The Affinity Medical Patient Cable Systems are intended to transmit data in the form of electrocardiographic signals from patient ECG electrode pads to ECG monitors.

Device Description

The Affinity Cable and Leadwire System includes ECG cables, individual leadwires, and accessories. The Affinity Cable and Leadwire System is based upon proven designs to assure secure connections for patient safety and operator ease of use. The Affinity Cable and Leadwire System is reusable and is designed and tested to conform to the following standards: ANSI/AAMI EC53-1995 and 21 CFR Part 898.

The Affinity Cable and Leadwire System is manufactured of materials with a proven history of use for ECG cables. The Affinity Cable and Leadwire System contains no latex or latex products which are external and exposed to the patient.

The Affinity Cable and Leadwire System is provided non-sterile.

The Affinity Cable and Leadwire System is designed to minimize the potential for incorrect attachments. Leadwires are color coded for positive identification. Leadwire connectors include recessed sockets to preclude attachment to power cables or outlets.

AI/ML Overview

The provided text describes the regulatory clearance for the "Affinity Medical Patient Cable Systems" (K980806) and states that it is substantially equivalent to a predicate device, the "Tronomate™ Patient Cable and Leadwire System" (K952659).

However, the documentation provided does not contain information about specific acceptance criteria or a dedicated study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission relies on the concept of substantial equivalence to a predicate device and adherence to recognized standards.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as performance metrics in the document, but rather design and standards adherence)	Reported Device Performance (As implied by substantial equivalence and standards)
Conformity to ANSI/AAMI EC53-1995 (ECG Cable and Leadwires)	The device is designed and tested to conform to ANSI/AAMI EC53-1995. This implies it meets the electrical, mechanical, and safety requirements specified in that standard.
Conformity to 21 CFR Part 898 (Performance Standards for Diagnostic Devices)	The device is designed and tested to conform to 21 CFR Part 898 (though 898 specifically refers to Mammography Quality Standards - this might be a typo in the original document as it's for an ECG cable given the general context of ECG and the product code 74DSA which is for 'Cable, transducer and electrode, patient').
Secure connections for patient safety	Demonstrated through proven designs and testing based on the predicate device and standards.
Operator ease of use	Demonstrated through proven designs and testing based on the predicate device and standards.
Reusability	Stated as a characteristic of the device.
No external latex or latex products	Stated as a material characteristic.
Minimization of incorrect attachments	Achieved through color coding and recessed sockets.
Same technological characteristics (design, material composition) as predicate	Stated explicitly as a basis for substantial equivalence.
Intended Use: Transmit electrocardiograph signals from patient ECG electrode pads to ECG monitors.	The device meets this intended use, as cleared by the FDA based on substantial equivalence.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document does not describe a clinical or performance study with a 'test set' in the conventional sense of evaluating a diagnostic algorithm. The testing mentioned appears to be related to engineering design verification and validation against standards, not patient data analysis.
Data Provenance: Not applicable, as no clinical data test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

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

No. This is an ECG cable system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

No. This is an ECG cable system, which is a passive device for signal transmission. It does not involve algorithms or human-in-the-loop performance that would require such a study.

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

Not applicable in the context of a performance study evaluating diagnostic accuracy. The "ground truth" here is adherence to engineering standards (ANSI/AAMI EC53-1995, 21 CFR Part 898) and functional equivalence to the predicate device.

8. The sample size for the training set

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

Summary of Device Acceptance:

The Affinity Medical Patient Cable Systems were accepted for market clearance based on substantial equivalence (SE) to a legally marketed predicate device (Tronomate™ Patient Cable and Leadwire System, K952659) and through demonstrating conformity to applicable performance standards (ANSI/AAMI EC53-1995 and 21 CFR Part 898). The submission focuses on design, material composition, and adherence to safety and performance standards for medical cables, rather than clinical performance metrics from a typical diagnostic algorithm study. The device's function is to reliably transmit ECG signals, and its acceptance criteria are primarily related to its physical and electrical properties ensuring that function, patient safety, and compatibility with monitors, as dictated by the predicate device and relevant standards.

Summary

{0}------------------------------------------------

K980806

AFFINITY

510(k) Summarv Prepared 3/17/98

MAR 25 1998

1. Manufacturer: Affinity Medical Technologies, LLC 17332 Von Karman, Suite 115 Irvine, CA 92614 714-477-9495 Contact: Mary F. Phillipp
1. Trade Name: Affinity Medical Patient Cable Systems Common Name: Patient Cable Icable, transducer and electrode, patient (including connector)]

Classification: Class II 74DSA (CFR 870.2900)

1. Predicate Device: This device is substantially equivalent to the Tronomate™ Patient Cable and Leadwire System (K952659).
1. Description: The Affinity Cable and Leadwire System includes ECG cables, individual leadwires, and accessories. The Affinity Cable and Leadwire System is based upon proven designs to assure secure connections for patient safety and operator ease of use. The Affinity Cable and Leadwire System is reusable and is designed and tested to conform to the following standards: ANSI/AAMI EC53-1995 and 21 CFR Part 898.

The Affinity Cable and Leadwire System is provided non-sterile.

ട. Intended Use: The Affinity Cable and Leadwire System is intended transmit data in the form of electrocardiograph signals from patient ECG electrode pads to ECG monitors.
1. 1. Comparison to Predicate Device: This device has the same technological characteristics (i.e., design, material composition) as the Tronomate™ Patient Cable and Leadwire System (K952659). Further, the Affinity Medical Patient Cable Systems are designed and tested in accordance with ANSI/AAMI EC53-1995, ECG Cable and Leadwires.

Attachment VII

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1998

Ms. Mary F. Phillipp Affinity Medical Technologies, LLC 17332 Von Karman, Suite 115 Irvine, CA 92614

Re: K980806 Affinity Medical Patient Cable Systems Regulatory Class: II (two) Product Code: 74 DRX February 27, 1998 Dated: March 3, 1998 Received:

Dear Ms. Phillipp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21.CER.Part 820) and that, through periodic (QS) = inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Ms. Mary F. Phillipp

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

"Indications For Use" Statement

Unknown 510(k) Number:

Affinity Medical Patient Cable Systems Device Names:

Indications for Use: The Affinity Medical Patient Cable Systems are intended to transmit data in the form of electrocardiographic signals from patient ECG electrode pads to ECG monitors.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-counter Use
------------------------------------------	----	----------------------

Optional Format 1-2-96
------------------------

3/24/98 C. Casey R. W. Saperstein
(Division Sign-Off)

Division of Card and Neurological D 510(k) Number

Attachment I

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).