(253 days)
Not Found
No
The description focuses on the reprocessing of a standard oximetry sensor and does not mention any AI or ML components or functionalities.
No
The device is described as a sensor for monitoring oxygen saturation and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
The device monitors functional oxygen saturation and pulse rate, which are diagnostic indicators of a patient's physiological state.
No
The device description explicitly details hardware components like a sensor head, LEDs, a detector, cable, and connector, and describes a reprocessing process involving physical manipulation and replacement of adhesive. This is not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). This device is a sensor that is applied to the body (specifically, to a patient's finger or toe) to measure physiological parameters (oxygen saturation and pulse rate) in vivo.
- The description focuses on the physical components of the sensor and its application to the patient. There is no mention of collecting or analyzing biological samples.
- The intended use is for monitoring physiological signs directly from the patient.
Therefore, the reprocessed AllFit Oximetry sensor, OXY-AFR, is a medical device, but it falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The reprocessed AllFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate. The device is indicated for use by qualified medical personnel only.
Product codes (comma separated list FDA assigned to the subject device)
NLF
Device Description
This OXY-AFR sensor has a sensor head, consisting of a red LED and two infrared LEDS mounting on a leadframe, wired to a detector with a 1 meter cable and custom "happisnap" connector. There are two optical windows where the LED light is transmitted between the detector and LEDS. These components are packaged in a heat sealed package. The OXY-AFR is identical to the OXY-AF sensor with the exception of the new patient window adhesive. The ICU, a FR Sensor is for use in small adult and pediatric patients in the hospital, ICU, anesthesia, respiratory therapy, and during transport.
The Datex-Ohmeda OXY-AFR Sensor has the following differences when compared to the Datex-Ohmeda OXY-AF predicate device. The OXY-AFR sensor is a reprocessed OXY-AF sensor During reprocessing the used OXY-AF sensor is tested, cleaned, inspected and decontaminated. After decontamination new patient adhesive is installed over the optical windows and the reprocessed sensor is repacked with new removable tape. The OXY-AFR Sensor and the predicate OXY-AF SENSOR have the same performance specifications. The changes in the labels and instructions for use were made to add the reprocessed part numbers and name of the new device to the IFU. No changes in the warnings, cautions or contraindications have been made
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
small adult and pediatric patients
Intended User / Care Setting
hospital, ICU, anesthesia, respiratory therapy, and during transport.
qualified medical personnel only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation data, safety testing report and Accuracy testing is included.
The decontamination process validation was conducted and this report is included.
Biocompatibility summary and testing reports are included as well.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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Image /page/0/Picture/2 description: The image shows a black and white logo. The logo consists of a large circle with a white letter 'D' inside. There is a small square in the upper right corner of the circle, resembling a camera flash.
JUN 2 9 2005
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda OXY-AFR Sensor
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
Datex-Ohmeda, Inc 1315 W Century Dr Louisville, Colorado 80021 USA FDA Registration No. 1719176. Tel: 303-666-7001 Fax: 303-665-9176
NAME OF CONTACT:
Mr. Joel Kent Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344
DATE:
October 17, 2004
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda OXY-AFR Sensor
COMMON NAME:
Reprocessed Pulse Oximetry Sensor
CLASSIFICATION NAME:
The following Class II classifications appear applicable:
73 NLF (Reprocessed) Oximeter 21 CFR 870.2700
1
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
The Datex-Ohmeda OXY-AFR Sensor is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda OXY-AF SENSOR (K021265).
DEVICE DESCRIPTION as required by 807.92(a)(4)
This OXY-AFR sensor has a sensor head, consisting of a red LED and two infrared LEDS mounting on a leadframe, wired to a detector with a 1 meter cable and custom "happisnap" connector. There are two optical windows where the LED light is transmitted between the detector and LEDS. These components are packaged in a heat sealed package. The OXY-AFR is identical to the OXY-AF sensor with the exception of the new patient window adhesive. The ICU, a FR Sensor is for use in small adult and pediatric patients in the hospital, ICU, anesthesia, respiratory therapy, and during transport.
The Datex-Ohmeda OXY-AFR Sensor has the following differences when compared to the Datex-Ohmeda OXY-AF predicate device. The OXY-AFR sensor is a reprocessed OXY-AF sensor During reprocessing the used OXY-AF sensor is tested, cleaned, inspected and decontaminated. After decontamination new patient adhesive is installed over the optical windows and the reprocessed sensor is repacked with new removable tape. The OXY-AFR Sensor and the predicate OXY-AF SENSOR have the same performance specifications. The changes in the labels and instructions for use were made to add the reprocessed part numbers and name of the new device to the IFU. No changes in the warnings, cautions or contraindications have been made
INTENDED USE as required by 807.92(a)(5)
Intended use:
The reprocessed AllFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate
Indications for use:
The reprocessed AllFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate. The device is indicated for use by qualified medical personnel only.
2
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The Datex-Ohmeda OXY-AFR Sensor is substantially equivalent in safety and Fffectiveness to the legally marketed (predicate) Datex-Ohmeda OXY-AF SENSOR (K040831).
The Datex-Ohmeda OXY-AFR Sensor has the following similarities to the Datex-Ohmeda OXY-AF SENSOR predicate device:
-have the same indicated use
-have the same fundamental scientific technology and use the same operating principle -are manufactured using the same processes
-constructed of identical materials except for the patient window adhesive which is equivalent to the original window adhesive
The Datex-Ohmeda OXY-AFR Sensor has the following differences when compared to the Datex-Ohmeda OXY-AF SENSOR predicate device:
-The OXY-AFR sensor is a reprocessed OXY-AF sensor
-The patient window adhesives are different but equivalent.
In summary, the Datex-Ohmeda OXY-AFR Sensor, described in this submission is substantially equivalent to the predicate OXY-AF SENSOR (K040831).
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
Datex-Ohmeda OXY-AFR Sensors are normally used and installed by a trained nurse or doctor. Necessary precautions and warnings are stated on the instructions for use. The Verification and Validation data, safety testing report and Accuracy testing is included.
The decontamination process validation was conducted and this report is included.
Biocompatibility summary and testing reports are included as well.
CONCLUSION:
The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda OXY-AFR Sensor as compared to the predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.
SEP - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel C. Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492
Re: K042891
Trade/Device Name: Datex-Ohmeda OXY-AFR Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: May 17, 2005 Received: May 18, 2005
Dear Mr. Kent:
This letter corrects our substantially equivalent letter of June 29, 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.
4
Page 2 - Mr. Kent
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,
Clive, 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
5
List of Models: Datex Ohmeda Reprocessed Sensors
1
Datex Ohmeda OxyTip+ OXY-AFR
6
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Datex-Ohmeda OXY-AFR Sensor
Indications for Use:
The reprocessed AllFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate. The device is indicated for use by qualified medical personnel only.
Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aingulion
on Siyn-Off) (Di-Divin of Anesthesiology, General Hospital, Infection Collast, Deman De vices
510(k) Number _
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