(84 days)
The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.
The CerOx Model 3215FO uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue.
The provided text describes the CerOx Model 3215FO as being identical to its predicate device, CerOx Model 3210F, technically and operationally. Therefore, there are no specific acceptance criteria or a dedicated study for the CerOx Model 3215FO described in this document. Instead, the submission relies on the established safety and effectiveness of the predicate device.
The "study" described is a comparison study demonstrating equivalence to the predicate device, not an independent assessment against performance criteria.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Predicate Device) | Reported Device Performance (CerOx Model 3215FO) |
|---|---|
| Equivalence to CerOx Model 3210F in optical output power of lasers | Optical output power of lasers found to be equivalent to CerOx 3210F |
| Equivalence to CerOx Model 3210F in acoustic output power of ultrasound transducers | Acoustic output power of ultrasound transducers found to be equivalent to CerOx 3210F |
| Equivalence to CerOx Model 3210F in amplitude of light signals detected | Amplitude of light signals detected on a laboratory setup found to be equivalent to CerOx 3210F |
| Same intended use and indications for use as CerOx 3210F | Same intended use and indications for use as CerOx 3210F |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the traditional sense of patient data. The "tests performed" were laboratory-based comparisons of physical characteristics (optical output power, acoustic output power, amplitude of light signals) between the new device and the predicate device. Therefore, there's no information on a sample size of patient data or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is the performance of the predicate device, CerOx Model 3210F, as assessed through physical measurements, not clinical expert interpretation.
4. Adjudication method for the test set
Not applicable. The "tests performed" were technical comparisons, not clinical evaluations requiring adjudication.
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
Not applicable. This device is a blood flow monitor, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a device's standalone performance. While the device does generate data independently, the study described is a comparison of physical characteristics, not a standalone clinical performance study. The device's function is to "monitor blood flow in tissue," which implies generating readings for a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this submission is the established performance and technical specifications of the predicate device, CerOx Model 3210F. The tests validated that the CerOx Model 3215FO matched these established metrics.
8. The sample size for the training set
Not applicable. This describes a medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This describes a medical device, not an AI/ML algorithm that requires a training set.
{0}------------------------------------------------
KT31854
Special 510(k) Premarket Notification CerOx Model 3215FO
Or-Nim Medical Ltd.
9. 510(K) SUMMARY
par
a)
Submission Date: June 18, 2013
Submitter Information:
Company Name: Or-Nim Medical Ltd.
Company Address:
Atir Yeda St. Kfar Saba. 4464312 Israel
Contact Person:
Micha Oestereich QA/RA Director Or-Nim Medical Ltd. Tel: +972-8-9282801 Fax: +972-8-9282805 micha@ornim.com
Device Information:
| Trade Name: | CerOx Model 3215FO |
|---|---|
| CommonName: | Flowmeter, blood, cardiovascular |
| ClassificationName: | Cardiovascular blood flowmeter (21 CFR870.2100) |
| ProductCode: | DPW |
| RegulatoryClass: | II |
Predicate Device: CerOx 3210F. Or-Nim Medical Ltd.
Device Description: The CerOx Model 3215FO uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue.
SEP 1 3 2013
{1}------------------------------------------------
.
CerOx Model 3215FO is identical to the CerOx Model 3210F technically and operationally.
The CerOx Model 3215FO is intended to monitor blood flow in Intended Use: tissue
Indications for Use: The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.
Comparison to Predicate Device: The CerOx 3215FO is identical to the CerOx 3210F technically and operationally, and has the same intended use and indications for use as the CerOx 3210F with respect to blood flow monitoring.
Tests performed: The optical output power of the lasers and the acoustic output power of the ultrasound transducers of the CerOx 3125FO was tested and found to be equivalent to that emitted by the CerOx 3210F. In addition the amplitude of the light signals detected by the CerOx 3215FO on a laboratory set up was tested and found to be equivalent to that detected by the CerOx 3210F.
The tests performed on CerOx Model 3215FO support the Conclusions: conclusion that it remains as safe and effective as, and remains substantially equivalent to the cleared predicate device CerOx 3210F for the monitoring of microcirculation blood flow in tissue.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-0002
September 13. 2013
Or-Nim Medical Ltd. Mr. Micha Oestercich QA/RA Director 15 Atir Yeda Street Kfar Saba, 4464312 l sraci
Re: K131854
Trade/Device Name: CerOx Model 3215FO Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II Product Code: DPW Dated: August 7, 2013 Received: August 16. 2013
Dear Mr. Oestereich:
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 Amendnents, or 10 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. 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 cither 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 FIDA'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 - Mr. Micha Oestereich
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 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 331-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 CDRI4'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.hum.
Sincerely yours.
David Krause -S
- Mark N. Melkerson for: Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number: K131854
Device Name: CerOx Model 3215FO
Indications for Use:
The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults.
The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Neil R Ogden 2013.09.13 10:41:26 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ___ K131854
Page 1 of __ 1 __ 1
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).