(693 days)
No
The summary describes a traditional medical device (catheter and pacing wire) for monitoring and pacing, with no mention of AI or ML capabilities in its function, description, or performance testing.
Yes
The device is used for "temporary ventricular pacing," which is a therapeutic intervention to regulate heart rhythm.
Yes
The "Intended Use / Indications for Use" section explicitly states that the SafPace™ System is designed for "accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring" and "intraventricular ECG monitoring," all of which are diagnostic functions.
No
The device description clearly states it is a two-part system consisting of a catheter and a pacing wire, which are physical hardware components.
Based on the provided text, the SafPace™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
- SafPace™ System Function: The description clearly states the SafPace™ System is used for:
- Measurement of cardiac output
- Direct measurement of pulmonary artery blood temperature and pressure
- Infusing solutions
- Temporary ventricular pacing
- Intraventricular ECG monitoring
These functions involve direct interaction with the patient's body (in vivo) for monitoring, pacing, and infusion, not the analysis of specimens outside the body.
Therefore, the SafPace™ System falls under the category of in vivo medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
LDF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary artery, intraventricular
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Flow | |
| Directed Catheter | American Edwards | |
| Laboratories | ||
| K923551 | VascoStim | Vascor Medical |
| Corporation | ||
| K822806/A | Balloon Wedge | |
| Pressure, | ||
| Angiographic and | ||
| Pacing Catheters | formally; | |
| Nova Medical | ||
| Specialties | ||
| now a division of | ||
| B. Braun Medical | ||
| Inc. |
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.
1
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.
2
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.
3
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