(75 days)
Not Found
No
The summary describes a standard medical device for electrophysiology and does not mention any AI or ML components or capabilities.
No
The device is indicated for "temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping," which are diagnostic functions, not therapeutic interventions.
Yes
The device is explicitly referred to as "Diagnostic Electrophysiology Catheters" and its intended use includes "sensing, recording... and electrophysiology mapping," which are diagnostic functions.
No
The device description clearly outlines a physical medical device (catheter) with a hand piece, flexible shaft, and electrodes. The performance studies also focus on physical aspects like biocompatibility, reprocessing, sterilization, and function tests, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures." This describes a device used within the body to interact with and measure electrical activity of the heart.
- Device Description: The description details a catheter with electrodes designed to transmit and record electrical impulses endocardially (within the heart).
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not process or analyze biological specimens in this manner.
The device is a medical device used for diagnostic and therapeutic procedures in vivo (within a living organism), not in vitro (in glass/outside the body).
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 Electrophysiology 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.
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.
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)
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, K043393
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
Kosa414
·
NOV 1 6 2005
SECTION B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Elizabeth Renken
Regulatory Affairs Specialist
(480) 763-5300 (o)
(480) 763-5310 (f)
erenken@alliance-medical.com |
| Date of preparation: | August 26, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology
Catheters
Common or Usual Name: Electrophysiology Catheter or
Electrode Recording Catheter
Classification Name: Electrode Recording Catheter |
| Predicate device: | |
| K924109
K924163
K003452
K954651
K012708
K043393 | Steerocath Dx
Polaris LE
Polaris X
Electrode Recording Catheter
Reprocessed Electrophysiology Catheters
Reprocessed EP Technologies Electrophysiology Catheters |
| 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. |
| Intended use: | Reprocessed Electrophysiology Catheters are intended for
temporary intracardiac sensing, recording, stimulation, and
electrophysiology mapping of cardiac structures. |
| Indications
statement: | Reprocessed Diagnostic Electrophysiology Catheters are
indicated for temporary intracardiac sensing, recording,
stimulation, and electrophysiology mapping of cardiac
structures. |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Electrophysiology Catheters are identical to the predicate |
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K052414". The characters are written in a dark ink on a white background. The handwriting is somewhat messy and uneven.
devices. The mechanism of action of Reprocessed Electrophysiology Catheters is identical to the predicate devices in that the same standard mechanical design, materials 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.
Performance data: 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.
Conclusion:
Alliance Medical Corporation concludes that the modified device (the Reprocessed Electrophysiology Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a snake-like form at the bottom. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2005
Alliance Medical Corporation c/o Ms. Elizabeth Renken, Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044
Re: K052414
Trade Name: Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: August 26, 2005 Received: September 2, 2005
Dear Ms. Renken:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it 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 device in the Federal Register.
3
Page 2 - Ms. Elizabeth Renken
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies 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 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 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/industry/support/index.html.
Sincerely vours,
B.Jimmumfor
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. Elizabeth Renken
List of Models:
...
| 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
55708
55718
55728
55738
5574S
5577
5579
54278
તેરણે તે જણાવતા વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્યત્વે આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી,
ર્રતત્
5576
5578
Polaris LE Mapping (2)
ર રેતે 3
ર રતેર
SteeroCath-Dx (2)
2027BL
and the same of the same of the same of the same of the same of the same of the states of the seat the states of the states of the states of the states of the states of the s
2028BL
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | EP Technologies, Inc., Mo |
|---|---|
| ______________________________________________________________________________________________________________________________________________________________________________ | |
| and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of | |
| and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s | |
5
Indications for Use
510(k) Number (if known): K052414
Device Name: Reprocessed Electrophysiology Catheters
Indications For Use: Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Prescription Use X (Part 21 CFR 801 Subpart D)
: 10
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blythman
Division Sign-Off
(Division Sign-Off) Division of Cardlovascular Deyloss 510(k) Number 4/5 。
Alliance Medical Corporation Reprocessed Electrophysiology Catheter Traditional 510(k)
14