(103 days)
Not Found
No
The description focuses on the physical components and function of a standard EP catheter, and there is no mention of AI or ML in the text, including the sections specifically checked for these terms.
No
The device is described as diagnostic, used for sensing, recording, stimulation, and mapping, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states "Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures," and the "Device Description" states "Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters...".
No
The device description explicitly details hardware components (hand piece, flexible shaft, distal tip with electrodes) and the performance studies focus on hardware-related testing (biocompatibility, reprocessing validation, sterilization, function tests, packaging).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures." This describes a procedure performed within the body (in vivo) to gather electrical information about the heart.
- Device Description: The description details a catheter with electrodes designed to be positioned endocardially (inside the heart). This is consistent with an in vivo device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a patient's health. The provided information does not mention any analysis of specimens or any in vitro testing.
Therefore, this device is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
- Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Product codes (comma separated list FDA assigned to the subject device)
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. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.
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
Prescription Use
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters.
- Biocompatibility
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended.
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.
K924109, K924163, K003452, K954651, K012708
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
K043393
1 of 2
SECTION B: 510(k) SUMMARY
10232 South 5 Ist Street Phoenix, Arizona 85044
TEL 480.763.5300 FAX 480,763,5310 Toll Free 888.888.3433 www.alliance-medical.com
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|------------|-----------------------------------------------------------------------------------|
| Contact: | Jenn Selvey |
Research and Development Specialist (480) 763-2950 (o) (480) 763-5310 (f) iselvey@alliance-medical.com
November 16, 2004 Date of preparation:
Trade/Proprietary Name: Reprocessed EP Technologies Name of device: Electrophysiology Catheters Common or Usual Name: Electrophysiology Catheter or Electrode Recording Catheter Classification Name: Electrode Recording Catheter
MAR 2 3 2005
Predicate device:
| K924109 | Steerocath Dx |
|---|---|
| K924163 | Polaris LE |
| K003452 | Polaris X |
| K954651 | Electrode Recording Catheter |
| K012708 | Reprocessed Electrophysiology Catheters |
Diagnostic electrophysiology (EP) catheters are specially Device description: designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.
- Reprocessed Electrophysiology Catheters are intended for Intended use: temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
- Reprocessed diagnostic EP catheters are indicated for Indications temporary intracardiac sensing, recording, stimulation, and statement: electrophysiology mapping of cardiac structures.
The design, materials, and intended use of Reprocessed Technological Electrophysiology Catheters are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed
Alliance Medical Corporation Reprocessed EP Technologies EP Catheters Traditional 510(k)
1
Image /page/1/Picture/0 description: The image shows handwritten text. The first line reads "K043393". The second line reads "2 of 2". The handwriting is somewhat rough, but the characters are still legible.
Electrophysiology Catheters is identical to the predicate devices in that the same standard mechanical design, marerials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
Alliance Medical Corporation's reprocessing of EP Technologies Electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations.
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters.
- Biocompatibility
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended.
Alliance Medical Corporation concludes that the modified device Conclusion: (the Reprocessed Electrophysiology Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings, conveying a sense of motion and progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2005
Alliance Medical Corporation c/o Ms. Jenn Selvey Research and Development Specialist 10232 South 51st Street Phoenix, AZ 85044
Re: K043393
K043393
Trade Name: Reprocessed EP Technologies Electrophysiology Catheters (See Enclosed List)
Trade Name: Reprocessed EP Technologies Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: January 19, 2005 Received: January 21, 2005
Dear Ms. Selvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) press.) presidentially equivalent (for the indications for use stated in the enclosure) the aveced predicate devices marketed in interstate for use stated in the encrosure) to regally manative in commerce prior to May 20, 1770, the enascance with the provisions of the Federal Food, Drug, devices that have bech recalismed in asserval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicati and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 abs. 19) ins. Existing major regulations affecting your device can hiay be subject to such additional controller. Entroller of the 21, Parts 800 to 898. In addition, FDA may the found in the Gods acements concerning your device in the Federal Register.
3
Page 2 - Ms. Jenn Selvey
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a budenice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of ally reachardes and regularents aincluding, but not limited to: registration and listing (21 Comply with an the Hot 810 CFR Part 801); good manufacturing practice requirements as set CTN Fart 807), rabeing (21 OFR 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 pro horoms (seting your device as described in your Section 510(k) This icher wifi anow you to oegin maining of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of basification 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 acrisoliation of (240) 276-0120 Also, please note the regulation entitled, Connect the Office of Comparket 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
Sincerely yours,
B. Limmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 – Ms. Jenn Selvey
Г
..
| Orig models found to be SE |
|---|
| EPT-Dx (5) |
| 1101 |
| 1102 |
| 1103 |
| 1300 |
| 1301 |
| Valve Mapper SteeroCath-Dx (7) |
| 2200 |
| 2250 |
| 2270 |
| 2250K2 |
| 2270K2 |
| 2270L |
| 2270N4 |
| Polaris-Dx (15) |
| 5571 |
| 5572 |
| 5574 |
| 5570S |
| 5571S |
| 5572S |
| 5573S |
| 5574S |
| 5577 |
| 5579 |
| 5427S |
| 9663S |
| 5575 |
| 5576 |
| 5578 |
| Polaris LE Mapping (2) |
| 5593 |
| 5595 |
.
5
Indications for Use Statement 2.
510(k) Number (if known):
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed EP Technologies Electrophysiology (EP) Catheters
Indications for Use: Reprocessed diagnostic EP catheters are indicated for Indications for ooking, recording, stimulation, and electrophysiology mapping of cardiac structures.
Prescription Use
(per 21 CFR 801.109)
✓
or
Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hummer
Division Sign-Of Division of Cardlovascular Devices 510(k) Number