(27 days)
The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO2 sensor).
The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients. The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpOz value, the high and low SpO2 and pulse rate alarms, 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 (SpO-) and pulse rate, and provide for the connection to the connecting cable. The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8,8 lbs. The unit is powered either with a voltage input of 100-240 Vac. 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module) and a charge time of about 4,5 hours to 80% capacity. The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor. The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in lenath. 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 oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).
The Dolphin Medical 2100 Pulse Oximeter and Accessories were evaluated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The information provided heavily emphasizes regulatory compliance and substantial equivalence to previously marketed devices, rather than a detailed standalone performance study.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria and direct reported performance metrics (e.g., accuracy +/- X%) are not explicitly stated. However, the document refers to compliance with several standards, including FDA Guidance Document for Pulse Oximeters: 9/7/1992 and EN 865:1997. These standards typically define accuracy requirements for pulse oximeters. Without access to the specific content of these standards and the detailed testing reports, precise numerical acceptance criteria cannot be extracted.
Implicit Acceptance Criteria (based on standards listed):
- Accuracy for SpO2: Based on the FDA Guidance Document for Pulse Oximeters, this would typically involve a root mean square (Arms) difference between the pulse oximeter reading and a co-oximeter reference within a specified range (e.g., ±2% or ±3% for 70-100% SpO2 in adults, and potentially different for neonates).
- Accuracy for Pulse Rate: Typically defined as a range of difference (e.g., ±3 bpm or ±2% of reading) compared to an ECG reference.
- Performance in Motion and Low Perfusion: Testing would ensure the device maintains accuracy under these challenging conditions, again with specified accuracy limits.
- Safety and EMC Standards Compliance: As indicated by compliance with a long list of IEC, CSA, UL, and other standards.
Reported Device Performance:
The document states: "Additional performance validation testing has been performed for the 560 neonatal disposable sensor and has been included in this submission." However, the results of this testing, including specific accuracy figures or performance data, are not provided in this summary. The document primarily asserts "substantial equivalence" to predicate devices, implying that its performance meets the level demonstrated by those devices, which would have adhered to the same general performance standards.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature) for the performance validation testing mentioned for the neonatal sensor.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Given that this is a pulse oximeter, ground truth for performance testing is typically established using a co-oximeter for SpO2 and an ECG device for pulse rate, rather than human experts interpreting data. The document does not mention human experts being used to establish ground truth for performance testing. If studies involved human subjects, medical professionals would be involved in monitoring, but not typically in "establishing ground truth" in the way an expert panel would for image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as ground truth is established by objective measurement devices (co-oximeter, ECG) rather than human interpretation requiring adjudication.
5. 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
Not applicable. This device is a standalone medical device (pulse oximeter) for direct measurement, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the device is intrinsically standalone. A pulse oximeter provides direct measurements (SpO2 and pulse rate) without requiring human interpretation of complex outputs in the way an AI-driven image analysis system would. The performance validation testing would be on the algorithm's ability to accurately calculate these parameters based on the sensor's optical signals. The document implicitly supports this by stating it "receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate".
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For pulse oximeters, the accepted gold standard (ground truth) for SpO2 accuracy is typically:
- Co-oximetry: Direct measurement of arterial oxygen saturation (SaO2) from arterial blood samples using a laboratory co-oximeter. This is usually performed during a "hypoxia study" where subjects' oxygen levels are carefully lowered.
- Electrocardiogram (ECG): For pulse rate, an ECG device is the gold standard.
The document refers to "performance validation testing" and compliance with standards like the "FDA Guidance Document for Pulse Oximeters: 9/7/1992" and "EN 865: 1997", both of which mandate the use of co-oximetry and ECG for establishing ground truth during such studies.
