(364 days)
P950005, P960016
No
The summary describes a standard electrophysiology catheter and does not mention any AI or ML components or functionalities.
No
The device is indicated for sensing, recording, stimulation, and electrophysiological mapping, which are diagnostic or mapping functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states: "Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures." The term "diagnostic" is explicitly used.
No
The device description clearly outlines physical components including a connector, handpiece, shaft, and electrodes, indicating it 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 "temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures." This describes a device used within the body to interact with and measure physiological signals.
- Device Description: The description details a catheter with electrodes designed for endocardial recording or stimulation. This is consistent with an invasive medical device used for diagnosis and treatment in vivo.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any interaction with specimens or analysis performed in vitro.
Therefore, this device falls under the category of an invasive medical device used for electrophysiological procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
Product codes
NLH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures
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)
K891908, K892265, K914278, K913375, K931794, K904080, K953663, K942379, K924108, K951347, K912213, K953678, K002976, K924109, K953185, K921872, K955817, K924163, K964272, K971265, K991531, K940167, K981642, K992965, K940168, K002333, K003452
Reference Device(s)
P950005, P960016
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
Page 2 - K012708
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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1000
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 be | |
| SE | |
| 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
8
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
| Bard | Cordis
Webster* | Daig** | EP
Technologies | Medtronic |
|---------|--------------------|---------|--------------------|-----------|
| K891908 | K892265 | K914278 | K913375 | K931794 |
| K904080 | K953663 | K942379 | K924108 | K951347 |
| K912213 | K953678 | K002976 | K924109 | K953185 |
| K921872 | K955817 | | K924163 | K964272 |
| K971265 | K991531 | | K940167 | K981642 |
| | K992965 | | K940168 | |
| | K002333 | | K003452 | |
*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.
9
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.