(26 days)
Not Found
Not Found
No
The summary describes a temporary pacing system with a lead and guide catheter, focusing on mechanical and electrical performance. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is designed for "temporary intracardiac pacing," which involves applying electrical stimulation to the heart to regulate its rhythm, thereby treating or managing a physiological condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is designed for "temporary intracardiac pacing and/or EGM recording." EGM (electrogram) recording is a diagnostic function, as it involves measuring and recording the electrical activity of the heart.
No
The device description clearly outlines physical components like a lead, guide catheter, torque tool, and introducer, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary intracardiac pacing and/or EGM recording." This involves interacting directly with the patient's body for therapeutic (pacing) and diagnostic (EGM recording) purposes.
- Device Description: The description details a lead and catheter system designed for insertion into the heart.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform such analysis.
The device is clearly an implantable medical device used for temporary cardiac pacing and recording electrical activity within the heart.
N/A
Intended Use / Indications for Use
The Model 6416 Bipolar Transvenous Temporary Pacing System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording. The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile. The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector.
Product codes (comma separated list FDA assigned to the subject device)
LDF
Device Description
The Model 6416 Bipolar Transvenous Temporary Pacing Lead System comprises a temporary lead and a soft-tipped Medtronic guiding catheter. The pacing lead is designed to provide pacing characteristics similar to presently marketed bipolar temporary leads. The lead is introduced percutaneously through the guiding catheter. The lead system is provided in varying lengths to allow for jugular, subclavian, or femoral approach. A removable silicone rubber torque tool is provided on the proximal portion of the lead, to facilitate rotation of the lead during implant and explant. The disposable introducer currently packaged with the system is the Medtronic Vector X coronary guiding catheter, size 6 French. This catheter guides or steers the temporary lead during placement, and shrouds the active fixation helix from blood vessel walls and other inappropriate tissue until actual implantation in the atrium or ventricle. A hemostasis valve tightens and loosens around the lead and controls the passage of the lead through the guide catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac (atrium or ventricle)
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)
Medtronic, Inc. performed system compatibility testing to support that the modified Model 6416 Bipolar Transvenous Temporary Pacing System is equivalent to the predicate device. Device testing included:
- . Environmental Conditioning
- . Visual Verification
- Lead/ Catheter Compatibility testing
- Preclinical confirmation of safety and performance
All system tests performed have demonstrated that the modified Model 6416 Bipolar Transvenous Temporary Pacing System meets the specified requirements.
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.
The current market released Model 6416 Bipolar Transvenous Temporary Pacing System.
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
§ 870.3680 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
Special 510(k) Premarket Notification Attachments
Model 6416 Bipolar Transvenous Temporary Pacing System
pl /3
SEP = 7 2004
510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE
Submitter
Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432
Contact: Paula Cordero, Regulatory Affairs Specialist Telephone: (763) 514-8233 Fax: (763) 514-6424 E-Mail: paula.cordero@medtronic.com Date Prepared: August 10, 2004
Name of Device
Trade Name: Model 6416 Bipolar Transvenous Temporary Pacing System Common Name: Temporary Pacing Lead System Classification: Class II
Predicate Devices
The predicate device for the Modified Model 6416 Bipolar Transvenous Temporary Pacing System is the current market released Model 6416 Bipolar Transvenous Temporary Pacing System.
Device Description
The Model 6416 Bipolar Transvenous Temporary Pacing Lead System comprises a temporary lead and a soft-tipped Medtronic guiding catheter. The pacing lead is designed to provide pacing characteristics similar to presently marketed bipolar temporary leads. The lead is introduced percutaneously through the guiding catheter. The lead system is provided in varying lengths to allow for jugular, subclavian, or femoral approach. A removable silicone rubber torque tool is provided on the proximal portion of the lead, to facilitate rotation of the lead during implant and explant. The disposable introducer currently packaged with the system
Image /page/0/Picture/13 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left, followed by the word "Medtronic" in bold, black letters. To the right of "Medtronic" is the word "Confidential" in a smaller, non-bold font.
