The EDAC™ QUANTIFIER is a standalone system in which the ultrasonic sensing system consists of a three-channel ultrasonic pulser-receiver unit, a touchpanel computer, ultrasound transducers and clamps for attached the transducers to the circuit. This system is currently being certified according to voluntary medical device safety standards UL 60601-1 . IEC 60601-1-2 and IEC 60601-1-4, covering electrical device safety in medical products and IEC-60601-2-37, covering ultrasonic diagnostic safety. It also employs software and firmware to provide the embedded signal processing needed to detect gas emboli over the range of sizes described.

AI/ML Overview

The EDAC™ QUANTIFIER is an ultrasonic cardiopulmonary bypass bubble detector. The study validates the device's ability to detect gaseous emboli in an extracorporeal bypass circuit.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it describes "performance claims" and then details the testing conducted to validate these claims. Based on the "Technological Characteristics Comparison Summary" and the "Non-clinical Testing" section, the following can be inferred as the performance claims (which act as acceptance criteria) and the reported performance.

Acceptance Criteria (Performance Claim)	Reported Device Performance
Detection Sensitivity: Detect microemboli at least 10 microns in diameter.	Detect emboli from 10 microns in diameter up to the diameter of the EDAC™ QUANTIFIER connector (1/2" dia.).
Detection Rate: Provide count rates up to at least 1000/sec.	Provides counts rates up to at least 1000/sec.
Monitoring Locations: Monitor gas emboli at multiple locations on the bypass circuit.	Up to three simultaneously measured locations.
Tubing Compatibility: Compatible with various common arterial tubing sizes.	Sensors are clamped to polycarbonate connectors for insertion into tubing with inner diameters of 1/4", 3/8", and 1/2".
Fluid Compatibility: Detect gas emboli in clear fluid and blood of all physiologic hematocrits.	Performance validated using a 28% glycerin solution to mimic blood, canine blood, and a crystalloid solution.
Operational Duration: Ability to operate over a full 6-hour surgery.	Tests performed to validate functional claims such as the ability to operate over a full 6-hour surgery.
Flow Rate: Operate effectively within a specified flow rate range.	2.0 L/minute - 6.0 L/minute.
Data Provided: Real-time and/or archive data for various parameters.	Provides: Detected emboli tracks (Time vs. Range), COUNT (1-second interval), ESTIMATE volume (1-second interval), SUM (total/average counts & volumes), CHART (1-second count/volume for 5 minutes), User-adjustable alarm/warning, Size distributions into user-selected bins, Embolic load per time interval.

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

Sample Size: Not explicitly stated. The document mentions "extensive non-clinical testing" and refers to a "System Test Plan (Attachment 5.7)" which would contain specific details, but this attachment is not provided.
Data Provenance: The testing was conducted in a laboratory setting.
- Country of Origin: Not explicitly stated, but the parent company (Luna Innovations Inc.) is based in Blacksburg, Virginia, USA.
- Retrospective or Prospective: Prospective, as the tests were performed specifically to validate the device's performance before marketing.

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

This information is not provided. The testing appears to be based on engineering and scientific measurements of bubble detection and sizing, rather than human interpretation of data for ground truth.

4. Adjudication method for the test set:

Not applicable. The ground truth appears to be based on controlled experimental conditions and expected physical phenomena of bubble generation and detection, not on expert consensus or adjudication.

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 device is a standalone bubble detector, not an AI-assisted diagnostic tool that human readers would interpret. Its primary function is automated detection, not to improve human reader performance.

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

Yes, a standalone study was performed. The non-clinical testing was conducted to evaluate the EDAC™ QUANTIFIER's performance as a "standalone accessory," focusing on its ultrasonic sensing system and embedded signal processing. The device is designed to detect gas emboli automatically.

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

The ground truth for the non-clinical testing was established through controlled laboratory conditions using:

Standardized fluid mimics (28% glycerin solution to mimic blood).
Biological fluids (canine blood).
Common medical solutions (crystalloid solution used to prime bypass circuits).
Presumably, controlled introduction of known sizes and quantities of gaseous emboli into these systems, with measurement of the device's ability to accurately detect and quantify them. The "System Test Plan (Attachment 5.7)" would detail the precise methodology for generating and verifying these "ground truth" emboli.

8. The sample size for the training set:

Not applicable. This device is an ultrasonic sensor with embedded signal processing, not a machine learning or AI model that requires a "training set" in the conventional sense. Its "training" would be more akin to software and firmware development and calibration based on known physical principles and experimental validation.

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

Not applicable, as there is no traditional "training set" in the context of machine learning. The device's operational parameters and signal processing algorithms would have been developed and calibrated based on engineering principles and experimental data derived from various types and sizes of bubbles in different fluid environments, but this is not typically referred to as a "training set" for ground truth establishment in this type of device.

Summary

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K071231/
Page 1 of 3

510(k) Premarket Notification Submission (Traditional) EDACTM QUANTIFIER Luna Innovations Inc. Confidential

1 510(k) Summary

MAY 17 2007

Date of Submission:

April 5, 2007

Owner Information:

Luna Innovations Incorporated 3157 State Street Blacksburg, Virginia 24060 (540) 552-5128 (main phone) (540)951-0760 (fax) Contact Person: Kristine Richardson, (540) 557-5735 (direct dial)

Device Name:

Trade Name: EDAC™ QUANTIFIER Common Name: Ultrasonic Cardiopulmonary Bypass Bubble Detector Classification Name: Cardiopulmonary Bypass Bubble Detector (21 CFR 870.4205, Product Code: KRL)

The new EDAC™ QUANTIFIER is a device with the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line. It is substantially equivalent to the Sams Ultrasonic Air Sensor that was cleared for marketing by the FDA following review of Sams' 510(k) submission K940651.

