Cardiac Trigger Monitor

K202138 · Ivy Biomedical Systems, Inc. · DRT · May 14, 2021 · Cardiovascular

Device Facts

• Record ID: K202138
• Device Name: Cardiac Trigger Monitor
• Applicant: Ivy Biomedical Systems, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: May 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse output used by a third-party ablation and lithotripsy systems.

Device Story

The 7600EP/7800EP Cardiac Synchronization Monitor functions as a cardiac monitor that captures ECG signals from a patient. It processes these signals to identify specific cardiac cycle timing and generates a cardiac trigger pulse output. This output is transmitted to third-party diagnostic imaging systems (e.g., CT, PET, nuclear medicine) or therapeutic systems (e.g., ablation, lithotripsy) to synchronize their operation with the patient's heart cycle. The device is intended for use in clinical settings by healthcare professionals. By providing precise synchronization, the device enables imaging or therapeutic systems to function in coordination with the patient's cardiac activity, potentially improving the quality of diagnostic images or the accuracy of therapeutic interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cardiac monitor providing trigger pulse outputs for external imaging and therapeutic systems. Operates as a standalone monitor. Technical details regarding materials, specific sensing principles, or software architecture are not provided in the source document.

Indications for Use

Indicated for patients requiring ECG-synchronized cardiac trigger pulse outputs for diagnostic imaging (nuclear medicine, CAT, PET) or therapeutic procedures (ablation, lithotripsy). Prescription use only.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

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May 14, 2021

Ivy Biomedical Systems, Inc. Alejandra Aceves Regulatory Manager 11 Business Park Drive Branford, Connecticut 06405

Re: K202138

Trade/Device Name: Cardiac Trigger Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: DRT Dated: April 5, 2021 Received: April 12, 2021

Dear Alejandra Aceves:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K202138

Device Name

7600EP, 7800EP Cardiac Synchronization Monitor

## Indications for Use (Describe)

The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse output used by a third-party ablation and lithotripsy systems.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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