(133 days)
Not Found
No
The description details a standard pulse oximetry device that uses an algorithm to calculate oxygen saturation and pulse rate based on light absorption. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the reprocessing of existing devices.
No
The device is described as a sensor used for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate. It measures physiological parameters but does not actively treat or diagnose a disease or condition.
No
The device monitors physiological parameters (oxygen saturation and pulse rate) but does not provide a diagnosis or aid in diagnosing a condition. Its function is to provide real-time data for ongoing patient monitoring.
No
The device description explicitly states the primary components are hardware (light-emitting diodes and a photosensor) embedded within a taping system. The reprocessing activities also involve physical manipulation and testing of these hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this device is a sensor that is wrapped around a patient's finger, foot, or hand to noninvasively monitor oxygen saturation and pulse rate. It does not involve the collection or analysis of any bodily fluids or tissues.
- The mechanism of action is based on light absorption through the vascular bed. This is a physical measurement taken directly from the patient, not an analysis of a sample.
- The intended use is continuous noninvasive monitoring. This is a real-time measurement on a living patient, not a laboratory test performed on a specimen.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
Product codes
NLF
Device Description
Oximeter sensors are used with compatible pulse oximeters to noninvasively continually monitor oxygen saturation and pulse rate. The primary components of the sensors are light-emitting diodes (red and infrared LED) and a photosensor. These components are embedded within a taping system to wrap the sensor around a patient's finger, foot or hand so that the LED and photosensor are directly opposite each other. As light is emitted and received across the vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood. The pulse oximeter detects the changes in absorption and utilizes an algorithm to calculate the corresponding pulse rate (beats/minute) and percent arterial oxygen saturation. Vanguard receives previously used pulse oximeter sensors from healthcare facilities; cleans, reworks, (replaces the tape [all patient-contacting materials]), inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's finger, foot or hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
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
Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN - 6 2005
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC
Director, Regulatory Affairs
(863) 683-8680
(863) 683-8703 (facsimile)
hcrawford@safe-reuse.com |
| Date | August 25, 2004 |
| Device | • Trade Name: Vanguard Reprocessed Pulse Oximeter Sensors
• Common Names: Pulse oximeter sensor, oximeter sensor, oxygen
transducer, O2 transducer
• 21 CFR 870.2700 – Oximeter, Reprocessed - Class II
• Product Code NLF |
| Predicate
Devices | • Nellcor Puritan Bennett, OxiMAX Pulse Oximetry System with N-595
Pulse Oximeter and OxiMAX Sensors and Cables (aka "Accessories"),
K012891 |
| Indications for
Use | The sensor is indicated for use in continuous noninvasive arterial oxygen
saturation and pulse rate monitoring. |
| Contra-
indications | This device should not be used on patients who exhibit allergic reactions to
the adhesive tape. |
| Device
Description | Oximeter sensors are used with compatible pulse oximeters to noninvasively
continually monitor oxygen saturation and pulse rate. The primary
components of the sensors are light-emitting diodes (red and infrared LED)
and a photosensor. These components are embedded within a taping system
to wrap the sensor around a patient's finger, foot or hand so that the LED and
photosensor are directly opposite each other. As light is emitted and received
across the vascular bed, the rates of absorption at the two wavelengths vary
depending upon the ratios of oxygenated and deoxygenated hemoglobin
within the blood. The pulse oximeter detects the changes in absorption and
utilizes an algorithm to calculate the corresponding pulse rate (beats/minute)
and percent arterial oxygen saturation.
Vanguard receives previously used pulse oximeter sensors from healthcare
facilities; cleans, reworks, (replaces the tape [all patient-contacting
materials]), inspects, tests, repackages and sterilizes the devices; and returns
them to a healthcare facility. |
| Technological
Characteristics | Vanguard Reprocessed Pulse Oximeter Sensors are essentially identical to the
original equipment manufacturer (OEM) devices. No changes are made to
the electro-optical components; the reprocessed sensors possess equivalent
technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance and
biocompatibility testing demonstrate that the reprocessed devices perform as
intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that the Vanguard
Reprocessed Pulse Oximeter Sensors are substantially equivalent to their
predicate devices under the Federal Food, Drug and Cosmetic Act. |
1
510(k) Summary of Safety & Effectiveness, Continued
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
SEP - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Heather Crawford Director, Regulatory Affairs Vanguard Medical Concepts, Incorporated 5307 Great Oak Drive Lakeland, Florida 33815
Re: K042316
Trade/Device Name: Vanguard Reprocessed Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: December 22, 2004 Received: December 27, 2004
Dear Ms. Crawford:
This letter corrects our substantially equivalent letter of January 6, 2005.
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 (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 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.
3
Page 2 - Ms. Crawford
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 continue 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Cove
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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List of Models: Vanguard Reprocessed Pulse Oximeter Sensors
:
Nellcor OxiMax |
---|
MAX-A |
MAX-AL |
MAX-I |
MAX-P |
MAX-N |
: