(120 days)
Not Found
No
The device description focuses on the mechanical and electrical components of a diagnostic EP catheter for mapping cardiac structures. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are focused on the physical and functional integrity of the reprocessed device.
No.
The device's intended use is for "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This indicates a diagnostic purpose (identifying issues) rather than a therapeutic one (treating issues).
Yes
The "Intended Use / Indications for Use" section explicitly states "The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." The term "Diagnostic" and "mapping" directly indicate its use for diagnosis.
No
The device description clearly details a physical catheter with electrodes, a steerable tip, and a handpiece with mechanical controls, 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 is "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This describes a procedure performed within the body (in vivo) to assess electrical activity.
- Device Description: The description details a catheter designed to be inserted into the coronary sinus for mapping and stimulation. This is an invasive procedure.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside the body. IVDs are specifically designed for testing these types of samples in a laboratory setting.
Therefore, this device is a medical device used for an in-vivo diagnostic procedure, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
NLH
Device Description
The reprocessed Biosense Webster® Coronary Sinus (CS) EZ STEER™ Diagnostic Electrophysiology (EP) Catheter (hereinafter CS Bi-Directional Diagnostic EP Catheter) is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a braided bi-directional deflectable tip section containing platinum electrodes that can be used for recording and stimulation. Two asymmetric curve types, DF and FJ, are available providing two 180° opposed, single plane curves. The rocker lever located on the handpiece is used to deflect the tip section. A Friction Control Knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip at the preferred site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures, coronary sinus
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 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 (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
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | | MAY 2 8 2010 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|--------------|
| Contact: | Amanda Babcock
Senior Regulatory Affairs Specialist
(480) 763-5300 (o)
(863) 904-2312 (f)
ababcock@ascenths.com | | |
| Date of preparation: | January 27, 2010 | | |
| Name of device: | Trade/Proprietary Name: Reprocessed CS Bi-Directional
Diagnostic Electrophysiology Catheter
Classification Name: Electrode recording catheter or electrode
recording probe | | |
| Predicate Device
K050877 | 510(k) Title
Coronary Sinus Deflectable Mapping
Catheter | Manufacturer
Biosense Webster, Inc. | |
| Device description: | The reprocessed Biosense Webster® Coronary Sinus (CS) EZ
STEER™ Diagnostic Electrophysiology (EP) Catheter
(hereinafter CS Bi-Directional Diagnostic EP Catheter) is a
steerable, multi-electrode catheter with a deflectable tip
designed to facilitate electrophysiological mapping of the heart.
The device is a 7FR catheter with a usable length of 115 cm.
The catheter has a high-torque shaft with a braided bi-
directional deflectable tip section containing platinum electrodes
that can be used for recording and stimulation. Two asymmetric
curve types, DF and FJ, are available providing two 180°
opposed, single plane curves.
The rocker lever located on the handpiece is used to deflect the
tip section. A Friction Control Knob is located on the opposite
side of the rocker lever and can be rotated clockwise to lock
both the tip curve and rocker lever in place. The high torque
shaft allows the plane of the curved tip to rotate, enabling
accurate positioning of the catheter tip at the preferred site. | | |
| Indications for Use: | The Reprocessed CS Bi-Directional Diagnostic EP Catheter is
indicated for electrophysiological mapping of cardiac structures;
i.e., stimulation and recording only. The catheter is designed for
use in the coronary sinus. | | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed CS Bi-
Directional Diagnostic EP Catheters are identical to the | | |
Ascent Healthcare Solutions Reprocessed Coronary Sinus Bi-Directional Diagnostic Electrophysiology Catheter
Traditional 510(k)
.
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Page 13
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predicate devices. The mechanism of action of Reprocessed CS Bi-Directional Diagnostic 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. In addition, Ascent Healthcare Solutions' reprocessing of CS Bi-Directional Diagnostic EP Catheters includes removal of adherent visible soil and decontamination. Each individual CS Bi-Directional Diagnostic EP 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 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 devices (Reprocessed CS Bi-Directional Diagnostic EP Catheter) are safe, effective, and substantially equivalent to the predicate devices as described herein.
Conclusion:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a distinctive design of intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ascent Healthcare Solutions c/o Ms. Amanda Babcock Senior Regulatory Affairs Specialist, 10232 South 51st Street Phoenix, AZ 85044
MAY 2 8 2010
Re: K100254
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: May 19, 2010 Received: May 21, 2010
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, 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.
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,
W. Wood.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 – Ms. Amanda Babcock
. . . . .
List of Models Found SE:
:
.
.
| Item No. | Description | French
Size | Insertion
Length | Curve Type |
|---------------|--------------------------------------------------------------------|----------------|---------------------|---------------------------------------------------------------------------|
| BD710FJ282RTS | Biosense Webster
CS Bi-Directional
Diagnostic EP
Catheter | 7Fr | 115 cm | B-directional;
J curve with a
10.2 cm
deflectable
span length |
| BD710DF282RTS | Biosense Webster
CS Bi-Directional
Diagnostic EP
Catheter | 7Fr | 115 cm | Bi-directional;
D curve with
6.4 cm
deflectable
span length |
:
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Reprocessed Coronary Sinus Bi-Directional Diagnostic Electrophysiology Catheter
Indications For Use:
The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
Prescription Use _ × (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)
W.M.D.
ision Sign-Off) sion of Cardiovascular Devices
510(k) Numbe
Page 12