(484 days)
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Not Found
No
The description focuses on spectrophotometric measurement principles and standard hardware components (optical fibers, detector, spectrometer, microprocessor) without mentioning any AI/ML algorithms or capabilities.
No
The device is intended to measure hemoglobin oxygen saturation, but the intended use statement explicitly states that "The value of these measurements in disease states has not been demonstrated," indicating it is not for therapeutic use.
No
The device measures hemoglobin oxygen saturation, but the intended use statement explicitly says, "The value of these measurements in disease states has not been demonstrated." This indicates it's currently not cleared for diagnosing diseases.
No
The device description explicitly details hardware components including patient probes, a monitor containing a spectrometer, light assembly, microprocessor, power supply, display monitor, keyboard, and reference canisters.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Biospectrometer - NB 1111 is described as a noninvasive device that measures hemoglobin oxygen saturation in tissue by placing a probe on intact skin. It does not analyze blood, urine, or other bodily fluids or tissues that have been removed from the body.
- The measurement is performed in vivo. The device directly interacts with the patient's tissue to obtain the measurement.
The device is a noninvasive medical device that uses spectrophotometry to measure physiological parameters in vivo.
N/A
Intended Use / Indications for Use
The Biospectrometer - NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation:
- in the ear lobe with the 3mm probe
- in the arm, leg, or shoulder with the 15mm probe. The value of these measurements in disease states has not been demonstrated.
Product codes (comma separated list FDA assigned to the subject device)
74 MUD
Device Description
The Biospectrometer - NB Oximeter Model 1111 is a spectrophotometric monitoring system which measures an approximated value of percent hemoglobin oxygen saturation in tissue (S,O2). More specifically, the Biospectrometer - NB Oximeter measures the percent hemoglobin oxygen saturation of blood contained within the volume of tissue illuminated by the noninvasive probe. The S.O2 value is a function of the relative contribution of arterial, venous, and capillary blood.
The system consists of a patient probe (either 3mm or 15mm) containing optical fibers for transmitting light to tissue and receiving reflected light which is returned to a photo-sensitive detector. The nonsterile probe is designed to be placed on intact skin. The second system component is a monitor containing a spectrometer, light assembly, microprocessor, power supply, display monitor and kevboard. The third type of system component includes two (reference) canisters for use in calibration of the system. The Biospectrometer - NB Oximeter Model 1111 is AC operated.
The Biospectrometer - NB Oximeter Model 1111 measures an approximated value of the percent oxygen saturation of hemoglobin based on spectrophotometric measurement principles. Spectrophotometric measurements of hemoglobin have been well described by numerous authors. Today, spectrophotometric oximeters are commonly used clinically. By measuring absorbencies at suitable wavelengths, the ratio of oxygenated hemoglobin to total hemoglobin can be determined.
The depth of tissue measured by the Biospectrometer - NB Oximeter Model 1111 probe is determined by the probe design. The HTI Biospectrometer - NB 15mm probe measures to a maximum depth of 20mm. The 3mm probe measures to a maximum depth of 4mm.
The Biospectrometer - NB Oximeter Model 1111 has the following functional capabilities.
- An approximated value of the percent oxygen saturation of hemoglobin in tissue is measured to a maximum depth of 20 mm with the "15mm" probe and 4 mm with the "3mm" probe.
- The approximated value of the percent oxygen saturation of hemoglobin is presented numerically (current reading along with a trend line on a monitor screen.
- The operator can define an alarm sctting for the percent oxygen saturation of hemoglobin (a default value of 40% is provided upon power-up).
- Error messages are provided for the following unsatisfactory conditions:
- o a low signal error message alerts the operator if the signal falls below a factory set level.
- o a low light output alerts the operator if the light supplied to the probe is below a factory set level, and
- o an ambient light error message is presented to the operator if the probe is improperly attached to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Ear lobe, arm, leg, or shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.)
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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.
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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.
Not Found
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).
0
JAN 27 1998
"510(k) Summary"
I. General Information
- A. Proprietary Name Biospectrometer - NB Oximeter Model 1111
- B. Common Name Oximeter
- C. Manufacturer & Official Contact Person The manufacturer of the Biospectrometer - NB Oximeter Model 1111 is: Hutchinson Technology, Inc. (hercinafter called HTI) Medical Device Division 40 West Highland Park Hutchinson, MN 55350-9785 (320) 587-3797 phone (320) 587-1555 facsimile The Official Contact Person/Regulatory Consultant is:
Stephan Norsted, PhD., Vice President Regulatory Strategies, Inc. 7089 Crowne Oak Road Eden Prairie, Mn 55344 (612) 944-3142 phone (612) 944-3084 facsimile
- D. Regulatory Class and Associated Regulation per 21 CFR 8870.2700 oximeters are Class II (Tier 2) devices under the authority of the Cardiovascular Panel (i.e., MUD).
