The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated "finger".

The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type. The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.

The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.

Device Description

The device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type.

The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.

Index 2/CardioSat 100 simulates a human "finger" (toe/ear).utilize technology similar to that which the Pulse Oximeters utilize to measure SpO2 and pulse rate. This aspect of the technology used in Index 2/CardioSat 100 is protected by US Patent No. 5,348,005. Oximeters use the ratio of Red to InfraRed light to simulate readings related to the partial pressure and thus arterial oxygenation level of blood, which is expressed as SpO2 for this method of measurement. In Index 2/CardioSat 100 the pulsation of the signal serves to simulate the heart rate pulsation. This feature is identical to the predicate Index, K933519, SpO2 Simulator with the addition of a near simultaneous pulsing of the Red and InfraRed LEDs to test a wider range of Pulse Oximeter manufacturers models. Most Pulse Oximeters alternate the Red and InfraRed signals.

AI/ML Overview

This document describes the Bio-Tek Index 2 E, F, EF & CardioSat 100 E, F, EF, which are pulse oximeter simulators, testers, and analyzers. The information provided focuses on the device's performance testing and regulatory submission, rather than a clinical study evaluating the device's diagnostic accuracy or effectiveness in a patient setting.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific quantitative performance metrics. It generally states that the device is designed to "allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters" and "determine its performance qualities."

Acceptance Criteria (Implied)	Reported Device Performance
Work as intended over a wide range of Oximeter types	"Will be fully verified and validated per a written plan prior to release"
Electronically simulate pulse oximeter signals	Simulates signals electronically to the Oximeter under test
Analyze Oximeter Probes (continuity, shorts, opens, LED/Photodiode operation)	Can operate as intelligent volt/ohmmeters to analyze Oximeter Probes
Meet current CE Mark requirements for EMC testing	Meets current CE Mark requirements (EMC testing)
Prevent false results due to low battery	Low battery cutoff/alarm in design
Ensure correct operation of probe check sequence	Known voltage measured internally at start of each probe check sequence
Support all product claims for intended use including accuracy and full feature operation	"The testing conducted to date and that will be conducted prior to release will support all product claims for intended use including accuracy and full feature operation."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document refers to testing "over a wide range of Oximeter types" but does not give a number of oximeters or probes tested.
Data Provenance: The testing is internal to Bio-Tek Instruments, Inc., and is described as "verification and validation" of the device itself rather than a study on clinical data. The text doesn't mention specific countries of origin for test data or whether it was retrospective or prospective. It's an internal product development and regulatory submission document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document describes the testing of a medical device simulator/tester, not a device that makes clinical diagnoses. The "ground truth" for this device would be its own electrical and simulated physiological outputs, verified against known engineering standards and the expected behavior of pulse oximeters, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert adjudication of clinical findings. Verification and validation would involve engineering and quality assurance practices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe a MRMC comparative effectiveness study. The device is a simulator/tester for pulse oximeters, not a diagnostic tool for human readers.

6. Standalone Performance Study

Yes, in a sense. The described "Performance Testing: (Verification and Validation)" is essentially a standalone evaluation of the algorithm/device's functionality. The document states:

"The predicate INDEX design was extensively verified and validated to be working per the design and published specifications."
"The Index 2 and CardioSat 100 is being and will be fully verified and validated per a written plan prior to release. This plan includes verification/ validation that the device features work as intended over a wide range of Oximeter types and in some cases involves external confirmation of the features integrity (e.g. use a volt/ohm meter to determine appropriate outputs etc.)."

This indicates testing of the device's ability to accurately simulate and analyze, without human interpretation as part of its primary function.

7. Type of Ground Truth Used

The ground truth for this device is based on:

Engineering specifications and known electrical/physiological parameters: The device simulates pulse oximeter readings using ratios of Red to InfraRed light and pulsation for heart rate. Its ability to create these signals accurately is the ground truth.
External confirmation: "...involves external confirmation of the features integrity (e.g. use a volt/ohm meter to determine appropriate outputs etc.)." This implies calibration against known electrical standards and measurements.
Reference to predicate devices: The device's technological characteristics are compared to legally marketed predicate devices, implying that their established performance serves as a benchmark for what the new device should achieve.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm requiring a "training set" in the typical sense. Its functionality is based on direct simulation and measurement according to designed electronic and optical parameters.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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BIO-TEK® INSTRUMENTS, INC.

HIGHLAND PARK, BOX 998, WINOOSKI, VERMONT 05404-0998, USA

BIO-TEK 510(k) Index 2 E, F, EF & CardioSat 100 E, F, EF APPENDIX G

510(k) SUMMARY

TEL: 800/451-5172 FAX: 802/655-7941

OUTSIDE THE USA TEL: 802/655-4740

E-MAIL: sales@biotek.com WEB SITE: http://www.biotek.com

Image /page/0/Picture/6 description: The image shows a circular logo with the text "ISO 9001 / EN 46001" around the top half of the circle. The word "CERTIFIED" is written along the bottom of the circle. The logo appears to be a certification mark, possibly indicating that a product or organization meets certain quality or safety standards. The image is in black and white and has a slightly grainy texture.

