(616 days)
The Minolta Pulsox-3 and Pulsox-3i are the devices for determination of saturation of hemoglobin (SpO₂) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease, pulmonary dysfunction or who need sleep study.
The Minolta Pulsox-3 and Pulsox-3i are the devices for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease, pulmonary dysfunction or who need sleep study. SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
The provided text is a 510(k) summary for the Minolta PULSOX-3 and PULSOX-3i pulse oximeters, filed in 2000. These summaries are designed to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive clinical studies with acceptance criteria as would be found in a full efficacy study.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: Function, design, and construction similar to pre-1976 devices and existing marketed devices. | "similar in function, design and construction to other products which were in the market place prior to May 28, 1976." "similar to several other products currently being marketed in the United States including the legally marketed predicate device..." |
| Compliance with Published Literature: Performance in line with established pulse oximeter standards. | "The testing results are also in compliance with those in published literature for pulse oximeters." |
| Safety and Effectiveness: Demonstrate the device is safe and effective. | "The testing conducted demonstrates that the Minolta PULSOX-3 and PULSOX-3i are safe and effective." |
| Measurement Principle: Determination of SpO2 non-invasively, based on pulsatile blood flow, using two wavelengths of light. | "Minolta PULSOX-3 and PULSOX-3i are the devices for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients..." "The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow." |
| Definition of SpO2: Consistent with ISO 9919:1992. | "SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter and displayed as a percentage." |
Important Note: The provided text does not specify quantitative acceptance criteria (e.g., "accuracy within X% of a reference standard") or specific performance metrics (e.g., mean absolute difference). Instead, it makes broad statements of equivalence and compliance. This is typical for 510(k) summaries which focus on demonstrating "substantial equivalence" rather than presenting detailed clinical trial results with specific numerical acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It only generally states "The testing conducted demonstrates..." without providing details on how that testing was performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a pulse oximeter, ground truth often involves co-oximetry, which is a laboratory blood gas analysis, rather than expert interpretation of images. However, the text does not elaborate on the specific ground truth method used.
4. Adjudication Method for the Test Set
The document does not provide any information on an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable to the provided document. The Minolta PULSOX-3 and PULSOX-3i are pulse oximeters, which are direct measurement devices, not AI-assisted diagnostic tools that involve human readers interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is also not directly applicable in the context of this device. A pulse oximeter is inherently a standalone device that provides a numerical reading. Its "performance" refers to how accurately it measures SpO2 compared to a reference standard, not its performance in an AI-algorithm sense. The summary implies the device's standalone performance was evaluated against the predicate and published literature, but no specific study details are provided.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For pulse oximeters, the gold standard for SpO2 is often arterial blood gas analysis with co-oximetry. However, the summary does not detail the methods used for "testing." It implies comparison to the predicate device, which would involve comparing sensor readings, but the exact ground truth for the accuracy of those readings is not specified.
8. The Sample Size for the Training Set
The document does not specify any sample size for a training set. This is not an AI/machine learning device, so the concept of a "training set" as it relates to AI model development is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is not an AI/machine learning model and therefore does not have a "training set" in that context.
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K9845'70
AUG 3 0 2000
Image /page/0/Picture/2 description: The image is a logo for Inspired Respiratory Care Products. The logo is divided into two squares, with the left square being black and the right square being white. The letters "In" are in white on the black square, and the letter "X" is in black on the white square. The words "Inspired Respiratory Care Products" are written below the two squares.
In-X Corporation 1610 Pierce Street, Suite 150 Lakewood, Colorado 80214 -1489 (303) 238-4935 Fax: (303) 237-4010
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS Minolta PULSOX-3 and PULSOX-31
December 21, 1998
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 Minolta Pulsox-3 and Pulsox-3i are similar in function, design and construction to other products which were in the market place prior to May 28, 1976. The Minolta Pulsox-3 and Pulsox-3i are also similar to several other products currently being marketed in the United States including the legally marketed predicate device and a substantial equivalence claim made. The predicate device is the Minolta/Marquest Oxygen Saturation Monitor Pulsox-7. The predicate device is a legally marketed Class II post-amendment device, K-863918 currently manufactured by Minolta and marketed by Marquest/Vital Signs, Englewood, Colorado.
The Minolta PULSOX-3 and PULSOX-3i are the devices for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease, pulmonary dysfunction or who need sleep study. SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter 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 Minolta PULSOX-3 and PULSOX-3i are equivalent to the Minolta/Marquest Oxygen Saturation Monitor Pulsox-7. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Minolta PULSOX-3 and PULSOX-3i are safe and effective.
Charlie Henry President, In-X Corporation
12/21/98
Date
Date
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2000
Mr. Charlie Henry President In-X Corporation 1610 Pierce Street, Suite 150 Lakewood, Colorado 80214 -1489
Re: K984570 Minolta Pulsox-3 and Pulsox-3i Regulatory Class: II (two) Product Code: 74 DQA Dated: August 14, 2000 Received: August 17, 2000
Dear Mr. Henry:
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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 Requlation (QS) for Medical Devices: General requlation (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 requlatory 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
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Page 2 - Mr. Henry
under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4645. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Bme Jhon
signature
James ﻂ. Dillard III Directbr Divison of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Indications for Use Statement
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Minolta Pulsox-3/Minolta Pulsox-3i
Indications for Use:
The Minolta Pulsox-3 and Pulsox-3i are the devices for determination of saturation of The Minolia Pulsox-o and Pulsox of the usiness of two wavelengths transmitted
hemoglobin (SpO₂) non-invasively from light signals of two wavelength and nemogram (SpOz) normitablively from light organis and and the se, pulmonary dysfunction or who need sleep study.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Bmm Juh
(Division Sign/Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number £ 984(70
§ 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).