8. The sample size for the training set
The document does not provide any information regarding a training set sample size. Given this is a 510(k) submission for a traditional medical device (pulse oximeter), the concept of a "training set" in the context of machine learning algorithms is likely not directly applicable in the way it would be for AI/ML-driven devices. While the device contains electronic hardware and software, the development process might involve calibration and optimization using engineering data rather than a distinct "training set" as defined for AI models.
9. How the ground truth for the training set was established
As there is no mention of a distinct "training set" in the context of AI/ML, this information is not provided. For traditional medical device development, internal validation and calibration would occur using established measurement methods, but the document does not elaborate on these details.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Dolphin Medical 2100 Pulse Oximeter and Accessories 7/11/02
Submitter Company
Dolphin Medical - FL 13801 McCormick Dr Tampa, FL 33626
Contact: Jon Werner Phone: 813-818-7488 Fax: 813-818-7488
Sponsor Company
Dolphin Medical, Inc. 12525 Chadron Avenue Hawthorne, CA 90250
Contact: Tammy Conway Phone: 310-349-2308 Fax: 310-978-1816
Manufacturing Facility
Opto Sensors (M) Sdn. Bhd. No. 6 Jalan Angkasa Mas 1 Tebrau Industrial Estate II 81100 Johor Bahru. Malaysia
Common, Classification & Proprietary Names
Common Name: Oximeter Oximeter Class II - 21 CFR 870.2700 - 74 DQA Classification Name: Proprietary Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories.
Intended Use
The Dolphin Medical Stand-Alone Pulse Oximeter Model 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO- sensor). The Dolphin Medical Pulse Oximeter Model 2100 and Accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions and for patients who are well or poorly perfused in hospital-type facilities and home environments.
Predicate Device
The Dolphin Medical 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, . #K012533, #K012626, and #K020075.
The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients.
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The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpOz value, the high and low SpO2 and pulse rate alarms, 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 (SpO-) and pulse rate, and provide for the connection to the connecting cable.
The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8,8 lbs. The unit is powered either with a voltage input of 100-240 Vac. 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module) and a charge time of about 4,5 hours to 80% capacity.
The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor.
The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in lenath.
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 oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).
The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories have been designed to comply with the following standards:
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- CSA C22.2 No. 601.1
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- IEC 601-1. Part 1 and Amendments 1 and 2
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- IEC 601-1-1, Part 1
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- IEC 601-1-2, Part 1
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- ISO 9919: 1992
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- EN 865: 1997
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- FDA Guidance Document for Pulse Oximeters: 9/7/1992
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- ASTM 1415:1992, and Draft 10.1
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- UL2601-1: Second Edition, 1997
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- IEC 60068-2-6
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- IEC 60068-2-27
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- IEC 60068-2-64
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- ISTA Procedure 2A
The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories is substantially equivalent in design concepts, technologies and materials to the Dolphin Medical Stand-Alone Pulse Oximeter Model No. 2100 and Accessories previously reviewed. Additional performance validation testing has been performed for the 560 neonatal disposable sensor and has been included in this submission.
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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 stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community and support. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Public Health Service
JUL 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Werner Ouality Assurance Manager Dolphin Medical, Incorporated Dolphin Medical-FL 13801 McCormick Drive Tampa, Florida 33626
Re: K021959
Trade/Device Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 12, 2002 Received: June 14, 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 vour 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.
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Page 2 - Mr. Werner .
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 (OS) 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,
Timothy W. Ulteig
Timothy K. 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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INDICATIONS FOR INTENDED USE FOR 2100 PULSE OXIMETER
510(k) Number (if known): K021959
Device Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100
July 11, 2002
Indications for Use:
The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO2 sensor).
Accessories:
Dolphin ONE Disposable Sensors Dolphin ONE 210 Reusable Finger Clip intended for adults / pediatrics greater than 66.14 lbs. (30kg). Dolphin ONE 110 Extension Cable
(PLEASE DO NOT WRITE BELOW THIS LINE - CØNTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number: | Anesthesia, General Hospital, Infection Control & Dental Devices |
| 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).