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.

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.

AI/ML Overview

This document is a 510(k) summary for a medical device (SpO2 Wrap Sensor), which typically outlines the device, its intended use, comparison to predicate devices, and a summary of performance data to demonstrate substantial equivalence. However, it does not contain a detailed study proving acceptance criteria with specific performance metrics as commonly found for AI/ML-based devices.

The document states: "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."

Based on the provided text, a detailed study with specific acceptance criteria and performance data for the SpO2 Wrap Sensor's core function (SpO2 and pulse rate accuracy) is not provided. The performance data discussed focuses on verifying that the modifications to the predicate device (housing/attachment and smaller photodiode) do not negatively impact accuracy and that the device meets existing standards.

Therefore, many of the requested details about acceptance criteria and study particulars for a new device's performance cannot be extracted directly from this 510(k) summary because the focus is on demonstrating substantial equivalence of a modified device, not proving the de novo performance of a novel device.

Here's an attempt to answer the questions based only on the provided text, with many fields indicating "Not N/A" or "Not Applicable" due to the nature of this particular 510(k) summary:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Core Functionality (SpO2, Pulse Rate Accuracy)	"Changes to the predicate device do not affect those aspects of the device related to accuracy." (Implies meeting predicate's accuracy standards, but no new criteria/data presented.)
Oximeter Compatibility	Verified through simulated use bench testing.
Biocompatibility	Verified to meet the same standards as the predicate device.
EMC (Electromagnetic Compatibility)	Verified to meet the same standards as the predicate device.
Safety	Verified to meet the same standards as the predicate device.
Pulse Oximeter Standards	Verified to meet the same standards as the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "simulated use bench testing" and "other bench testing" but does not give a sample size for these tests.
Data Provenance: Not specified. Testing appears to be bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of device (SpO2 sensor) is typically validated against reference instrumentation or clinical measurements, not through expert ground truth establishment in the way AI/ML devices are validated.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are relevant for expert consensus on image interpretation or complex diagnostic tasks, which is not the nature of SpO2 sensor validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no human reader study is mentioned or relevant for this type of medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm; it's an electro-optical sensor.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated, but for SpO2 sensors, ground truth is typically established by co-oximetry (arterial blood gas analysis) for oxygen saturation and ECG or invasive arterial pressure monitoring for pulse rate in clinical studies. For bench testing, it would involve calibrated reference instruments. The document only mentions "simulated use bench testing" and "other bench testing" without detailing the ground truth methodology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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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 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.

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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:

1. it uses a different housing/method of attachment to the patient (wrap design vs. clip design); and
1. 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.

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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.

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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

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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)
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Prescription Use	✓	or	Over-the-Counter Use
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AWentersh

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number . 9922

Regulation Number and Section

§ 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).