accessories is substantially equivalent in design concepts, technologies and materials to the Dolphin Stand-Alone Pulse Oximeter. Formal testing has been performed for the device including Safety and Emissions, and performance validation which has been included in this submission.
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The Dolphin Medical Voyager and Accessories were clinically validated in two breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee (Dr. Philip Clifford, MD). Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpOz values to functional SaO2 values. Fourteen volunteers participated in the breathe-down protocol at rest (i.e. no motion) while fully conscious at SaQ2 values ranging from 70-100%. Data was analyzed to determine the Aggs for each probe. Clinical validation for the Adult Reusable and Adult Disposable resulted in an accuracy determination of less than 2.0% Arms for adults and pediatrics > 30 kg in the range of 70-100% SaQ2. The Neonatal Disposable resulted in an accuracy determination of less than 2.2% for pediatrics < 30 kg and less than 3.5% for neonates in the range of 70-100% SaO2.
The Dolphin Medical Voyager Pulse Oximeter and Accessories have been designed to comply with the following standards:
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- EN60601-1 Medical Electrical Equipment; Part 1: General requirements for safety (includes Amendments 1 and 2)
- EN 60601-1-1: Medical Electrical Equipment; Part 1: General requirements for safety 1. 2. Collateral standard: Safety requirements for medical electrical systems.
- UL 2601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety 3.
- EN 865 Pulse Oximeter Particular requirements ব
- CSA C22.2 #601 Medical Electrical Equipment Part 1: General Requirements for Safety 5.
- EN 60601-1-2: Medical Electrical Equipment; Part 1: General requirements for safety 2. 6. a. Collateral standard: Electromagnetic compatibility - Requirements and tests
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- ISO 9919: Pulse Oximeters for medical use Requirements
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- IEC 60068-2-6: Environmental testing Part 2: Tests Test Fc: Vibration (sinusoidal)
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- IEC 60068-2-27: Environmental testing. Part 2: Test Ea and guidance: Shock
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- IEC 60068-2-64: Environmental testing Part 2: Test methods Test Fh: Vibration, a. broad-band random (digital control) and guidance
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- ISTA Procedure 2A: Integrity-Plus Test Procedure, Performance Test for Individual i. Package-Product 150lb (68.2kg) or Less
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- MIL-STD-810E, 501.3 Operating and Storage High Temperature
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- MIL-STD-810E. 502.3 Operating and Storage Low Temperature
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- MIL-STD-810E. 503.3 Temperature Shock
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- MIL-STD-810E, 507.3 Procedure III: Humidity
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure with three wavy lines extending from the head, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
od and Drug Administratio 00 Corporate Boulevard Rockville MD 20850
Mr. Jon Werner Ouality Assurance Manager Dolphin Medical, Incorporated OSI Medical, Incorporated 13801 McCormick Drive Tampa, Florida 33626
Re: K014218
Trade/Device Name: Dolphin Medical Voyager Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 10, 2002 Received: August 12, 2002
Dear Mr. Werner:
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. Werner
.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Timothy A. Ulatowski
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) Premarket Notification Intended Use and Indications for Use Statement
510(k) Number (if known):
Device Name: Dolphin Medical Voyager Pulse Oximeter
November 6, 2002
Intended Use:
The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
William A. Wot
(Division Sign-Off)
Division of Anesthesia, General Hospital, Infection Control, and Dental Devices (DAGID)
510(k) Number: K014218
Prescription Use (Per 21 CFR 801.109)
OR
over-the-counter Use
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).