(88 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the catheter for recording and stimulation, with no mention of AI or ML for data analysis, interpretation, or device control.
No
The device is used for recording and mapping intracardiac signals during diagnostic electrophysiology studies, which is for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" states, "For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies." This explicitly indicates the device's role in diagnosis.
No
The device description clearly details a physical catheter with electrodes, a connecting cable, and a steerable handle, 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 "For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies." This describes a procedure performed within the patient's body (in vivo) to diagnose heart conditions by analyzing electrical activity.
- Device Description: The description details a catheter designed to be inserted into the heart to record electrical signals and potentially stimulate the heart. This is an invasive medical device used for diagnosis in vivo.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a patient's health. This device does not process or analyze biological specimens in this manner.
Therefore, the Inquiry AFocusII™ Bi-Directional Steerable Electrophysiology Catheter is a medical device used for in vivo diagnostic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping atrial regions of the heart.
Product codes
DRF
Device Description
The Inquiry AFocusII™ Bi-Directional Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices.
The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop are steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape.
The device is supplied sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial regions 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
The test plan for the Inquiry™ AFocus™, Inquiry AFocusII™, or Inquiry™ Optima™ Steerable Electrophysiology Catheter was based on the guidance document "Electrode Recording Catheter Preliminary Guidance, Draft Version", March 1995. Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product.
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
MAR 2 ] 2006
K05 3582
page 1 of 3
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.
- ﺎ . Submitter's name, address, telephone number, contact person, and date summary prepared:
Submitter: Irvine Biomedical, Inc.
2375 Morse Avenue Irvine, CA 92614 Tel. (949) 851-3053
Contact Person: Elvia Zavala Regulatory Affairs Associate Tel. (949) 271-1135 Date Summary Prepared: December 22, 2005 (Revised February 24, 2006)
-
- Name of device, including trade name and classification name:
| Trade/Proprietary Name: | Inquiry™ AFocusII™ Diagnostic Catheter |
|---|---|
| ------------------------- | ---------------------------------------- |
- b. Classification names: Catheter, Electrode Recording
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Irvine Biomedical, Inc. |
|---|---|
| Device: | Inquiry™ AFocus™ Steerable Electrophysiology Catheter, |
| Inquiry™ AFocusII™ Steerable Electrophysiology Catheter, | |
| Inquiry™ Optima™ Steerable Electrophysiology | |
| 510(k): | K042775 |
Date Cleared: November 4, 2004
- A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Inquiry AFocusII™ Bi-Directional Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at
RageNo
1
K053582
page 20 of 3
predetermined distances. A connecting cable is used to connect the catheter to electrogram devices.
The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop are steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape.
The device is supplied sterile and is intended for single use only.
-
Statement of intended use: న్.
For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping atrial regions of the heart. -
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.
The Inquiry AFocusII™ (bi-directional) Steerable Electrophysiology Catheter and its predicate devices are intended for electrogram recording and stimulation during electrophysiological studies. The modifications do not affect the intended use or scientific technology of the device, as embodied in the catheter. -
Brief summary of nonclinical tests and results: 7.
The test plan for the Inquiry™ AFocus™, Inquiry AFocusII™, or Inquiry™ Optima™ Steerable Electrophysiology Catheter was based on the guidance document "Electrode Recording Catheter Preliminary Guidance, Draft Version", March 1995. Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product. -
Comparison characteristics of uni-directional and bi-directional. 8.
The table below compares the design of unilateral catheter and bi-directional catheter.
| No. | Design | Inquiry AFocusIIT TM (Uni-Directional) Diagnostic Catheter | Inquiry AFocus TM (Bi-Directional) Diagnostic Catheter |
|---|---|---|---|
| 1 | Curve Configurations | SM curve | SM curve (symmetrical in both directions) |
| 2 | Electrodes | Platinum-iridium | Platinum-iridium |
| 3 | Tubing | Pebax (33 series) | Pebax (33 series) |
| 4 | Handle | Moves only way for | Moves up and down to allow |
2
Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text includes the identifier "K05-3582" on the first line. The second line reads "page 3 of 3", indicating this is the third page of a three-page document. The handwriting is in black ink and appears to be cursive.
| unidirectional steering | bidirectional steering | |
|---|---|---|
| 5 Pulling Wire | Contains one pulling wire | |
| for unidirectional steering | Contains two pulling wires for | |
| bidirectional steering | ||
| 7 Flat Wire | Contains a flat wire | Contains a flat wire with a tail |
| 8 Hypo tube | None | Contains a hypo tube that |
| contains two channels where | ||
| one of them supports the | ||
| pulling wire and the other | ||
| supports the flat wire and a | ||
| second pulling wire |
3
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a low-resolution image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 ] 2006
Irvine Biomedical, Inc. c/o Elvia Zavala Regulatory Affairs Specialist 2375 Morse Ave. Irvine, CA 92614
Re: K053582
K033762
Trade Name: Inquiry™ AFocus II™ Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Probe Regulatory Class: Class II (two) Product Code: DRF Dated: February 24, 2006 Received: February 27, 2006
Dear Ms. Zavala:
We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 910(x) premainted in the interest of in the indications
referenced above and have determined the device is substantially interests a referenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule for tegally manatible to the Medical Device American be and Food. Days commerce prior to May 28, 1776, the encenters and of the provisions of the Federal Food, Drug, devices that have been reclassified in accordance "Hat a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmelle Act (Act) that to not require appro the general controls provisions of the Act. The You may, increfore, market the device, subject to the memor registration, listing of
general controls provisions of the Act include requirements for annual registered in and general controls provisions of the Fee neides >> ]
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), in If your device is classffred (see above) me etails and one allecting your device can
may be subject to such additional controls. Existing major and contribution EDA move may be subject to such adultional controller estisons. Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar regular regular in the Federal Register. publish furner announcents concerning your as not issues and more of the more of the Act Please be advised that FDA s issualled of a saconamial squirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act
4
Page 2 - Ms. Elvia Zavala
or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 prematted 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
B. Ammerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ___K053582
Device Name: Inquiry AFocus II™ Diagnostic Catheter
Indications for Use: For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping atrial regions 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of Cardiovascular Device:
510(k) Number
Page 1 of 1
(Posted November 13, 2003)
B. Simmons
h Sign-Off Division of Cardiovascular Devices 510(k) Number