(29 days)
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No
The document describes a pulse oximeter with ECG synchronization technology to reduce motion artifact. There is no mention of AI or ML in the intended use, device description, or performance studies. The modification is a labeling change based on clinical evaluation, not a change in the underlying technology.
No.
The device is intended for monitoring oxygen saturation, pulse rate, and pulse amplitude, not for treating any condition or disease.
No
Explanation: The device is described as a pulse oximeter intended for monitoring physiological parameters (oxygen saturation, pulse rate, pulse amplitude), not for diagnosing a specific disease or condition. While the data it provides can be used by a healthcare professional for diagnosis, the device itself performs monitoring, not diagnosis.
No
The device description explicitly states it is a "Pulse Oximeter" and functions with "reusable and disposable oximeter sensors," indicating it is a hardware device with associated software, not a software-only device. The 510(k) is for a labeling modification, not a new software-only device.
Based on the provided text, the Nellcor N-200 pulse oximeter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude." This describes a device that measures physiological parameters directly from the patient's body, not from a sample taken from the body (which is characteristic of IVDs).
- Device Description: The description reinforces the non-invasive nature of the device, mentioning its use with "reusable and disposable oximeter sensors." These sensors are applied externally to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on such samples, which are the defining features of IVDs.
Therefore, the Nellcor N-200 pulse oximeter is a non-invasive medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
74DQA
Device Description
The Nellcor N-200 Pulse Oximeter provides continuous non-invasive measurement and display of pulse rate and oxygen saturation values with visual and audible alarms, and features C-Lock, Nellcor's patented ECG Synchronization technology which reduces motion artifact. The N-200 Pulse Oximeter functions with all Nellcor reusable and disposable oximeter sensors.
This Special 510(k) covers the labeling modification of Nellcor N-200 Pulse Oximeter that was cleared under 510(k) #K863784. The modification involves revising the N-200 labeling to add performance specifications for motion and low perfusion when the N-200 is used with C-Lock ECG synchronization. Results from clinical evaluation are provided to support the labeling change. No device modifications have been made to the N-200. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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).
0
SEP 2 4 2002
KQ2819
4280 Hacienda Drive Pleasanton, CA 94588
Tele: 925 463-4000 Fax: 925 463-4020
tyco Healthcare
Nellcor
510(k) Summary
| Submitted by: | Nellcor Puritan Bennett, Incorporated
4280 Hacienda Drive
Pleasanton, CA 94588 |
|---------------------------------------|------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To
Senior Regulatory Affairs Project Manager
(925) 463-4427
(925) 463-4020 - FAX |
| Date Summary Prepared: | August 22, 2002 |
| Trade Name: | Nellcor N-200 Pulse Oximeter |
| Common/Usual Name: | Pulse Oximeter |
| Classification Name: | Oximeter (74DQA) per 21 CFR §870.2700 |
| Legally Marketed (Unmodified) Device: | Nellcor N-200 Pulse Oximeter, 510(k) #K863784 |
Device Description
The Nellcor N-200 Pulse Oximeter provides continuous non-invasive measurement and display of pulse rate and oxygen saturation values with visual and audible alarms, and features C-Lock, Nellcor's patented ECG Synchronization technology which reduces motion artifact. The N-200 Pulse Oximeter functions with all Nellcor reusable and disposable oximeter sensors.
This Special 510(k) covers the labeling modification of Nellcor N-200 Pulse Oximeter that was cleared under 510(k) #K863784. The modification involves revising the N-200 labeling to add performance specifications for motion and low perfusion when the N-200 is used with C-Lock ECG synchronization. Results from clinical evaluation are provided to support the labeling change. No device modifications have been made to the N-200. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.
Intended Use
The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.
1
Summary of Technological Characteristics of the Device Compared to the Legally Marketed (Unmodified) Device
No design modifications have been made to the N-200 Pulse Oximeter. Only labeling has been revised.
Tests Performed to Support Determination of Substantial Equivalence
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
Conclusions
The technological characteristics of the N-200 Pulse Oximeter and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed (unmodified) device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2002
Ms. Gina To Senior Regulatory Affairs Project Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588
Re: K022819
Trade/Device Name: N-200 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 22, 2002 Received: August 26, 2002
Dear Ms. To:
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.
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.
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Page 2 -- Ms. To
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runne
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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| 510(k) Number (if known): | K022519 |
|---|---|
| Device Name: | N-200 Pulse Oximeter |
Indications For Use:
The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
frivol
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022819