(111 days)
Not Found
No
The document describes a cable accessory for a Pacing System Analyzer (PSA) and its function in transmitting signals. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The document states that the device is an "accessory indicated for use with external PSA equipment" and is used for "transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators." It facilitates the evaluation of lead placement and integrity, but does not itself provide therapy.
Yes
The device is described as assisting in the "evaluation of lead placement characteristics" and "evaluating the placement and integrity of leads and to determine the appropriate pacing parameters" during pacemaker and defibrillator implantation, which falls under diagnostic activity.
No
The device description explicitly states it is an "external cable" and describes its physical components and function in transmitting signals, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The PSA cable's intended use and description clearly state it's an accessory used during the implantation of pacemakers and defibrillators. It transmits signals and pacing pulses to and from the implanted lead and an external PSA device. This is an in vivo (within the living body) process, not an in vitro process.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens.
Therefore, the PSA cable is a medical device used in a surgical/clinical setting for evaluating lead placement and supporting pacemaker functionality, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PSA cable is an accessory indicated for use with external PSA equipment distributed by Boston Scientific and is used for the transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators and for the support of other pacemaker functionality.
Product codes
DTC
Device Description
The Pacing System Analyzer (PSA) cable, Model 6763, is an external cable used to transmit signals to and from a connected PSA device. The connected PSA equipment is used during the implantation of pacemakers and defibrillators to evaluate the placement and integrity of leads and to determine the appropriate pacing parameters for the implanted device. The PSA cable leadwires are affixed to the implanted lead while the other end of the cable, the trunk cable, is plugged into the external PSA device. The PSA cable is used with the BSC distributed PSA devices.
The PSA cable leadwires may incidentally contact the patient's skin as they lay across the body while attached to the leads. Per ISO 10993-1, skin/body contact for this device is categorized as Limited (
§ 870.3630 Pacemaker generator function analyzer.
(a)
Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2017
Boston Scientific Corporation Melissa Klamerus Regulatory Specialist 4100 Hamline Ave North St. Paul. Minnesota 55112
Re: K170815
Trade/Device Name: PSA Cable Regulation Number: 21 CFR 870.3630 Regulation Name: Pacemaker Generator Function Analyzer Regulatory Class: Class II Product Code: DTC Dated: March 16, 2017 Received: March 17, 2017
Dear Melissa Klamerus:
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. 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 801); medical device reporting (reporting of medical device
1
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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
M.A. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170815
Device Name PSA Cable
Indications for Use (Describe)
The PSA cable is an accessory indicated for use with external PSA equipment distributed by Boston Scientific and is used for the transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators and for the support of other pacemaker functionality
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K170815 Page 1 of 3
4100 Hamline Avenue North St. Paul, MN 55112-5798
651.582.4000 Tel 651.582.5134 Fax
510(k) Summary for PSA Cable, Model 6763
Email: Melissa.klamerus@bsci.com
1. Submitter
Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, Minnesota 55112-5798
Contact: Melissa Klamerus Regulatory Affairs Phone: (651) 582-6771
Date Prepared: February 25, 2017
2. Device
Trade Name: PSA Cable Common Name: PSA Cable Product Code and Panel: DTC, Cardiovascular Classification Regulation: 21 CFR 870.3630
3. Predicate Device
Trade Name: PK-141 Patient Cable (PSA Cable) Manufacturer: Biotronik Clearance Number: K083674, April 1 2009 Common Name: PSA Cable Product Code: DTC Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR 870.3630
4. Device Description
The Pacing System Analyzer (PSA) cable, Model 6763, is an external cable used to transmit signals to and from a connected PSA device. The connected PSA equipment is used during the implantation of pacemakers and defibrillators to evaluate the placement and integrity of leads and to determine the appropriate pacing parameters for the implanted device. The PSA cable leadwires are affixed to the implanted lead while the other end of the cable, the trunk cable, is plugged into the external PSA device. The PSA cable is used with the BSC distributed PSA devices.
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K170815 Page 2 of 3
The PSA cable leadwires may incidentally contact the patient's skin as they lay across the body while attached to the leads. Per ISO 10993-1, skin/body contact for this device is categorized as Limited (