(14 days)
Not Found
No
The description focuses on the physical characteristics and materials of a passive-fixation pacing lead, with no mention of AI or ML capabilities for sensing, pacing algorithms, or data analysis.
Yes
The device is intended to provide permanent pacing and sensing in the atrium and/or ventricle, which is a therapeutic intervention for heart rhythm disorders.
No
Explanation: The "Intended Use" states that the device is "intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator." This describes a therapeutic function (pacing) and a monitoring function (sensing) for a pulse generator, not a diagnostic function which would involve identifying or characterizing a disease or condition.
No
The device description clearly details physical components such as leads, electrodes, tines, and connectors, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text clearly describes a pacing lead, which is an implantable device used to deliver electrical impulses to the heart. Its intended use is to "provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator." This is a direct intervention within the body, not an examination of specimens outside the body.
The device is an implantable medical device used for cardiac pacing.
N/A
Intended Use / Indications for Use
Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.
Product codes (comma separated list FDA assigned to the subject device)
DTB
Device Description
The BIOTRONIK Arox lead is a bipolar, passive-fixation, endocardial pacing lead available in straight and " J"-shaped configurations, for placement in the ventricle or atrium. The designation Arox xx-BP refers to Arox straight leads, which are available in lengths (xx) of 53 or 60 cm; Arox xx-JBP refers to Arox "J"-shaped leads, which are available in lengths of 45 and 53 cm.
The Arox xx-JBP model has a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage.
Arox xx-BP and Arox xx-JBP leads feature four silicone tines for passive-fixation in the heat's trabeculae. The tip electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 3.5 mm². The ring electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 22.6 mm². The lead conductor consists of quadrifilar MP35N wire in a coaxial configuration, insulated with silicone rubber tubing. All Arox leads utilize a 3.2 mm IS-1 connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrium and 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)
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
§ 870.3680 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
MAY 01 2002
BIOTRONIK, Inc.
April 16, 2002
Arox Passive-Fixation, Bipolar, Endocardial Pacing Lead Special 510(k) Premarket Notification
1. 510(K) SUMMARY
Name and Address of Sponsor:
6024 Jean Road Lake Oswego, OR 97035 Establishment Registration Number: 1028232 Device Name: Proprietary Name: Arox Leads Classification: Class III (21 CFR 870.3680(b)) Classification Name: Cardiovascular Permanent Pacemaker Electrode Product Code: DTB Date Prepared: April 16, 2002
General Description:
The BIOTRONIK Arox lead is a bipolar, passive-fixation, endocardial pacing lead available in straight and " J"-shaped configurations, for placement in the ventricle or atrium. The designation Arox xx-BP refers to Arox straight leads, which are available in lengths (xx) of 53 or 60 cm; Arox xx-JBP refers to Arox "J"-shaped leads, which are available in lengths of 45 and 53 cm.
The Arox xx-JBP model has a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage.
Arox xx-BP and Arox xx-JBP leads feature four silicone tines for passive-fixation in the heat's trabeculae. The tip electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 3.5 mm². The ring electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 22.6 mm². The lead conductor consists of quadrifilar MP35N wire in a coaxial configuration, insulated with silicone rubber tubing. All Arox leads utilize a 3.2 mm IS-1 connector.
Device Modification:
The Arox leads introduced in this Special 510(k) notification are modified versions of BIOTRONIK's currently marketed Merox leads (#K010281, dated 04-09-02). The modifications are a change in the tip electrode surface area from 1.3 mm² to 3.5 mm² and a change in the shape of the tip from segmented to lenticular. The tip electrode surface area size and shape are identical to BIOTRONIK's currently marketed Polyrox family of passive-fixation, endocardial leads (#K000763, dated 04-06-00).
Predicate Devices:
BIOTRONIK proposes the following leads cleared through 510(k) notifications as predicate devices for the Arox leads:
- BIOTRONIK's Merox passive-fixation, endocardial leads (#K010281, dated 04-09-02)
- BIOTRONIK's Polyrox passive-fixation, endocardial leads (#K000763, dated 04-06-00) ●
Indication for Use:
Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.
Name and Address of Manufacturing Site:
BIOTRONIK GmbH & Co. (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304
Contact Person(s) and Phone Number:
Jon Brumbaugh Director, Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936
Name and Address of Contract Manufacturing Site:
BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked one above the other.
Public Health Service
MAY 01 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Brumbaugh Director of Regulatory Affairs BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Re: K021217
Trade Name: Arox Passive-Fixation, Bipolar Pacemaker Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Permanent Pacemaker Electrode Regulatory Class: Class III (three) Product Code: DTB Dated: April 16, 2002 Received: April 17, 2002
Dear Mr. Brumbaugh:
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.
2
Page 2 - Mr. Jon Brumbaugh
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Touse be actived a determination that your device complies with other requirements of the Act that i Dr Haral statutes and regulations administered by other Federal agencies. You must or uny 1 vith 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 Of A ratt 007), accems (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.
This letter 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 premated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Dale Tull
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): KO2 1217
Device Name: Arox Passive-Fixation, Bipolar Pacemaker Lead
Indications For Use:
Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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ratory Devi ) Number