(51 days)
Not Found
No
The summary describes a reprocessed medical device (EP catheter) and its intended use and testing. There is no mention of AI, ML, or any computational analysis of data that would suggest the use of such technologies. The testing focuses on the physical and functional performance of the reprocessed device.
No
The device is described as diagnostic, used for sensing, recording, stimulation, and mapping, rather than treating a condition.
Yes
The device description explicitly states "Diagnostic Electrophysiology (EP) Catheters" and the "Intended Use / Indications for Use" mentions "electrophysiological mapping of cardiac structures."
No
The device description clearly states it is a physical catheter with 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 describes the device as being used for "temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures." This involves direct interaction with the patient's body to measure electrical activity within the heart.
- Device Description: The device description details a catheter with electrodes that transmit electrical impulses and are positioned for "endocardial recording or stimulation." This is a description of an invasive medical device used for diagnosis and potentially treatment within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples in vitro (outside the body).
Therefore, this device falls under the category of an in vivo diagnostic or therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
Reprocessed diagnostic 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 and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.
Product codes (comma separated list FDA assigned to the subject device)
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 (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
K090323
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | APR - 1 2005 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Contact: | Katie Bray
Regulatory Affairs Manager
(480) 763-5386 (o)
(480) 763-6089 (f)
kbray@ascenths.com | |
| Date of preparation: | February 6, 2009 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology
Catheters
Classification Name: Electrode recording catheter or electrode
recording probe | |
| Predicate Device
K072012 | 510(k) Title
Reflexion SpiralTM Variable Radius
Catheter | Manufacturer
St. Jude Medical |
| K062251 | Reflexion SpiralTM Variable Radius
Catheter | St. Jude Medical |
| 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 diagnostic 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 and the
Reflexion SpiralTM Variable Radius Catheter are 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 | |
:
·
and the state of the states of the states
:
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:
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Healthcare Solutions' 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 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.
Conclusion:
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.
Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2009
Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Manager, 10232 South 51st Street Phoenix, AZ 85044
Re: K090323
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: February 6, 2009 Received: February 9, 2009
Dear Ms. Bray:
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. Katie Bray
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,
signature
& 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. Katie Bray
List of Models Found SE:
. .
、
| Item
No. | Description | Electrodes | French
Size | Electrode
Spacing | Lasso
Diameter | Insertion
Length | Curve Type |
|-------------|----------------------------------------------------------|------------|----------------|----------------------|-------------------|---------------------|------------------------------------------|
| 402800 | Daig Reflexion™
Steerable EP
Catheter | 10 | 6Fr | 2-5-2 mm | N/A | 105 cm | Bi-Directional
Med Curl |
| 402804 | Daig Reflexion
Spiral™ Variable
Radius EP Catheter | 20 | 7Fr | 1-4-1 mm | 25-15 mm | 99 cm | Bi-Directional
90°/180°
Asymmetric |
| 402865 | Daig Reflexion
Spiral™ Variable
Radius EP Catheter | 10 | 7Fr | 6.30 mm | 25-15 mm | 99 cm | Bidirectional
180° |
| 401661 | Daig Reflexion™
Diagnostic EP
Connecting Cable | N/A | N/A | N/A | N/A | 150 cm | N/A |
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Reprocessed Electrophysiology Catheters
Indications For Use:
Reprocessed diagnostic 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 and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Atul Bhattar for B Zuckerman
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K090323
Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)