(28 days)
Not Found
No
The summary describes a device using near infrared spectroscopy (NIRS) and standard signal processing, with no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The CerOx monitor should not be used as the sole basis for diagnosis or therapy." This indicates it is a monitoring device, not a therapeutic one.
No
The "Intended Use / Indications for Use" states that the device "should not be used as the sole basis for diagnosis or therapy."
No
The device description explicitly states that the CerOx Model 3210 comprises a "display and processing unit and probes," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states the device is "noninvasive" and uses probes "coupled to the patient" to monitor tissue blood oxygen saturation. This indicates direct measurement on the patient, not analysis of a sample like blood, urine, or tissue in a lab setting.
- The intended use describes monitoring in the body. The device monitors regional hemoglobin oxygen saturation of blood in the brain and in a region of skeletal muscle tissue. This is in-vivo measurement.
Therefore, the Or-Nim CerOx Model 3210 monitor is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The CerOx Model 3210 is intended to monitor oxygen saturation of blood in the body.
Indications for Use: The noninvasive Or-Nim CerOx Model 3210 monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the CerOx monitor has not been demonstrated in disease states. The CerOx monitor should not be used as the sole basis for diagnosis or therapy.
Product codes
MUD
Device Description
The CerOx Model 3210 uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood. CerOx Model 3210 comprises a display and processing unit and probes that are coupled to the patient using a single-use biocompatible adhesive. When the probes are attached to the patient, the system is operated to monitor the tissue blood oxygen saturation level. The CerOx Model 3210 can be operated in two modes: Cerebral Mode and Muscle Mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near infrared spectroscopy (NIRS)
Anatomical Site
Brain, skeletal muscle tissue
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
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)
The risk analysis method used to assess the impact of the modifications was Failure Modes, Effects and Criticality Analysis (FMECA). For risks which were identified as a result of the modifications, mitigations were designed and implemented in accordance with the Quality System Regulations. Hardware and software tests were then performed to validate the mitigations.
Conclusions: The results of the design control process and the tests performed on the modified device (CerOx Model 3210) support the conclusion that it remains as safe and effective as, and remains substantially equivalent to, the cleared predicate device (Pacifica 01).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K093923
Or-Nim Medical Ltd.
ತಿ
Special 510(k) Premarket Notification CerOx 3210 (Pacifica 01 Modification)
9. 510(K) SUMMARY
Submission Date:
ﺗﺮ
December 14, 2009
Submitter Information:
Company Name: Or-Nim Medical Ltd.
Company Address:
1 Yodfat Street Lod, 71291 Israel
Contact Person:
Michal Balberg, PhD Chief Technical Officer Or-Nim Medical Ltd. Tel: +972-8-9282801 Fax: +972-8-9282805 michalb@ornim.com
Device Information:
| Trade Name: | CerOx Model 3210 |
|---|---|
| Common | |
| Name: | Oximeter/Cerebral Oximeter/Tissue Oximeter |
| Classification | |
| Name: | Oximeter, Tissue Saturation (21 CFR 870.2700) |
| Product | |
| Code: | MUD |
| Regulatory | |
| Class: | II |
Predicate Device: The Or-Nim CerOx Model 3210 is a modification of the cleared Or-Nim Pacifica 01 (K073407), which serves as the predicate device.
Device Description: The CerOx Model 3210 uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood.
CerOx Model 3210 comprises a display and processing unit and probes that are coupled to the patient using a single-use biocompatible adhesive.
CONFIDENTIAL
'JAN 1 9 2010
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093923
Special 510(k) Premarket Notification CerOx 3210 (Pacifica 01 Modification)
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Or-Nine Medical Ltd.
When the probes are attached to the patient, the system is operated to monitor the tissue blood oxygen saturation level.
The CerOx Model 3210 can be operated in two modes: Cerebral Mode and Muscle Mode.
Intended Use: The CerOx Model 3210 is intended to monitor oxygen saturation of blood in the body.
Note: the Intended Use of the modified device has not changed as a result of the modifications outlined in this submission.
Indications for Use: The noninvasive Or-Nim CerOx Model 3210 monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the CerOx monitor has not been demonstrated in disease states. The CerOx monitor should not be used as the sole basis for diagnosis or therapy.
Note: the Indications for Use statement for the modified device has not changed as a result of the modifications outlined in this submission.
Comparison to Predicate Device: ﻟﺴﻌﺔ
The Or-Nim CerOx Model 3210 represents a modification to the cleared Or-Nim Pacifica 01 (K073407). The original and modified devices have the same intended use, the same indications for use, the same technological characteristics, and are used on the same sites of the body.
Summary of Design Control and Test Activities:
The risk analysis method used to assess the impact of the modifications was Failure Modes, Effects and Criticality Analysis (FMECA). For risks which were identified as a result of the modifications, mitigations were designed and implemented in accordance with the Quality System Regulations. Hardware and software tests were then performed to validate the mitigations.
Conclusions: The results of the design control process and the tests performed on the modified device (CerOx Model 3210) support the conclusion that it remains as safe and effective as, and remains substantially equivalent to, the cleared predicate device (Pacifica 01).
CONFIDENTIAL
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3 3 edical Ltd.
Special 510(k) Premarket Notification CerOx 3210 (Pacifica 01 Modification)
10. STANDARDS DATA REPORT FOR 510(K)S
FDA Recognized Voluntary Consensus Standards 10.1.
Both the original Pacifica and the modified CerOx are in compliance with FDA-recognized performance and safety standards. Form 3654 (Appendix H) lists the standards cited and the table attached to it specifies sections to which the CerOx conforms. For each standard, sections other than those listed in the table attached to Form 3654 were deemed Not Applicable.
Testing of acoustic parameters and display was performed in accordance with standards from the American Institute of Ultrasound in Medicine (AIUM) (Table 11.2). Design and testing of the Cer Ox was performed in accordance with 21 CFR§1040.10 and 21 CFR§1040.11.
CONFIDENTIAL
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized human figure with outstretched arms, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the logo. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Or-Nim Medical, Ltd. % Michal Balberg, Ph.D. Chief Technical Officer 1 Yodfat Street Lod, 71291 Israel
JAN 1 9 2010
Re: K093923
Trade/Device Name: CerOx Model 3210 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: December 17, 2009 Received: December 22, 2009
Dear Dr. Balberg:
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 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 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.
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); medical device reporting (reporting of medical
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Page 2 - Mr. Michal Balberg, Ph.D.
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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8. STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K093923
CerOx Model 3210 Device Name:
Indications for Use:
The noninvasive Or-Nim CerOx Model 3210 monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the CerOx monitor has not been demonstrated in disease states. The CerOx monitor should not be used as the sole basis for diagnosis or therapy.
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A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ro. Rr. mo Des. R.R.
(Division Sign-Off) (Division of Surgical, Orthopedic, Division of Surgious.
and Restorative Devices
098923
510(k) Number
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