(108 days)
Not Found
No
The summary describes a standard pulse oximetry sensor that measures oxygen saturation and pulse rate using optical methods. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on clinical accuracy against a reference method, not on the performance of an AI/ML algorithm.
No
The device is described as a sensor for monitoring arterial oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
This device continuously monitors arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status. While it doesn't offer a diagnosis itself, the data it provides is crucial for clinicians to diagnose conditions related to oxygenation and heart function.
No
The device description explicitly details physical hardware components (emitter and detector diodes, cables, adhesive bandage backing, clothespin-style clip) that are essential to its function. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "continuous monitoring of arterial oxygen saturation and pulse rate." This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The device is a sensor that attaches to a patient's finger or toe to measure oxygen saturation and pulse rate. This is a non-invasive, direct measurement from the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Reagents or test kits
- Performing tests in a laboratory setting
The device is a medical device used for patient monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dolphin 2000™ Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Dolphin 2000™ Datex Compatible Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands af pulse oximeter monitors. They represent a design change to the existing Dolphin Aristo Datex Compatible Sensors and the Dolphin 2000 Nellcor Compatible Sensors.
The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate fo that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use. Disposable sensors are connected to the host oximeter through the use of an adapter cable.
The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin–style clip that is placed on the end of a finger clip sensor consistes of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's fingeoloolear windows within these pads permit the optical energy to pass through the finge for the measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger or toe
Indicated Patient Age Range
adult, pediatric, infant and neonatal
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: Biocompatibility tests, appropriate for skin-contacting devices for prolonged exposure, were performed on the each of the device components used in the assembly of the Dolphin 2000™ pulse oximetry sensors. Test results demonstrated the materials to be non-toxic, non-irritant, and non-sensitiing.
Electrical Safety: The Dolphin 2000 Oximetry Sensors have been tested and found to comply with the applicable clauses of the following standards: EN 60601-1 (1990) Medical electrical equipment - part 1: General requirements for safety; ASTM F1415-92 Standard Specification for Pulse Oximeters
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 2000 SpO2 values to functional SaO2 values. Volunteers participated in the breathe-down protocol at rest (i.e. no motion) while fully conscious at SaO2 values ranging from 70-100%. Data was analyzed to determine the ARMS for each probe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ARMS
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
K ob0524
16. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Dolphin 2000™ Datex Compatible Oximeter sensors 2/16/06
Submitter ( Consultant name and Address)
Bill Curnan 9433 S. Morning Glory Lane Highlands Ranch, CO 80130
Phone: 720-939-6482 Fax: 786-551-8221
Sponsor Company Name and Address and Contact Person
Dolphin Medical Inc. 12525 Chadron Avenue Hawthorne, CA 90250
Tammy Conway, QA Manager phone: (310) 978-0516 fax: (310) 978-1816
Manufacturing Facility Names and Addresses
Opto Sensors (M) Sdn. Bhd. No. 6 Jalan Angkasa Mas 1 Tabrau Industrial Estate II 81100 Johor Bahru, Malaysia
OSI Systems Pvt. Ltd. B1, Vikram Puri Secunderbad, Andhra Pradesh, 5000076, India
Common, Classification & Proprietary Names
Common Name: oximetry sensor Classification Name: oximeter Proprietary Name: Dolphin™ 2000 Oximetry Sensors
Predicate Devices
| Model # | Predicate
Model # | Predicate
510(k) # | Predicate
Model # | Predicate
510(k) # |
|------------------------------|----------------------|-----------------------|----------------------|-----------------------|
| 2030 Sensor | Model 2010 | K030952 | | |
| 2331 Sensor | 2351 | K012989 | 251-1 | K970769 |
| 2332 Sensor | 2352 | K012989 | 251-2 | K970769 |
| 2333 Sensor | 2353 | K012989 | 251-3 | K970769 |
| 2334 Sensor | 2354 | K012989 | 251-4 | K970769 |
| 2413 & 2423 Extension Cables | 2421 | K030952 | | |
1
Device Description
The Dolphin 2000™ Datex Compatible Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands af pulse oximeter monitors. They represent a design change to the existing Dolphin Aristo Datex Compatible Sensors and the Dolphin 2000 Nellcor Compatible Sensors.
The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate fo that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use. Disposable sensors are connected to the host oximeter through the use of an adapter cable.
The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger clip sensor consistes of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's fingeoloolear windows within these pads permit the optical energy to pass through the finge for the measurements.
Intended Use
The Dolphin 2000™ Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
Technological Characteristics Comparison
The Dolphin 2000™ Oximetry Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to commercially ovailable oximetry sensors.
All of the Dolphin 2000™ oximetry sensors and the predicate devices operate on the identical principles of non-invasive optical assessment of tissue oxygenation using emitters (LEDs) and detectors (photodiode).
The Dolphin 2000™ oximetry sensors are designed, configured, and manufactured for full compatibility for use with the labeled, commercially-available oximetry monitors. They are constructed of similar materials and components of equivalent specifications as used in the predicate devices.
The Dolphin 2000™ oximetry sensors, like the predicate devices are available in both disposable and re-usable styles, labeled for use in adult, pediatric, infant and neonatal populations.
The labeled accuracy of the Dolphin 2000 sensors is equivalent to those of the predicate devices.
2
Performance Testing
. Biocompatibility
The sensors in this application utilize only previously approved skin contact materials. Biocompatibility tests, appropriate for skin-contacting devices for prolonged exposure, were performed on the each of the device components used in the assembly of the Dolphin 2000™ pulse oximetry sensors. Test results demonstrated the materials to be non-toxic, non-irritant, and non-sensitiing.
Electrical Safety .
The Dolphin 2000 Oximetry Sensors have been tested and found to comply with the applicable clauses of the following standards:
- -EN 60601-1 (1990) Medical electrical equipment - part 1: General requirements for safety
- -ASTM F1415-92 Standard Specification for Pulse Oximeters
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 2000 SpO2 values to functional SaO2 values. Volunteers participated in the breathe-down protocol at rest (i.e. no motion) while fully conscious at SaO2 values ranging from 70-100%. Data was analyzed to determine the ARMS for each probe.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. Department of Health and Human Services, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing the bird's body and wings. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 15 2006
Dolphin Medical Incorporated C/O Mr. Bill Curnan Regulatory Specialist 9433 S. Morning Glory Lane Highlands Ranch, Colorado 80130
Re: K060524
Trade/Device Name: Dolphin 2000 Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 6, 2006 Received: May 22, 2006
Dear Mr. Curnan
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 (fix 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 gemeral controls provisions of the Act. The general controls provisions of the Act in turn 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 offecting 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.
4
Page 2 - Mr. Curnan
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 ground in 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 prectice 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, (S 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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
5
Indications for Use
510(k) Number (if known):
Device Name: Dolphin 2000 Oximetry Sensors
Indications For Use:
The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
11:11:11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sian-
Division: . stology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K060524
б