(717 days)
Corresponding Mallinckrodt, Inc., Nellcor Oxisensors legally marketed under various 510(k) premarket notifications.
Not Found
No
The device description details a standard optical pulse oximetry technology based on light absorption and interpretation by an oximeter instrument, with no mention of AI or ML algorithms for data processing or interpretation.
No
This device is for monitoring SpO2 and pulse rate, which is a diagnostic function, not a therapeutic one. It provides information but does not treat any condition.
No
Explanation: The device provides continuous SpO2 monitoring and pulse rate, which are physiological measurements. While these measurements can contribute to a diagnosis, the device itself does not interpret the data to make a diagnosis or identify a disease state. It acts as a monitoring device.
No
The device description explicitly details hardware components (LED, photodiode sensor, adhesive pad) and their physical interaction with the patient and an Oximeter instrument. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Hygia Health Services Reprocessed Nellcor Oxisensor is a non-invasive device that measures SpO2 and pulse rate by shining light through tissue (typically a finger or earlobe) and analyzing the light absorption. This is a physiological measurement taken directly from the patient's body, not a test performed on a sample in vitro (outside the body).
Therefore, the description clearly indicates a device used for physiological monitoring rather than an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Hygia Health Services Reprocessed Nellcor Oxisensor is used 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, DQA
Device Description
The Hygia Health Services Oxisensors are non-invasive probes used to provide continuous SpO2 monitoring and pulse rate. The probes 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 Oxisensors legally marketed under various 510(k) premarket notifications.
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
AUG - 1 2003
510K Summary of Safety & Effectiveness
رڪاري
play
| 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: | August 1, 2003 |
| Trade or
Proprietary Name: | Hygia Health Services Reprocessed D-25 and N-25 Nellcor
Oxisensors |
| Common Name: | Pulse Oximeter sensor, oxygen transducer |
| Classification: | 21CFR 870-2700 - Oximeter
DQA |
| Equivalent Device: | Corresponding Mallinckrodt, Inc., Nellcor Oxisensors legally
marketed under various 510(k) premarket notifications. |
| Device Description: | The Hygia Health Services Oxisensors are non-invasive probes
used to provide continuous SpO2 monitoring and pulse rate. The
probes 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 Health Services 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 (cont'a)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 - 2004
Hygia Health Services, Inc. c/o Tracy Wood Comas 434 Industrial Lane Birmingham, AL 35211
Re: K012715
Trade/Device Name: Hygia Health Services Reprocessed Pulse Oximeter Sensors
(Models D-25 and N-25)
Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF, DQA Dated: May 27, 2004 Received: May 28, 2004
Dear Ms. Comas:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 1, 2003. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernination Act of 2002. After reviewing your supplemental validation data, we have determined the davice 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, TDA earl 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. You must comply with all the Act's applicable requirements, including, but not limited to: registration and
3
Page 2 - Ms. Tracy Wood Comas
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 device to a legally marketed predicate device results in a classification for your device and thus, permits you to legally market the device. This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification, including the supplemental validation data you submitted.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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 yours,
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
Indications For Use
Hygia Health Services, Inc. Applicant:
K012715 510(k) Number:
Device Name: Hygia Health Services Reprocessed D-25 and N-25 Nellcor Oxisensors
Indications For Use:
The Hygia Health Services Reprocessed Nellcor Oxisensor is used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
L. A. Witterman
Infecti
510(k) Number: K012715
X PRESCRIPTION DEVICE