(99 days)
No
The document explicitly states that the software modifications have not altered the basic fundamental technology and there are no mentions of AI, DNN, or ML.
No
The device is described as a monitor for oxygen saturation and pulse rate, and it produces alarms, but it does not treat or directly intervene in a disease state.
Yes
The device monitors functional oxygen saturation and pulse rate, providing information about a patient's physiological state, which can be used to identify medical conditions or risks.
No
The device description explicitly states "The release of software version VA2 includes a re-labeling of the MicrO2+ and the recognition of Masimo LNOP sensors." This indicates the device is a pulse oximeter which is a hardware device that uses sensors, not a software-only device. The software update is for an existing hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate". This describes a device that monitors physiological parameters directly from the patient's body, not a device that analyzes samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description talks about sensors and monitoring, which aligns with a non-invasive monitoring device.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device is a pulse oximeter, which is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for 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
Product codes
74 DQA, 74 DPZ
Device Description
The release of software version VA2 includes a re-labeling of the MicrO2+ and the recognition of Masimo LNOP sensors. The modifications implemented with the release of software version VA2 have not altered the basic fundamental technology of the MicrO2+. Testing with VA2 software indicates no new issues relative to safety and efficacy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
NOV 2 5 2003
Special 510(k) Notification MicrO2+ VA2 Modifications
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Draeger Medical Systems, Inc. Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Connie Hertel, Director Official Correspondent: Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco November 24, 2003 Date submission was prepared:
Trade Name, Common Name and Classification Name:
-
A. Trade Name:
Draeger MicrO2+ -
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) K030640, K012770 Masimo SET Radical Pulse Oximeter and LNOP Series Sensors, K013792
Description of Modification:
The release of software version VA2 includes a re-labeling of the MicrO2+ and the recognition of Masimo LNOP sensors. The modifications implemented with the release of software version VA2 have not altered the basic fundamental technology of the MicrO2+. Testing with VA2 software indicates no new issues relative to safety and efficacy.
Image /page/0/Figure/16 description: The image shows the text "Page 1 of 2". This indicates that the current page is the first page of a document that has a total of two pages. The text is written in a clear, legible font.
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc.
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
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax (978) 750-6879
2
Public Health Service
NOV 25 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Penelope H. Greco Draeger Medical System, Incorporated 16 Electronics Avenue Danvers, MA 01923
Re: K032537
Trade/Device Name: Draeger Infinity MicrO2+ Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: November 14, 2003 Received: November 17, 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. Iisting 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.
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
3
Page 2 - Ms. Penelope H. Greco
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 Purnell
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
4
Page_l_of_1
510(k) Number (if known): KO32537
Device Name: 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 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_ V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
S.A. Wutcher
neral Hospital.
510(k) Number