The Medtronic Model 5492A, 5492V, 5492AL, 5492VL patient cables are intended for use as part of a temporary cardiac pacing system. They connect atrial and ventricular pacing lead systems to a temporary external pacemaker. They are intended for use by trained clinicians in a clinical environment. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular stimulating instruments.

The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with:

Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long.
Medtronic cardiovascular stimulating instruments.

Device Description

The 5492 A-V Patient Cables are reusable patient cables that are designed to connect a temporary pacemaker to atrial and ventricular pacing lead systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables. These are reusable patient cables intended to connect atrial and ventricular pacing lead systems to a temporary external pacemaker. The submission asserts substantial equivalence to a predicate device, the Medtronic Model 5487/5487L Disposable Patient Cables (K960446).

However, the document does not contain specific acceptance criteria values or detailed performance data from a study that proves the device meets those criteria. It lists the types of tests performed (Sterilization, Biocompatibility, Electrical Safety, and Performance Testing - Bench) and concludes that the device is substantially equivalent, but it does not provide the results of these tests in a way that allows for a table of acceptance criteria vs. reported performance.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific numerical targets or the reported performance data against those targets. It only states that the following tests were completed:

Sterilization
Biocompatibility
Electrical Safety
Performance Testing (Bench)

The "Conclusion" section broadly states that "Medtronic has demonstrated that the 5492 A-V Patient Cables described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are substantially equivalent from the predicate device." This implies the device met the criteria outlined in these tests, but the specific criteria and results are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text only mentions "bench tests" were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes a medical device (patient cables) and its physical/electrical performance, not an AI or diagnostic imaging device that requires expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reason as point 3.

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

This information is not applicable as the document is about patient cables, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a patient cable, not an algorithm.

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

This information is not applicable as the device is a patient cable, not a diagnostic tool requiring ground truth for clinical interpretation. The "ground truth" for performance would be established by engineering and safety standards, but the specifics are not detailed.

8. The sample size for the training set

This information is not applicable as the device is a patient cable, not a machine learning model.

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

This information is not applicable as the device is a patient cable, not a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

July 12, 2021

Medtronic, Inc. Alexandra Theisen Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K203556

Trade/Device Name: Medtronic Model 5492A. 5492V. 5492AL. 5492VL Patient Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: June 14, 2021 Received: June 15, 2021

Dear Alexandra Theisen:

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.

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

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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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Hetal Odobasic 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)

K203556

Device Name

Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables

Indications for Use (Describe)

The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with: · Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long.

· Medtronic cardiovascular stimulating instruments.

Type of Use (Select one or both, as applicable)	Remediation Use (Part 21 CFR 601 Subpart D) Same Therapeutic Context Use (21 CFR 601 Subpart C)	Remediation Use (Part 21 CFR 601 Subpart D)	Same Therapeutic Context Use (21 CFR 601 Subpart C)
Remediation Use (Part 21 CFR 601 Subpart D)
Same Therapeutic Context Use (21 CFR 601 Subpart C)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: December 04, 2020

General Information
Trade Name	Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
Common Name	Patient cable
Product Code	DSA
Classification	II
Regulation Number	21 CFR 870.2900
Panel	Cardiovascular
Predicate Device	Medtronic Model 5487/5487L Disposable Patient Cables K960446
Submitter	Medtronic, Inc.Cardiac Rhythm Management8200 Coral Sea StreetMounds View, MN 55112
Contact Person	Primary ContactAlexandra TheisenSenior Regulatory Affairs Specialistalexandra.r.theisen@medtronic.comTel: 763.526.6758 (direct)Fax: 651.367.0603	Alternate ContactWendy SaundersRegulatory Affairs Directorwendy.a.saunders@medtronic.comTel: 763.526.8134 (direct)Fax: 651.367.0603

Brief Device Description

The 5492 A-V Patient Cables are reusable patient cables that are designed to connect a temporary pacemaker to atrial and ventricular pacing lead systems.

Indications for Use

The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with:

. Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long.
Medtronic cardiovascular stimulating instruments. ●

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Technological Characteristics

Intended use, design, performance and technological characteristics are substantially equivalent to the predicate devices referenced.

When compared to the predicate device (K960446), the 5492 A-V Patient Cables presented in this submission have similar:

o Intended use/indications for use
Operating principle ●
Design features ●
Device functionality .

The 5492 A-V Patient Cables and the predicate device differ in the following:

Usage (i.e. reusable versus disposable) ●
Sterility (i.e. supplied non-sterile versus supplied sterile) ●

Substantial Equivalence and Summary of Studies:

Technological differences between the subject and predicate devices have been evaluated through bench tests. The following test data provided in this Traditional 510(k) submission has been completed:

Sterilization (reference Sterilization)
Biocompatibility (reference Biocompatibility) ●
o Electrical Safety (reference EMC and Electrical Safety)
o Performance Testing (reference Performance Testing - Bench)

Conclusion

Medtronic has demonstrated that the 5492 A-V Patient Cables described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are substantially equivalent from the predicate device.

Regulation Number and Section

§ 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).