1
Special 510(k) Premarket Notification Attachments
Model 6416 Bipolar Transvenous Temporary Pacing System
KO42190
p.2/3
is the Medtronic Vector X coronary guiding catheter, size 6 French. This catheter guides or steers the temporary lead during placement, and shrouds the active fixation helix from blood vessel walls and other inappropriate tissue until actual implantation in the atrium or ventricle. A hemostasis valve tightens and loosens around the lead and controls the passage of the lead through the guide catheter.
Packaging
The sterile packaging for the Model 6416 Bipolar Transvenous Temporary Pacing System consists of a single pouch configuration. The pouch materials are transparent Tyvek- polyester/polyethylene laminate. The pouches are heat-sealed.
Intended Use
The Model 6416 Bipolar Transvenous Temporary Pacing System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording. The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile. The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector.
Technological Characteristics
The technology used with the Model 6416 Bipolar Transvenous Temporary Pacing System has not changed with the modified Model 6416 Bipolar Transvenous Temporary Pacing System.
Summary of Studies
Medtronic, Inc. performed system compatibility testing to support that the modified Model 6416 Bipolar Transvenous Temporary Pacing System is equivalent to the predicate device. Device testing included:
- . Environmental Conditioning
- . Visual Verification
- Lead/ Catheter Compatibility testing �
- Preclinical confirmation of safety and performance �
Image /page/1/Picture/15 description: The image shows the Medtronic logo and the word "Confidential" to the right of the logo. The Medtronic logo consists of a stylized image of a person inside of a circle. The word "Medtronic" is in bold, sans-serif font.
2
Special 510(k) Premarket Notification Attachments
Model 6416 Bipolar Transvenous Temporary Pacing System
p 3 /3
All system tests performed have demonstrated that the modified Model 6416 Bipolar Transvenous Temporary Pacing System meets the specified requirements.
Sterilization
The Modified Model 6416 Bipolar Transvenous Temporary Pacing System is sterilized using the same100% Ethylene Oxide (EtO) sterilization process as the predicate device. Sterilization certification of the Modified Model 6416 Bipolar Transvenous Temporary Pacing System is based on the manufacturer's determination of substantial equivalence to the predicate device.
Biocompatibility
Biocompatibility testing was not repeated for the modified Model 6416 Bipolar Transvenous Temporary Pacing System. No change was made to material type or material formulation from previously cleared predicate devices.
Conclusion
Through data and information presented, numerous similarities support a determination of substantial equivalence and show the device modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. Market clearance of the Modified Model 6416 Bipolar Transvenous Temporary Pacing System is supported through this Special 510(k) PreMarket Notification.
Image /page/2/Picture/9 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a stylized human figure inside of a circle. The word "Medtronic" is in bold, black letters. The word "Confidential" is in a smaller, non-bold font.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2004
Medtronic, Inc. c/o Ms. Paula Cordero Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432
Re: K042190
Trade Name: Medtronic® Model 6146 Bipolar Transvenous Temporary Pacing System Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: II (two) Product Code: LDF Dated: August 10, 2004 Received: August 12, 2004
Dear Ms. Cordero:
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 such 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.
4
Page 2 - Ms. Paula Cordero
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); 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. production will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince noticate 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal miormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nut RP Ogden
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) Premarket Notification Indications for Use
Model 6416 Bipolar Transvenous Temporary Pacing System K
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications For Use:
NA K042190
Medtronic Model 6416 Bipolar Transvenous Temporary Pacing System
The Model 6416 Bipolar Transvenous Temporary Pacing System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording.
The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile.
The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ________ |
|---|---|---|
| ------------------------------------------ | ------------------------------------------ | ------------------------------- |
| (Division Sign-Off) | Neil Arogen |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | KO 42190 |
Image /page/5/Picture/12 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo is a stylized image of a person inside of a circle. The word "Medtronic" is in a bold, sans-serif font.