(207 days)
Not Found
No
The document describes a reprocessed medical device (EP catheter) and its intended use, focusing on its physical characteristics and performance testing related to reprocessing and function. There is no mention of AI, ML, or any related computational techniques.
No
The device is indicated for sensing, recording, stimulation and mapping, which are diagnostic and procedural guidance functions, not therapeutic interventions.
Yes
The "Intended Use / Indications for Use" states "temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures," and the "Device Description" section explicitly calls them "Diagnostic electrophysiology (EP) catheters," used for "endocardial recording or stimulation." These functions are characteristic of diagnostic devices.
No
The device description explicitly details physical components like a handpiece, flexible 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 clearly states "temporary intracardiac sensing, recording, stimulation and electrophysiological 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 be positioned endocardially (inside the heart). This is a physical device used for direct interaction with the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body). IVDs are typically used to diagnose conditions based on the analysis of these specimens.
Therefore, this device falls under the category of a medical device used for diagnostic and therapeutic procedures in vivo (within the body), not an IVD.
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 (EP) 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
cardiac structures (intracardiac)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.)
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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.
K992965 Cordis Webster Fixed Curve Catheters, Models D-11
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 seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal, there is a stylized representation of three human profiles facing to the right, with three parallel lines above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2004 NOV
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, AZ 85044
Re: K030109 - Supplemental Validation Submission 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 9, 2003 Received: January 13, 2003
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 8, 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 - K030109
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,
B. Zimmer, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Page 3 – K030109
1000 - 1000
.
:
.
.
Enclosure – List of Devices
| K030109 |
|---|
| Models [OEM, (n)] |
| (n = 38) |
| Cordis Webster (38) |
| 1086-182-RT |
| 1086-223-RT |
| 1086-259-S |
| 1086-463-S |
| 1086-508-S |
| 1086-515-RT |
| 1086-577-S |
| F5-QA-005-PS |
| F5-QA-252-PS |
| F5-QD-005-PS |
| F5-QF-005-PS |
| F5-QF-005-TS |
| F5-QF-010-PS |
| F5-QL-005-PS |
| F6-20T-282-FS |
| F65-QA-005-PS |
| F6-DF-252-FS |
| F6-HA-002-FS |
| F6-HA-002-RT |
| F6-HF-002-TS |
| F6-HF-005-FS |
| F6-HF-010-TS |
| F6-OA-002-TS |
| F6-OF-002-FS |
| F6-QA-002-PS |
| F6-QA-005-PS |
| F6-QA-005-RT |
| F6-QA-010-PS |
| F6-QA-252-PS |
| F6-QD-002-PS |
| F6-QD-005-PS |
| F6-QD-010-PS |
| F6-QF-002-PS |
| F6-QF-005-PS |
| F6-QF-010-PS |
| F6-QF-010-TS |
3
1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
Image /page/3/Picture/1 description: The image shows a label with the text "K030109" at the top, followed by "Models [OEM (n))". Below this, the text "(#=38)" is visible. The label also contains two lines of text: "F6-QF-252-PS" and "F6-QL-005-PS". The text appears to be machine-printed on a label, which is likely affixed to a product or component.
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Carlos Concession
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4
Indications for Use Statement II.
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 (EP) Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K030109 |
| Prescription Use | X | or | Over-the-Counter Use ______ |
|---|---|---|---|
| (per 21 CFR 801.109) |
Alliance Medical Corporation Reprocessed Electrophysiology Catheters Traditional 510(k)
13
5
AUG - 8 2003
Image /page/5/Picture/1 description: The image shows the text "KO30109" in a stylized, handwritten font. Below the text, there are three curved lines that resemble brush strokes, adding a decorative element to the image. The text and lines are black against a white background.
A L L I A N C E
MEDICAL CORPORATION
g
PART B: 510(k) SUMMARY
| | 10232 South 51st Street
Phoenix, Arizona 85044 | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 | TEL 480.763.5300
FAX 480.763.5310
Toll Free 888.888.3433
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): | K992965 Cordis Webster Fixed Curve Catheters, Models D-11 | |
| 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. | |
| 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 | |
6
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.
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters.
- Biocompatibilitv ●
- 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.