(154 days)
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.
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.
The provided document K053419 is a 510(k) summary for the Konica Minolta PULSOX-300 and PULSOX-300i. It states that the device is substantially equivalent to legally marketed predicate devices (Minolta Oxygen Saturation Monitor PULSOX-3 and PULSOX-3Si).
Because this is a 510(k) summary for a pulse oximeter, and it claims substantial equivalence to predicate devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrated through comparison to the predicate devices and adherence to relevant standards. The document states that performance indicates equivalence and compliance with published literature, but it does not provide detailed study data, acceptance criteria values, sample sizes, or information about ground truth establishment as requested.
Therefore, many of the requested fields cannot be filled directly from this document.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This document does not provide a specific table of acceptance criteria or detailed reported device performance values. It generally states: "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."
To meet the requirements of ISO 9919:2005 (mentioned in the document as defining SpO2), pulse oximeters are typically evaluated for accuracy (Arms - accuracy root mean square) against a reference CO-oximeter across a range of SpO2 values, usually under conditions of induced hypoxia. However, the exact acceptance criteria (e.g., Arms ≤ 3.0% for SpO2 70-100%) and the performance achieved by the PULSOX-300/300i are not detailed in this summary.
2. Sample size used for the test set and the data provenance:
- Sample size used for the test set: Not specified in the provided summary. Clinical testing for pulse oximeters often involves a small number of healthy volunteers who undergo induced hypoxia.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable in the context of pulse oximetry accuracy studies.
- Qualifications of experts: Ground truth for pulse oximeter accuracy is established by a reference method, typically a co-oximeter measuring arterial blood samples, not by expert interpretation of images or other subjective assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable for a pulse oximetry accuracy study where ground truth is based on objective physiological measurements (co-oximetry).
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:
- MRMC comparative effectiveness study: No. This device is a standalone physiological monitoring device, not an AI-assisted diagnostic tool requiring human reader interpretation change.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone performance: Yes, the device itself provides a direct reading of SpO2 and pulse rate. The "performance" mentioned in the summary refers to this standalone operation. The summary states that "Performance indicates that the Konica Minolta Models PULSOX-300 and PULSOX-300i, are equivalent to the Minolta PULSOX-3 and PULSOX 3Si."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: For pulse oximeters, the ground truth for SpO2 accuracy is typically established by co-oximetry (laboratory analysis of arterial blood samples for fractional oxygen saturation).
8. The sample size for the training set:
- Sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML device that requires a "training set" in the machine learning sense. Its operation is based on established optical principles for measuring light absorption of hemoglobin.
9. How the ground truth for the training set was established:
- How ground truth for training set was established: Not applicable, as there is no "training set."
In summary, as per the provided text, a detailed breakdown of the performance study is not available. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting detailed performance metrics and study methodologies typically found in a full efficacy report.
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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
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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.
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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
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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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§ 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).