(179 days)
Not Found
No
The description focuses on the mechanical and electrical components of the catheter for electrophysiologic mapping and pacing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is solely intended for mapping, recording, and temporary pacing for diagnostic purposes, not for treating any condition.
Yes
Explanation: The device is described as an "electrophysiologic mapping" catheter and is intended for "recording intracardiac electrograms," which are diagnostic activities used to understand the electrical activity of the heart.
No
The device description clearly details a physical catheter with a control handle, shaft, electrodes, wires, and a connector cable. This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart." This describes a procedure performed within the body (in vivo) to assess electrical activity of the heart.
- Device Description: The description details a catheter designed to be inserted into the body. It has a shaft, electrodes, and a control handle for manipulation within the heart.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
This device is clearly designed for direct interaction with the patient's internal anatomy for diagnostic and therapeutic purposes, which is characteristic of an in vivo medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Encirclr AL catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.
The Encirclr AL Adjustable Loop Mapping Catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The device consists of a control handle and a closed lumen 7 French catheter shaft that transitions to a 5 French distal tip section. The distal tip section has an adjustable loop with 10 evenly spaced radiopaque active electrodes that are .75 to 1.3 mm in width, and a non-active 5 French distal tip. The catheter contains two control wires, insulated recording wires, and a nickel/titanium forming wire which has memory and elasticity that allows for adjustability of the loop. The control handle enables the user to steer the device, and adjust the diameter of the loop at the distal end of the catheter in order to fit various ostial anatomy. These catheters are available in four models (1045AL1, 1045AL2, 1060AL1, 1060AL2) with a usable length of 110 cm measuring from the strain relief to the center of the distal loop. They have curve reaches that range from 45 to 60 mm, and adjustable loop diameters that range from 14 to 28 mm (AL1's range is14-22mm and AL2's range is 18-28mm). The catheter connects to a cable that serves as the interface between the catheter and a standard EP recording system using a Medtronic 10-pin connector cable. The catheter is supplied sterile and is intended for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atria of the heart
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)
Representative samples of the device underwent electrical and mechanical testing to demonstrate comparable functional and performance characteristics to the predicate device.
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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
MAR 2 6 2004
Special 510(k) Exhibits
Encirclr™ AL Diagnostic Catheter
Exhibit l
| Submitter: | Medtronic, EP Systems Inc.
CRM East Facility
7000 Central Avenue
Fridley, MN 55432 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mac McKeen, RAC
Principal Regulatory Affairs Specialist
Phone: (763) 514-3687
Fax: (763) 514-6424
Cell: (651) 270-4282
Email: mac.mckeen@medtronic.com |
| Date Prepared: | September 17, 2003 |
| Trade Name: | Encirclr™ AL |
| Classification Name and Number: | 21 CFR 870.1220 |
| Product 1642: | DRF |
| Predicate Device Name and 510(k)
Number | StableMapr
K981642
Cleared August 5, 1998 |
| Device Description: | DEVICE DESCRIPTION
The device consists of a control handle and a
closed lumen 7 French catheter shaft that
transitions to a 5 French distal tip section. The
distal tip section has an adjustable loop with 10
evenly spaced radiopaque active electrodes that
are .75 to 1.3 mm in width, and a non-active 5
French distal tip. The catheter contains two
control wires, insulated recording wires, and a
nickel/titanium forming wire which has memory
and elasticity that allows for adjustability of the
loop. The control handle enables the user to steer
the device, and adjust the diameter of the loop at
the distal end of the catheter in order to fit
various ostial anatomy. These catheters are
available in four models (1045AL1, 1045AL2,
1060AL1, 1060AL2) with a usable length of 110
cm measuring from the strain relief to the center
of the distal loop. They have curve reaches that |
| | range from 45 to 60 mm, and adjustable loop
diameters that range from 14 to 28 mm (AL1's
range is14-22mm and AL2's range is 18-28mm).
The catheter connects to a cable that serves as the
interface between the catheter and a standard EP
recording system using a Medtronic 10-pin
connector cable. The catheter is supplied sterile
and is intended for single-use. |
| Indication for Use: | The Encirclr AL catheter is intended for
electrophysiologic mapping, recording
intracardiac electrograms, and temporary pacing
in the atria of the heart. |
| Statement of Technological
Comparison | Representative samples of the device underwent
electrical and mechanical testing to demonstrate
comparable functional and performance
characteristics to the predicate device. The
patient contact materials of the Encirclr AL are
identical to those used in other legally marketed
predicate devices from Medtronic that have
undergone appropriate biocompatibility testing.
Therefore biocompatibility testing of the Encirclr
has been fulfilled by analogy to those catheters. |
| Conclusion: (statement of
equivalence) | The Encirclr AL is substantially equivalent to the
StableMapr EP catheter. This conclusion is based
upon the fact that this device is substantially
equivalent to the predicate device in terms of
functional design, materials, intended use, and
principles of operation. |
510(k) Summary
C Confidential
1
KO33050
p.2012
Special 510(k) Exhibits
Encirclr™ AL Diagnostic Catheter
Image /page/1/Picture/4 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image of a person inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2004
Medtronic, Inc. c/o Mr. Mac McKeen, RAC Principal Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432
Re: K033050
. Trade Name: Encirclr™ AL Adjustable Loop Mapping Catheter Regulation Number: 21 CFR 870 1220 Regulation Name: 21 CFR 878 1220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: January 14, 2004 Received: January 15, 2004
Dear Mr. McKeen:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your section 310(t) presidentially equivalent (for the indications for use stated in the enclosure) the are are are are are are as marketed in interstate for use stated in the encrosule) to regard the Medical Device Amendments, or (or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug, devices mat have been recuired in wore approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, merclore, market the do rec, nolude requirements for annual registration, listing of general controls provisions of the riot rest 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 If your device is classified (500 abs. 9) ins. Existing major regulations affecting your device can may be subject to such additional controller Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of I cases oncerning your device in the Federal Register.
3
Page 2 -- Mr. Mac McKeen, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast oc advised that I Dr is assum that your device complies with other requirements of the Act that I D. I has made a aved regulations administered by other Federal agencies. You must or any I coclar batated and regisments, including, but not limited to: registration and listing (21 Comply with an the 11et 31equirements,01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2) see as described in your Section 510(k) This letter with anow you to begin mailing of substantial equivalence of your device to a legally prematicated predicated on "The stassification 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 If you desire specific advice for your 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 general 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.
Sincercly yours,
Duna R. la lunel
QLBram D. Zuckerman, M.D. 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):_ K033050
Device Name: Encirclr™ AL Adjustable Loop Mapping Catheter
Models 1045AL1, 1045AL2, 1060AL1, 1060AL2
Indications For Use:
The Encirclr AL Adjustable Loop Mapping Catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R-Vichner
Division Sign-Off) ivision of Cardiovascu'a Devices
10/k) Number_K033050
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