(324 days)
Nellcor Oxisensor II™ Pediatric, Part D-20
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No
The document describes a standard pulse oximeter sensor that uses LEDs and a photodiode to acquire data for an oximeter system. There is no mention of AI or ML in the device description, intended use, or any other section.
No
The device is described as an accessory sensor that acquires patient data for an oximeter, which then determines functional oxygen saturation and pulse rate. It does not provide any therapy or treatment.
No
The device, an oxisensor, is an accessory that acquires patient data (electrical signals) and transmits them to an oximeter for analysis and display. While it plays a role in data acquisition for diagnostic measurements (oxygen saturation and pulse rate), the oxisensor itself is not performing the diagnostic function but rather serving as a data input transducer for the oximeter system.
No
The device description clearly states it is an accessory device containing hardware components (LEDs, photodiode, cable, connector) for acquiring patient data. It is a physical sensor, not software only.
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 description clearly states that the Oxisensor is a transducer that transmits electrical signals to the patient and receives modified signals back for analysis by the oximeter. This is a non-invasive method of monitoring physiological parameters (oxygen saturation and pulse rate) directly from the patient's body.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the patient. The device interacts directly with the patient.
Therefore, the pediatric Oxisensor, model D-20, is a non-invasive medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.
The reprocessed ClearMedical/Nellcor D-20 Oxisensor is intended as a single patient use O transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of pediatric patients. The D-20 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
Product codes
NLF
Device Description
The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturering and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.
The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LED's and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.
Intended User / Care Setting
hospital environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Nellcor Oxisensor II™ Pediatric, Part D-20
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines representing human profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2004
Clear Medical, Inc. c/o Wayne Pong Quality Team Leader 1776 136th Place NE Bellevue, WA 98005
Re: K012622 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: August 8, 2001 Received: August 13, 2001
Dear Mr. Pong:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on July 3, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
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Page 2 - Mr. Wayne Pong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If vou desire specific advice for your devices on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. 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.
Clare
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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Statement of Indications for Use
510(K) NUMBER (IF KNOWN):
ClearMedical/Nellcor Oxisensor II, O2 Transducer, Part No. D-20 DEVICE NAME:
INDICATIONS FOR USE:
The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.
(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter-Use __
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K012622
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K012622 – Trade/Device Name List
Clear Medical/Nellcor Oxisensor II, O2 Transducer, Model D-20
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