(196 days)
Not Found
No
The summary describes a standard pulse oximetry sensor and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is indicated for continuous monitoring of arterial oxygen saturation and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device monitors arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it is a "reusable sensor" with physical components like an emitter, detector, adhesive disc, and headband, indicating it is a hardware device, not software-only.
No, based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Dolphin ONE Oximetry Sensors are described as devices for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate. This is done by placing the sensor on the forehead and measuring light absorption through the skin and tissue.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The measurement is performed directly on the body.
Therefore, the Dolphin ONE Oximetry Sensors fall under the category of medical devices used for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.
Product codes
DQA
Device Description
The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors.
The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
adults and pediatrics > 30 kg
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)
Performance Testing
- Biocompatibility .
- The Dolphin ONE Model 420 Forehead Sensor utilizes the same sensor body, cable, and keyed The Dolphin ONE MOGOF LEO PORTONE Sensors approved in #K030629 and have been sold worldwide with no reports of biocompatibility issues. The material changes from the Model 320 Sensor have either been approved in other Dolphin Medical Sensor Models or have certifications to demonstrate the materials to be non-toxic, non-initant, and non-sensitizing.
- Validation Testing . The Dolphin ONE Oximetry Sensors have been tested and found to comply with environmental specifications, pulse rate specifications, and skin temperature requirements as per ASTM 1415.
Clinical Testing
The sensors were validated in breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee, (Dr. Phillip Clifford, MD) Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpO2 values to functional SaO2 values. Volunteers participated in the breathe-down protocol at rest (i.e. no runtion) while fully conscious at SaO2 values ranging from 70-100%. Data was analyzed to determine the ARMS for each probe. Clinical validation for the Dolphin ONE Forehead Sensor resulted in an accuracy determination of less than 2.0 ARMS in the range of 70-100% SaO2 for adults and pediatrics > 30 kg.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
accuracy determination of less than 2.0 ARMS in the range of 70-100% SaO2
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.
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
AUG 3 1 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 14.0
Dolphin ONE 1 Pulse Oximetry Forehead Sensor 1/23/04
Submitter (Consultant Name and Address)
Jon Werner 14240 N 42nd St #205 Tampa, FL 33613
Phone: 813-431-1444 Fax: 501-646-5851
Sponsor Company Name and Address and Contact Person
Dolphin Medical, Inc. 12525 Chadron Avenue Hawthorne, CA 90250
Tammy Conway, QA Manager Phone: 310-349-2308 Fax: 310-978-1816
Manufacturing Facility Name and Address
Opto Sensors (M) Sdn. Bhd. No. 6 Jalan Angkasa Mas 1 Tebrau Industrial Estate II 81100 Johor Bahru, Malaysia
Common, Classification & Proprietary Names
Oximetry Sensor Common Name: Classification Name: Oximeter Dolphin ONETM Oximetry Sensors Proprietary Name:
Predicate Devices
| Sensor | Dolphin Model | Dolphin ONE Predicate Model found in
K030629 |
|--------------------------------------------------|---------------|-------------------------------------------------|
| Dolphin ONE Reusable
Oximetry Forehead Sensor | 420 | 320 |
Device Description
The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors.
The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.
Intended Use
The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
Technonological Characteristics Comparison
The Dolphin ONE Oximetry Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to commercially available oximetry sensors.
1
All of the Dolphin ONE Oximetry Sensors and the predicate devices operate on the identical principles of All of the Dulphill ONE Oxinony Online and produced as not as a series and detectors (photodiode).
The Dolphin ONE Oximetry Sensors are designed, and manufactured for full compatibility for The Dolphili ONE OXImon of Concert and Connects. They are constructed of similar materials ase with the labords, equivalent specifications as used in the predicate devices.
The labeled accuracy of the Doiphin ONE Sensors is equivalent to those of the predicate devices.
Performance Testing
- Biocompatibility .
- The Dolphin ONE Model 420 Forehead Sensor utilizes the same sensor body, cable, and keyed The Dolphin ONE MOGOF LEO PORTONE Sensors approved in #K030629 and have been sold worldwide with no reports of biocompatibility issues. The material changes from the Model 320 Sensor have either been approved in other Dolphin Medical Sensor Models or have certifications to demonstrate the materials to be non-toxic, non-initant, and non-sensitizing.
- Validation Testing . The Dolphin ONE Oximetry Sensors have been tested and found to comply with environmental specifications, pulse rate specifications, and skin temperature requirements as per ASTM 1415.
Clinical Testing
The sensors were validated in breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee, (Dr. Phillip Clifford, MD) Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpO2 values to functional SaO2 values. Volunteers participated in the breathe-down protocol at rest (i.e. no runtion) while fully conscious at SaO2 values ranging from 70-100%. Data was analyzed to determine the ARMS for each probe. Clinical validation for the Dolphin ONE Forehead Sensor resulted in an accuracy determination of less than 2.0 ARMS in the range of 70-100% SaO2 for adults and pediatrics > 30 kg.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above a wavy base.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Dolphin Medical, Incorporated C/O Mr. Jon Werner Regulatory Consultant 14240 N. 42nd Street Tampa, Florida 33613
Re: K040380
Ko 10:500
Trade/Device Name: Dolphin Medical Dolphin ONE Adult Reusable Forehead Senor Model 420 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 20, 2004 Received: August 23, 2004
ਵੱ
Dear Mr. Werner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 merslate commerce prior to tray and been reclassified in accordance with the provisions of Antendinents, or to de rood alla metic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Counting, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or 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 (I MA), it may of subject to tack and federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Werner
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be auvrsou mat 1 Dr. o letermination that your device complies with other requirements mean that I DA mas made a acteriand regulations administered by other Federal agencies. of the Act of ally I ederal statues and reguirements, including, but not limited to: registration You must comply with an all all the Prec 8 requirements (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Pat 007), labality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality systems (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) This letter will anon 700 be Finding of substantial equivalence of your device to a premarket notification - 11 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), If you desire specific at 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 may ovean other generational 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 Runns
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 Use
510(k) Number (if known): K040380
Device Name: Dolphin Medical Dolphin ONE Adult Reusable Forehead Sensor Model 420
Indications For Use:
The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aun Secom
(Division Sign-Qff) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of
510(k) Number: K040380
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