(103 days)
Not Found
No
The device description focuses on standard optical pulse oximetry technology and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is used for monitoring and diagnosis (providing continuous SpO2 and pulse rate monitoring), not for treating a condition, disease, or injury.
Yes.
The device provides continuous SpO2 monitoring and pulse rate monitoring, which are measurements used for diagnostic purposes (e.g., detecting hypoxemia or arrhythmias).
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 a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a pulse oximeter sensor. Pulse oximetry is a non-invasive method that measures oxygen saturation in the blood by shining light through the skin (typically on a finger or earlobe). It does not involve the analysis of a specimen taken from the body.
The description clearly states:
- "The Hygia Health Services Reprocessed Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate monitoring."
- "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."
These characteristics are consistent with a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hygia Health Services Reprocessed Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate monitoring.
This device is intended for prescription use.
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
Adult, Pediatric, Infant
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. Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter 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.
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
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MAY 2 8 2008
| Submitter: | Hygia Health Services, Inc.
434 Industrial Lane
Birmingham, Alabama 35211
Phone: (205) 314-3920
Fax: (205) 314-3959 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jerome James
Director of R&D
Phone: (205) 314-3920
Fax: (205) 314-3959
Email: jerry.james@hygia.net |
| Date: | February 12, 2008 |
| Trade or
Proprietary Name: | Hygia Health Services Reprocessed Sensors |
| Common Name: | Oximeter, Reprocessed |
| Classification: | 21 CFR 870-2700-Oximeter
NLF |
| Equivalent Device: | Corresponding Masimo LNCS Pulse Oximeter Sensors legally
marketed under various 510(k) premarket notifications and Hygia
reprocessed Nellcor Pulse Oximeter sensors |
| | Masimo 510(k) K041815
Masimo 510(k) K051212
Hygia Health Service's 510(k) K041867 |
| 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. |
| | Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective. |
| Conclusion: | Based on the assessment of clinical testing, non-clinical 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 Masimo LNCS predicate sensors. |
11:44:47 PM IST 11:00 PM IST 11:00 PM IST 1
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510K Summary of Safety & Effectiveness (Con't)
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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 with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font. The eagle is black, and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2008
Mr. Jerome James Director of R&D Hygia Health Services, Incorporated 434 Industrial Lane Birmingham, Alabama 35211
Re: K080424
Trade/Device Name: Hygia Health Services Reprocessed Sensors | Adult Pulse Oximeter Sensor (HHS-1859); Adult-N Pulse Oximeter Sensor (HHS-1862); Pediatric Pulse Oximeter Sensor (HHS-1860); Infant Pulse Oximeter Sensor (HHS-1861)]
Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: April 28, 2008 Received: April 29, 2008
Dear Mr. James:
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.
3
Page 2 -- Mr. James
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 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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Clus
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
Applicant:
Hygia Health Services, Inc.
510 (k):
K
Device Name:
Hygia Health Services Reprocessed Sensors
Indications for Use:
The Hygia Health Services Reprocessed Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate monitoring.
This device is intended for prescription use.
inhal
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080924
2-2
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List of Models
:
and the comments of the comments of the country of
:
| Sensor Model | Intended Oximeter | Hygia Catalog # |
|---|---|---|
| Adult Pulse Oximeter sensor | Masimo Radical SET | HHS 1859 |
| Adult-N Pulse Oximeter Sensor | Masimo Radical SET | HHS-1862 |
| Pediatric Pulse Oximeter Sensor | Masimo Radical SET | HHS-1860 |
| Infant Pulse Oximeter Sensor | Masimo Radical SET | HHS-1861 |
the submit and the submit of the subscription in the subject of