(14 days)
Not Found
No
The summary describes "embedded signal processing" but does not mention AI, ML, or related terms, nor does it describe training or test sets typical of AI/ML development.
No
The device is intended to detect gaseous emboli, not to treat a condition or disease.
Yes
The device is intended to "detect gaseous emboli in an extracorporeal bypass circuit line," which is a process of identifying a specific condition (gaseous emboli) within a system (extracorporeal bypass circuit line). This act of detection for a medical purpose aligns with the definition of a diagnostic device. Additionally, the device brief states it is being certified according to IEC-60601-2-37, which covers "ultrasonic diagnostic safety."
No
The device description explicitly states it includes hardware components such as an ultrasonic pulser-receiver unit, a touchpanel computer, ultrasound transducers, and clamps. While it also employs software and firmware, it is not solely software.
Based on the provided information, the EDAC™ QUANTIFIER is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "detect gaseous emboli in an extracorporeal bypass circuit line." This involves monitoring a process happening outside the body (extracorporeal) within a medical circuit.
- Mechanism: The device uses ultrasound to detect gas bubbles within the fluid flowing through the circuit. This is a physical detection method, not a test performed on a biological sample in vitro (in glass or outside the living organism).
- Anatomical Site: The anatomical site is the "Extracorporeal bypass circuit line," which is a medical device component, not a part of the human body where a biological sample would be taken.
IVDs are typically used to examine biological samples (like blood, urine, tissue) to diagnose diseases, monitor health, or determine treatment. The EDAC™ QUANTIFIER is monitoring the integrity of a medical circuit during a procedure.
N/A
Intended Use / Indications for Use
The EDAC™ QUANTIFIER is a device with the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.
The EDAC™ QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.
Product codes (comma separated list FDA assigned to the subject device)
KRL
Device Description
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulse-echo ultrasound (4 MHz)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity range: Detect emboli from 10 microns in diameter up to the diameter of the EDACTM QUANTIFIER connector (1/2" dia.). Provides counts rates up to at least 1000/sec.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 in | |
| the line during extracorporeal | ||
| procedures. | Detection of gaseous emboli in | |
| an extracorporeal bypass circuit | ||
| line. | ||
| Contraindications | Use only as indicated. | Use only as indicated. Should |
| not be used in procedures lasting | ||
| greater than 6 hours. | ||
| Detection | ||
| Modality | 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 simultaneously |
| measured locations. | ||
| Arterial tubing | PVC, 3/8" x 3/32" | |
| PVC, 1/4" x 3/32" | ||
| PVC, 1/4" x 1/16" | Sensors are clamped to | |
| polycarbonate connectors | ||
| inserted into tubing. The | ||
| connectors are available for | ||
| insertion into tubing with inner | ||
| diameters of 1/4", 3/8" and 1/2". | ||
| Sensitivity range | 0.5 cc for 3/8" sensor | |
| 0.3 cc for 1/4" sensor | Detect emboli from 10 microns | |
| in diameter up to the diameter of | ||
| the EDACTM QUANTIFIER | ||
| connector (1/2" dia.). | ||
| Provides counts rates up to at | ||
| least 1000/sec. | ||
| Data Provided | Real-Time On/Off alarm | Data provided for Real-time |
| and/or Archive data of the | ||
| following: | ||
| Detected emboli tracks on a map | ||
| with Time (x-axis) and | ||
| Range (y-axis). | ||
| COUNT emboli detections in the | ||
| most recent 1-second | ||
| interval. | ||
| ESTIMATE volume of emboli | ||
| detections in the most recent | ||
| 1-second interval. | ||
| SUM all counts and volumes | ||
| detected during a | ||
| measurement session to | ||
| provide total and average | ||
| counts and volumes. | ||
| CHART the 1-second count rate | ||
| and volume for the last 5 | ||
| minutes. | ||
| User-adjustable count and | ||
| volume alarm and warning | ||
| settings. | ||
| Provide size distributions for a | ||
| population of gaseous emboli | ||
| into 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" | |
| sensor | ||
| Max. of 3.0 L/min for 1/4" | ||
| sensor | 2.0 L/minute - 6.0 L/minute | |
| Company Catalog | ||
| References | Sarns 5773, Sarns 5791, Sarns | |
| 5785 | EDACTM QUANTIFIER |
1
KC71231
Page 3 of 3
510(k) Premarket Notification Submission (Traditional)
EDAC™ QUANTIFIER Luna Innovations Inc. Confidential
Intertek ref. 500008236
2
KC71231
Page 3 of 3
510(k) Premarket Notification Submission (Traditional) EDACTM QUANTIFIER Luna Innovations Inc. Confidential
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. A complete description of our software documentation and quality assurance procedures is provided as an attachment to this application.
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.
3
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.
4
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
5
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