(301 days)
CerOx 3210, Laserflo Blood Perfusion Monitor. BPM2
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using established principles of NIRS and Laser Doppler flowmetry without mentioning any AI/ML components.
No
The device is described as a non-invasive monitor intended for measuring regional hemoglobin oxygen saturation and microcirculation blood flow, and the "Intended Use" section explicitly states it "should not be used as the sole basis for diagnosis or therapy."
No
The "Intended Use / Indications for Use" section explicitly states, "The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy." While it monitors physiological parameters, it is not intended for diagnostic purposes on its own.
No
The device description explicitly states it uses near infrared spectroscopy (NIRS) and Laser Doppler flowmetry, which are hardware-based technologies requiring physical sensors and equipment to acquire data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Description: The CerOx 3210F is described as a non-invasive monitor that uses near infrared spectroscopy (NIRS) and Laser Doppler flowmetry. These are techniques that measure physiological parameters directly on or within the body without taking a sample.
- Intended Use: The intended use is to monitor regional hemoglobin oxygen saturation and microcirculation blood flow in the brain or skeletal muscle tissue. This is a measurement taken in vivo (within the living body).
Therefore, because the device operates non-invasively and measures parameters directly within the body rather than analyzing samples taken from the body, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The non-invasive CerOx 3210F monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults.
The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.
Product codes
MUD, DPW
Device Description
The CerOx Model 3210F 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. In addition, it employs principles similar to those of Laser Doppler flowmetry to monitor the microcircular blood flow in tissue.
CerOx Model 3210F is identical to the CerOx Model 3210. It utilizes the same technical and operational methods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain or in a region of skeletal muscle tissue
Indicated Patient Age Range
adults
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CerOx 3210, Laserflo Blood Perfusion Monitor. BPM2
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
K 100875
Or-Nim Medical Ltd.
9. 510(K) SUMMARY
Submission Date: March 25, 2010
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 3210F |
|---|---|
| Common | |
| Name: | Oximeter/Cerebral Oximeter/Tissue Oximeter |
| Flowmeter, blood, cardiovascular | |
| Classification | |
| Name: | Oximeter, Tissue Saturation (21 CFR 870.2700) |
| Cardiovascular blood flowmeter (21 CFR 870.2100) | |
| Product | |
| Code: | MUD, DPW |
| Regulatory | |
| Class: | II |
Predicate Device: CerOx 3210, Or-Nim Medical Ltd. Laserflo Blood Perfusion Monitor. BPM2, Vasamedics L.L.C. Device Description: The CerOx Model 3210F 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. In addition, it employs principles similar to those of Laser Doppler flowmetry to monitor the microcircular blood flow in tissue.
CONFIDENTIAL
1
CerOx Model 3210F is identical to the CerOx Model 3210. It utilizes the same technical and operational methods.
- Intended Use: The CerOx Model 3210F is intended to monitor oxygen saturation and blood flow in tissue
The non-invasive CerOx 3210F monitor is intended for use as an adjunct Indications for Use: monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults.
The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.
Comparison to Predicate Device: The CerOx 3210F is identical to the CerOx 3210 in hardware and operation, and has the same intended use and indications for use for tissue oximetry as the CerOx 3210. The CerOx 3210F performs an additional analysis of the light signals to enable monitoring of microcirculatory blood flow in tissue. In this respect it is substantially equivalent to the Laserflo Blood Perfusion Monitor BPM2 for this indication.
Conclusions: The tests performed on CerOx Model 3210F support the conclusion that it remains as safe and effective as, and remains substantially equivalent to, the cleared predicate device CerOx 3210 for the monitoring of tissue blood oxygen saturation. The data presented and the tests performed also support the conclusion that the CerOx 3210F is substantially equivalent to the cleared predicate device Laserflo Blood Perfusion Monitor BPM2, for the monitoring of microcirculation blood flow in tissue.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Or-Nim Medical Ltd. % Michal Balberg, Ph.D. 1 Yodfat Street Lod, 71291, Israel
JAN 2 5 2011
Re: K100875
Trade/Device Name: CerOx Model 3210F Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD, DPW Dated: December 08, 2010 Received: December 15, 2010
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
:
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Page 2 -- Michal Balberg, Ph.D.
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 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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
K 100875 510(k) Number (if known):
Device Name:
CerOx Model 3210F
Indications for Use:
The non-invasive CerOx 3210F monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults.
The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K100875
Concurrence of CDRH. Office of Device Evaluation (ODE)
CONFIDENTIAL