The EXHALOMETER™ EX100 is intended to measure the tidal volume, minute volume and respiration rate being delivered to the patient via expiratory ports of resuscitation devices such as transport ventilators and resuscitators. The device is primarily used by Emergency Medical Technicians during emergency transport operations and can also be used for intra-hospital transport. The device is used for indicating how well the resuscitator is functioning. In addition, the device is used for periodically checking the adequacy of the ventilation effort of patients who have initiated spontaneous respiration. The EXHALOMETER can also be used for training and developing resuscitation techniques.

Device Description

The EXHALOMETER™ EX100 is a device that is a self contained and internally powered analyzer designed to connect to a specially designed filter assembly, which in turn, connects to the expiratory port of resuscitation devices such as transport ventilators and resuscitators. The device measures exhaled air from the patient and provides data that indicates the tidal volume, minute volume, and respiration rate being delivered to the patient. The patient does not inhale through the device.

This device is primarily used by Emergency Medical Technicians and has been designed to be rugged enough to reliably operate in environments encountered in emergency transport operation, including a wide range of temperatures, shock and vibration and electro-magnetic fields. The device and its parts have been designed with adequate mechanical strength so that when subjected to mechanical stress caused by normal use such as pushing, impact, dropping, and rough handling, the will device function normally and will present no potential safety hazard to the patient.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CALDYNE, Inc. EXHALOMETER™ EX100. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with all the requested information for a comprehensive acceptance criteria and study description. However, I can extract the available information to address your points.

Here's a breakdown of the acceptance criteria and available study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from "Conclusions drawn from the Non-Clinical Tests")	Reported Device Performance
Expiratory flow measurements (via bar graph) accuracy	Within ± 10% of the actual value
Digital exhalation tidal volumes accuracy	Within ± 2% of the performance curve
Digital expiration minute volumes accuracy (amount of gas exhaled during previous one-minute period)	Within ± 10% of the actual value
Displays total number of respiration per minute during the previous minute	(Implied to be accurate, but no specific numerical performance stated. This is more of a functional requirement.)
Filter Attachment Viral Filtration Efficiency (VFE)	%> 99.83% at an increased challenge
Software function	Verified to function correctly as designed and to operate the device according to design specifications and requirements.

Note: The document states that "Test data also demonstrates that the device is safe and effective and functions according to its indications for use as well as meeting the requirements of the device's design specifications." The table above reflects the specific quantitative performance metrics mentioned within the "Conclusions drawn from the Non-Clinical Tests" section.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Test data" but provides no details on the experimental setup or participants.

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

The document does not provide any information about experts used to establish ground truth or their qualifications. The testing appears to be primarily engineering or laboratory-based, focused on comparing device readings against a known standard or "actual value" (which would be considered the ground truth in this context).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of the measurements (e.g., accuracy of flow, volume), the "ground truth" would likely be established through calibrated reference instruments rather than expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with and without AI assistance. The EXHALOMETER™ EX100 is a measurement device, not an interpretive AI, so an MRMC study is not relevant here.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The testing described appears to be a standalone performance evaluation of the device's measurement capabilities. The "algorithm" here refers to the embedded software that calculates air flow values and rates. The "Conclusions drawn from the Non-Clinical Tests" section directly addresses the device's accuracy in providing these measurements.

7. The Type of Ground Truth Used

The type of ground truth used for the quantitative performance metrics (e.g., expiratory flow, tidal volume, minute volume) would almost certainly be measurements from calibrated reference instruments or standards. For the Viral Filtration Efficiency (VFE) testing, the ground truth would be established through a controlled laboratory experiment with a known challenge concentration of viruses/bacteria.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the EXHALOMETER™ EX100 is described as a device with embedded software containing algorithms for calculating air flow values, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The algorithms are likely based on physical principles and engineering formulas, not statistical learning from data.

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

As noted in point 8, there is no mention of a training set in the context of machine learning. The algorithms embedded in the device are presumed to be deterministic and derived from engineering principles. Therefore, the concept of establishing ground truth for a training set does not apply here.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2006

Caldyne, Incorporated C/O Mr. Tom Shanks MD Ventures 29201 Via Norte Palm Beach Gardens, Florida 33410

Re: K051279

Trade/Device Name: Caldyne, Incorporated Exhalometer EX100, Model EX100 Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: II Product Code: BZK, CAH Dated: September 2, 2005 Received: September 6, 2005

Dear Mr. Shanks:

This letter corrects our substantially equivalent letter of September 7, 2005.

