(155 days)
Not Found
No
The description focuses on standard pulse oximetry technology and does not mention AI or ML.
No
The device is a diagnostic tool designed for monitoring physiological parameters (SpO2 and pulse rate) rather than providing treatment or therapy.
Yes
Explanation: A pulse oximeter is a diagnostic device that measures the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, providing information crucial for diagnosing and monitoring various medical conditions.
No
The device description explicitly details hardware components including a portable stand-alone device, connecting cable, oximetry sensor(s), screen, electronic hardware, and a battery. It also provides physical dimensions and weight.
Based on the provided text, the Dolphin Medical 2100 Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body. They are used to provide information about a person's health status, diagnose diseases, or monitor treatment.
- The Dolphin Medical 2100 Pulse Oximeter is a non-invasive device. It measures oxygen saturation and pulse rate by shining light through the skin (typically on a finger or earlobe) and analyzing the light absorption. It does not require taking any samples from the body.
- The intended use and device description clearly state that it is for continuous noninvasive monitoring of SpO2 and pulse rate. This is a physiological measurement taken directly from the patient, not a test performed on a specimen.
Therefore, the Dolphin Medical 2100 Pulse Oximeter falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
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).
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
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 (SpO2) and pulse rate for adult, pediatric and neonatal patients. arterial hemoqlobin
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 alarm limits, 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 function of arterial hemoglobin (SpQz) 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, 300mA System 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 length.
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).
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
adult, pediatric and neonatal patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002036, K012533, K012626, K020075, K021959, K024235
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows a date, "OCT 1 0 2003". The date is written in a simple, sans-serif font. The letters and numbers are bold and black, and the background is white. The date is likely part of a document or label.
Image /page/0/Picture/1 description: The image shows the logo for Dolphin Medical. The logo features a black silhouette of a dolphin leaping over the words "Dolphin Medical" in bold, black font. The text "K031465" is written diagonally in the upper left corner, and the letters "OCT" are in the upper right corner.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Dolphin Medical 2100 Pulse Oximeter and Accessories 4/16/03
Submitter Company Dolphin Medical - FL 13801 McCormick Dr Tampa, FL 33626
Contact: Jon Werner Phone: 813-818-7488 x208 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 Classification Name: Oximeter Class II - 21 CFR 870.2700 - 74 DQA Proprietary Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories.
Intended Use
The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
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, #K020075, #K021959 and #K024235.
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 (SpO2) and pulse rate for adult, pediatric and neonatal patients. arterial hemoqlobin
1
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 alarm limits, 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 function of arterial hemoglobin (SpQz) 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, 300mA System 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 length.
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:
-
- CSA C22.2 No. 601.1
- IEC 601-1, Part 1 and Amendments 1 and 2 2.
- IEC 601-1-1, Part 1 3.
-
- 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
- UL2601-1: Second Edition, 1997 9.
-
- IEC 60068-2-6
-
- IEC 60068-2-27
-
- IEC 60068-2-64
-
- ISTA Procedure 2A
The Dolphin Medical Stand-Alone Pulse Oximeter. Model No. 2100 and Accessories are identical to the Dolphin Medical Stand-Alone Pulse Oximeter Model No. 2100 and Accessories previously reviewed under #K024235 with only one exception. The software was updated in the Dolphin ONE OEM-601 Module, the component that functions as the oximetry engine. A review of the FDA guidance document "Deciding When to Submit a 510(k) for Change to an Existing Device," (January 10, 1997) was performed to determine if a 510(k) submission is necessary for the modified device. Based on the review of the product documentation and an evaluation of the 510(k) decision tree, it is our assessment that the product does not raise any new patient safety issues but does require a 510(k) review of the clinical data to establish safety and effectiveness for purposes of substantial equivalence. As a result, the clinical data and the internal software validation of the OEM-601 Module have been provided for your review.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Mr. Jon Werner QA Manager Dolphin Medical Incoporated 13801 McCormick Drive Tampa, Fl 33626
Re: K031465
Trade/Device Name: Model 2100 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 11, 2003 Received: September 12, 2003
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.
3
Page 2 - Mr. Jon 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR INTENDED USE FOR 2100 PULSE OXIMETER
KO31465 510(k) Number (if known):
Device Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100
May 2, 2003
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).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesia, General Hospital, Infection Control, and Dental Devices (DAGID)
| 510(k) Number: | K031465 |
|---|---|
| ---------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) |
|---|
| ------------------------------------------ |
OR
| over-the-counter Use |
|---|
| ---------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K031465 |
|---|---|
| ---------------- | --------- |