(437 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 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 the healthcare facility.
The provided text is a 510(k) summary for Vanguard Reprocessed Pulse Oximeter Sensors. While it asserts that the reprocessed devices perform as intended and are safe and effective, it does not contain detailed acceptance criteria or a study write-up with specific performance metrics, sample sizes, or ground truth establishment methods typically found in a clinical study report.
The document is a regulatory submission for substantial equivalence based on the technological characteristics and functional testing compared to a predicate device. It indicates that "Sterilization validations, and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." However, it does not elaborate on the specific methodologies or results of these tests in a way that would allow for the construction of the requested table and detailed description.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not provide specific numerical acceptance criteria or performance metrics for the reprocessed pulse oximeter sensors beyond the general statement that they perform as intended and are safe and effective.
- Sample sized used for the test set and the data provenance: No sample sizes for testing are mentioned.
- Number of experts used to establish the ground truth...: Not applicable as no clinical study with ground truth establishment is described.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical sensor, not an algorithm, so this is not applicable in the way it's framed for AI/algorithm performance.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as it's not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The "Test Data" section merely states: "Sterilization validations, and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." This is a high-level summary and does not provide the granular information needed to describe acceptance criteria or a study that proves the device meets those criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Ms. Heather Crawford Director, Regulatory Affairs Vanguard Medical Concepts, Incorporated 5307 Great Oak Drive Lakeland, Florida 33815
Re: K012344
Trade/Device Name: Vanguard Reprocessed Pulse Oximeter Sensors (Models D-25, D-25L, N-25, D-20 and I-20) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF, DQA Dated: May 19, 2004 Received: May 21, 2004
Dear Ms. Crawford:
This letter corrects our substantially equivalent letter of August 4, 2006.
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 Eederal 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 yours,
Chin-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
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List of Models: Vanguard Reprocessed Pulse Oximeter Sensors
100 million in the state
:
| Nellcor Oxisensor II |
|---|
| D-20 |
| D-25L |
| D-25 |
| N-25 |
| I-20 |
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510(k) Summary of Safety & Effectiveness, Continued
| 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 oximeter sensors from healthcarefacilities; cleans, reworks, (replaces the tape [all patient-contactingmaterials]), inspects, tests, repackages and sterilizes the devices; and returnsthem to the healthcare facility. | |
| TechnologicalCharacteristics | The Vanguard reprocessed oximeter sensors are essentially identical tothe currently marketed OEM sensors. No changes are made to the currentlymarketed device's specifications and they possess the same technologicalcharacteristics. Biocompatibility and performance/functional testingdemonstrate that the devices are equivalent and continue to be safe andeffective for their intended use. |
| Test Data | Sterilization validations, and functional/performance and biocompatibilitytesting demonstrates that the reprocessed devices perform as intended and aresafe 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 thepredicate devices, Mallinckrodt, Inc., Nellcor Oxisensor® II Sensors,under the Federal Food, Drug and Cosmetic Act. |
Nellcor, Nellcor Puritan Bennett and Oxisensor are registered trademarks of Mallinckrodt, Inc.
:
:
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Indications for Use
2012344 510(k) Number:
Device Name: Vanguard Reprocessed Pulse Oximeter Sensors
Indications for Use:
The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseV (Per 21 CFR 801.109)
OR
Over-The-Counter Use ---------------------------------------------------------------------------------------------------------------------------------------------------------
(Optional Format 1-2-96)
iK
iv
Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number: K012344
§ 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).