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 (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 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.

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Page 2 - Mr. Tom Shanks

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 (OS) 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 continue 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

EXHALOMETER™ EX100

Indications for Use:

(PLEASE NO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CRDH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Over-the-Counter Use

Prescription Use
(per 21 CFR 801 109)

510(k) Number.
OR

(Optional Format 1-2-96)

0010

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K051279
SE 9/7/05

510(k) SUMMARY 4.0

In accordance with 21 CFR section 807.92, CALDYNE, Inc. is submitting the following 510(k) summary:

Submitter Information: 4.1

CALDYNE, Inc. Contact: Mark Grady, President 2425 Maryland Rd. Willow Grove, PA 19090 USA Phone Number: (215) 830-3076

FDA Registration No.: Pending Owner / Operator No .: Pending

Preparer of Submission and Contact for Information: 4.2

MD Ventures

Tom Shanks*, Principal 29201 Via Norte Temecula, CA 92591 Telephone: (951) 506-2674 Fax: (951) 506-3040

*Submission contact for correspondence and additional information.

4.3 Name of Device:

Proprietary Name:	CALDYNE Inc.'s EXHALOMETER™ EX100.
Common Name:	Respiratory Monitor or Ventilator Monitor.
Classification Name:	Monitoring Spirometer, [21 CFR 868.1850(a)].
Regulation Number:	21 CFR 868.1850(a) for Monitoring Spirometers
Product Code:	BZK
Class:	Class II (performance standards)

0012

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4.4 Substantial Equivalence:

This submission establishes the substantial equivalence of the CALDYNE, Inc. EXHALOMETER™ EX100 to two predicate devices:

The StarTrack Infant Graphics Monitor, K983274, SE letter: 12/09/98. (1)
The Newport Compass Exhaled Tidal Volume Monitor, K973314, (2) SE letter: 10/25/93.

Description of the Device: 4.5

Intended Use of the Device: 4.6

The EXHALOMETER™ EX100 is intended to measure the tidal volume, minute volume, and respiration rate being delivered to the patient. The device is primarily used by Emergency Medical Technicians during emergency transport operations and can also be used for intra-hospital transport. The device is used for accessing how well the resuscitator is functioning. In addition, the device is used for periodically checking the adequacy of the ventilation effort of patients who have initiated spontaneous The EXHALOMETER can also be used for training and developing respiration. resuscitation techniques.

Technological Characteristics in Comparison to the Predicates: 4.7

The CALDYNE, Inc. EXHALOMETER EX100 is substantial equivalent to the two predicate devices with respect to the following design characteristics and functions:

The devices are intended for the measurement and display of the patient's 1. expiratory flow, respiration rate, tidal volume, minute volume, and respiration rate.

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These devices are used for assessing resuscitator function and adequacy of 2. ventilation efforts.
1. The devices are intended for use in intra-hospital environments and patient transport.
The device housing components are fabricated from the same or similar plastic 4. resin materials used in the predicate devices. The devices use front panel LCD screens to display readings, graphics, and values as well as providing visual alarms and messages.
ട. The devices use pressure transducers and embedded software (not operator programmable) that contain algorithms for calculating air flow values and rates.

4.8 Conclusions drawn from the Non-Clinical Tests:

Data provided in this submission indicate that the basic functional characteristics of the CALDYNE. Inc. EXHALOMETER EX100 are substantially equivalent to those of the predicate devices. Test data also demonstrates that the device is safe and effective and functions according to its indications for use as well as meeting the requirements of the device's design specifications.

1. The instrument provides expiratory flow measurements (via bar graph) with accuracy of displayed parameters that are within ± 10% of the actual value.
1. The device displays digital exhalation tidal volumes in milliliters accurate within ± 2% of the performance curve.
1. The instrument displays digital expiration minute volumes (amount of gas exhaled during previous one-minute period expressed in Liters) ± 10% of the actual value. .
1. The device displays total number of respiration per minute during the previous minute
The Filter Attachment was underwent Viral Filtration Efficiency (VFE) testing ട്. and demonstrated the Filter Attachment, at an increased challenge, to be %VFE = > 99.83% and thus prevent contamination of the device by bacteria and viruses.
The software (which is embedded within the device and not programmable by റ. the user) has been verified to function correctly as designed and to operate the device according to the device design specifications and requirements.

Regulation Number and Section

§ 868.1850 Monitoring spirometer.

(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).