(717 days)
The Hygia Health Services Reprocessed Nellcor Oxisensor is used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
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.
The provided document is a 510(k) summary for a reprocessed medical device, specifically pulse oximeter sensors, and does not contain the detailed information typically found in a study report for device performance against specific acceptance criteria. The document focuses on demonstrating substantial equivalence to a predicate device.
Therefore, it is not possible to fully answer your request with the provided input.
However, based on the available information, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. It generally states that "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and are safe and effective for their intended use." and "Functional testing, cleaning validation, and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective."
The "performance" referred to here is likely in comparison to the predicate device, aiming for substantial equivalence rather than meeting specific numerical targets for accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document lists "Functional testing, cleaning validation, and biocompatibility testing" but does not detail the methodology, sample sizes, or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The concept of "ground truth" as typically used in the context of diagnostic device studies (like those involving image interpretation or disease detection) is not directly applicable to the functional testing of a reprocessed pulse oximeter sensor as described here. The focus is on the device's ability to measure SpO2 and pulse rate, which would be compared to established measurement methods, not expert interpretation of a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As mentioned above, the type of testing described does not typically involve adjudication in the way diagnostic algorithm studies do.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The product is a physical reprocessed medical device (pulse oximeter sensor), not an AI algorithm or a diagnostic tool that involves human readers interpreting results. Therefore, an MRMC study with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The product is a physical sensor, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the diagnostic sense is not directly applicable. For a pulse oximeter, the "ground truth" for its measurements (SpO2 and pulse rate) would typically be established by highly accurate, reference measurement techniques (e.g., arterial blood gas analysis for oxygen saturation) run concurrently with the device being tested. The document does not specify the ground truth methods used for their functional testing.
8. The sample size for the training set
This information is not applicable/provided. The device is a reprocessed physical sensor, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
{0}------------------------------------------------
AUG - 1 2003
510K Summary of Safety & Effectiveness
رڪاري
play
| Submitter: | Hygia Health Services, Inc.434 Industrial LaneBirmingham, Alabama 35211Phone: (205) 314-3920Fax: (205) 314-3959 |
|---|---|
| Contact: | Mrs. Tracy Wood ComasChief Operating OfficerPhone: (205) 314-3920Fax: (205) 314-3959Email: tracy.comas@hygia.net |
| Date: | August 1, 2003 |
| Trade orProprietary Name: | Hygia Health Services Reprocessed D-25 and N-25 NellcorOxisensors |
| Common Name: | Pulse Oximeter sensor, oxygen transducer |
| Classification: | 21CFR 870-2700 - OximeterDQA |
| Equivalent Device: | Corresponding Mallinckrodt, Inc., Nellcor Oxisensors legallymarketed under various 510(k) premarket notifications. |
| Device Description: | The Hygia Health Services Oxisensors are non-invasive probesused to provide continuous SpO2 monitoring and pulse rate. Theprobes contain a dual wavelength light emitting diode (LED), andan optical photodiode sensor which are housed in a pad whichattaches to the patient using adhesive material. The LED emits redand infrared light in alternate pulses, governed by the Oximeterinstrument. The photodiode sensor responds to the light andgenerates a current that is interpreted by the Oximeter instrument.The Oximeter instrument interprets the different amounts of eachlight type (red and infrared) from the output of the photodiode andinterprets the information and displays a reading. The sensoroperates without any type of tissue penetration, electrical contact,or heat transfer to the patient. The sensors use optical means todetermine the light absorption of functional arterial hemoglobin. |
| Indications forUse: | The sensor is indicated for use as a non-invasive method to providecontinuous SpO2 monitoring and pulse rate. |
| TechnologicalCharacteristics: | The predicate device and the Hygia Health Services reprocesseddevice contain dual wavelength LED and a photodiode. The LEDand photodiode are encased in a pad which attaches to the patientusing adhesive material. The sensors are connected to a cable andthey terminate in a pin connector.Biocompatibility and performance/functional testing demonstratethat the devices are equivalent and are safe and effective for theirintended use. |
| Testing: | Functional testing, cleaning validation, and biocompatibilitytesting demonstrates that the reprocessed devices perform asintended and are safe and effective. |
| Conclusion: | Based on the assessment of functional testing, cleaning validation,and biocompatibility testing performed, Hygia Health Servicesconcludes that the Hygia Health Services reprocessed pulseOximeter 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
§ 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).