(72 days)
Because there is no "Predicate Device(s) K/DEN number" in the text, I will state "Not Found".
Not Found
No
The description focuses on signal processing techniques (filtering based on correlation) to remove CPR artifact from the ECG signal, which is a traditional signal processing method, not AI/ML. There is no mention of AI, ML, or related terms in the document.
Yes.
The device is used for defibrillation and ECG monitoring to evaluate a patient's heart rhythm, which are medical treatments or diagnostics.
Yes
The device is described as acquiring and analyzing an adult or pediatric patient's ECG signal to detect a shockable rhythm and evaluate the patient's heart rate or ECG morphology, which are diagnostic functions.
No
The device description clearly states it is a "portable, battery powered automated external defibrillator (AED)" and mentions hardware components like electrodes (ZOLL CPR-D•padz™ electrodes) and an LCD screen. It also describes the device acquiring and analyzing an ECG signal, which requires hardware input.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an automated external defibrillator (AED) used for defibrillation and ECG monitoring. It analyzes the patient's ECG signal (electrical activity of the heart) directly from electrodes placed on the body.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
The device is a therapeutic and monitoring device that interacts directly with the patient's body, not with samples taken from the body.
N/A
Intended Use / Indications for Use
The functionality (See-Thru CPR) being added to the ZOLL AEDPRO uses a filter to help remove the artifact from the ECG signal.
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by:
- Unconsciousness
- Absence of breathing, and
- Absence of pulse and other signs of circulation
When the victim is less than 8 years old or weighs less than 55 lb. (25kg), use 20LL pedi-padz® Il pediatric When the victim is less than o years one of weight food than bo 121 (2005), we shart age or weight.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
Product codes
MKJ
Device Description
The ZOLL AEDPRO with See-Thru CPR enables the user to see a close approximation of the patient's underlying ECG rhythm while performing CPR in conjunction with ZOLL CPR-D•padz™ electrodes in manual mode.
The ZOLL AEDPRO® with See-Thru CPR™ is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AEDPRO acquires and andlyzes an adult or attemption is but nation fessue. "The AcDerico acquires and recommends of poulatio pation o EOG Signal and, if a shockable migri recommends delivery of a defibrillation shock via voice and visual prompts.
See-Thru CPR uses a filter that relies on the correlation between CPR compressions, as detected by the ZOLL CPR-Dypadz electrodes, and the CPR artifact to remove CPR artifact to remove CPR related antiact from the ECG signal. See-Thru CPR filtering continues as long as the CPR-Drom the Lock agains. See-Thu OFF illiening communism are detected, filtering stops, unfiltered ECG signals are displayed, and the unit removes the CPR FLTR message from the LCD screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device is indicated for use on victims of cardiac arrest. When the victim is less than 8 years old or weighs less than 55 lb. (25kg), use ZOLL pedi-padz® II pediatric electrodes.
Monitoring function is not intended for use on patients under 8 years of age.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive performance testing ensures that the ZOLL AEDPRO with See-Thru CPR performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications.
Functional testing of the device's features and functions was conducted to ensure that the modifications to the software did not degrade or impact other product features, functions or performance specifications.
Conclusion
Testing of the ZOLL AEDPRO with See-Thru CPR demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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07/025 pg 1 of 2
ZOLL Medical Corporation
Worldwide Headquarters 269 Mill Road Chelmsford, Massachusetts 01824-4105 U.S.A.
978 421-9655
978 421-0025 Main Fax
JUN 2 2 2007
Image /page/0/Picture/5 description: The image shows the logo for ZOLL Medical Corporation. The logo consists of the word "ZOLL" in large, bold, black letters. Below the company name is the tagline "Advancing Resuscitation. Today.", and below the tagline is a curved line.
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Eileen M. Boyle (978) 421-9655, Ext. 9171
Date Summary Prepared:
February 14, 2007
Device:
ZOLL AEDPRO® with See-Thru CPR™
Classification:
Defibrillator, Low-energy - DC: Class II (21 CFR 870.5300)
Automatic External Defibrillators have been considered Class III devices by FDA.
Cardiac Monitors (including Cardiotachometers and Rate alarms): Class II (21 CFR 870.2300)
Description:
The ZOLL AEDPRO with See-Thru CPR enables the user to see a close approximation of the patient's underlying ECG rhythm while performing CPR in conjunction with ZOLL CPR-D•padz™ electrodes in manual mode.
The ZOLL AEDPRO® with See-Thru CPR™ is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AEDPRO acquires and andlyzes an adult or attemption is but nation fessue. "The AcDerico acquires and recommends of poulatio pation o EOG Signal and, if a shockable migri
recommends delivery of a defibrillation shock via voice and visual prompts.
See-Thru CPR uses a filter that relies on the correlation between CPR compressions, as detected by the ZOLL CPR-Dypadz electrodes, and the CPR artifact to remove CPR artifact to remove CPR related antiact from the ECG signal. See-Thru CPR filtering continues as long as the CPR-Drom the Lock agains. See-Thu OFF illiening communism are detected, filtering stops, unfiltered ECG signals are displayed, and the unit removes the CPR FLTR message from the LCD screen.
1
K071025 pg 2 of 2
Intended Use:
The functionality (See-Thru CPR) being added to the ZOLL AEDPRO uses a filter to help remove the artifact from the ECG signal.
Substantial Equivalence:
The features and functions of the ZOLL AEDPRO with See-Thru CPR are identical to other ZOLL Defibrillators equipped with this technology.
Comparison of Technological Characteristics
The ZOLL AEDPRO with See-Thru CPR uses a filter that relies on the correlation between the CPR compressions, as detected by the ZOLL CPR-Drpadz electrodes, and the ECG signal to remove CPR related artifact from the ECG signal.
Performance Testing:
Extensive performance testing ensures that the ZOLL AEDPRO with See-Thru CPR performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications.
Functional testing of the device's features and functions was conducted to ensure that the modifications to the software did not degrade or impact other product features, functions or performance specifications.
Conclusion
Testing of the ZOLL AEDPRO with See-Thru CPR demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ZOLL Medical Corporation c/o Ms. Eileen M. Boyle Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824-4105
JUN 2 2 2007
Re: K071025
Trade Name: ZOLL AEDPO® with See-Thru CPR™ Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: April 13, 2007 Received: May 22, 2007
Dear Ms. Boyle:
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.
3
Page 2 - Ms. Eileen M. Boyle
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 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,
Blymmma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use
510(k) Number (if known): K071025
ZOLL AEDPRO® with See-Thru CPR™ Device Name:
Indications for use
Indications for use
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by:
- . Unconsciousness
- . Absence of breathing, and
- Absence of pulse and other signs of circulation
When the victim is less than 8 years old or weighs less than 55 lb. (25kg), use 20LL pedi-padz® Il pediatric When the victim is less than o years one of weight food than bo 121 (2005), we shart age or weight.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
Contraindications for Use
Defibrillation
َ Never use the AEDPRO unit for defibrillation when the patient:
ls conscious s breathing, or Has a detectable pulse or other sign of circulation
Nonitoring
f monitoring function is not intended for use on patients under 8 years of age.
801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
ffice of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071025