(108 days)
Not Found
No
The summary describes a simple extension cable and connection hub for existing medical devices, with no mention of AI/ML capabilities or data processing beyond signal transmission.
No
The device acts as an extension cable and connection hub for pacing leads and an ECG monitor, supporting existing therapeutic devices by facilitating their connection and monitoring, but it does not directly administer therapy itself.
Yes
The device supports "monitoring of intra-cardiac signals" which implies the acquisition of biological signals for diagnostic purposes, even though its primary function is an extension cable for pacing.
No
The device description explicitly states it acts as a "connection hub" and is a "sterile, single patient use device," indicating it is a physical hardware component. The performance studies also include tests for sterility, sterile barrier integrity, biocompatibility, and shelf life, which are relevant to a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The AtriAmp is described as an extension cable and connection hub that facilitates pacing and monitoring of intra-cardiac signals directly from the patient's heart. This involves direct interaction with the patient's internal anatomy and electrical signals, not the analysis of samples taken from the body.
- Intended Use: The intended use clearly states it supports pacing and monitoring of intra-cardiac signals, which are in vivo (within the living body) activities.
The device's function and intended use fall under the category of devices used for direct patient intervention and monitoring of physiological signals, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Tests were conducted to confirm compliance with performance requirements.
- ANSI/AAMI EC53:2013 compliance: The AtriAmp complies with applicable requirements of EC53:2013 and performs the same as the predicate for Subclause 5.3.2 Cable and leadwire noise. Result: Pass.
- ANSI/AAMI ES 60601-1 and IEC 60601-2-31 compliance: The AtriAmp with accessory external pacemaker interface cables complies with applicable requirements of ANSI/AAMI ES60601-1:2005 & A1:2012 and IEC 60601-2-31:2011. Result: Pass.
- ES60601-1 Subclause 8.5.2.3: In support of 21 CFR Part 898 compliance, the AtriAmp complies with ES60601-1 Subclause 8.5.2.3 Patient leads or patient cables. Result: Pass.
- Sterility: Sterilization of the subject device was validated according to ISO 11137-1:2006(R)2015 & A1:2013 & A2:2018, demonstrating the device is provided with a minimum sterility assumed level (SAL) of $10^{-6}$. Result: Pass.
- Sterile barrier integrity: The sterile barrier package is a flexible pouch. The methods applied to evaluate the sterile barrier package integrity included post terminal sterilization simulated distribution, seal peel and bubble emission testing. Result: Pass.
- Biocompatibility: The ISO 10993-5:2009 and ISO 10993-10:2020 test methods were applied, with passing results: for Cytotoxicity, Sensitization, Irritation. Result: Pass.
- Shelf life two (2) years: Confirmation of device functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096). Result: Pass.
- Duration of use: Operation use was evaluated to verify use for up to 14 days. Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
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July 1, 2020
Atrility Medical, LLC % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K200674
Trade/Device Name: AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: May 15, 2020 Received: May 15, 2020
Dear Gary Syring:
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. 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.
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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); 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200674
Device Name AtriAmp
Indications for Use (Describe)
The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Atrility Medical. The word "Atrility" is in red, with the "A" being larger than the other letters. Below "Atrility" is the word "MEDICAL" in gray, smaller font. The logo is simple and modern.
510(k) Summary
This 510(k) summary was prepared to provide an understanding of the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.
| Submitters Name: | Atrility Medical, LLC
313 Price Place, Suite #13
Madison, WI 53705 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Matthew Knoespel, Regulatory Engineer
Atrility Medical, LLC |
| Contact Phone: | Phone: 920-619-8737 |
| Date Summary Prepared: | June 22, 2020 |
| Device Trade Name: | AtriAmp |
| Common Name: | Passive interface cable to external pacemaker, epicardial pacing lead wire and
cardiac monitor |
| Classification Name: | 21 CFR 870.290 Patient transducer and electrode cable (including connector)
Product Code: DSA, Class II |
| Predicate Devices: | K080621, Fastlock Pacing Wire Extension (Primary Predicate)
K070926, Electrode/Extension Cables, Model series ATAR |
Device Description
The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device.
Intended Use of the Device
The AtriAmp is a single-use device that is intended to connect an electrode/lead from a patient to a Type CF, defibrillation-proof ECG Monitor and/or an external pacemaker.
Summary of Technological Characteristics
The following table provides a side-by-side comparison of the predicate devices applied to support this pre-market notification.
| Technical Characteristics Comparison | ||||
|---|---|---|---|---|
| Feature | AtriAmp and | |||
| Accessories | ||||
| Under Review | Fastlock Pacing | |||
| Wire Extension | ||||
| Cable | ||||
| (Primary Predicate: | ||||
| K080621) | Electrode/Extension | |||
| Cables, Model series | ||||
| ATAR | ||||
| Predicate: K070926 | Equivalence | |||
| Comments | ||||
| Product Code, | ||||
| Classification | DSA, | |||
| 21 CFR 870.2900, | ||||
| Class II | DSA, | |||
| 21 CFR 870.2900, | ||||
| Class II | IKD, | |||
| 21 CFR 890.1175 | ||||
| Class II | Identical to primary | |||
| predicate. |
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| Technical Characteristics Comparison | ||||
|---|---|---|---|---|
| Feature | AtriAmp and | |||
| Accessories | ||||
| Under Review | Fastlock Pacing | |||
| Wire Extension | ||||
| Cable | ||||
| (Primary Predicate: | ||||
| K080621) | Electrode/Extension | |||
| Cables, Model series | ||||
| ATAR | ||||
| Predicate: K070926 | Equivalence | |||
| Comments | ||||
| Indications for | ||||
| Use | The AtriAmp supports | |||
| pacing by acting as an | ||||
| extension cable between | ||||
| an external pacemaker | ||||
| and cardiac pacing | ||||
| leads. The AtriAmp also | ||||
| supports monitoring of | ||||
| intra-cardiac signals by | ||||
| transmitting signals to | ||||
| one of the unipolar | ||||
| precordial chest leads | ||||
| (leads V1-V6) of a Type | ||||
| CF, defibrillation- | ||||
| proof ECG monitor. | Fastlock pacing wire | |||
| extension cable with | ||||
| connectors is indicated | ||||
| for use as an electrical | ||||
| extension cable used to | ||||
| transmit signal from, or | ||||
| power or excitation | ||||
| signal to patient- | ||||
| connected electrodes. | Electrode/extension | |||
| cable is intended to | ||||
| connect an | ||||
| electrode/lead from a | ||||
| patient or another | ||||
| cable to a diagnostic | ||||
| machine or an | ||||
| external pacemaker. | Equivalent | |||
| The same as the | ||||
| predicate devices, the | ||||
| AtriAmp interfaces | ||||
| between an external | ||||
| pacemaker and patient | ||||
| applied intra-cardiac | ||||
| pacing lead wires. | ||||
| Equivalent to the | ||||
| secondary predicate, the | ||||
| AtriAmp interfaces the | ||||
| signal from the | ||||
| epicardial lead wires to | ||||
| a, defibrillation-proof | ||||
| ECG Monitor, one of | ||||
| the leads (V1 to V6) of | ||||
| an ECG monitor. | ||||
| Duration of | ||||
| use | Anticipated to be less | |||
| than 14 days |