(67 days)
No
The summary describes a cable for a pulse oximetry system and does not mention any AI or ML components or capabilities. The performance studies listed are standard electrical and safety tests for medical devices.
No
The device is indicated for continuous noninvasive monitoring of oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic interventions.
Yes
The device continuously monitors functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it is an "in-line cable" and mentions physical connectors and interfaces to a host device, indicating it is a hardware component.
Based on the provided information, the Masimo SET® uSpO2™ Pulse Oximetry Cable is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Masimo SET® uSpO2™ Pulse Oximetry Cable is described as a device for continuous noninvasive monitoring of functional oxygen saturation and pulse rate. It works by interfacing with a sensor that is applied to the patient's body (implied by "noninvasive monitoring" and "measured by an SpO2 sensor").
- No Specimen Analysis: The description does not mention the analysis of any specimens taken from the body. The device directly measures physiological parameters from the patient.
Therefore, the device falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET uSpO2 Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Masimo SET® uSpO2™ Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when installed in a compatible OEM host system.
In this submission, the uSpO2 Pulse Oximetry Cable incorporates a distal integrated LNCScompatible 9-pin sensor connector with a length of cable used to interface to the host device, the GE ApexPro Telemetry System (K080251). The proximal end of the cable incorporates a connector that is compatible with the host device.
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
hospitals 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 following testing of the uSpO2 Pulse Oximetry Cable was performed in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence of the modified device to the cleared device:
- . Design Review Process
- Risk Analysis per ISO 14971 .
- Software Verification and Validation per FDA Guidance Documents .
- Electromagnetic Compatibility per IEC 60601-1-2 t
- . Electrical Safety Testing per IEC 60601-1
- Environmental Testing (Operating Temperature, Humidity, Fluid Ingress) .
- . Component and System Testing
- System Compatibility Testing (GE ApexPro Telemetry System) .
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.
K040259 - Masimo SET® IntelliVue Pulse Oximeter Module
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
| 510(k) Summary | K121914 | SEP 7 2012 |
|---|---|---|
| Submitter: | Masimo Corporation | |
| 40 Parker | ||
| Irvine, CA 92618 | ||
| Phone: (949) 297-7000 | ||
| FAX: (949) 297-7592 | ||
| Contact: | David Collette | |
| Sr. Manager, Regulatory Affairs | ||
| Date Summary Prepared: | September 6, 2012 | |
| Trade Name: | Masimo SET® uSpO2™ Pulse Oximetry Cable | |
| Regulation Name: | Pulse Oximeter | |
| Classification Regulation: | 21 CFR 870.2700 | |
| Class II | ||
| Product Code: | DQA | |
| Existing Device: | K040259 - Masimo SET® IntelliVue Pulse Oximeter Module |
Device Description
The Masimo SET® uSpO2™ Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when installed in a compatible OEM host system.
In this submission, the uSpO2 Pulse Oximetry Cable incorporates a distal integrated LNCScompatible 9-pin sensor connector with a length of cable used to interface to the host device, the GE ApexPro Telemetry System (K080251). The proximal end of the cable incorporates a connector that is compatible with the host device.
Indications for Use
The Masimo SET uSpO2 Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET uSpO2 Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
1
Predicate Device Comparison
| Characteristic | Masimo SET® IntelliVue
Pulse Oximeter Module
K040259 | Masimo SET® uSpO2™ Pulse
Oximetry Cable
K121912 |
|----------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Host system | Philips IntelliVue | GE ApexPro Telemetry
System |
| Physical configuration | Plug-in module
Direct connect to host
system. | Plug-in module with in-line
cable to connect to host
system. |
| Pulse oximetry technology | Masimo SET Technology | Masimo SET Technology |
| Communication protocol | IntelliVue host-system
specific | GE ApexPro host-system
specific |
| Compatible sensors and
cables | Masimo LNOP and LNCS
oximetry sensors
Masimo LNC patient cables | Masimo LNCS oximetry
sensors
Masimo LNOP oximetry
sensors (with adapter)
(patient cables not required) |
Summary of Testing
The following testing of the uSpO2 Pulse Oximetry Cable was performed in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence of the modified device to the cleared device:
- . Design Review Process
- Risk Analysis per ISO 14971 .
- Software Verification and Validation per FDA Guidance Documents .
- Electromagnetic Compatibility per IEC 60601-1-2 t
- . Electrical Safety Testing per IEC 60601-1
- Environmental Testing (Operating Temperature, Humidity, Fluid Ingress) .
- . Component and System Testing
- System Compatibility Testing (GE ApexPro Telemetry System) .
Conclusion
The information in this 510(k) submission demonstrates that the subject Masimo SET uSpO2 Pulse Oximetry Cable is substantially equivalent to the existing device with respect to safety, effectiveness, and performance.
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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a curved line representing its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 7 2012
Masimo Corporation Mr. David Collette Senior Manager, Regulatory Affairs 40 Parker Irvine, California 92618
Re: K121914
Trade/Device Name: Masimo Set® uSpO2™ Pulse Oximetry Cable Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 8, 2012 Received: August 9, 2012
Dear Mr. Collette:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Collette
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
B. Sheth
B. Sheth m.D.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4. Indications for Use
Indications for Use
510(k) Number: K12|914
Device Name: Masimo SET® uSpO2™ Pulse Oximetry Cable
Indications for Use:
The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® uSpO2" Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Prescription Use, X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
L. Schultk
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121914