(364 days)
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
Diagnostic Electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. EP catheter designs all incorporate a connector, a handpiece, a flexible polymeric shaft, and a distal tip containing two or more electrodes. The distal tips of steerable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.
This looks like a 510(k) clearance letter for reprocessed diagnostic electrophysiology (EP) catheters, noting the FDA's acceptance of supplemental validation data. Unfortunately, the provided document does not contain the detailed acceptance criteria or the specific study results that confirm the device meets these criteria. The letter primarily states that the reprocessed devices are found to be substantially equivalent to legally marketed predicate devices, and lists the specific models cleared.
The letter explicitly mentions "supplemental validation data as required for reprocessed single-use devices," but it does not describe the methodologies or the outcomes of this validation.
Therefore, I cannot provide the requested information based solely on the text provided. The document you've given is a regulatory clearance letter, not a detailed study report.
To provide the requested details, I would need access to the actual "supplemental validation data" mentioned in the letter, which would typically be included in the 510(k) submission itself (a much larger document).
However, I can extract what is implied or stated generally about the device and its intended use:
- Device Name: Electrophysiology (EP) Catheter (reprocessed)
- Intended Use/Indications for Use: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
- Technological Features Comparison: The document states, "Since reprocessing does not significantly change any of these parameters, the reprocessed catheters are the same as the original devices." This implies that the performance characteristics (e.g., integrity, electrical properties, mechanical properties) after reprocessing are expected to be equivalent to new devices.
Without the actual validation study report, I must state that the following information is NOT available in the provided text:
- Table of acceptance criteria and reported device performance: Not provided.
- Sample size used for the test set and data provenance: Not provided.
- Number of experts used to establish ground truth and their qualifications: Not provided.
- Adjudication method for the test set: Not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study effect size: This type of study is more common for diagnostic imaging AI devices, not typically for reprocessed catheters. The document does not mention it.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not provided. For reprocessed catheters, the "ground truth" would likely involve comparison to original device specifications and performance rather than a clinical ground truth like pathology for a diagnostic imaging device.
- Sample size for the training set: Not applicable; this is not an AI/ML device that requires a training set.
- How ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, AZ 85044
NOV 1 2004
Re: K012708 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: NLH Dated: August 14, 2001 Received: August 14, 2001
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 13, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. 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 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,
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Enclosure – List of Devices
| Orig models found to be | SE |
|---|---|
| Bard (55) | |
| 006245 | |
| 008567 | |
| 200060 | |
| 200066 | |
| 200067 | |
| 200069 | |
| 200151 | |
| 200202 | |
| 200203 | |
| 200472 | |
| 200473 | |
| 200573 | |
| 200574 | |
| 200578 | |
| 200580 | |
| 200581 | |
| 200583 | |
| 200584 | |
| 200591 | |
| 200594 | |
| 200596 | |
| 200597 | |
| 200624 | |
| 200719 | |
| 200792 | |
| 400001 | |
| 400004 | |
| 400005 | |
| 400006 | |
| 400007 | |
| 400008 | |
| 400011 | |
| 400012 | |
| 400014 | |
| 400016 | |
| 400017 | |
| 400023 | |
| Orig models found to be | SE |
| 400044 | |
| 400045 | |
| 400046 | |
| 400047 | |
| 400048 | |
| 400071 | |
| 400099 | |
| 400100 | |
| 500202 | |
| 500203 | |
| 006245P | |
| 200060E | |
| 200588E | |
| 5FVS00010 | |
| 6FMC00098 | |
| 6FMC00518 | |
| 6FMC00687 | |
| Cordis Webster (68) | |
| D5-08D-P10-FS | |
| D5S-06AL-252-MS | |
