(30 days)
Not Found
No
The summary describes a passive-fixation pacing lead with a specific physical shape modification. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is described as "endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator," which indicates a therapeutic function by regulating heart rhythm.
No
Explanation: The device is described as a pacing lead intended for permanent pacing and sensing, indicating a therapeutic rather than diagnostic function.
No
The device description clearly describes physical pacing leads, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Arox and Merox leads are "endocardial pacing leads" intended to "provide permanent pacing and sensing in the atrium and or ventricle." This describes a device that is implanted within the body to regulate heart rhythm, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory analysis.
This device is an implantable medical device used for cardiac pacing.
N/A
Intended Use / Indications for Use
Arox and Merox bipolar, passive-fixation, endocardial pacing leads 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 and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox lead families have been approved by FDA for distribution in the U.S. (K021217, dated 05-01-02 and #K010281, dated 04-09-02, respectively).
The designations Arox xx-JBP and Merox xx-JBP refer to "J"-shaped leads, which are available in lengths of 45 and 53 cm. The Arox and Merox xx-JBP models have 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.
The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads. Previously, BIOTRONIK did not specify the precise J-shape of the leads.
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
OCT 1 8 2002
BIOTRONIK, Inc., Arox and Merox J-Shape Specification, Special 510(k)
September 17, 2002
Arox and Merox J-Shape Specification Special 510(k) Premarket Notification
1. 510(K) SUMMARY
| Name and Address of Sponsor: | BIOTRONIK, Inc.
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 |
| | Proprietary Name: Merox Leads
Classification: Class III (21 CFR 870.3680(b))
Classification Name: Cardiovascular Permanent Pacemaker Electrode
Product Code: DTB |
| Date Prepared: | September 11, 2002 |
General Description:
The BIOTRONIK Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox lead families have been approved by FDA for distribution in the U.S. (K021217, dated 05-01-02 and #K010281, dated 04-09-02, respectively).
The designations Arox xx-JBP and Merox xx-JBP refer to "J"-shaped leads, which are available in lengths of 45 and 53 cm. The Arox and Merox xx-JBP models have 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.
Device Modification:
The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads. Previously, BIOTRONIK did not specify the precise J-shape of the leads.
Indication for Use:
Arox and Merox bipolar, passive-fixation, endocardial pacing leads 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
Name and Address of Contract Manufacturing Site:
BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169
Contact Person(s) and Phone Number:
Jon Brumbaugh Director, Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936
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 design featuring three abstract shapes that resemble human figures or waves, creating a sense of movement and connection.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2002
BIOTRONIK, Inc. c/o Mr. Jon Brumbaugh Director of Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035
Re: K023099
Trade Name: Arox and Merox Bipolar, Passive-Fixation Pacemaker Leads Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: Class III (three) Product Code: DTB Dated: September 17, 2002 Received: September 18, 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 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. 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 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 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,
i?
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ko23699 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Arox and Merox bipolar, passive-fixation pacemaker leads
Indications For Use:
Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number 4023006
(Optional Format 3-10-98)