(308 days)
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No
The document describes a reusable SpO2 sensor, which is a hardware component for pulse oximeters. There is no mention of AI, ML, or any software processing that would indicate the use of such technologies. The device description focuses on its function as an after-market replacement and its equivalence to predicate devices.
No.
The device is a sensor used to non-invasively measure pulse frequency and oxygen saturation. While it provides diagnostic information, it does not directly treat or alleviate a disease, injury, or condition, which is characteristic of a therapeutic device.
Yes
The device measures pulse frequency and functional oxygen saturation (SpO2), which are diagnostic parameters used to assess a patient's physiological status.
No
The device description explicitly states it is a reusable SpO2 sensor, which is a hardware component.
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 performed outside of the living organism.
- Device Function: This device is a SpO2 sensor that non-invasively measures pulse frequency and oxygen saturation on the human body (specifically, through human tissue like a finger). This is an in vivo measurement, meaning it's performed within the living organism.
Therefore, because the measurement is taken directly from the patient's body and not from a sample outside the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IT Dr. Gambert's reusable SpO2 sensors are intended to noninvasively measure the pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2) when used in conjunction with various medical pulse oximeters. The sensors are to be used in accordance with the recommendations and specifications of the oximeter manufacturer.
IT Dr. Gambert's reusable medical SpO2 sensors, the FS and PS "silc touch" Series and FC, FP and Y Series, are intended to non-invasively measure the pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2) when used in conjunction with the BCI Advisor, Datex Ohmeda TuffSat, HP Philips M3, Nellcor NPB-40 and Novametrix 512 pulse oximeters. The sensors are to be used in accordance with the recommendations and specifications of the oximeter manufacturer.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
IT Dr. Gambert's SpO2 Sensors operate on the principle of light absorption emitted through human tissue, e.g. through the index finger. The sensors use two light emitting diodes, one red and one infrared as light sources, and a photodiode to receive the light passing through the tissue. The photodiode converts the measurable light to an electrical current which is read on the measuring instrument as oxygen saturation. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin (HbO2) compared to the total hemoglobin.
SpO2 = HbO2 / (Hb + HbO2)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of Measurement Technique, Cable Length, Measurement Range, Pulse Range (beats per minute), Accuracy (70 - 100%), Accuracy (Pulse rate), and Operating Temperature between predicate devices and the subject device. All listed parameters are "same" between the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (70 - 100%): ± 2 digits
Accuracy (Pulse rate): ± 3 digits
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.
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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).
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§ 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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PREMARKET NOTIFICATION [510(k)] SUMMARY
Date: July 19, 2006
1. Submitter:
International Business Strategies, LLC 1667A Marsh Harbor Lane Mount Pleasant, SC 29464
-
- Establishment Registration #: 3005159777
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- Contact Person: William H. Roettger Manaqing Member
4. Contact Information:
| Telephone: | 843.224.0553 |
|---|---|
| Facsimile: | 843.202.8915 |
| Email: | bill@ibs-usa.com |
5. Proprietary Device Name:
SpO2 Sensor FS and PS "silc-touch" Series SpO2 Sensor FC, FP and Y Series (accessory to pulse oximeter)
6. Classification Name:
Oximeter (DQA 870.2700)
7. Common Name:
SpO2 Sensor (accessory to Pulse Oximeter)
8. Manufacturer:
IT Dr. Gambert GmbH Hinter dem Chor 21 23966 Wismar Germany
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- Establishment Registration #: 9613449
10. Contact Person:
Rainer Boettcher Business Development Manager
1
11. Contact Information:
| Telephone: +49 3841 22 00 50 | |
|---|---|
| Facsimile: | +49 3841 22 00 522 |
| Email: | rboettcher@it-wismar.de |
12. Predicate Devices:
Beta Biomed Services, Inc. K011518
13. Intended Use:
IT Dr. Gambert's reusable SpO2 sensors are intended to noninvasively measure the pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2) when used in conjunction with various medical pulse oximeters. The sensors are to be used in accordance with the recommendations and specifications of the oximeter manufacturer.
