(249 days)
Not Found
No
The summary describes a reprocessed medical device (EP catheter) and its intended use for sensing, recording, stimulation, and mapping. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies. The performance studies focus on reprocessing validation, sterilization, and basic functional/performance testing, not on algorithmic performance metrics.
No
Explanation: The device is described as diagnostic, used for sensing, recording, stimulation, and mapping, which are diagnostic functions, not therapeutic.
Yes
The device description explicitly states, "Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation." Additionally, the predicate devices listed are "Marinr Series EP Diagnostic Catheters" and "Stablemapr Steerable Intracardiac Catheters," further supporting its diagnostic function.
No
The device description clearly outlines physical components like a handpiece, flexible shaft, and electrodes, indicating it is a hardware device. The performance studies also focus on testing the physical characteristics and reprocessing of these hardware components.
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 electrophysiological mapping of cardiac structures." This describes a device used within the body for diagnostic and therapeutic procedures, not a device used to examine specimens outside the body (which is the definition of an IVD).
- Device Description: The description details a catheter with electrodes designed to be positioned endocardially. This further reinforces its use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device is a medical device used for in-vivo procedures, 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 (comma separated list FDA assigned to the subject device)
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
Intracardiac
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)
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
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
1 2004 NoW
K030279 - Supplemental Validation Submission Re: Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter and Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: NLH & DSA Dated: January 24, 2003 Received: January 27, 2003
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on October 3, 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 - K030279
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.
Blymmmon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Page 3 – K030279
Enclosure – List of Devices
| K030279 Models |
|---|
| [OEM, (n)] |
| (n=6) |
| Medtronic (6) |
| 043302M |
| 043325M |
| 043328M |
| 04401SM |
| 04402SM |
| 072322M |
.
.
3
Indications for Use Statement 11.
KO30279 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. De Cert
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030279
Prescription Use
(per 21 CFR 801.109)
or
Over-the-Counter Use __
nce Medical Corporatio montvslology ( fitional 510/k
13
4
OCT 03 2003
PART B: 510(k) SUMMARY
Image /page/4/Picture/2 description: The image shows the logo for Alliance Medical Corporation. Above the logo is the text "KO30279 p 1/2". The logo itself is a stylized image of three curved lines above the company name, which is written in a serif font.
MEDICAL CORPORATION
TEL 480.763.5300
FAX 480.763.5310
Free 888.888.888.3433
Free 888.888.888.3433
alliance-medical.com
| Submitter: | Alliance Medical Corporation 10232 South 51 st Street Phoenix, Arizona 85044 | TEL 480.763.5300 FAX 480.763.5302 Toll Free 888.888.3424 www.alliance-medical.com |
|---|---|---|
| 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): | Legally marketed Electrophysiology Catheter devices under various 510(k) premarket notifications. | |
| K931794 Marinr Series EP Diagnostic Catheters K951347 Marinr Series EP Diagnostic Catheters K981642 Stablemapr Steerable Intracardiac 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 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. | |
| Reprocessed electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies. |
5
The design, materials, and intended use of Reprocessed Technological Electrophysiology (EP) Catheters are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed Electrophysiology (EP) 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 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.
030279
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