(179 days)
The Encirclr AL Adjustable Loop Mapping Catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.
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 is 14-22mm 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.
The provided text details the submission of a Special 510(k) for the Encirclr™ AL Diagnostic Catheter, indicating its intended use and a comparison to a predicate device for substantial equivalence. However, the document does not contain specific acceptance criteria or the results of a study designed to prove the device meets those criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This is not present in the document. The document describes the device and states it underwent electrical and mechanical testing for comparison to a predicate, but no specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is an electrophysiologic mapping catheter, not an AI diagnostic tool, so such a study would not be applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device, not an algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to an existing predicate device (StableMapr EP catheter, K981642) rather than presenting a performance study against predefined acceptance criteria. The statement of technological comparison mentions: "Representative samples of the device underwent electrical and mechanical testing to demonstrate comparable functional and performance characteristics to the predicate device." Biocompatibility was assessed by analogy to existing Medtronic catheters. This suggests that the "acceptance criteria" were implied by the performance of the predicate device, and the testing aimed to show that the Encirclr™ AL performed comparably.
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MAR 2 6 2004
Special 510(k) Exhibits
Encirclr™ AL Diagnostic Catheter
Exhibit l
| Submitter: | Medtronic, EP Systems Inc.CRM East Facility7000 Central AvenueFridley, MN 55432 |
|---|---|
| Contact Person: | Mac McKeen, RACPrincipal Regulatory Affairs SpecialistPhone: (763) 514-3687Fax: (763) 514-6424Cell: (651) 270-4282Email: 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 | StableMaprK981642Cleared August 5, 1998 |
| Device Description: | DEVICE DESCRIPTIONThe device consists of a control handle and aclosed lumen 7 French catheter shaft thattransitions to a 5 French distal tip section. Thedistal tip section has an adjustable loop with 10evenly spaced radiopaque active electrodes thatare .75 to 1.3 mm in width, and a non-active 5French distal tip. The catheter contains twocontrol wires, insulated recording wires, and anickel/titanium forming wire which has memoryand elasticity that allows for adjustability of theloop. The control handle enables the user to steerthe device, and adjust the diameter of the loop atthe distal end of the catheter in order to fitvarious ostial anatomy. These catheters areavailable in four models (1045AL1, 1045AL2,1060AL1, 1060AL2) with a usable length of 110cm measuring from the strain relief to the centerof the distal loop. They have curve reaches that |
| range from 45 to 60 mm, and adjustable loopdiameters that range from 14 to 28 mm (AL1'srange is14-22mm and AL2's range is 18-28mm).The catheter connects to a cable that serves as theinterface between the catheter and a standard EPrecording system using a Medtronic 10-pinconnector cable. The catheter is supplied sterileand is intended for single-use. | |
| Indication for Use: | The Encirclr AL catheter is intended forelectrophysiologic mapping, recordingintracardiac electrograms, and temporary pacingin the atria of the heart. |
| Statement of TechnologicalComparison | Representative samples of the device underwentelectrical and mechanical testing to demonstratecomparable functional and performancecharacteristics to the predicate device. Thepatient contact materials of the Encirclr AL areidentical to those used in other legally marketedpredicate devices from Medtronic that haveundergone appropriate biocompatibility testing.Therefore biocompatibility testing of the Encirclrhas been fulfilled by analogy to those catheters. |
| Conclusion: (statement ofequivalence) | The Encirclr AL is substantially equivalent to theStableMapr EP catheter. This conclusion is basedupon the fact that this device is substantiallyequivalent to the predicate device in terms offunctional design, materials, intended use, andprinciples of operation. |
510(k) Summary
C Confidential
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KO33050
p.2012
Special 510(k) Exhibits
Encirclr™ AL Diagnostic Catheter
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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.
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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
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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
Page 1 of 1
§ 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).