| D5S-06AL-252-RT | |
| D5S-AL-252-PS | |
| D6-06DR-002-FS | |
| D6-06DR-002-RT | |
| D6-06DR-005-FS | |
| D6-08DR-002-FS | |
| D6-08DR-002-RT | |
| D6-10DR-P10-FS | |
| D6-10DR-P10-RT | |
| D6-10FR-005-FS | |
| D6-AG-252-PS | |
| D6-AL-252-PS | |
| D6-BL-252-PS | |
| D6-DG-252-PS | |
| D6-DL-252-PS | |
| D6-DR-005-PS | |
| D6-DR-010-PS | |
| D6-DR-252-PS | |
| D6S-08DR-PRY-FS | |
| D6S-270L-252-PS | |
| D7-06DL-002-FS | |
| Orig models found to be | |
| SE | |
| D7-06DL-002-TS | |
| D7-06DR-002-TS | |
| D7-08DL-002-FS | |
| D7-08DL-002-RT | |
| D7-08DR-002-FS | |
| D7-08DR-002-RT | |
| D7-08DR-005-FS | |
| D7-08R-HIS-FS | |
| D7-10DR-P10-FS | |
| D7-10DR-P10-RT | |
| D7-10FR-010-FS | |
| D7-270L-252-PS | |
| D7-270RL-252-PS | |
| D7-A20-131-FS | |
| D7-AG-252-PS | |
| D7-AL-252-PS | |
| D7-BG-252-PS | |
| D7-BL-252-PS | |
| D7-CG-252-PS | |
| D7-CL-252-PS | |
| D7-DG-252-PS | |
| D7-DL-005-PS | |
| D7-DL-252-PS | |
| D7-DR-005-PS | |
| D7-DR-010-PS | |
| D7-DR-252-PS | |
| D7-EG-252-PS | |
| D7-EL-252-PS | |
| D7-FG-252-PS | |
| D7-FL-252-PS | |
| D7-PSL-252-PS | |
| D7R-20-P14-FS | |
| D7-T20-282-FS | |
| D7-T20-P15-FS | |
| D8BR-BG-252-PS | |
| D8BR-BL-252-PS | |
| D8BR-DG-252-PS | |
| D8BR-DL-252-PS | |
| D8BR-FL-252-PS | |
| D8-CG-252-PS | |
| D8-DG-252-PS | |
| Orig models found to be | |
| SE | |
| D8-DL-252-PS | |
| D8-FG-252-PS | |
| OD7-3X4D-010-FS | |
| OD7-8X2D-005-FS | |
| Daig (29) | |
| 401430 | |
| 401434 | |
| 401435 | |
| 401436 | |
| 401440 | |
| 401441 | |
| 401442 | |
| 401443 | |
| 401444 | |
| 401445 | |
| 401449 | |
| 401450 | |
| 401451 | |
| 401453 | |
| 401466 | |
| 401474 | |
| 401475 | |
| 401528 | |
| 401860 | |
| 401863 | |
| 401864 | |
| 401872 | |
| 401873 | |
| 401876 | |
| 401878 | |
| 401890 | |
| 401891 | |
| 401894 | |
| 401904 | |
| EPT (23) | |
| 5291 | |
| 5291S | |
| 5292 | |
| 5292S | |
| 5294 | |
| 5294S | |
| Orig models found to beSE | |
| 5298S | |
| 5404S | |
| 5414S | |
| 5418 | |
| 5420 | |
| 5429 | |
| 5433 | |
| 5434 | |
| 5457 | |
| 5458 | |
| 5470 | |
| 5472 | |
| 5481 | |
| 5482 | |
| 5491 | |
| 5563 | |
| 5920 | |
| Medtronic (9) | |
| 041002JM | |
| 041002UM | |
| 041005DM | |
| 041005JM | |
| 041005UM | |
| 04122JM | |
| 04125JM | |
| 04125UM | |
| 044216J |
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Electrophysiology Catheters Alliance Medical Corporation Part D. Certifications
CONFIDENTIAL 08/14/01
510(k) Premarket Notification
Page 2 of 2
Indications for Use Statement 2.
INDICATIONS FOR USE STATEMENT
Kol 2708
510(k) Number: (if known)
.
Device Name:
Electrophysiology (EP) Catheter
Sponsor Name:
Alliance Medical Corporation
Indications for Use:
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
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 | K012708 |
| Emballus |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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PART C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter 1.
Alliance Medical Corporation 10232 51st Street Phoenix, Arizona 85044
2. Contact Person
Don Selvey Vice President, Regulatory Affairs & Quality Assurance Alliance Medical Corporation (480) 763-5300 – Telephone (480) 763-5310 -- Facsimile dselvey@reprocessing.com
3. Device Name
a. Trade or Proprietary Name
Electrophysiology Catheter
b. Common Name, Usual or Classification Name
Electrode recording catheter
4. Predicate Devices
*The Celsius/CelsiusII diagnostic catheters were approved under PMA P950005. **The Livewire diagnostic catheter was approved under PMA P960016.
5. Description of the Device
Diagnostic Electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
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EP catheter designs all incorporate a connector, a handpiece, a flexible polymeric shaft, and a distal tip containing two or more electrodes. The distal tips of steerable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.
6. Intended Use of the Device
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
7. Comparison of the Technological Features of the Reprocessed and Original Devices
Diagnostic catheters are available in various configurations. Key parameters include the size of the tip, number of electrodes, length, curve of the tip, and whether or not the tip is deflectable. Since reprocessing does not significantly change any of these parameters, the reprocessed catheters are the same as the original devices.
§ 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).