(301 days)
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.
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.
The provided text is a 510(k) summary for the CerOx Model 3210F device. It describes the device, its intended use, comparison to predicate devices, and FDA clearance. However, it does not contain specific details about clinical studies, acceptance criteria, ground truth establishment, sample sizes for test or training sets, expert qualifications, or adjudication methods in the way a detailed study report would.
The document states that the CerOx Model 3210F is identical to the CerOx Model 3210 in hardware and operation for tissue oximetry, and performs an additional analysis for microcirculatory blood flow. The conclusion of the 510(k) is based on substantial equivalence to predicate devices (CerOx 3210 for tissue oximetry and Laserflo Blood Perfusion Monitor BPM2 for microcirculation blood flow) rather than detailed clinical effectiveness studies with explicit acceptance criteria and performance metrics for the new device.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth data are not present in this 510(k) summary. I can only provide information that is explicitly stated or can be inferred from the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary concludes substantial equivalence based on the device being "as safe and effective as" and "substantially equivalent to" the predicate devices, rather than on specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) and direct reporting of the device's performance against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing is based on substantial equivalence to existing devices.
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.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
There is no indication of an MRMC comparative effectiveness study being performed, nor is there any mention of AI in the context of this device. The CerOx Model 3210F is an oximeter/flowmeter and does not appear to involve AI assistance for human readers/clinicians, according to this summary.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is described as a monitor intended for use by medical professionals ("adjunct monitor").
7. The Type of Ground Truth Used
This information is not explicitly stated in the document. Since the device monitors regional hemoglobin oxygen saturation and microcirculation blood flow, ground truth would typically come from a reference standard for these physiological measurements, but the summary does not specify how this was established or if such ground truth was used for a specific clinical trial (which is not described in detail). The basis for equivalence is the device's mechanism and performance being similar to the predicate devices.
8. The Sample Size for the Training Set
This information is not provided in the document. There is no mention of a training set, as the filing is for substantial equivalence and not a de novo clearance requiring extensive performance data derived from machine learning or similar algorithms that would involve training sets.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document, as no training set is mentioned or implied.
{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 |
|---|---|
| CommonName: | Oximeter/Cerebral Oximeter/Tissue OximeterFlowmeter, blood, cardiovascular |
| ClassificationName: | Oximeter, Tissue Saturation (21 CFR 870.2700)Cardiovascular blood flowmeter (21 CFR 870.2100) |
| ProductCode: | MUD, DPW |
| RegulatoryClass: | 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
:
{3}------------------------------------------------
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
{4}------------------------------------------------
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
§ 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).