(24 days)
Not Found
No
The description focuses on the electro-optical nature of the sensor and standard signal processing for SpO2 and pulse rate measurement. There is no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
No.
The device is indicated for continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate, which are diagnostic or monitoring functions rather than therapeutic.
Yes
The device is indicated for "continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring," which are diagnostic measurements used to assess a patient's physiological state.
No
The device description explicitly details hardware components (electro-optical sensors, LEDs, photodiode, cable, connector) and their function in measuring SpO2, indicating it is a hardware device with potential software components for data processing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
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 description clearly states that the SpO2 sensors are "non-invasive" and function "without skin penetration, electrical contact, or heat transfer." They use optical means to measure light absorption through the skin.
- Measurement Method: The device measures functional arterial oxygen saturation and pulse rate directly from the patient's body, not from a sample taken from the body.
- Performance Study: The performance study compares the sensor's measurement to a laboratory co-oximeter, which does analyze blood samples (an in vitro method), but the device itself is not performing the in vitro analysis.
Therefore, because the device operates non-invasively and measures physiological parameters directly from the patient's body rather than analyzing a sample taken from the body, it does not fit the definition of an In Vitro Diagnostic. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The Finger Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
The Ear Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg.
The Neonatal-Adult Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
The Adult/Pediatric Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DPZ
Device Description
SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor body contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The sensor body is connected to a cable that is terminated with a 9-pin D-connector for connecting the sensor to a patient monitor or an interconnect cable.
The Finger and Ear sensors are durable, multiple-patient-use sensors. The sensor structure has a spring structure that easily and comfortably accomodates the sensor to the application site. The Neonatal-Adult and Adult/Pediatric sensors are disposable single-patient-use sensors. The attachment mechanism of these sensors is a soft adhesive tape that is wrapped around the application site.
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
The Finger Sensor is indicated for patients weighing >= 20 kg.
The Ear Sensor is indicated for patients weighing >= 10 kg.
The Neonatal-Adult Sensor is indicated for adult, pediatric, and neonatal patients.
The Adult/Pediatric Sensor is indicated for patients weighing >= 20 kg.
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)
SpO2 accuracy testing was conducted during induced hypoxia studies on healthy adult volunteer subjects during no motion conditions conducted in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the sensors was compared to arterial hemoglobin oxygen value determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples was measured to be +/-3 digits over the SpO2 range 70-100%.
Bench testing with a simulator and the same patient monitors was performed to verify pulse rate measurement accuracy.
Patient interface temperature (Sensor surface temperature) testing was conducted to ensure the sensor surface temperature during the use of the sensors is not higher than for the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: +/-3 digits over the SpO2 range 70-100%.
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.
K042704, K042675, K042705, K041522
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/0 description: The image shows the text "K06 1191" in a handwritten style. Below this text, the date "MAY 22 2006" is printed in a bold, sans-serif font. The date indicates that the image or document is related to May 22, 2006.
Image /page/0/Picture/1 description: The image shows the logo for Measurement Specialties. The logo consists of the word "measurement" in bold, sans-serif font, with the word "SPECIALTIES" in a smaller, sans-serif font underneath. To the right of the word "measurement" is a series of dots that get progressively larger.
movation performance reliability
Section 10 - Premarket Notification 510(k) Summary
Premarket Notification 510(k) Summary As required by section 807.92
SpO2 Sensors for use with Nellcor® R-Cal SpO2 (Finger sensor, reusable; Ear sensor, reusable; Neonatal-Adult sensor, disposable; Adult/Pediatric sensor, disposable)
GENERAL COMPANY INFORMATON as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
Measurement Specialties, Inc 1000 Lucas Way Hampton, VA 23666 Telephone: 757-766-1500 Fax: 757-766-4347
NAME OF CONTACT: Susan Zaks, Product Line Manager, Optical products
DATE: April 25, 2006
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME(S):
Finger Sensor for use with Nellcor® R-Cal SpO2 Ear Sensor for use with Nellcor® R-Cal SpO2 Neonatal-Adult Adhesive Sensor for use with Nellcor® R-Cal SpO2 Adult/Pediatric Adhesive Sensor for use with Nellcor® R-Cal SpO2
COMMON NAME:
SpO2 Sensor (accessory to pulse oximeter and ear oximeter)
CLASSIFICATION NAME:
수수
The following Class II classification appear applicable DQA 21 CFR 870.2700, Finger Sensor for use with Nellcor® R-Cal SpO2 DQA 21 CFR 870.2700, Neonatal-Adult Adhesive Sensor for use with Nellcor® R-Cal SpO2
1000 Lucas Way. Hampton, VA 23666 Toll Free: 800 745 8008 ● Tcl: 757 766 1500 ● Fax: 757 766 4297
,
1
Image /page/1/Picture/0 description: The image shows the logo for "measurement SPECIALTIES". The word "measurement" is in bold, black, sans-serif font. Below it, "SPECIALTIES" is in a smaller, less bold font. To the right of the text, there is a curved line of black dots that decrease in size as they move away from the text.
