ISCALERT SENSOR SYSTEM by ALERTIS MEDICAL AS

The IscAlert™ sensor system measures the partial pressure of carbon dioxide in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended for monitoring trends in this parameter as an adjunct in the evaluation of the perfusion status of tissue in patients at risk of developing ischemia. IscAlert values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy. The IscAlert™ sensor system should not be used in peripheral brain tissue, intra cranial tissue, all organ tissues including cardiac and kidney, and other peripheral muscle tissues other than forearm muscle.

Device Description

The IscAlert sensor system measures partial pressure of CO2 (pCO2) in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended to monitor pCO2 trends as an adjunct in the evaluation of perfusion status of tissue in patients at risk of developing ischemia.

Ischemia is a medical term for a shortage of blood supply to tissue. If severe, it can lead to death of the affected tissue (infarction). The tissue pCO2 increases significantly during the early and reversible stages of ischemia. This methodology provides the ability to identify the onset of ischemia events through real-time data.

The IscAlert sensor system consists of three parts:

1. The sterile disposable Sensors
1. The Connection Unit (CU)
1. Software to be installed in an off-the-shelf PC unit

The sterile, disposable, catheter tip sensors are placed 2-5 cm into organ tissue with a split-off needle that is removed after insertion.

The sensor is connected via a cable to the Connection Unit (CU). The CU processes the signals from the sensor unit. It is connected via a cable to a PC with the IscAlert software application installed. The software enables visualisation of the monitoring results.

AI/ML Overview

The provided text describes the IscAlert Sensor System (K071165), which measures partial pressure of CO2 (pCO2) in peripheral tissue, specifically forearm muscle. The system is intended to monitor pCO2 trends as an adjunct in evaluating the perfusion status of tissue in patients at risk of ischemia.

Unfortunately, the provided text does not contain detailed acceptance criteria or the specific results of a study that proves the device meets these criteria in a structured format. It mentions that "The IscAlert Sensor System has been tested for function according to the product requirements" and that "The results of these tests and a proof-of-concept clinical study using Neurotrend as comparative device show the IscAlert Sensor System to be safe and effective for its intended use." However, it does not elaborate on what those product requirements (acceptance criteria) were or the specific performance metrics achieved.

Therefore, I cannot provide a table of acceptance criteria and reported device performance.

Here's a breakdown of what can be extracted from the provided text regarding a study, even without specific performance metrics:

Study Information (Based on text)

Study Type: A "proof-of-concept clinical study" was conducted.
Comparative Device: The Neurotrend Cerebral Tissue Monitoring System (K980308) was used as a comparative device.
Purpose: To demonstrate the safety and efficacy of the IscAlert Sensor System for its intended use.
Outcome (General): The study results, along with other tests (EMC and safety), "show the IscAlert Sensor System to be safe and effective for its intended use."

The remaining requested information (sample size, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth type, training set details) is not available in the provided document.

Here is a summary of the information that could be extracted and the information that is missing:

Information Type	Details from Provided Text
1. Acceptance criteria and reported device performance	MISSING. The text states: "The IscAlert Sensor System has been tested for function according to the product requirements." However, the specific product requirements (acceptance criteria) and the quantitative results demonstrating compliance are not provided.
2. Sample size and data provenance (test set)	MISSING. The text mentions a "proof-of-concept clinical study" but does not specify the sample size, country of origin, or whether the data was retrospective or prospective.
3. Number of experts and qualifications (ground truth for test set)	MISSING. There is no mention of experts or their qualifications for establishing ground truth in the clinical study.
4. Adjudication method (test set)	MISSING. No mention of any adjudication method for establishing ground truth or interpreting results in the clinical study.
5. MRMC comparative effectiveness study, effect size	Unlikely to be applicable / MISSING details. This device measures pCO2 trends, not an interpretation task typically suited for MRMC studies with human readers. The clinical study used a comparative device (Neurotrend), but not in an "AI vs. without AI assistance" context as described for MRMC. The effect size of human readers with/without AI assistance is not relevant to the described device.
6. Standalone (algorithm only without human-in-the-loop) performance	PARTIALLY ADDRESSED, but no metrics. "The IscAlert sensor system measures partial pressure of CO2 (pCO2) in peripheral tissue... The system is intended to monitor pCO2 trends..." This implies standalone measurement capability. However, specific standalone performance metrics (e.g., accuracy, precision against a gold standard) are not provided.
7. Type of ground truth used	MISSING (for clinical study). The text indicates the device measures pCO2, and a "proof-of-concept clinical study using Neurotrend as comparative device" was done. This implies that the Neurotrend data might have served as a comparative reference, but it's not explicitly stated as the "ground truth" and no details are given for how Neurotrend's measurements were validated as ground truth within this study.
8. Sample size for the training set	NOT APPLICABLE / MISSING. The device is described as an electrochemical sensor system, not an AI/machine learning algorithm that typically requires a distinct training set. If there are internal calibration or signal processing algorithms developed using data, this is not specified.
9. How ground truth for the training set was established	NOT APPLICABLE / MISSING. (See point 8).

