(174 days)
Not Found
No
The device description and performance studies focus on electro-optical sensing and compatibility with existing oximeters, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is a sensor used for monitoring, not for treating a condition.
Yes
The device is indicated for "continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring." Monitoring physiological parameters to assess a patient's health status is a core function of diagnostic devices.
No
The device description clearly outlines physical hardware components (electro-optical sensor, LEDs, photodiode, housing, cable, connectors) and describes its function as an accessory to existing oximeters, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The SpO2 Wrap Sensor is a non-invasive device that measures physiological parameters (oxygen saturation and pulse rate) on the patient's body using optical means. It does not analyze blood, urine, tissue, or any other sample taken from the patient.
- The intended use is for continuous, non-invasive monitoring. This is a typical function of a medical device used for patient monitoring, not an IVD which is used for diagnostic testing of samples.
The device description and intended use clearly indicate it's a sensor for a pulse oximeter, which is a medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The SpO2 Wrap Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
The SpO2 Wrap Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 contains three optical components; two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector.
The LED's and photodiode are contained in a flexible, L-shaped housing that is positioned over the desired patient digit and secured in place with a fabric wrap. The sensor cable is 3-12 feet in length and is terminated in DB-9 and Hypertronics style connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient digit
Indicated Patient Age Range
The SpO2 Wrap Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 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)
Changes to the predicate device do not affect those aspects of the device related to accuracy. Changes to the photodiode's mechanical size affects the device's ability to be recognized by the compatible oximeter. Simulated use bench testing was performed to verify oximeter compatibility with the smaller photodiode.
Other bench testing was performed to verify that the device meets the same standards as the predicate device, with regard to biocompatibility, EMC, safety, and pulse oximeter standards.
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/2 description: The image shows three parallel lines that appear to be ribbons or strips of material. The lines are oriented diagonally from the upper right to the lower left. The middle and bottom lines have a wave-like pattern, with a single curve that dips down and then rises back up. The top line is mostly straight, but it has a small curve at the beginning.
Epic Medical Equipment Services 1800 10TH STREET, SUITE 300, PLANO, TEXAS 75074 -1; 22 PM
Appendix C Page 1 of 2
510(k) Summary
Submitter Information:
Epic Medical Equipment Services, Inc. 1800 E. 10th Street. Suite 300 Plano, TX 75074
Contact:
Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: (972) 801-9854 Fax: (972) 801-9859
Date Prepared:
June 30, 1999
Product Name:
Common Name: SpO2 Sensor (accessory to pulse oximeter) Trade Name(s): SpO2 Wrap Sensor
Predicate Device:
This product is a modification to the Epic 100 Series SpO2 sensor marketed under 510(k) # K970098 and the Epic 200 Series Flexi-Site sensor marketed under K964055.
Description:
The SpO2 Wrap Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 contains three optical components; two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector.
The LED's and photodiode are contained in a flexible, L-shaped housing that is positioned over the desired patient digit and secured in place with a fabric wrap.
1
The sensor cable is 3-12 feet in length and is terminated in DB-9 and Hypertronics style connectors.
Intended Use:
The SpO2 Wrap Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg.
Comparison to Predicate Device:
The SpO2 Wrap Sensor uses the same theory and principle of operation as the predicate device. The Wrap Sensor differs from the predicate device in essentially two ways:
-
- it uses a different housing/method of attachment to the patient (wrap design vs. clip design); and
-
- it uses a smaller photodiode (3mm2 vs. 8.23mm2)
The LED specifications, as well as the electrical/optical specifications of the photodiode, are identical to the predicate device.
Performance Data & Conclusions:
Changes to the predicate device do not affect those aspects of the device related to accuracy. Changes to the photodiode's mechanical size affects the device's ability to be recognized by the compatible oximeter. Simulated use bench testing was performed to verify oximeter compatibility with the smaller photodiode.
Other bench testing was performed to verify that the device meets the same standards as the predicate device, with regard to biocompatibility, EMC, safety, and pulse oximeter standards.
2
Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an emblem of an eagle with its wings spread. The eagle is facing left and has three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1999
Ms. Krista Oakes Epic Medical Equipment Services, Inc. 1800 10th Street, Suite 300 Plano, TX 75074
Re : K992211 Sp02 Wrap Sensor Requlatory Class: II (two) Product Code: 74 DQA Dated: October 1, 1999 Received: October 4, 1999
Dear Ms. Oakes:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Krista Oakes
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
fcamsA Weiterhausen fer,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix B Page 1 of 1
Statement of Indications For Use
210(k) # _ KSA 22 7 Device Name: SpO2 Wrap Sensor
Indications for Use:
The SpO2 Wrap Sensor is indicated for continuous, non-invasive functional arterial The Upo2 Wrap Seizor is andrew onitoring for patients weighing more than 30 kg.
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | ✓ | or | Over-the-Counter Use |
|---|---|---|---|
| ------------------ | ----------------------------------------- | ---- | ---------------------- |
|--|
AWentersh
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number . 9922