Both the EDAC™ QUANTIFIER and Sarns Ultrasonic Air Sensor use ultrasound detection modality and therefore detect gas emboli in clear fluid and blood of all physiologic hematocrits. The Sams Ultrasonic Air Sensor is indicated for detecting gross air emboli in the arterial return line of the cardiopulmonary bypass circuit. The EDAC™ OUANTIFIER is an improvement over the Sarns Ultrasonic Air Sensor in two key respects. The improved detection sensitivity of the EDAC™ QUANTIFIER allows for monitoring of microemboli at least 10 microns in diameter in addition to gross gas detection, while the multi-channel design allows for simultaneous monitoring of gas emboli at multiple locations on the bypass circuit.

Technological Characteristics Comparison Summary
Characteristic	Predicate Device:Sarns Ultrasonic Air Sensor	New Device:EDACTM QUANTIFIER
Indications	Detection of gross air bubbles inthe line during extracorporealprocedures.	Detection of gaseous emboli inan extracorporeal bypass circuitline.
Contraindications	Use only as indicated.	Use only as indicated. Shouldnot be used in procedures lastinggreater than 6 hours.
DetectionModality	Through-transmission ultrasound(2 MHz)	Pulse-echo ultrasound(4 MHz)
Technological Characteristics Comparison Summary
Characteristic	Predicate Device:Sarns Ultrasonic Air Sensor	New Device:EDAC™ QUANTIFIER
Monitoring locations	One	Up to three simultaneouslymeasured locations.
Arterial tubing	PVC, 3/8" x 3/32"PVC, 1/4" x 3/32"PVC, 1/4" x 1/16"	Sensors are clamped topolycarbonate connectorsinserted into tubing. Theconnectors are available forinsertion into tubing with innerdiameters of 1/4", 3/8" and 1/2".
Sensitivity range	0.5 cc for 3/8" sensor0.3 cc for 1/4" sensor	Detect emboli from 10 micronsin diameter up to the diameter ofthe EDACTM QUANTIFIERconnector (1/2" dia.).Provides counts rates up to atleast 1000/sec.
Data Provided	Real-Time On/Off alarm	Data provided for Real-timeand/or Archive data of thefollowing:Detected emboli tracks on a mapwith Time (x-axis) andRange (y-axis).COUNT emboli detections in themost recent 1-secondinterval.ESTIMATE volume of embolidetections in the most recent1-second interval.SUM all counts and volumesdetected during ameasurement session toprovide total and averagecounts and volumes.CHART the 1-second count rateand volume for the last 5minutes.User-adjustable count andvolume alarm and warningsettings.Provide size distributions for apopulation of gaseous emboliinto sizing bins of a user-selected width.Embolic load per time interval
Technological Characteristics Comparison Summary
Characteristic	Predicate Device:Sarns Ultrasonic Air Sensor	New Device:EDACTM QUANTIFIER
Flow rate	Max. of 6.0 L/min for 3/8"sensorMax. of 3.0 L/min for 1/4"sensor	2.0 L/minute - 6.0 L/minute
Company CatalogReferences	Sarns 5773, Sarns 5791, Sarns5785	EDACTM QUANTIFIER

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KC71231
Page 3 of 3

510(k) Premarket Notification Submission (Traditional)

EDAC™ QUANTIFIER Luna Innovations Inc. Confidential

Intertek ref. 500008236

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KC71231
Page 3 of 3

510(k) Premarket Notification Submission (Traditional) EDACTM QUANTIFIER Luna Innovations Inc. Confidential

Luna Innovations Incorporated will ensure that the EDAC™ QUANTIFIER will not be marketed for clinical use until certified to the above referenced voluntary safety standards.

The EDAC™ QUANTIFIER also employs a sterile, disposable connector that is inserted into the bypass circuit. Safety data and engineering drawings for the connector, which is a repackaged version of a 510(k) cleared connector used for oxygen saturation monitoring, is provided.

Finally, Luna has performed extensive non-clinical testing to conclude the effectiveness of the EDACTM QUANTIFIER. Performance claims were validated on a laboratory circuit using a 28% glycerin solution to mimic the properties of blood, and on a closed loop bypass circuit using canine blood for some tests and a crystalloid solution commonly used to prime bypass circuits prior to surgery for others. Additional tests were also performed to validate functional claims such as the ability to operate over a full 6hour surgery. The test results show that the EDAC™ QUANTIFER performs as claimed for its intended use. The tests were performed according to accepted scientific standards, as fully outlined in the System Test Plan (Attachment 5.7), and therefore substantiate the equivalence of the EDAC™ QUANTIFIER to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2007

Intertek Testing Services NA, Inc. c/o Mr. Daniel W. Lehtonen Responsible Third Party Official 2307 East Aurora Road, Unit B7 Twinsburg, OH 44037

Re: K071231

Edac™ Quantifier Regulation Number: 21 CFR 870.4205 Regulation Name: Cardiopulmonary Bypass Bubble Detector Regulatory Class: Class II Product Code: KRL Dated: May 2, 2007 Received: May 3, 2007

Dear Mr. Lehtonen:

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.

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Page 2 - Mr. Daniel W. Lehtonen

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. 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: _EDAC™ QUANTIFIER

Indications for Use:

The EDAC™ QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.

Prescription Use X (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)

Duna R. Vorhnes
(Division Sign-Off)

Division of Cigh Oil)
Division of Cardiovascular Devices

510(k) Number_K07 |231

Page 1 of /

(Posted November 13, 2003)

Intertek ref. 500008236

Regulation Number and Section

§ 870.4205 Cardiopulmonary bypass bubble detector.

(a)
Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).