(111 days)
Not Found
No
The device description and intended use focus on a patient cable for signal transmission and pacing, with no mention of AI/ML capabilities or data processing beyond basic signal analysis.
No
The device is described as an accessory cable used for transmission of signals and pulses, not as a standalone therapeutic device. Its functions relate to diagnostics and aiding in procedures and tests for pacemakers.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "used for the transmission of sensing signals and pacing pulses for diagnostics and therapy." The subsequent bullet points detail diagnostic activities such as "Lead Threshold Determination" (e.g., determining impedance, capture threshold, P/R wave amplitude) and "Pacemaker Function Test" which analyzes various parameters of pulse generators.
No
The device description explicitly states it is a "patient cable" made up of a "2.8m cable with four touch-proof alligator clips," which are physical hardware components.
Based on the provided information, the PK-141 patient cable is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The PK-141 patient cable is used to connect external equipment to intracardiac leads within the patient's body for direct sensing and pacing. It does not analyze biological samples like blood, urine, or tissue.
- The intended use describes direct interaction with the patient's electrical signals and pacing. This is a direct physiological interaction, not an in vitro analysis of a specimen.
- The device description emphasizes connecting to leads and being in the sterile field. This further reinforces its use within the body during procedures.
Therefore, the PK-141 patient cable is a medical device used for in-vivo procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities:
-
Temporary External Pacing ●
Provides temporary stimulation during implantable pacemaker procedures or physician evaluations. -
Lead Threshold Determination .
Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
Pacemaker Function Test ●
Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval. .
Product codes (comma separated list FDA assigned to the subject device)
KRG, DTC
Device Description
The PK-141 patient cable is compatible with the following BIOTRONIK external equipment: ICS 3000 Implant Control System, EDP 20/30 B External Pacemakers, and ERA 300/3000 Pacing System Analyzers. The PK-141 is intended to connect to the patient's sensing and pacing leads. The PK-141 is connected to the Redel connector provided by the external equipment and the alligator clips connect to the electrode.
The PK-141 is made up of a 2.8m cable with four touch-proof alligator clips. The alligator clips are clamped directly to the tip or the contact ring of the leads. During its use, the cable is in the sterile field; therefore it must be sterile itself. Skin contact with the patient is not anticipated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K083674
p112
PK-141 Patient Cable APR - 1 2009 510(k) Premarket Notification
1. PATIENT CABLE 510(K) SUMMARY
Name and Address of Applicant:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
Device Name:
Proprietary Name: PK-141 Common Name: Programmer, Pacemaker (Accessories) Classification: Class II (21 CFR 870.3700) Classification Name: Cabling
510(k) Number:
1028232
Date Prepared:
December 10, 2008
Product Code: KRG
General Description:
The PK-141 patient cable is compatible with the following BIOTRONIK external equipment: ICS 3000 Implant Control System, EDP 20/30 B External Pacemakers, and ERA 300/3000 Pacing System Analyzers. The PK-141 is intended to connect to the patient's sensing and pacing leads. The PK-141 is connected to the Redel connector provided by the external equipment and the alligator clips connect to the electrode.
The PK-141 is made up of a 2.8m cable with four touch-proof alligator clips. The alligator clips are clamped directly to the tip or the contact ring of the leads. During its use, the cable is in the sterile field; therefore it must be sterile itself. Skin contact with the patient is not anticipated.
Predicate Device:
BIOTRONIK proposes the following programmer accessory cleared through 510(k) notification as the predicate device for the PK-141 cable:
- BIOTRONIK's PK-67-L (K022360 ERA 3000 Dual Chamber Pacing Analyzer, cleared . January 27, 2003)
Indications for Use:
The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities:
- . Temporary External Pacing Provides temporary stimulation during implantable pacemaker procedures or physician evaluations.
- . Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold. P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
- . Pacemaker Function Test
1
Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, AV delay, and rate/interval.
Name and Address of Manufacturing Site:
BIOTRONIK GmbH & Co. KG Woermannkehre 1 D-12359 Berlin, Germany
Manufacturer's Establishment Registration Number
9610139
510(k) Contact Person and Phone Number:
Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 (888) 345-0374
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 9 2011
BIOTRONIK, Inc c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035
Re: K083674
Trade/Device Name: PK-141 Patient Cable Regulation Number: 21 CFR 870.3630 Regulation Name: Analyzer, Pacemaker Generator Function Regulatory Class: II Product Code: DTC Dated: March 25, 2009 Received: March 26, 2009
Dear Mr. Brumbaugh:
This letter corrects our substantially equivalent letter of April 1, 2009.
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 (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
3
Page 2- Mr. Brumbaugh
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-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/ucm1115809.htm for 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.
hr
Bram D. Zuckerman, M.D.
Bra
Dir
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K083674
Device Name: PK-141 Patient Cable
Indications For Use:
The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities:
-
Temporary External Pacing ●
Provides temporary stimulation during implantable pacemaker procedures or physician evaluations. -
Lead Threshold Determination .
Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
Pacemaker Function Test ●
Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval. .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
QML
(Division Sign-Off) Division of Cardlovascular Devices K093674 510(k) Number