nnovation performance reliability
DQA 21 CFR 870.2700, Adult/Pediatric Adhesive Sensor for use with Nellcor® R-Cal SpO2 DPZ 21 CFR 870.2710. Ear Sensor for use with Nellcor® R-Cal SpO2
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
SpO2 sensors for use with Nellcor® R-Cal SpO2 (Finger sensor, reusable; Ear sensor, reusable; Neonatal-Adult sensor, disposable; Adult/Pediatric sensor, disposable) are substantially equivalent to the predicate SpO2 sensors:
K042704 Flexi-Stat(tm) Finger clip SpO2 sensor K042675 Flexi-Stat(tm) Ear sensor K042705 All-fit Flexi-Stat(tm) Disp SpO2 sensor (Nellcor-compatible) K041522 Flexi-Stat(tm) Disposable Adhesive SpO2 sensor (Nellcor-compatible)
DEVICE DESCRIPTION as required by 807.92(a)(4)
SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor body contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The sensor body is connected to a cable that is terminated with a 9-pin D-connector for connecting the sensor to a patient monitor or an interconnect cable.
The Finger and Ear sensors are durable, multiple-patient-use sensors. The sensor structure has a spring structure that easily and comfortably accomodates the sensor to the application site. The Neonatal-Adult and Adult/Pediatric sensors are disposable single-patient-use sensors. The attachment mechanism of these sensors is a soft adhesive tape that is wrapped around the application site.
INTENDED USE as required by 807.92(a)(5)
Finger sensor:
The Finger sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
Ear sensor:
.
The Ear sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg.
Neonatal-Adult sensor:
1000 Lucas Way, Hampton, VA 23666 Toll Free: 800 745 8008 ● Tel: 757 766 1500 ● Fax: 757 766 4297 www.meas-spec.com
2
Image /page/2/Picture/0 description: The image contains the words "measurement" in large bold font on the top line and "SPECIALTIES" in smaller font on the second line. The word "measurement" is the primary focus of the image. There are some decorative dots on the right side of the image.
novation performance reliability
The Neonatal-Adult sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
Adult/Pediatric Sensor:
The Adult/Pediatric sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The Finger sensor, Ear sensor, Neonatal-Adult sensor and Adult/Pediatric sensor use the same theory and principle of operation as the predicate devices. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by validation tests.
SUMMARY OF THE PERFORMANCE TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
SpO2 accuracy testing was conducted during induced hypoxia studies on healthy adult volunteer subjects during no motion conditions conducted in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the sensors was compared to arterial hemoglobin oxygen value determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples was measured to be +/-3 digits over the SpO2 range 70-100%.
Bench testing with a simulator and the same patient monitors was performed to verify pulse rate measurement accuracy.
Patient interface temperature (Sensor surface temperature) testing was conducted to ensure the sensor surface temperature during the use of the sensors is not higher than for the predicate devices.
CONCLUSION:
The summary above shows that there are no new questions of safety and effectiveness for the SpO2 sensors Finger Sensor for use with Nellcor® R-Cal SpO2, Ear Sensor for use with Nellcor® R-Cal SpO2, Neonatal-Adult Adhesive Sensor for use with Nellcor® R-Cal SpO2 and Adult/Pediatric Adhesive Sensor for use with Nellcor® R-Cal SpO2 as compared to the predicate devices.
3
Image /page/3/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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, a symbol often associated with the United States.
Public Health Service
MAY 2 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Measurement Specialties, Incorporated C/O Ms. Krista Oakes Amica Solutions 2300 McDermott Road, #200-207 Plano, Texas 75025
Re: K061191
Trade/Device Name: Finger Sensor for use with Nellcor R-cal SpO2, Ear Sensor for use with Nellcor R-cal SpO2, Neonatal-Adult Sensor for use with Nellcor R-cal SpO2, Adult/Pediatric Sensor for use with Nellcor R-cal SpO2 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, DPZ Dated: April 28, 2006 Received: April 28, 2006
Dear Ms. Oakes:
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.
4
Page 2 - Ms. Oakes
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) 276-0120. 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 yours,
Sylite y. Michael Dm's
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
5
Section 5 - Indications For Use Statement
Indications for Use
510(k) Number (if known): ΚΟ 6 || 91
Device Name(s): Finger Sensor for use with Nellcor R-cal SpO2, Ear Sensor for use with Nellcor Rcal SpO2, Neonatal-Adult Sensor for use with Nellcor R-cal SpO2, Adult/Pediatric Sensor for use with Nellcor R-cal SpO2.
Indications for Use:
Finger sensor:
The Finger Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
Ear sensor:
The Ear Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg.
Neonatal-Adult sensor:
The Neonatal-Adult Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
Adult/Pediatric Sensor:
The Adult/Pediatric Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Section Control, Dental Devices | |
| K Number: | K061191 |
| 23 |