(62 days)
No
The summary describes a standard medical device (EP catheter) and its reprocessing. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on standard device testing like biocompatibility and sterilization.
No.
The device is indicated for sensing, recording, stimulation, and mapping of cardiac structures, 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." The intended use also mentions "intracardiac sensing, recording, stimulation and electrophysiological mapping," which are diagnostic functions.
No
The device description clearly outlines physical components like a hand piece, flexible shaft, and electrodes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for sensing, recording, stimulation, and mapping of cardiac structures. This is an in vivo application.
- Device Description: The description details a catheter with electrodes designed to be positioned endocardially (inside the heart). This further supports an in vivo use.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is the defining characteristic of an IVD.
Therefore, this device falls under the category of a medical device used for diagnostic and therapeutic procedures within the patient's body, 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. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures, atria of the 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
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters. This included the following tests: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation. Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
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
082023
:
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Contact: | Amanda Babcock
Regulatory Affairs Specialist
(480) 763-5376 (o)
(480) 763-6089 (f)
ababcock@ascenths.com | |
| Date of preparation: | July 15, 2008 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology
Catheters
Classification Name: Electrode recording catheter or electrode
recording probe | |
| Predicate Device | 510(k) Title | Manufacturer |
| K031161 | Lasso™ 2515 Variable Circular
Mapping Catheter | Biosense Webster, Inc. |
| K002333 | Lasso™ Deflectable Circular
Mapping Catheter | Biosense Webster, Inc. |
| 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. | |
| Indications for Use: | Reprocessed Electrophysiology Catheters are indicated for
temporary intracardiac sensing, recording, stimulation, and
electrophysiology mapping of cardiac structures. In addition, the
Lasso® 2515 Variable Circular Mapping Catheter is designed
for electrophysiological mapping of the atria of the heart. | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Electrophysiology Catheters are identical to the predicate
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. In addition, Ascent
Healthcare Solutions' reprocessing of Electrophysiology
Catheters includes removal of adherent visible soil and | |
Reprocessed Electrophysiology Catheters
1
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 Reprocessed Electrophysiology Catheters. This included the following tests:
- . Biocompatibility
- Validation of reprocessing ●
- Sterilization Validation .
- Function test(s) .
- Packaging Validation .
Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.
Ascent Healthcare Solutions concludes that the modified Conclusion: devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions c/o Ms. Amanda Babcock Regulatory Affairs Specialist, 10232 South 51st Street Phoenix, AZ 85044
Re: K082023
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 (two) Product Code: NLH Dated: July 15, 2008 Received: July 16, 2008
Dear Ms. Babcock:
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. Ilisting 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. Amanda Babcock
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
e. Attebery
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Ms. Amanda Babcock
List of Models Found SE:
.
.
| Item No. | Description | Electrodes | French
Size | Electrode
Spacing | Lasso
Diameter | Insertion
Length | Curve
Type |
|--------------------|--------------------------------------------|------------|----------------|----------------------|-------------------|---------------------|---------------|
| D7-L10-2515-
RT | Lasso 2515
Variable Mapping
Catheter | 10 | 7Fr | 8mm | 25-15 mm | 115 cm | Lasso |
| D7-L20-2515-
RT | Lasso 2515
Variable Mapping
Catheter | 20 | 7Fr | 2-6-2 mm | 25-15mm | 115 cm | Lasso |
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
082023
Device Name: Reprocessed Electrophysiology Catheters
Indications For Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
for Buckerman
vision Sianvision of Cardiovascular Devices
K082023 510(k) Number
Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)
Page 12