14. Method of Operation:
IT Dr. Gambert's SpO2 Sensors operate on the principle of light absorption emitted through human tissue, e.g. through the index finger. The sensors use two light emitting diodes, one red and one infrared as light sources, and a photodiode to receive the light passing through the tissue. The photodiode converts the measurable light to an electrical current which is read on the measuring instrument as oxygen saturation. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin (HbO2) compared to the total hemoglobin.
SpO2 = HbO2 / (Hb + HbO2)
All IT Dr. Gambert SpO2 sensors, and all predicate devices operate on the same principle described above and are substantially equivalent.
15.0 Performance Comparison at constant Temperature, Pressure and Humidity:
| Product | Beta Biomed
K011518 | IT Dr. Gambert | | | | | |
|-----------------------------------|------------------------|----------------|------|------|------|------|------|
| | | FC | FP | FS | PS | CA | CE |
| Measurement
Technique | Dual wavelength | same | same | same | same | same | same |
| Cable Length | 4 ft / 10 ft | same | same | same | same | same | same |
| Measurement Range | 0 - 100% SpO2 | same | same | same | same | same | same |
| Pulse Range
(beats per minute) | 20 - 250 bpm | same | same | same | same | same | same |
| Accuracy (70 - 100%) | ± 2 digits | same | same | same | same | same | same |
| Accuracy (Pulse rate) | ± 3 digits | same | same | same | same | same | same |
| Operating
Temperature | 5 - 45°C | same | same | same | same | same | same |
15.1 Re-usable SpO2 Sensors
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KU6 2149
Sensor types differ only in body shape and connection. They are otherwise identical and are treated the same for technical comparison.
16. Description:
IT Dr. Gambert's reusable SpO2 sensors are produced in several configurations as after market replacements for use with a wide variety of commercially available pulse oximeters. They are substantially equivalent (identical) to the listed predicate devices and all other SpO2 sensors currently cleared for marketing in the United States.
17. Recognized Quality Assurance Standards:
IT Dr. Gambert's SpO2 sensors are classified as Class IIa devices according to EC Council Directive 93/42/EEC, Annex I. All IT Dr. Gambert products display CE Mark 0124.
18. Conclusion:
IT Dr. Gambert's re-usable SpO2 sensors are substantially equivalent to the listed predicate devices in terms of materials, performance, construction and operating principles. They have been tested, and according to EC-Council Directive 93/42/EEC, have been found to be safe and effective when used in conjunction with manufacturer's recommendations.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2007
Mr. Bill Roettger Managing Member International Business Strategies, LLC 1667A Marsh Harbor Lane Mount Pleasant, South Carolina 29464
Re: K062149
Trade/Device Name: SpO2 Sensor FS and PS "Silc-Touch" Series; SpO2 Sensor FC, FP. and Y Series
Regulation Number: 870. 2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 3, 2007 Received: May 4, 2007
Dear Mr. Roettger:
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.
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Page 2 -Mr. Roettger
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); 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Syria Y. Michael MD.
Chiu Lin, Ph.D. 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
510(k) Number K062149:
Device Name: SpO2 Sensors, the FS and PS "silc touch" Series and FC, FP and Y Series
Indications for Use:
IT Dr. Gambert's reusable medical SpO2 sensors, the FS and PS "silc touch" Series and FC, FP and Y Series, are intended to non-invasively measure the pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2) when used in conjunction with the BCI Advisor, Datex Ohmeda TuffSat, HP Philips M3, Nellcor NPB-40 and Novametrix 512 pulse oximeters. The sensors are to be used in accordance with the recommendations and specifications of the oximeter manufacturer.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q. 2
Sion Sign-Off) ... sion of Anesthesiology, General Hospital, Interion Control, Dental Devices
: 3(K) Number: K062149
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