(616 days)
K-863918
K-863918
No
The description focuses on standard pulse oximetry principles and does not mention AI or ML.
No
The device is described as a diagnostic tool for determining hemoglobin saturation, not for treating or providing therapy to patients.
Yes
Explanation: The device is used for the "determination of saturation of hemoglobin (SpO₂)," which is a measurement used to assess a patient's physiological state, particularly for those with pulmonary disease or dysfunction, indicating a diagnostic purpose.
No
The device description explicitly states it determines SpO2 from "light signals of two wavelengths transmitted through from tissues," indicating the use of hardware components (light emitters and sensors) to acquire the data.
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.
- Device Function: The description clearly states that the device determines SpO2 non-invasively from light signals transmitted through tissues. This means it's measuring a physiological parameter directly from the patient's body without taking a sample.
Therefore, the Minolta Pulsox-3 and Pulsox-3i are considered non-invasive medical devices used for monitoring, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
74 DQA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light signals of two wavelengths
Anatomical Site
Tissues (of patients)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K-863918
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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
3
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