- E. Performance Standards & Special Controls
The Food & Drug Administration has not developed a performance standard for oximeters. Furthermore, oximeters have not been assigned any special controls (e.g., device tracking or postmarket surveillance).
II. Description
The Biospectrometer - NB Oximeter Model 1111 is a spectrophotometric monitoring system which measures an approximated value of percent hemoglobin oxygen saturation in tissue (S,O2). More specifically, the Biospectrometer - NB Oximeter measures the percent hemoglobin oxygen saturation of blood contained within the volume of tissue illuminated by the noninvasive probe. The S.O2 value is a function of the relative contribution of arterial, venous, and capillary blood.
Page 1 of 3
1
III. Indications
The Biospectrometer - NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation:
- in the ear lobe with the 3mm probe
- in the arm, leg, or shoulder with the 15mm probe. The value of these measurements in disease states has not been demonstrated.
IV. Device Description
A. Introduction
The system consists of a patient probe (either 3mm or 15mm) containing optical fibers for transmitting light to tissue and receiving reflected light which is returned to a photo-sensitive detector. The nonsterile probe is designed to be placed on intact skin. The second system component is a monitor containing a spectrometer, light assembly, microprocessor, power supply, display monitor and kevboard. The third type of system component includes two (reference) canisters for use in calibration of the system. The Biospectrometer - NB Oximeter Model 1111 is AC operated.
The Biospectrometer - NB Oximeter Model 1111 measures an approximated value of the percent oxygen saturation of hemoglobin based on spectrophotometric measurement principles. Spectrophotometric measurements of hemoglobin have been well described by numerous authors. Today, spectrophotometric oximeters are commonly used clinically. By measuring absorbencies at suitable wavelengths, the ratio of oxygenated hemoglobin to total hemoglobin can be determined.
The depth of tissue measured by the Biospectrometer - NB Oximeter Model 1111 probe is determined by the probe design. The HTI Biospectrometer - NB 15mm probe measures to a maximum depth of 20mm. The 3mm probe measures to a maximum depth of 4mm.
-
B. Functional Description
The Biospectrometer - NB Oximeter Model 1111 has the following functional capabilities. -
An approximated value of the percent oxygen saturation of hemoglobin in tissue is measured to a maximum depth of 20 mm with the "15mm" probe and 4 mm with the "3mm" probe.
-
The approximated value of the percent oxygen saturation of hemoglobin is presented numerically (current reading along with a trend line on a monitor screen.
Page 2 of 3
2
- The operator can define an alarm sctting for the percent oxygen saturation of hemoglobin (a default value of 40% is provided upon power-up).
- Error messages are provided for the following unsatisfactory conditions:
- o a low signal error message alerts the operator if the signal falls below a factory set level.
o a low light output alerts the operator if the light supplied to the probe is below a factory set level, and
- o an ambient light error message is presented to the operator if the probe is improperly attached to the patient.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1998
Hutchinson Technology, Inc. c/o Stephan Norsted, Ph.D. Requlatory Strategies, Inc. 7089 Crowne Oak Road Eden Prarie, MN 55344
Re: K963903 Biospectrometer - NB Oximeter Model 1111 Requlatory Class: II (two) Product Code: 74 MUD Dated: October 27, 1997 October 29, 1997 Received:
Dear Ms. Trimm:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medica1 Devices: ¯ General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
of_ Page__________________________________________________________________________________________________________________________________________________________________________
长963903 510(k) Number lif known):_____________________________________________________________________________________________________________________________________________________
Vavice Name: Biospectrometer - NB Oximeter Model 1111
Indications For Use:
INDICATIONS
The Biospectrometer - NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation:
- in the ear lobe with the 3mm probe .
- in the arm. leg, or shoulder with the 15mm probe. The value of these measurements in disease states has not been demonstrated.
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/5/Figure/9 description: The image shows a form regarding the concurrence of CDRH, Office of Device Evaluation (ODE). The form indicates whether the device is for prescription use or over-the-counter use. A checkmark indicates that the device is for prescription use, as defined by 21 CFR 801.109.
(Optional Format 1-2-96)