(437 days)
NLF, DQA
Not Found
No
The description details a standard pulse oximetry sensor and reprocessing process, with no mention of AI or ML in the device's function or the reprocessing steps. The algorithm mentioned is a standard calculation for pulse oximetry.
No
The device is described as a sensor used for monitoring oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic interventions.
Yes
The device is described as monitoring arterial oxygen saturation and pulse rate, and the output (oxygen saturation calculation based on absorption rates of hemoglobin) provides information about the patient's physiological state, which is used for diagnosis.
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 handling and testing of these hardware components.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a pulse oximeter sensor. It works by shining light through a part of the body (finger, foot, or hand) and measuring the absorption of that light by hemoglobin in the blood. This is a non-invasive method that measures physiological parameters directly from the body.
- Lack of Sample Analysis: The device does not analyze a sample taken from the body. It interacts with the body directly to obtain its measurements.
Therefore, based on the intended use and device description, this pulse oximeter sensor falls under the category of a non-invasive medical device used for monitoring, not an in vitro diagnostic device.
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, DQA
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 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 the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization validations, and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mallinckrodt, Inc., Nellcor Oxisensor® II Sensors
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Ms. Heather Crawford Director, Regulatory Affairs Vanguard Medical Concepts, Incorporated 5307 Great Oak Drive Lakeland, Florida 33815
Re: K012344
Trade/Device Name: Vanguard Reprocessed Pulse Oximeter Sensors (Models D-25, D-25L, N-25, D-20 and I-20) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF, DQA Dated: May 19, 2004 Received: May 21, 2004
Dear Ms. Crawford:
This letter corrects our substantially equivalent letter of August 4, 2006.
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 Eederal Register.
1
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 yours,
Chin-Lin, Ph.D.
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
2
List of Models: Vanguard Reprocessed Pulse Oximeter Sensors
100 million in the state
:
| Nellcor Oxisensor II |
|---|
| D-20 |
| D-25L |
| D-25 |
| N-25 |
| I-20 |
3
510(k) Summary of Safety & Effectiveness, Continued
| 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 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 the healthcare facility. |
| Technological
Characteristics | The Vanguard reprocessed oximeter sensors are essentially identical to
the currently marketed OEM sensors. No changes are made to the currently
marketed device's specifications and they possess the same technological
characteristics. Biocompatibility and performance/functional testing
demonstrate that the devices are equivalent and continue to be safe and
effective for their intended use. |
| Test Data | Sterilization validations, and functional/performance and biocompatibility
testing demonstrates 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 the
predicate devices, Mallinckrodt, Inc., Nellcor Oxisensor® II Sensors,
under the Federal Food, Drug and Cosmetic Act. |
Nellcor, Nellcor Puritan Bennett and Oxisensor are registered trademarks of Mallinckrodt, Inc.
:
:
4
Indications for Use
2012344 510(k) Number:
Device Name: Vanguard Reprocessed Pulse Oximeter Sensors
Indications for Use:
The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseV (Per 21 CFR 801.109)
OR
Over-The-Counter Use ---------------------------------------------------------------------------------------------------------------------------------------------------------
(Optional Format 1-2-96)
iK
iv
Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number: K012344