(63 days)
The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
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.
This document is a 510(k) summary for the Hygia Health Services Reprocessed Sensors, which are reprocessed pulse oximeter sensors. It asserts substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the reprocessed sensors in a format that would typically be seen for AI/software-as-a-medical-device (SaMD) performance.
Instead, the summary focuses on demonstrating that the reprocessed sensors are substantially equivalent to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness comparable to predicate devices | Biocompatibility, functional testing, and cleaning validation demonstrate equivalence and safety/effectiveness for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on sample size, data origin (country), or whether the study was retrospective or prospective for the performance testing. It generally refers to "functional testing, cleaning validation, and biocompatibility testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the context of this device. The device is a reprocessed physical sensor, not an AI or diagnostic imaging system that relies on expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable or provided for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable or provided. This is not an AI/SaMD product, so a MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable or provided. The device is a physical sensor, not an algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/diagnostic performance is not directly relevant here. For a a reprocessed physical medical device like this, performance is usually assessed against:
- Predicate device performance specifications: Ensuring the reprocessed device performs within the same range as the original.
- Biocompatibility standards: Ensuring no adverse tissue reactions.
- Cleaning validation: Ensuring proper sterilization and absence of contaminants.
- Functional tests: Verifying physical and electrical properties.
The summary states that "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and are safe and effective for their intended use."
8. Sample Size for the Training Set
This information is not applicable or provided. This device is not an AI/machine learning product and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As mentioned, there is no training set for this type of device.
{0}------------------------------------------------
510K Summary of Safety & Effectiveness
2041867
| 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: | July 7, 2004 |
| Trade orProprietary Name: | Hygia Health Services Reprocessed Sensors |
| Common Name: | Oximeter, Reprocessed |
| Classification: | 21 CFR 870-2700-OximeterNLF |
| Equivalent Device: | Corresponding Mallinckrodt, Inc., Nellcor OxiMAX andOxisensors legally marketed under various 510(k) premarketnotificationsHygia Health Service's 510(k) 012715Nellcor Puritan Bennett, Inc. 510(k) K012891Nellcor Puritan Bennett, Inc. 510(k) K863784 |
| Device Description: | The Hygia Health Services reprocessed pulse Oximeter sensors arenon-invasive sensors used to provide continuous SpO2 monitoringand pulse rate. The sensors contain a dual wavelength lightemitting diode (LED), and an optical photodiode sensor which arehoused in a pad which attaches to the patient using adhesivematerial. The LED emits red and infrared light in alternate pulses,governed by the Oximeter instrument. The photodiode sensorresponds to the light and generates a current that is interpreted bythe Oximeter instrument. The Oximeter instrument interprets thedifferent amounts of each light type (red and infrared) from the |
| output of the photodiode and interprets the information anddisplays a reading. The sensor operates without any type of tissuepenetration, electrical contact, or heat transfer to the patient. Thesensors use optical means to determine the light absorption offunctional arterial hemoglobin. | |
| Indications for Use: | 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 reprocessed device containdual wavelength LED and a photodiode. The LED and photodiodeare encased in a pad which attaches to the patient using adhesivematerial. The sensors are connected to a cable and they terminatein 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 (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 |
:
:
:
.
§ 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).