(95 days)
Not Found
No
The document describes a pulse oximeter and its software update, focusing on sensor compatibility and re-labeling. There is no mention of AI, ML, or related concepts in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is described as a "monitoring" device for oxygen saturation and pulse rate. The intended use focuses on detection and alarming, not on treating or preventing a condition.
No
The device is for monitoring functional oxygen saturation and pulse rate, which are physiological parameters, not for diagnosing a disease or condition. While the device does have alarms, the purpose is to indicate deviations from preset limits for monitored parameters, not to provide a diagnosis.
No
The description explicitly states the device is for "continuous, non-invasive monitoring" using "a range of compatible sensors," which implies the use of hardware (sensors) to acquire physiological data. The software version update is for an existing device that includes hardware.
Based on the provided information, the MICRO2+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is for "continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate". This involves monitoring physiological parameters directly from the patient's body, not analyzing samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the device's technology for monitoring, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The MICRO2+'s function falls under the category of patient monitoring, which is distinct from IVD.
N/A
Intended Use / Indications for Use
The MICRO2+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA, 74 DPZ
Device Description
The release of software version VA1 includes a re-labeling of the MicrO2+ and the recognition of Nellcor OxiMax sensors. The modifications implemented with the release of software version VA1 have not altered the basic fundamental technology of the MicrO2+. Testing with VA1 software indicates no new issues relative to safety and efficacy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k) Notification SIEMENS MicrO2+ VA1 Modifications
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: February 26, 2003
Trade Name, Common Name and Classification Name:
- A. Trade Name: Siemens MicrO2+ Nellcor N-45
- B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Oximeter | 74 DQA | II | 870.2700 |
| Ear Oximeter | 74 DPZ | II | 870.2710 |
Legally Marketed Device Identification: MICRO2+, 510(k) K012770
Description of Modification:
The release of software version VA1 includes a re-labeling of the MicrO2+ and the recognition of Nellcor OxiMax sensors. The modifications implemented with the release of software version VA1 have not altered the basic fundamental technology of the MicrO2+. Testing with VA1 software indicates no new issues relative to safety and efficacy.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
Intended Use:
The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits
Assessment of non-clinical performance data for equivalence: See Section J
Assessment of clinical performance data for equivalence: See Section J
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: See Section J
Page 2 of 2
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2003
Ms. Penelope H. Greco Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Re: K030640
Trade/Device Name: Siemens MicrO2+ with VA1 Software Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 23, 2003 Received: May 27, 2003
Dear Ms. Greco:
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.
3
Page 2 – Ms. Penelope H. Greco
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 (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 Rumm
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
Enclosure
4
Page 1 of 1 --
510(k) Number (if known): KC 306 YO
Device Name: Siemens INFINITY MICRO2+
Indications for Use:
The MICRO2+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.
MRI Compatibility Statement: The Siemens INFINITY MICRO2+ is not intended for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use____________
(Optional Format 1-2-96)
Susan Pearson
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: 4/3k3