(56 days)
Not Found
No
The description mentions a "Masimo SET OEM circuit board with Masimo's SpO2 measurement algorithm," but does not explicitly state or imply the use of AI or ML within this algorithm. The focus is on standard pulse oximetry technology.
No.
The device is for monitoring physiological parameters (SpO2 and pulse rate), not for providing therapy or treatment.
Yes
The device is intended for the "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which involves measuring physiological parameters to assess a patient's health status, a characteristic of diagnostic devices.
No
The device description explicitly states that the device is a "Pod" which contains a "Masimo SET OEM circuit board" and is connected externally via RS232 or USB. This indicates the presence of hardware components beyond just software.
Based on the provided text, the Infinity Masimo SET® SpO2 Pod is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Infinity Masimo SET® SpO2 Pod is described as a device for the "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This is done by attaching a sensor to the patient's finger.
- Method of Measurement: The measurement is taken directly from the patient's body using a sensor, not from a sample taken from the body.
Therefore, the device performs a non-invasive measurement on the patient, which is characteristic of a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Infinity Masimo SET® SpO2 Pod is intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Infinity Masimo SET® SpO2 Pod is intended for use with Adult, Pediatric, and Neonatal populations. The Infinity Masimo SET® SpO2 Pod is intended to be used by Healthcare Providers, i.e. Physicians, Nurses, and Technicians in hospital and hospital type facilities.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Infinity Masimo SET® SpO2 Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. The Infinity Masimo SET® SpO2 Pod is manufactured by Draeger Medical Systems, Inc. and contains the Masimo SET OEM circuit board with Masimo's SpO2 measurement algorithm.
The pod works as a component of the Infinity patient monitoring series and does not function on its own. The Infinity Masimo SET® SpO2 Pod is connected externally via RS232 using only the X8 connector on the modular monitors Delta/Kappa (USB connector on Gamma series). The Masimo SET® SpO2 pod is powered by the patient monitor.
An oximetry sensor is attached to a patients finger and one end of a patient cable is connected to the sensor and the other end connected to the Masimo SET® SpO2 Pod. The monitor will begin continuously displaying the patient's pulse rate and SpO2 value. Hi and Low SpO2 and pulse rate alarm limits, alarms, trends and status messages are all controlled by the bedside monitor.
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, Pediatric, and Neonatal patients
Intended User / Care Setting
Healthcare Providers, i.e. Physicians, Nurses, and Technicians in hospital and hospital type facilities.
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)
The Infinity Masimo SET® SpO2 Pod was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for Dräger medical. The logo is in black and white, with the word "Dräger" in a bold, sans-serif font. The word "medical" is in a lighter, sans-serif font. The logo is simple and modern.
A Dräger and Siemens Company
510(k) SUMMARY
as required per 807.92(c)
- Submitter's Name and Address:
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
- 7 2006
Contact Person:
Thomas M. McIntosh Quality Assurance & Regulatory Affairs Tel: (978) 907-7500 Fax: (978) 907-7734
Date submission was prepared: May 10, 2006
- Trade Name, Common Name and Classification Name:
A. Trade Name: Infinity Masimo SET® SpO2 Pod
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Oximeter | 74DQA | II | 870.2700 |
- Predicate Device Identification:
Masimo SET® Intellivue Pulse Oximeter Module 510(k) Number - K040259 Masimo SET® Rad-5 Pulse Oximeter 510(k) Number - K033296
- Device Description:
The Infinity Masimo SET® SpO2 Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. The Infinity Masimo SET® SpO2 Pod is manufactured by Draeger Medical Systems, Inc. and contains the Masimo SET OEM circuit board with Masimo's SpO2 measurement algorithm.
The pod works as a component of the Infinity patient monitoring series and does not function on its own. The Infinity Masimo SET® SpO2 Pod is connected externally via RS232 using only the X8 connector on the modular monitors Delta/Kappa (USB connector on Gamma series). The Masimo SET® SpO2 pod is powered by the patient monitor.
Page 1 of 2
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
1
Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The text is in a bold, sans-serif font. The word "Dräger" is in a larger font size than the word "medical". Below the logo, in a smaller font, is the text "A Dräger and Siemens Company".
An oximetry sensor is attached to a patients finger and one end of a patient cable is connected to the sensor and the other end connected to the Masimo SET® SpO2 Pod. The monitor will begin continuously displaying the patient's pulse rate and SpO2 value. Hi and Low SpO2 and pulse rate alarm limits, alarms, trends and status messages are all controlled by the bedside monitor.
5. Intended Use:
The Infinity Masimo SET® SpO2 Pod is intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Infinity Masimo SET® SpO2 Pod is intended for use with Adult, Pediatric, and Neonatal populations. The Infinity Masimo SET® SpO2 Pod is intended to be used by Healthcare Providers, i.e. Physicians, Nurses, and Technicians in hospital and hospital type facilities.
6. Comparison to Predicate Device:
Similar to Masimo SET® Intellivue Pulse Oximeter Module and Masimo SET® Rad-5 Pulse Oximeter, the Infinity Masimo SET® SpO2 Pod provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients.
7.Assessment of non-clinical performance data for equivelance:
The Infinity Masimo SET® SpO2 Pod was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.
- Biocompatability: Not applicable
-
- Sterilization: Not applicable
- Standards and Guidances: IEC 60601-1
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by four curved lines that suggest a head and torso.
Public Health Service
JUL - 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas McIntosh Director, Quality Assurance & Regulatory Affairs Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923
Re: K061329
Trade/Device Name: Infinity Masimo SET® Sp()2 Pod Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 5, 2006 Received: June 7, 2006
Dear Mr. McIntosh:
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 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.
3
Page 2 – Mr. McIntosh
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely vours.
Swette y Michael Oms
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
Indications for Use
510(k) Number (if known): K061329
Device Name: Infinity Masimo SET® SpO2 Pod
The Infinity Masimo SET® Pod is intended for use under the direct supervision of a licensed healthcare practioner (i.e. . Physicians, Nurses, and Technicians). It is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
The Infinity Masimo SET® SpO2 Pod is indicated for use with adult, pediatric and neonatal patients.
The Infinity Masimo SET® SpO2 Pod and accessories are indicated for use during both motion and non-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital type facilities.
MRI Compatibility Statement: The Infinity Masimo SET® SpO2 Pod is not compatible for use in a MRI magnetic field.
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Sign-Off)
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices
| Number | K061329 |
|---|---|
| -------- | --------- |