(133 days)
The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
Oximeter sensors are used with compatible pulse oximeters to noninvasively continually monitor oxygen saturation and pulse rate. The primary components of the sensors are light-emitting diodes (red and infrared LED) and a photosensor. These components are embedded within a taping system to wrap the sensor around a patient's finger, foot or hand so that the LED and photosensor are directly opposite each other. As light is emitted and received across the vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood. The pulse oximeter detects the changes in absorption and utilizes an algorithm to calculate the corresponding pulse rate (beats/minute) and percent arterial oxygen saturation.
Vanguard receives previously used pulse oximeter sensors from healthcare facilities; cleans, reworks, (replaces the tape [all patient-contacting materials]), inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The provided text does not specify numerical acceptance criteria for performance (e.g., accuracy, precision). Instead, it states that the testing "demonstrates that the reprocessed devices perform as intended and are safe and effective." The performance is implicitly demonstrated by showing that the reprocessed sensors are "essentially identical to the original equipment manufacturer (OEM) devices" and that "No changes are made to the electro-optical components; the reprocessed sensors possess equivalent technological characteristics."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Perform as intended | Demonstrated |
| Safe and effective | Demonstrated |
| Equivalent technological characteristics to OEM devices | Possesses equivalent technological characteristics, no changes to electro-optical components. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for performance testing of the reprocessed pulse oximeter sensors, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The type of device (reprocessed pulse oximeter sensors) typically relies on measurable physical parameters rather than expert interpretation for performance evaluation.
4. Adjudication method for the test set
This information is not provided. Given the nature of pulse oximetry performance testing, adjudication methods typically seen in image or data interpretation studies (like 2+1 or 3+1 for consensus) would not be applicable.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. This type of study is typically relevant for interpretative devices (e.g., AI in radiology), not for a device like a reprocessed pulse oximeter sensor, which directly measures physiological parameters. This device does not involve AI or human interpretation in its core function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. A pulse oximeter sensor is a hardware device for measurement. While it contains an algorithm to calculate pulse rate and SpO2 from collected data, the "standalone" performance here refers to the device's ability to accurately measure these parameters. The evaluation confirms that the reprocessed device functions equivalently to the original device, which inherently means its embedded algorithm (unchanged) performs as expected. The study likely involved comparing readings from the reprocessed sensor against a reference standard, not assessing an algorithm in isolation from the hardware.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for specific performance metrics. However, for pulse oximetry, the ground truth would typically be established by a reference method for arterial oxygen saturation and pulse rate, such as co-oximetry for SaO2 and ECG for heart rate, or tightly controlled hypoxic studies. The phrase "performance testing" implies comparison to such established standards.
8. The sample size for the training set
This information is not applicable and not provided. As a reprocessed hardware device with an existing, unchanged algorithm, there is no "training set" in the context of machine learning or AI algorithm development.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
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JAN - 6 2005
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector, Regulatory Affairs(863) 683-8680(863) 683-8703 (facsimile)hcrawford@safe-reuse.com |
| Date | August 25, 2004 |
| Device | • Trade Name: Vanguard Reprocessed Pulse Oximeter Sensors• Common Names: Pulse oximeter sensor, oximeter sensor, oxygentransducer, O2 transducer• 21 CFR 870.2700 – Oximeter, Reprocessed - Class II• Product Code NLF |
| PredicateDevices | • Nellcor Puritan Bennett, OxiMAX Pulse Oximetry System with N-595Pulse Oximeter and OxiMAX Sensors and Cables (aka "Accessories"),K012891 |
| Indications forUse | The sensor is indicated for use in continuous noninvasive arterial oxygensaturation and pulse rate monitoring. |
| Contra-indications | This device should not be used on patients who exhibit allergic reactions tothe adhesive tape. |
| DeviceDescription | Oximeter sensors are used with compatible pulse oximeters to noninvasivelycontinually monitor oxygen saturation and pulse rate. The primarycomponents of the sensors are light-emitting diodes (red and infrared LED)and a photosensor. These components are embedded within a taping systemto wrap the sensor around a patient's finger, foot or hand so that the LED andphotosensor are directly opposite each other. As light is emitted and receivedacross the vascular bed, the rates of absorption at the two wavelengths varydepending upon the ratios of oxygenated and deoxygenated hemoglobinwithin the blood. The pulse oximeter detects the changes in absorption andutilizes an algorithm to calculate the corresponding pulse rate (beats/minute)and percent arterial oxygen saturation.Vanguard receives previously used pulse oximeter sensors from healthcarefacilities; cleans, reworks, (replaces the tape [all patient-contactingmaterials]), inspects, tests, repackages and sterilizes the devices; and returnsthem to a healthcare facility. |
| TechnologicalCharacteristics | Vanguard Reprocessed Pulse Oximeter Sensors are essentially identical to theoriginal equipment manufacturer (OEM) devices. No changes are made tothe electro-optical components; the reprocessed sensors possess equivalenttechnological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance andbiocompatibility testing demonstrate that the reprocessed devices perform asintended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the VanguardReprocessed Pulse Oximeter Sensors are substantially equivalent to theirpredicate devices under the Federal Food, Drug and Cosmetic Act. |
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510(k) Summary of Safety & Effectiveness, Continued
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
SEP - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Heather Crawford Director, Regulatory Affairs Vanguard Medical Concepts, Incorporated 5307 Great Oak Drive Lakeland, Florida 33815
Re: K042316
Trade/Device Name: Vanguard Reprocessed Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: December 22, 2004 Received: December 27, 2004
Dear Ms. Crawford:
This letter corrects our substantially equivalent letter of January 6, 2005.
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.
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Page 2 - Ms. Crawford
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 continue 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) 276-0120. 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/dsma/dsmamain.html
Sincerely vours.
Cove
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
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List of Models: Vanguard Reprocessed Pulse Oximeter Sensors
:
| Nellcor OxiMax |
|---|
| MAX-A |
| MAX-AL |
| MAX-I |
| MAX-P |
| MAX-N |
:
§ 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).