(570 days)
No
The description focuses on standard pulse oximetry technology using light emission and detection, and a microprocessor for signal processing. There is no mention of AI, ML, or related concepts.
No.
The IM2001 Pulse Oximeter is a monitoring device that measures and displays physiological parameters (SpO2 and pulse rate), but it does not provide any treatment or therapy to the patient.
No
The device is a pulse oximeter that monitors physiological parameters (SpO2 and pulse rate) but does not provide a diagnosis or identify the presence of a disease or condition.
No
The device description explicitly states it consists of a sensor, holder, cable, and a microprocessor-controlled monitoring console, indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The IM2001 Pulse Oximeter measures oxygen saturation and pulse rate non-invasively by shining light through the skin (specifically the forehead in this case). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring physiological parameters directly from the patient, not analyzing biological samples.
Therefore, based on the provided information, the IM2001 Pulse Oximeter falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IM2001 Pulse Oximeter is indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment.
Product codes (comma separated list FDA assigned to the subject device)
74DQA
Device Description
The IM-2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate based on the principal of Reflection. The device consists of a small and light-weight sensor and is intended to monitor arterial SaO2 from the forehead.
IM2001 Pulse Oximeter consists of a sensor that emits and detects red and infrared light, a holder, a connecting cable, and a microprocessorcontrolled monitoring console Signal Processing Unit (monitor). The monitor displays digital values of Sp02 and Pulse Rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
pediatric and adult population
Intended User / Care Setting
For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use 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)
Not Found
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.
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).
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510(K) SUMMARY
IM2001 Pulse Oximeter
MAR 0 7 2003
510(k) Number K012706 (Revised 7-22-02)
E-Mail: julie.powell@imagyn.com
| Applicant's Name: | Cybro Medical Ltd. (Subsidiary of Imagyn, Inc.)
Matam, Bldg. 30,
Haifa 31905, Israel
Tel: 972-4-8550063
Fax: 972-4-8550277
E-Mail: cybro@cybro.co.il |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Powell
Imagyn Medical Technologies, Inc. |
| | 8850 M-89, P.O. Box 351
Richland, MI 49083 |
| | Tel: 616 629 2787 |
| | Fax: 616 629 9654 |
Trade Name: IM2001 Pulse Oximeter
Classification Name: Oximeter
Classification:
The FDA has classified pulse oximeters as class II devices (product code 74DQA, Regulation No. 870.2700) and they are reviewed by the Cardiovascular Panel.
Predicate Device:
N-395 Pulse Oximeter (Nellcor Puritan Bennett, Inc) cleared under K991823 and K993637 when operates with its RS-10 sensor (Nellcor Puritan Bennett, Inc) cleared under K904039.
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Intended Use:
The IM2001 Pulse Oximeter is indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment.
Device Description:
The IM-2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate based on the principal of Reflection. The device consists of a small and light-weight sensor and is intended to monitor arterial SaO2 from the forehead.
IM2001 Pulse Oximeter consists of a sensor that emits and detects red and infrared light, a holder, a connecting cable, and a microprocessorcontrolled monitoring console Signal Processing Unit (monitor). The monitor displays digital values of Sp02 and Pulse Rate.
The IM2001 is intended for prescription use with adult and pediatric patients in hospitals. hospital-type facilities, and intra-hospital transport environments.
Substantial Equivalence:
Cybro Medical Ltd. believes that, based on calculations, validations, and performance testing results, the IM2001 Pulse Oximeter is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 7 2003
Cybro Medical, Ltd. c/o Ms. Julie Powell Vice President of Quality Assurance and Regulatory Affairs Imagyn Medical Technologies, Inc. 8850 M-89 Box 351 Richland, Michigan 49083-9416
Re: K012706
Trade/Device Name: IM2001 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: 74 DQA Dated: December 6, 2002 Received: December 9, 2002
Dear Ms. Powell:
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 such 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 -- Ms. Julie Powell
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 begin 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_)(△l2706
Device Name: IM2001 Pulse Oximeter
Indications for Use:
The IM2001 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use only.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
KO12706 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use_____________
(Division Sign-Off)
OR
510(k) Number: K012706
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