(63 days)
Not Found
No
The description details a standard pulse oximetry sensor using optical principles and signal interpretation by the oximeter instrument, with no mention of AI or ML.
No
The device is a sensor used for monitoring SpO2 and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
The device is a pulse oximeter sensor, which measures SpO2 and pulse rate. The information gathered from these measurements is used to assess the patient's physiological state, which can aid in diagnosis.
No
The device description explicitly details hardware components (LED, photodiode sensor, pad, adhesive material) and their physical interaction with the patient and the Oximeter instrument.
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 "non-invasive method" and "operates without any type of tissue penetration." It measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using optical means.
- The intended use and device description focus on monitoring physiological signals. There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or substance.
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 as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
Product codes (comma separated list FDA assigned to the subject device)
NLF
Device Description
The Hygia Health Services reprocessed pulse Oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Functional testing, cleaning validation, 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): 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.
Corresponding Mallinckrodt, Inc., Nellcor OxiMAX and Oxisensors legally marketed under various 510(k) premarket notifications, Hygia Health Service's 510(k) 012715, Nellcor Puritan Bennett, Inc. 510(k) K012891, Nellcor Puritan Bennett, Inc. 510(k) K863784
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.
Not Found
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).
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
510K Summary of Safety & Effectiveness
2041867
| Submitter: | Hygia Health Services, Inc.
434 Industrial Lane
Birmingham, Alabama 35211
Phone: (205) 314-3920
Fax: (205) 314-3959 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mrs. Tracy Wood Comas
Chief Operating Officer
Phone: (205) 314-3920
Fax: (205) 314-3959
Email: tracy.comas@hygia.net |
| Date: | July 7, 2004 |
| Trade or
Proprietary Name: | Hygia Health Services Reprocessed Sensors |
| Common Name: | Oximeter, Reprocessed |
| Classification: | 21 CFR 870-2700-Oximeter
NLF |
| Equivalent Device: | Corresponding Mallinckrodt, Inc., Nellcor OxiMAX and
Oxisensors legally marketed under various 510(k) premarket
notifications
Hygia Health Service's 510(k) 012715
Nellcor Puritan Bennett, Inc. 510(k) K012891
Nellcor Puritan Bennett, Inc. 510(k) K863784 |
| Device Description: | The Hygia Health Services reprocessed pulse Oximeter sensors are
non-invasive sensors used to provide continuous SpO2 monitoring
and pulse rate. The sensors contain a dual wavelength light
emitting diode (LED), and an optical photodiode sensor which are
housed in a pad which attaches to the patient using adhesive
material. The LED emits red and infrared light in alternate pulses,
governed by the Oximeter instrument. The photodiode sensor
responds to the light and generates a current that is interpreted by
the Oximeter instrument. The Oximeter instrument interprets the
different amounts of each light type (red and infrared) from the |
| | output of the photodiode and interprets the information and
displays a reading. The sensor operates without any type of tissue
penetration, electrical contact, or heat transfer to the patient. The
sensors use optical means to determine the light absorption of
functional arterial hemoglobin. |
| Indications for Use: | The sensor is indicated for use as a non-invasive method to provide
continuous SpO2 monitoring and pulse rate. |
| Technological
Characteristics: | The predicate device and the Hygia reprocessed device contain
dual wavelength LED and a photodiode. The LED and photodiode
are encased in a pad which attaches to the patient using adhesive
material. The sensors are connected to a cable and they terminate
in a pin connector. |
| | Biocompatibility and performance/functional testing demonstrate
that the devices are equivalent and are safe and effective for their
intended use. |
| Testing: | Functional testing, cleaning validation, and biocompatibility
testing demonstrates that the reprocessed devices perform as
intended and are safe and effective. |
| Conclusion: | Based on the assessment of functional testing, cleaning validation,
and biocompatibility testing performed, Hygia Health Services
concludes that the Hygia Health Services reprocessed pulse
Oximeter sensors are substantially equivalent to the Mallinckrodt,
Inc., Nellcor predicate sensors. |
1
510K Summary of Safety & Effectiveness (Con't)
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right and appears to be in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
SEP - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy Wood Comas Chief Operating Officer Hygia Health Services, Incorporated 434 Industrial Lane Birmingham, Alabama 35211
Re: K041867
Trade/Device Name: Hygia Health Services Reprocessed Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: July 7, 2004 Received: July 19, 2004
Dear Ms. Wood Comas:
This letter corrects our substantially equivalent letter of July 19, 2004.
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. Wood Comas
Please be advised that FDA's issuance of a substantial equivalence determination does not i Ticast be auvisod that I DT of issuains on that your device complies with other requirements mean that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of any I ederal bita reguirements, including, but not limited to: registration 1 ou must comply with and are reseling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 607), laooling (21 CFR Part 820); and if requirements as set form in the quality sign ---------------------------------------------------------------------------------------------------------------------------------21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section This letter will anow you to continue marketing your destantial equivalence of your device to 510(k) promative notificate 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), IT you desire specific advice for your do at (240) 276-0120. Also, please note the regulation in 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 may obtain 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,
Chiu 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
4
List of Models: Hygia Health Services Reprocessed Sensors
| Nellcor Oxisensor II |
|---|
| D-20 |
| I-20 |
| Nellcor OxiMax |
| MAX-A with event history |
| MAX-AL with event history |
| MAX-N with event history |
| MAX-P with event history |
| MAX-I with event history |
| MAX-A with event history disabled |
| MAX-AL with event history disabled |
| MAX-N with event history disabled |
| MAX-P with event history disabled |
| MAX-I with event history disabled |
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