The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.

The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

Device Description

PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A

AI/ML Overview

The provided text is a 510(k) Summary for St. Jude Medical PSA Cables and Adapters. It primarily focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a study related to acceptance criteria and device performance in the context of an AI/ML medical device.

Therefore, the requested information elements related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not present in this document.

The document does not detail specific acceptance criteria for performance metrics that would be relevant to an AI/ML system, nor does it describe a study to prove such criteria were met. Instead, it attests to the substantial equivalence of the new devices (PSA cables and adapter) to previously approved devices based on their intended use and design, as per the 510(k) premarket notification process for conventional medical devices.

Here's what can be extracted and what cannot:

Table of acceptance criteria and reported device performance: This information is not provided in the context of performance metrics that would typically apply to an AI/ML device (e.g., sensitivity, specificity, AUC). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no such performance study for an AI/ML model is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of cardiac pacing system cables and adapters through the 510(k) pathway, which primarily relies on demonstrating substantial equivalence to predicate devices, not on the performance evaluation of an AI/ML algorithm against specific acceptance criteria.

Summary

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PREMARKET NOTIFICATION [510(K)] SUMMARY

Date Prepared:

March 30, 2010

Sylmar, CA 91342

St. Jude Medical, CRMD 15900 Valley View Court APR - 2 2010

Submitter: Address:

Phone: Fax:

Contact Person:

Beena Flynn

818-493-3592

818 493-3615

Trade Name/Proprietary Name:

PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A

Disposable Surgical PSA cables Non-Disposable PSA adapters

Class II, 21 CFR 870.3720

Class II, 21 CFR 870.2900

Classification:

Common Name:

Legally marketed device to which your firm is claiming equivalence:

St. Jude Medical PSA cables and adapters under review are all currently commercially available.

ModelNumber(Cables)	EquivalentDevice	PMA Number	Approval Date
4160	4160	P910023 / S154,P030054 / S67,P950022 / S42	January 13, 2009
4161	4161	P910023 / S154,P030054 / S67,P950022 / S42	January 13, 2009

Model Number(Adaptor)	Equivalent Device	510(k) Number	Approval Date
4053A	RemingtonMedicalcableadapterModel 4053	K971968	July 23, 1997

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a logo for the Department of Health & Human Services-GSA. The logo consists of a circular arrangement of text surrounding a stylized image of a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-GSA" in a circular pattern. The bird is depicted with flowing lines, suggesting movement and freedom.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

St. Jude Medical CRMD c/o Ms. Beena Flynn Regulatory Affairs 15900 Valley View Court Sylmar, CA 91342

APR - 2 2010

Re: K093858

Trade/Device Name: PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: Class II (two) Product Code: DSA and DTA Dated: December 15, 2009 Received: December 16, 2009

Dear: Ms. Flynn

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 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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Page 2 - Ms. Beena Flynn

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115800.html from the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

Device Name: PSA Cable Model Numbers 4160 and 4161

Indications for Use: The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

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

(Division Sign-Off)
Division of Cardiovascular Devi

510(k) Number	K693858
---------------	---------

Page 2

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STATEMENT OF INDICATIONS FOR USE

Device Name: PSA Cable Adapter Model Number 4053A

Indications for Use: The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

. .

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

Carlos Concession Company Control Concession Company Controller Collection Come Concession Comercial Concession

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).