(87 days)
The Dolphin 2000™ Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
The Dolphin 2000™ Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands of pulse oximeter monitors. They are Nellcor and BCI 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 of tapes and development an adhesive bandage that is connected to the cable assombly. "The consortient by wrapping it around a finger backing that allows the sensor to be upplied to the End (Colphin 2000 Oximetry Sensors are of toe (measurement site). Tour sizes of aloposes, infant and neonatal application available, which are indicated for doc for duall, positive, mon-sterile for single patient use.
The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin-The re-usable Dolphil 2005 Finger Olip Oximony Consor consists of the style clip that is placed on the one on anyon one on anyon maintained in mild emitter and detector components mounted in opposing clip halves, mainter and consected emitter and delection components mounted in opposing only his house the optiolection in complession by a spring mings. The montain contact with the patient's finger. Clear components within contoured paids that the read to pass through the finger for the measurements.
The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in The Re-usable 1 Sensor is for use on the sensor can also be used on the adult ear with the place with a disposable bandage. The concer or enounted in a sealed pouch (same ear clip accessory." The emitter and other cructed in a Y shape. All Dolphin sensors are provided non-sterile.
Here's an analysis of the provided text regarding the Dolphin 2000™ Pulse Oximetry Y Sensor, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The given text does not explicitly state quantitative acceptance criteria for SpO2 accuracy that Dolphin Medical Inc. aims to meet. Instead, it states that "The labeled accuracy of the Dolphin 2000 sensors is equivalent to those of the predicate devices." For the purpose of this analysis, we will infer the de-facto acceptance criteria based on standard pulse oximeter testing practices and the reported performance.
| Acceptance Criteria (Inferred from standard practice) | Reported Device Performance (Dolphin 2000 SpO2 Accuracy) |
|---|---|
| ARMS (Accuracy Root Mean Square) for SpO2 values within the range of 70-100% must be within a clinically acceptable limit (typically ≤ 3% for pulse oximeters). | Data was analyzed to determine the ARMS for each probe. Specific ARMS values are not provided, but the study was conducted to demonstrate "scientific accuracy" by "statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Volunteers participated in breathing down protocols," indicating human subjects.
- Data Provenance:
- Country of Origin: USA (VA Hospital of Wisconsin - Milwaukee).
- Retrospective or Prospective: Prospective, as it involved "breathe-down protocols" with "volunteers" specifically for the validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The study was overseen by "Dr. Phillip Clifford, MD." It is common for a physician or a team of physicians to oversee such clinical studies and approve the ground truth, but the exact number establishing the ground truth is not specified.
- Qualifications of Experts: Dr. Phillip Clifford, MD. His specific specialization (e.g., pulmonologist, anesthesiologist) is not mentioned, but an MD degree suggests appropriate medical expertise for overseeing oxygen saturation studies.
4. Adjudication Method for the Test Set
Not specified. The clinical testing involved comparing SpO2 values to functional SaO2 values, implying a direct comparison to a gold standard, rather than a consensus-based adjudication of the device's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. This device is a sensor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The study focused on the standalone accuracy of the sensor itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The "Clinical Testing" section describes a study where "Dolphin 2000 SpO2 values" were statistically compared to "functional SaO2 values," which is a direct measurement of the sensor's accuracy in a human clinical setting without human interpretation of the sensor's raw output.
7. The Type of Ground Truth Used
The ground truth used was functional SaO2 values. This is typically measured using arterial blood gas analysis (CO-oximetry), which is considered the gold standard for measuring arterial oxygen saturation.
8. The Sample Size for the Training Set
Not applicable. The Dolphin 2000 Oximetry Sensor is a hardware device (sensor) and not an AI/Machine Learning algorithm that requires a training set. Its "performance" is based on its physical design and electro-optical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not use a training set in the context of AI/ML. Its ground truth for performance validation (as described in point 7) was established through clinical measurements against a gold standard.
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KG33876
MAR 1 1 2004
14. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Dolphin 2000™ Pulse Oximetry Y Sensor 12/11/03
Submitter ( Consultant name and Address)
Bill Cuman 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 (310) 978-0516 phone: (310) 978-1816 fax:
Manufacturing Facility Name and Address
Opto Sensors (M) Sdn. Bhd. No. 6 Jalan Angkasa Mas 1 Tabrau Industrial Estate II 81100 Johor Bahru, Malaysia
Common, Classification & Proprietary Names
Common Name: oximetry sensor Classification Name: oximeter Dolphin™ 2000 Oximetry Sensors Proprietary Name:
Predicate Devices
| Sensor Model # | PredicateModel # | Predicate510(k) # |
|---|---|---|
| 2020, 2040, 2060, &2070 | Model 2010 | K030952 |
| 2321 & 2341 | 2351 | K012989 |
| 2342 | 2352 | K012989 |
| 2323, & 2343 | 2353 | K012989 |
| 2344 | 2354 | K012989 |
| 2220 & 2260 | 2210 | K032947 |
| 2422, 2424, & 2426 | 2421 | K030952 |
| Extension Cables |
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Device Description
Device Describition
The Dolphin 2000™ Oximetry Sensors are fully compatible disposable and re-usable The Dolphin 2000 ~ Oximelly Ochson's are raily of pulse oximeter monitors. They replacement sensors for use with major brands of pares while in the first and BCI Compatabile Sensors.