Michael N. Sevigny Quality Assurance Manager 2- Contact Person: 802-655-4040 ext 336 Establishment Registration Number: 1217454 Preparation date April 4, 1997
1-

Oximeter (Pulse), accessory to, 74 DQA, and Ear 3- Classification Name: Oximeter, accessory to, 74 DPZ; Cardiovascular Panel; Oximeters Class 2 per 21 CFR §870.2700 Ear Oximeters Class 2 per 21 CFR §870.2710 Oximeter Simulator, Analyzer or Tester Common Name: Index 2 E, F, EF & CardioSat 100 E, F, EF Proprietary Name:

4- Substantially Equivalent to: The device family is equivalent to the legally marketed predicate devices: Bio-Tek Instruments, Inc. Index, K933519, SpO2 Simulator which has many of the same features for total oximeter testing; and to the Clinical Dynamics Corp. SmartSat™ Pulse Oximetry Analyzer, K952327 primarily in the area of electrical simulation of the pulse oximeter and the testing of oximeter probes.

Index 2 and CardioSat 100 and the predicate Pulse Oximeter testers have an identical intended use and there are no new technological features or issues which would raise concern of safety and effectiveness.

5 & 6- Description of Device and Intended Use: The device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type.

Bro-Tek Instruments is an AA FOF employ

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The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.

7- Summary of technological characteristics of devices compared to predicate:

The simulators can also send this same types of signals electronically to the Oximeter under test simulating the Oximeter Probe's signal. Additionally, they can operate as intelligent volt/ohmmeters to analyze Oximeter Probes for continuity, shorts, opens, LED operation and Photodiode Operation. These last two features are similar in technology to the Clinical Dynamics Corp. SmartSat™ Pulse Oximetry Analyzer, K952327 :

8- Performance Testing: (Verification and Validation): The predicate INDEX designwas extensively verified and validated to be working per the design and published specifications. Many of the features have not changed so this work formed the basis for the new verification/validation plan. The Index 2 and CardioSat 100 is being and will be fully verified and validated per a written plan prior to release. This plan includes verification/ validation that the device features work as intended over a wide range of Oximeter types and in some cases involves external confirmation of the features integrity (e.g. use a volt/ohm meter to determine appropriate outputs etc.).

9- Clinical Testing: Clinical testing was not required since the devices comprise test equipment, and are never in contact with a patient nor do they have any therapeutic or

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BIO-TEK 510(k) Index 2 E, F, EF & CardioSat 100 E, F, EF APPENDIX G

diagnostic patient function. As stated above they are not intended to be used as calibrators and should not be used for clinical "calls".

10- Conclusions from testing: The testing conducted to date and that will be conducted prior to release will support all product claims for intended use including accuracy and full feature operation.

11. Other Information of Interest to FDA:

Potential System Hazards: Are classified as those which could affect the functionality of the system and or give erroneous results. The primary system function hazards which were reviewed and addressed were: a) EMC testing indicted that the system meets current CE Mark requirements and will neither interfere with, nor be susceptible to interference from other devices in the ranges given by the IEC standards. b) A Low battery cutoff/alarm is in the design to prevent false but believable results due to electronic circuits operating outside of their specified range. c) To ensure correct operation a known voltage, generated internally, is measured at the start of each probe check sequence.

User Safety Considerations: The device has been designed as a low voltage battery operated device and is thus intrinsically safe. Bio-Tek supplies a UL approved 110V battery charger with the instrument for North American sales.

The above information is certified to be truthful and accurate to the best of my knowledge.

Michael N. Sevigny

Quality Assurance Manager

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 1997

Mr. Michael N. Sevigny Bio-Tek Instruments, Inc. Highland Park, Box 998 Winooski, Vermont 05404-0998

Re: K971273 Models Index® -2E, -2F, -2FE and Cardiosat™ 100 Pulse Oximeter Simulators, Analyzers/Testers Regulatory Class: II (two) Product Code: 74 DQA Dated: July 31, 1997 Received: August 4, 1997

Dear Mr. Sevigny:

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 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). 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, qood manufacturing practice, labeling, and prohibitions aqainst misbrandinq 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 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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.

Image /page/3/Picture/9 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are written around the edge of the circle. The eagle is facing to the right and has three lines that make up its body.

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Page 2 - Mr. Michael N. Sevigny

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.qov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. -Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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<10(k) Number (if known):

Kq70273

Device Name:

Index 2 E, F FE and CardioSat 100 E, F, EF Pulse Oximeter Simulators, Testers/Analyzers

Indications For Use: The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. Png

(Division Sign-Off) (Division Sign Off)
Division of Cardiovascular, Respiratory, and Neurological Devices K971273 510(k) Number_

Prescription Use (Per 21 CFR §801.109)

Over-The-Counter Use

(Optional Formal 1-2-96)

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).