Summary

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IscAlert Sensor System (K071165)

Attachment 3

Ko 71165

Page 1 of 2

510(k) Summary

Submitter: Alertis Medical ASA Oslo, Norway

Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 6470 Riverview Terrace Fridley, MN 55432

NOV 0 7 2007

Submission Date: April 24, 2007

Device Name: IscAlert™ Sensor System

Classification: Class II, 21 CFR 882.1620, Code: GWM

Equivalent Device Identification: The IscAlert Sensor System is substantially equivalent in function to the Neurotrend™ Cerebral Tissue Monitoring System (K980308). The IscAlert sensing technology is substantially equivalent to the Paratrend 7 ™ Intravascular Blood Gas Monitoring System (K953893). The company provided performance data demonstrating the safety and efficacy of the Sensor System for the intended use of measurement of the partial pressure of carbon dioxide in peripheral tissue, such as the forearm muscle tissue.

Device Description: The IscAlert sensor system measures partial pressure of CO2 (pCO2) in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended to monitor pCO2 trends as an adjunct in the evaluation of perfusion status of tissue in patients at risk of developing ischemia.

The IscAlert sensor system consists of three parts:

1. The sterile disposable Sensors
1. The Connection Unit (CU)
1. Software to be installed in an off-the-shelf PC unit

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Ko 7/1/65

IscAlert Sensor System (K071165)

Page 2 of 2

The sterile, disposable, catheter tip sensors are placed 2-5 cm into organ tissue with a split-off needle that is removed after insertion.

Intended Use: The IscAlert™ sensor system measures partial pressure of carbon dioxide in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended for monitoring trends in this parameter as an adjunct in the evaluation of the perfusion status of tissue in patients at risk of developing ischemia. IscAlert values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy. The IscAlert™ sensor system should not be used in peripheral brain tissue, intra cranial tissue, all organ tissues including cardiac and kidney, and other peripheral muscle tissues other than forearm muscle.

Substantial Equivalence: The IscAlert Sensor System is similar in function to the Neurotrend Cerebral Tissue Monitoring System (K980380). The IscAlert and Neurotrend devices measure pCO₂ in peripheral tissue and monitor trends in this parameter as an adjunct for managing patients at risk for ischemia. The IscAlert sensing technology is equivalent to the sensing technology of the Paratrend device. Both devices utilize electrochemical sensors to measure partial gas pressure. Alertis Medical believes the IscAlert to be substantially equivalent to device technology currently available and the device raises no new issues of safety when compared to the predicate devices. The company provided performance data to demonstrate the safety and efficacy of the Sensor System for the intended use.

Summary of Testing: The IscAlert Sensor System has been tested for function according to the product requirements. The System has also been tested for EMC and safety requirements. The results of these tests and a proof-of-concept clinical study using Neurotrend as comparative device show the IscAlert Sensor System to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 7 2007

Alertis Medical AS % C.G. Bundy Associates, Inc. Ms. Constance G. Bundy 6470 Riverview Terrace Fridley, Minnesota 55432

Re: K071165

Trade/Device Name: IscAlert™ Sensor System Regulation Number: 21 CFR 868.1150 Regulation Name: Indwelling blood carbon dioxide partial pressure (Poo2) analyzer Regulatory Class: II Product Code: CCC Dated: October 13, 2007 Received: October 17, 2007

Dear Ms. Bundy:

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.

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.

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Page 2 - Ms. Constance G. Bundy

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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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IscAlert Sensor System (K071165)

Attachment 4

071165

Indications for Use

510(k) Number (if known): K071165

Device Name: IscAlert™ Sensor System

Indications For Use:

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devicesfage 1 of
510(k) Number
28 September 2007
2017
P

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Regulation Number and Section

§ 868.1150 Indwelling blood carbon dioxide partial pressure (P

2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”