The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to The disposable Dolphin 2000 Oximelly Ochson are embedded in a laminate of tapes
predicate devices. The emitter and detector diodes are embedded in a lands a predicate devices. The childer and development an adhesive bandage that is connected to the cable assombly. "The consortient by wrapping it around a finger backing that allows the sensor to be upplied to the End (Colphin 2000 Oximetry Sensors are of toe (measurement site). Tour sizes of aloposes, infant and neonatal application available, which are indicated for doc for duall, positive, mon-sterile for single patient use.
The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin-The re-usable Dolphil 2005 Finger Olip Oximony Consor consists of the style clip that is placed on the one on anyon one on anyon maintained in mild
emitter and detector components mounted in opposing clip halves, mainter and consected emitter and delection components mounted in opposing only his house the optiolection in complession by a spring mings. The montain contact with the patient's finger. Clear components within contoured paids that the read to pass through the finger for the measurements.
The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in The Re-usable 1 Sensor is for use on the sensor can also be used on the adult ear with the place with a disposable bandage. The concer or enounted in a sealed pouch (same ear clip accessory." The emitter and other cructed in a Y shape. All Dolphin sensors are provided non-sterile.
Intended Use
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, The Dolphill 2000 - Oximony Conbore e. e commercially available oximetry sensors.
All of the Dolphin 2000™ oximetry sensors and the predicate devices operate on the All of the Dolphin 2000 - (Allinor) optical assessment of tissue oxygenation using emitters (LEDs) and detectors (photodiode).
The Dolphin 2000™ oximetry sensors are designed, configured, and manufactured for The Dulphill 2000 - Uximistry beneercially-available oximetry monitors. full companibility for use with the laboled, connections of equivalent specifications as used in the predicate devices.
The Dolphin 2000™ oximetry sensors, like the predicate devices are available in both The Dolphin 2000 - oxinstly Schools, ill.o the programs, in adult, pediatric, infant and neonatal populations.
The labeled accuracy of the Dolphin 2000 sensors is equivalent to those of the predicate devices.
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Performance Testing
Biocompatibility t
Biocompatibility tests, appropriate for skin-contacting devices for prolonged in Blocompaniblity tests, approphiats for onf the device components used in the assembly of the Dolphin 2000™ pulse oximetry sensors. Test results assembly of the Dolphin 2000 - paiso existed , initiant, and non-sensitizing.
Electrical Safety 피
Electrical Salety
The Dolphin 2000 Oximetry Sensors have been tested and found to comply with the applicable clauses of the following standards:
- Medical electrical equipment part 1: General EN 60601-1 (1990) requirements for safety
- EN 60601-1-1 (1993) Medical electrical equipment part 1: General 1 EN 60001-1-1 (1507) Modical Standard: Safety requirements for medical electrical systems
- EN 60601-1-2 (1993) Medical electrical equipment part 1: General – requirements for safety - 2. Collateral standard: Electromagnetic compatibility requirements and tests
- Standard Specification for Pulse Oximeters ASTM F1415-92 .
Clinical Testing
The sensors were validated in breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee, (I)r. Phillip Clifford, MD.). Scientific accuracy was Wisconsin - Millindakoo, Companing Dolphin 2000 SpO2 values to functional SaO2 demorristiated by statistically oompanies as a the down protocol at rest (i.e. no motion) while values. Volunteers partionated in thing from 70-100%. Data was analyzed to determine the ARMS for each probe.
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Image /page/3/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 top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2004
Dolphin Medical, Incorporated C/O Mr. Bill Curnan Regulatory Specialist Bill Curnan 9433 S. Morning Glory Lane Littleton, Colorado 80130
Rc: K033876
Trade/Device Name: Dolphin 2000 Oximetry Senors: Models 2020, 2040, 2060, 2070, 2220, 2321, 2323, 2341, 2342, 2343, and 2344 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 10, 2004 Received: February 12, 2004
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 (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.
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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 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
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Attachment l
Indications for Use
510(k) Number (if known): K033876
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.
Prescription Use X (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)
fthh
(Division Sign-Off) ( Cholon Oigh-Oit)
Division of Anesthesiology, General Hospital, e Malon of Anesthesiology, Gene Infection Control, Dental Devices
Page 1 of
510(k) Number: K033876
§ 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).