(119 days)
Not Found
No
The summary describes a reprocessed medical device (electrophysiology catheters) and its intended use, device description, and performance testing. There is no mention of AI, ML, or any related technologies in the provided text. The focus is on the physical device and the reprocessing procedures.
No.
The device is used for sensing, recording, stimulation, and mapping, which are diagnostic and monitoring functions, not therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures," and the "Device Description" section begins with, "Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters..." This indicates its primary function is diagnostic.
No
The device description clearly states it is a physical catheter with a handpiece, flexible shaft, and electrodes, and the summary describes reprocessing and testing of this physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures." This involves interacting directly with the patient's body to gather electrical signals from the heart.
- Device Description: The description details a catheter with electrodes that are positioned inside the body for recording or stimulation.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
The device described is a medical device used for in vivo (within the living body) procedures, specifically electrophysiology studies of the heart.
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 structures (heart)
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.
K894500, K913940, K942379, K002976, 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2004
Alliance Medical Corporation c/o Ms. Moira Barton Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044
Re: K030026
Trade Name: Reprocessed Electrophysiology (EP) Catheters & Cables 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: April 7, 2003
Dear Ms. Barton:
Received: April 7, 2003
This letter corrects our substantially equivalent letter of May 02, 2003 regarding one of the product codes for your devices. The code was erroneously written as NHL when it should have been NLH.
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.
1
Page 2 - Ms. Moira Barton
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 (QS) 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 (301) 594-4646. 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,
Blyumman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
II. Indications for Use Statement
K030026 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)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K050026 |
|---|---|
| --------------- | --------- |
| Prescription Use (per 21 CFR 801.109) | or | Over-the-Counter Use | __________ | |
|---|---|---|---|---|
| --------------------------------------- | ---------------------------------------------------------- | ---- | ---------------------- | ------------ |
CONFIDENTIAL
Alliance Medical Corporation
Reprocessed Electrophysiology Catheters
Traditional 510(k)
13
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and converge, resembling a human figure in profile.
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: K030026 - 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 2, 2003 Received: January 3, 2003
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on May 2, 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.
4
Page 2 - K030026
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,
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
Page 3 – K030026
.
Enclosure – List of Devices
and the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of th
| K030026 |
|---|
| Models OEM (n)) |
| (total=37) |
| Daig (37) |
| 401206 |
| 401210 |
| 401211 |
| 401222 |
| 401223 |
| 401225 |
| 401226 |
| 401227 |
| 401228 |
| 401260 |
| 401261 |
| 401262 |
| 401275 |
| 401276 |
| 401281 |
| 401287 |
| 401305 |
| 401306 |
| 401309 |
| 401311 |
| 401328 |
| 401353 |
| 401356 |
| 401357 |
| 401362 |
| 401379 |
| 401380 |
| 401381 |
| 401382 |
| 401383 |
| 401386 |
| 401389 |
| 401392 |
| 401393 |
| 401399 |
| 401400 |
.
6
Page 4 - K030026
1
Image /page/6/Figure/1 description: The image shows a label with the text "K030026" at the top, followed by "M.4.1.1.5 OEM1" in the middle, and "L-370" below that. At the bottom of the label, there is a box with the number "401401" inside. The text is in black and the background is a light gray color.
100 Career States
: 上一篇:
- Participant
: 2017-02-20 1
7
AY - 2 2003
Image /page/7/Picture/1 description: The image shows the text "K030026" on the top line and "Q1/2" on the bottom line. The text is written in a handwritten style, with thick, dark strokes. The numbers and letters are clearly legible, although the handwriting is not perfectly neat.
Image /page/7/Picture/2 description: The image shows the word "ALLIANCE" in a serif font, with a stylized graphic above it. The graphic consists of three curved lines that are thick and black. The lines are arranged in a parallel fashion, with the top line being the shortest and the bottom line being the longest, creating a sense of depth and movement.
RATION
PART B: 510(k) SUMMARY
| 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 | TEL 480.763.53
FAX 480.763.53
Toll Free 888.888.34
www.alliance-medical. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Contact: | Moira Barton
Senior Regulatory Affairs Specialist
(480) 763-5300 (o)
(480) 763-5310 (f) | |
| Date of preparation: | 12/30/2002 | |
| 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): | Daig Response™ legally marketed Electrophysiology Catheter
devices under various 510(k) premarket notifications. | |
| | K894500 Daig Electrophysiology Catheter
K913940 Response™ Steerable Catheter
K942379 Daig Diagnostic Electrophysiology Catheter
K002976 Daig Electrophysiology Catheter - Response™ and Supreme™
K012708 Reprocessed 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 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. | |
8
K030026
p.2/2
| Technological characteristics: | The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters and Electrophysiology Catheter Cables are identical to the predicate devices. The mechanism of action 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. |
| BiocompatibilityValidation of reprocessingSterilization ValidationFunction 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. |
.