(281 days)
K-984570
Not Found
No
The description focuses on the physical principles of pulse oximetry and does not mention any AI/ML components or algorithms.
No
The device is used for monitoring purposes (measuring oxygen saturation and pulse rate) and does not provide any therapeutic intervention.
Yes
The device is described as "non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate" for patients with "pulmonary disease or pulmonary dysfunction", which directly indicates its use in diagnosing or monitoring health conditions.
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. This is not a software-only device.
Based on the provided information, the Minolta PULSOX-2 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This is a measurement taken directly from the patient's body, not from a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description explains that it determines SpO2 from light signals transmitted through tissues of patients. This reinforces the non-invasive, direct measurement from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.
IVD devices are designed to perform tests on samples taken from the human body to provide information about a physiological state, disease, or condition. The Minolta PULSOX-2 is a physiological monitoring device that measures a parameter directly from the living patient.
N/A
Intended Use / Indications for Use
The Minolta PULSOX-2 is indicated for the non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Minolta PULSOX-2 is intended for use with adult patients. The Minolta PULSOX-2 is for spot-checking only.
Product codes
DOA
Device Description
The Minolta PULSOX-2, is the device 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 or pulmonary dysfunction. 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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance indicates that the Minolta PULSOX-2, is equivalent to the Minolta PULSOX-3. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Minolta PULSOX-2 is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-984570
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
Image /page/0/Picture/1 description: The image shows a logo for Compliance Systems +, LLC. The logo features a square with a target symbol inside it. The logo also has a dotted line above the company name.
2703 Josephine Street Denver, CO 80205 Phone: (303) 359-9791
FEB 1 2 2003
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS Minolta PULSOX-2TM
May 01, 2002
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-2 is similar in function, design and construction to other products which were in the market place prior to May 28, 1976. The Minolta PULSOX-2 is also similar to several other products currently being marketed in the United States including the legally marketed predicate device and a substantial equivalence claim is made. The predicate device is the Minolta PULSOX-3. The predicate device is a legally marketed Class II post-amendment device, K-984570 currently manufactured by Minolta Co., Ltd., Osaka, Japan.
The Minolta PULSOX-2, is the device 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 or pulmonary dysfunction. 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-2, is equivalent to the Minolta PULSOX-3. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Minolta PULSOX-2 is safe and effective.
Nanci Dingle
Nanci Dexter Owner, Compliance Systems +, LLC
05/01/02
Date
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three overlapping profiles, suggesting a sense of community and support. The figure is enclosed within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2003
Minolta Company Limited C/O Ms. Nanci Dexter Compliance Systems, LLC 2703 Josephine Street Denver, Colorado 80205
Re: K021469
Trade/Device Name: PULSOX-2 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: December 20, 2002 Received: January 2, 2003
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 vour 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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Susan Ruane
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use Statement
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: PULSOX-2
Indications for Use:
The Minolta PULSOX-2 is indicated for the non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Minolta PULSOX-2 is intended for use with adult patients. The Minolta PULSOX-2 is for spot-checking only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Lisa Ettensohn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________ K021469