(324 days)
The adult Oxisensor, model D-25 and D-25L, is indicated for single patient use when continuous noninvasive artertal oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg.
The reprocessed ClearMedical/Nellcor D-25/ D-25L Oxisensor is intended as a single patient use transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor is the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of adult patients. The D-25/D-25L oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisens of the a the a transmission of functional oxygen saturation and and 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) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
The provided document is a 510(k) summary for the ClearMedical/Nellcor Oxisensor II O2 Transducer. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed study information required to fully answer the request. Specifically, it lacks comprehensive acceptance criteria with specific thresholds, detailed methodology of a study proving those criteria are met, and information about the training set.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Performance Indicators: Substantially equivalent to the Nellcor Oxisensor predicate device in all relevant safety and performance indicators. | Based on an assessment of bench tests, and clinical and/or non-clinical performance data, the ClearMedical/Nellcor Oxisensor demonstrates substantial equivalence to the Nellcor Oxisensor predicate device in all relevant safety and performance indicators. Specific metrics or quantitative comparisons are not provided. |
| Technological Characteristics: Optical sensitivity of optical diodes Continuity of sensor circuitry Comparative non-invasive Co-Oximetry and Oximetry data Infection control methodology Fit/attachment and connector function | The device "demonstrated equality in safety and performance" for all established indicators of substantial equivalence, which included the listed technological aspects. No specific performance values or comparison data are given. |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "clinical and/or non-clinical performance data" but does not give specific numbers for human subjects or test cases.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe how ground truth was established, or if experts were involved in a capacity to establish ground truth for a test set.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
-
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:
- No, an MRMC comparative effectiveness study involving AI or human readers is not mentioned. The device is an O2 Transducer, not an AI diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- The device is a hardware sensor, not an algorithm. Standalone performance for a sensor would typically refer to its accuracy against a gold standard; however, details of such a test are not provided. The comparison is against another physical device (the predicate).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. The comparison is based on "comparative non-invasive Co-Oximetry and Oximetry data" against a predicate device. This suggests the predicate device's readings or an external reference oximetry method might have served as a de facto "ground truth" for comparison, but this is not clearly defined.
-
The sample size for the training set:
- Not applicable as this is a hardware device, not an AI algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community and interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2004
Clear Medical, Inc. c/o Wayne Pong Quality Team Leader 1776 136th Place NE Bellevue, WA 98005
Re: K012600 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: August 8, 2001 Received: August 13, 2001
Dear Mr. Pong:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on July 3, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
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Page 2 - Mr. Wayne Pong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Carl
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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Statement of Indications for Use
510(K) NUMBER (IF KNOWN):
ClearMedical/Nelloor Oxisensor II O2 Transducer, Part No. D-25 / D-25L DEVICE NAME:
INDICATIONS FOR USE:
The adult Oxisensor, model D-25 and D-25L, is indicated for single patient use when continuous noninvasive artertal oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg.
(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter-Use
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K012600
6
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K012600 - Trade/Device Name List
. . . . .
Clear Medical/Nellcor Oxisensor II, O2 Transducer, Model D-25 Clear Medical/Nellcor Oxisensor II, O2 Transducer, Model D-25L
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510(k) Summary
KOIZ600
| Submitter's name and Address: | ClearMedical, Inc.1776 – 136th Place NEBellevue, WA 98005Ph (425) 401-1414Fax (425) 401-1515 |
|---|---|
| FDA Registration Number: | 3017110 |
| Contact Person: | Richard RadfordDirector of Research and Product Development |
| Date Summary Prepared: | August 8, 2001 |
| Trade or Proprietary Name: | ClearMedical/Nellcor Oxisensor II, Adult O2Transducer, Parts D-25/D-25L |
| Common Name: | Oxisensor |
| Classification: | Oximeter (per 21 CFR 870.2700) / DQA |
Equivalent Device
The reprocessed ClearMedical/Nellcor Oxisensor II, Adult O₂Transducer, Parts D-25/D-25L, is substantially equivalent to the Nelloor Oxisensor II™ Parts D-25/D-25L. This determinential has been reached based on an evaluation and analysis of the predicate device's technical and promotional labeling and specific bench and non-invasive clinical testing. For all established indicators of substantial equivalence the ClearMedical devices demonstrated equality in safety and performance.
Device Description
The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisens of the a the a transmission of functional oxygen saturation and and from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.
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510(k) Summary (Cont'd)
The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
Intended Use of the Oxisensor
The reprocessed ClearMedical/Nellcor D-25/ D-25L Oxisensor is intended as a single patient use transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor is the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of adult patients. The D-25/D-25L oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
Technological Characteristics of ClearMedical/Nellcor Oxisensor Compared with the Nellcor Oxisensor
The predicate device and the ClearMedical/Nellcor sensor contain three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient, which serves to align the optical sensors and retain the sensor to a patient digit. Attached to the laminated envelope is a sensor cable, which terminates in a molded PVC connector element that connects to the oximeter. In form, the predicate device and the ClearMedical/Nellcor Oxisensor are substantially equivalent.
Other technological indicators of substantial equivalence were identified and included functionality in optical sensitivity of the optical diodes, continuity of sensor circuitry, comparative non-invasive Co-Oximetry and Oximetry data, infection control methodology, fit/attachment and connector function.
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Summary of the ClearMedical/Nellcor Oxisensor Performance
Based on an assessment of bench tests, and clinical and/or non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/Nellcor Oxisensor demonstrates substantial equivalence to the Nellcor Oxisensor predicate device.
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§ 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).