The SafPace™ System is a two part system consisting of a Monitoring/Wedge Pressure Catheter and a Temporary Transluminal V- Pacing Wire. The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.

Device Description

AI/ML Overview

The provided document is a 510(k) summary for the SafPace™ System, a medical device for temporary cardiac pacing and monitoring. This type of submission focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed clinical study data with acceptance criteria for a novel AI/software component. Therefore, much of the requested information about AI model performance, multi-reader studies, and detailed ground truth establishment is not applicable or available in this document.

However, I can extract the information that is present and describe why other requested details are absent.

Acceptance Criteria and Device Performance

The document describes the device's acceptable performance in terms of safety and effectiveness through comparisons to predicate devices and adherence to manufacturing quality control. There are no explicit, quantifiable acceptance criteria or reported device performance metrics in the format requested for a specific AI model's output (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are implied by the following statements:

Substantial Equivalence: The device must be "substantially equivalent" in materials, form, and intended use to predicate devices, implying it meets similar safety and effectiveness profiles. This is the primary "acceptance criterion" for a 510(k) submission.
Material Suitability: Materials used "have an established history of medical use and that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product."
Manufacturing Quality Control: "All finished products are tested and must meet all required release specifications before distribution." This includes "physical testing, visual examination (in process and to: finished product)."
Conformance to Design Specifications: "Physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criterion (Implied/Stated)	Reported Device Performance (Implied/Stated)
Overall Regulatory Approval	Substantially Equivalent to Predicate Devices (K803058, K923551, K822806/A)	Determined to be "substantially equivalent" by the FDA.
Material Biocompatibility	Materials suitable for intended use, tested per Tripartite Guidance for Plastics.	Materials "have an established history of medical use" and "determined to be suitable."
Manufacturing Quality Control	Meet all required release specifications (physical testing, visual examination).	"All finished products are tested and must meet all required release specifications."
Design Conformance	Physical testing parameters conform to product design specifications.	Tests defined by Quality Control Test Procedures conform to design specifications.
Safety & Effectiveness (General)	No new issues of safety or effectiveness compared to predicate devices.	"There are no new issues of safety or effectiveness raised by the SafPace™ System."

Missing Information & Why

The following requested information is not present in the provided 510(k) summary because this document describes a traditional medical device (catheter and pacing wire), not an AI/ML-driven software product. Therefore, the concepts of "test sets," "training sets," "ground truth," "expert readers," and "AI models" are not applicable to this submission.

Sample size used for the test set and the data provenance: Not applicable. No test set for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for an AI model.
Adjudication method 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. There is no AI component involved.
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. No training set for an AI model.
How the ground truth for the training set was established: Not applicable.

This 510(k) submission focuses on demonstrating the physical, functional, and material equivalence of the SafPace™ System to previously cleared devices for cardiac monitoring and provisional pacing. It relies on established engineering principles, material science, and manufacturing quality controls rather than data-driven performance metrics for an AI algorithm.

Summary

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December 11, 1995

NON 1 8 1997 II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

B. Braun Medical, Inc. 824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

SafPace™ System PRODUCT NAME:

Wedge Pressure Catheter with Temporary TRADE NAME: Transluminal Pacing Wire.

CLASSIFICATION NAME: Cardiovascular Class II ,74 LDF, Temporary Pacemaker Electrode 21 CFR 870.3680

SUBSTANTIAL EQUIVALENCE, TO:

510 (k) number	Name	Applicant
K803058	Swan-Ganz FlowDirected Catheter	American EdwardsLaboratories
K923551	VascoStim	Vascor MedicalCorporation
K822806/A	Balloon WedgePressure,Angiographic andPacing Catheters	formally;Nova MedicalSpecialtiesnow a division ofB. Braun MedicalInc.

1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be These marketed without premarket approval or reclassification. products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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DEVICE DESCRIPTION:

ﻛﺴﺴﺴ

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce SafPace™ System. The SafPace™ System is a two part system consisting of a Monitoring/Wedge Pressure Catheter and a Temporary Transluminal V- Pacing Wire. The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.

MATERIAL:

The SafPace™ System is composed of materials which have an established history of medical use and that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

SUBSTANTIAL EQUIVALENCE:

The SafPace™ System is equivalent in materials, form, and intended use to the Swan-Ganz Flow Directed Catheter currently marketed by American Edwards Laboratories and the Pacing Catheter currently marketed by Nova Medical. There are no new issues of safety or effectiveness raised by the SafPace™ System.

SAFETY AND EFFECTIVENESS:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited physical testing, visual examination (in process and to: finished product) .

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three profiles facing to the right, representing the department's focus on health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

Mr. Mark S. Alsberge B. Braun Medical Inc. 824 12th Avenue Bethlehem, Pennsylvania 18018-0027

Re : K955829 Safpace™ System Requlatory Class: II (two) Product Code: LDF Dated: Auqust 4, 1997 Received: October 29, 1997

Dear Mr. Alsberge:

.. F

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 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 CFR 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 regulatory 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 requlations.

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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

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.