(154 days)
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No
The summary describes a standard pulse oximeter based on light transmission and does not mention any AI/ML components or related concepts like training/test sets.
No
The device is described as a non-invasive measurement device for oxygen saturation and pulse rate, which implies a diagnostic or monitoring function, not a therapeutic one.
Yes
The device measures physiological parameters (oxygen saturation and pulse rate) in patients with specific conditions (pulmonary disease, dysfunction, or needing sleep study), which are used to assess or monitor a patient's health status, fitting the definition of a diagnostic device.
No
The device description explicitly states it measures SpO2 and pulse rate from "light signals of two wavelengths transmitted through tissues," indicating the use of hardware components (light emitters and sensors) to acquire the data. This is not a software-only device.
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 (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Konica Minolta Models PULSOX-300 and PULSOX-300i are described as devices for non-invasive measurement of oxygen saturation and pulse rate. They work by transmitting light through tissues and measuring the signals. This is done on the patient's body, not on a specimen taken from the body.
Therefore, based on the provided information, the device is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.
Product codes
DQA
Device Description
The Konica Minolta PULSOX-300 and PULSOX-300i are similar in function, design and construction to other products which were in the market place prior to May 28, 1976. The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemogliobin (SpO2) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study. SpO2 is, as defined in ISO 9919:2005, percent of hemoglobin saturation with oxygen measured by a pulse oximer and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
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
adult patients
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)
Performance indicates that the Konica Minolta Models PULSOX-300 and PULSOX-300i, are equivalent to the Minolta PULSOX-3 and PULSOX 3Si. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Konica Minolta Models PULSOX-300 and PULSOX-300i are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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Image /page/0/Picture/1 description: The image shows a logo for Compliance Systems, LLC. The logo has a dark rectangle with the text "Compliance Systems +, LLC" on the right side. The left side of the rectangle has a seal or emblem. The top of the rectangle has a dotted line.
2703 Josephine Street Denver, CO 80205 Phone: (303) 359-9791
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS Konica Minolta PULSOX-300 and PULSOX-300i™ MAY 11 2006
December 2, 2005
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The Konica Minolta PULSOX-300 and PULSOX-300i are similar in function, design and construction to other products which were in the market place prior to May 28, 1976. The Konica Minolta PULSOX-300 and PULSOX-300i are also similar to several other products currently being marketed in the United States including the legally marketed predicate devices and a substantial equivalence claim is made, The predicate devices are the Minolta Oxygen Saturation Monitor PULSOX-3 and PULSOX-3Si. The predicate devices are legally marketed Class II post-amendment devices, K984570 and K010413 currently manufactured by Konica Minolta Sension. Inc., Aichi, Japan,
The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemogliobin (SpO2) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study. SpO2 is, as defined in ISO 9919:2005, percent of hemoglobin saturation with oxygen measured by a pulse oximer and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
Performance indicates that the Konica Minolta Models PULSOX-300 and PULSOX-300i, are equivalent to the Minolta PULSOX-3 and PULSOX 3Si. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Konica Minolta Models PULSOX-300 and PULSOX-300i are safe and effective.
Nance Dett
Nanci Dexter Owner, Compliance Systems +, LLC
12/02/05
Date
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2006
Konica Minolta Sensing, Incorporated C/O Ms. Nanci Dexter Compliance Systems, LLC 2703 Josephine Street Denver, Colorado 80205
Re: K053419
Trade/Device Name: PULSOX-300/300i Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 28, 2006 Received: May 3, 2006
Dear Ms. Dexter:
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.
2
Page 2 - Ms. Dexter
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,
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
3
Indications for Use Statement
510(k) Number: K053419
Device Name: PULSOX-300/300i
Indications for Use:
The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.
Prescription Use __ X (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)
Auy Sulhorn
sinlogy, General Hospital In of Anesth Control, Dent
() Number:
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