(246 days)
Not Found
No
The document describes a reprocessed medical device and its intended use, focusing on physical components and reprocessing procedures. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as being used for "sensing, recording, stimulation and electrophysiological mapping," which are diagnostic functions, not therapeutic. It helps in understanding the heart's electrical activity rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section states "temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures," and the "Device Description" explicitly mentions "Diagnostic electrophysiology (EP) catheters." These phrases indicate the device's role in diagnosing cardiac conditions.
No
The device description clearly outlines a physical medical device (catheter) that is being reprocessed, not a software-only device.
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 electrophysiological mapping of cardiac structures." This describes a device used within the body to interact with and measure physiological signals, not a device used to examine specimens outside the body.
- 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: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or performing tests on samples outside the body. The device's function is to interact directly with the patient's cardiac electrical activity.
Therefore, this device falls under the category of an in-vivo diagnostic or therapeutic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Reprocessed Electrophysiology Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
Product codes
NLH, DSA
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 handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable 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
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)
Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
K891908, K874208, K881966, K992373
Reference Device(s)
Not Found
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/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2004
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix. AZ 85044
Re: K030187 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 & 870.2900 Regulation Name: Electrode Recording Catheter and Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: NLH & DSA Dated: January 17, 2003 Received: January 21, 2003
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on September 24, 2003. 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 - K030187
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 littp://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Bfimmuman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Page 4 – K030187
Enclosure – List of Devices
:
| Bard (24) |
|---|
| 200131 |
| 200344 |
| 200526 |
| 200740 |
| 200769 |
| 200770 |
| 200794 |
| 200795 |
| 200796 |
| 200797 |
| 200798 |
| 201101 |
| 201102 |
| 201103 |
| 201104 |
| 201105 |
| 201106 |
| 201107 |
| 201109 |
| 201114 |
| 320001 |
| 320002 |
| 7FAM00004 |
| 7FAM00007 |
:
: 上一篇:
.
3
Indications for Use Statement ll.
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Electrophysiology (EP) Catheters
Indications for Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Indications for Use: Reprocessed Electrophysiology Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
Concurrence of CDRH, Office of Device Evaluation (ODE)
N. Q. Cetter
diovascular Devices
510(k) Number K030187
Prescription Use
(per 21 CFR 801.109)
ОГ
Over-the-Counter Use
Alliance Medical Corporation Reprocessed Electrophysiology Catheters Traditional 510(k)
4
Image /page/4/Picture/1 description: The image shows the text "p. 1/2" in the upper left corner. Below the text are three curved lines stacked on top of each other. The lines are thick and black, and they curve upwards.
A L L I A N C E
MEDICAL CORPORATION
PART B: 510(k) SUMMARY
SEP 2 4 2003
8.5100
8.5310
8.12.2018 12.00 10.000
2.1.2018
1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 | TEL 480.763
FAX 480.763
Toll Free 888.888
www.alliance-medic |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Contact: | Moira Barton
Senior Regulatory Affairs Specialist
(480) 763-5300 (o)
(480) 763-5310 (f) | |
| Date of preparation: | 6/13/2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology
Catheter
Common or Usual Name: Electrophysiology Catheter or
Electrode Recording Catheter
Classification Name: Electrode Recording Catheter | |
| Predicate device(s): | | |
| | K891908 Bard Tip Deflecting Electrode Catheter
K874208 Bard Octapolar Electrode Catheter
K881966 Electrophysiology Electrode Catheter with Silver/Silver
K992373 Orbiter ST Diagnostic Electrode Catheter | |
| 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 handpiece, a flexible
shaft and a distal tip section containing diagnostic electrodes.
The distal tips of deflectable catheters can be deflected into a
curve by manipulating the handpiece; fixed curve catheters have
an established distal tip shape. | |
| Intended use: | Reprocessed Electrophysiology Catheters are intended for
temporary intracardiac sensing, recording, stimulation, and
electrophysiological mapping of cardiac structures. | |
| Indications
statement: | Reprocessed diagnostic EP catheters are indicated for
temporary intracardiac sensing, recording, stimulation and
electrophysiological mapping of cardiac structures. | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Electrophysiology (EP) Catheters are identical to the predicate
devices. The mechanism of action of Reprocessed
Electrophysiology (EP) Catheters is identical to the predicate | |
5
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 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)
Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended.
Conclusion: Alliance Medical Corporation concludes that the modified device (the Reprocessed Electrophysiology (EP) Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.