(214 days)
The ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Masimo™ Oximeter system.
The LNCS Adult is used for patients >30 kg. The LNCS Pediatric is used for patients 10-50 kg. The LNCS Infant is used for patients 3-20 kg. The LNCS Neo is used for neonates <3 kg or adults >40 kg.
All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.
The ReNu Medical Reprocessed Masimo™ LNCS probes are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific performance metrics typically found in such documents for a medical device. The submission is a 510(k) summary for reprocessed oximetry sensors, focused on demonstrating substantial equivalence to a predicate device through comparison tests.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it indicates that "ReNu Medical Reprocessed Oximetry Sensors function in a manner that is Substantially Equivalent to that of the predicate devices." This implies that the performance of the reprocessed sensors, across all measured parameters, met a benchmark of being comparable to the predicate Masimo™ LNCS sensors.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reprocessed Oximetry Sensors function in a manner that is Substantially Equivalent to the predicate devices. | "Based on an assessment consisting of bench testing and clinical performance data the ReNu Medical Reprocessed Oximetry Sensors function in a manner that is Substantially Equivalent to that of the predicate devices." |
| Identical components to predicate devices (LED, photodiode, laminated envelope, cable, and connector). | "The predicate devices and the ReNu Medical Reprocessed devices contain identical components (LED, photodiode, laminated envelope, cable, and connector.)" |
| Identical means of patient attachment (adhesive bandage). | "The means of patient attachment (adhesive bandage) is identical." |
| Intended use matches predicate devices (non-invasive monitoring of SpO2 and pulse rate for specified patient weights). | The stated "Indications For Use" for the reprocessed sensors match the typical intended use of such oximetry sensors across different patient populations (adult, pediatric, infant, neonate). |
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical performance data," but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The filing is a 510(k) summary for reprocessed medical devices, which typically focuses on technical equivalence and performance, rather than requiring expert-adjudicated ground truth as would be common for diagnostic AI algorithms.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of oximetry sensor testing, "adjudication" in the context of expert consensus for ground truth is unlikely to be relevant; instead, measurement accuracy against a standard or established reliable method would be the primary focus.
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 is not applicable. The device is an oximetry sensor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical sensor, not a standalone AI algorithm. The performance being assessed is the sensor's ability to accurately measure SpO2 and pulse rate when connected to an oximeter system.
7. The Type of Ground Truth Used
The document refers to "bench testing and clinical performance data." For oximetry sensors, the "ground truth" for clinical performance is typically established by comparison against a gold standard method for measuring blood oxygen saturation (e.g., arterial blood gas analysis) and heart rate, under controlled conditions. For bench testing, it would involve measurement against calibrated equipment simulating physiological signals. The specific method used is not detailed in the provided text.
8. The Sample Size for the Training Set
This information is not provided in the document. The concept of a "training set" is usually relevant for machine learning algorithms. While there might be internal development and refinement leading to the reprocessed device, it's not described in terms of a formal training set for an algorithm as understood in AI/ML submissions.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as the concept of an AI training set and its associated ground truth is not applicable to this device type.
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FEB - 6 2009
510(k) Summary .
Submitters Name and Address: ReNu Medical, Inc. 9800 Evergreen Way Everett. WA 98024 Phone: 425-353-1110 Fax: 425-353-9116
FDA Registration Number: 3034520
Contact Person: L. Bruce Pierson Chief Operating Officer
Date Summary Prepared:
Trade or Proprietary Name(s): ReNu Medical Reprocessed Oximetry Sensors
Common Name: Oximetry Sensors
Classification: Oximeter (21 CFR 870.2700) / NLF
Equivalent Device(s)
The ReNu Medical Reprocessed Oximetry Sensors are substantially equivalent to the Masimo 110 LNCS Adtx, LNCS Pdtx, LNCS Inf and LNCS Neo Oximetry sensors.
Device Description:
The ReNu Medical Reprocessed Masimo™ LNCS probes are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
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Intended Use
The ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Masimo™ Oximeter system.
The LNCS Adult is used for patients >30 kg. The LNCS Pediatric is used for patients 10-50 kg. The LNCS Infant is used for patients 3-20 kg. The LNCS Neo is used for neonates <3 kg or adults >40 kg.
All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.
The predicate devices and the ReNu Medical Reprocessed devices contain identical components (LED, photodiode, laminated envelope, cable, and connector.) The means of patient attachment (adhesive bandage) is identical.
Summary of Comparison Tests
Based on an assessment consisting of bench testing and clinical performance data the ReNu Medical Reprocessed Oximetry Sensors function in a manner that is Substantially Equivalent to that of the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 6 2009
Mr. L. Bruce Pierson Chief Operating Officer Renu Medical. Incorporated 9800 Evergreen Way Everett, Washington 98204
K081927 Re:
Trade/Device Name: ReNu Reprocessed Masimo Oximeter Sensor Model LNCS Adult, LNCS Pediatric, LNCS Infant, LNCS Neo Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: January 26, 2009 Received: January 28, 2009
Dear Mr. Pierson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.
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Page 2 – Mr. Pierson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Suite Y. Michaud.
Ginette Y. Michaud, M.D. Acting 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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Indications for Use
510(k) Number (if known): K081927
Device Name: ReNu Reprocessed Masimo Oximeter Sensor Model LNCS Adult, LNCS Pediatric, LNCS Infant, LNCS Neo.
Indications For Use:
The ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Masimo™ Oximeter system.
The LNCS Adult is used for patients >30 kg. The LNCS Pediatric is used for patients 10-50 kg. The LNCS Infant is used for patients 3-20 kg. The LNCS Neo is used for neonates <3 kg or adults >40 kg.
All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fritz
(Division Sign-Off) Division of Anesthesiology, General Hos ital Infection Control, Dental Devices
108192 510(k) Number:
§ 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).