(29 days)
Not Found
No
The description focuses on the physical characteristics and function of a steerable catheter for electrogram recording and stimulation, with no mention of AI or ML capabilities.
No.
The device is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies and mapping the atrial regions of the heart, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies" and is "indicated for mapping the atrial regions of the heart," which are diagnostic activities.
No
The device description clearly describes a physical catheter with electrodes, a connecting cable, and a steerable handle, 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 is for "electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies" and "mapping the atrial regions of the heart." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The description details a physical catheter inserted into the body to interact directly with cardiac tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or using reagents. The device is used to record electrical signals and stimulate the heart directly.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic and diagnostic tool used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Inquiry™ AFocus™, Inquiry™ AFocus IITM, or Inquiry™ Optima™ Steerable Electrophysiology Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheter is designed to map the atrial regions of the heart.
Product codes
DRF
Device Description
The Inquiry™ AFocus™, Inquiry™ AFocus IITM, or Inquiry™ Optima™ 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 loon 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 shaft and/or loop is 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
electrophysiologist
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™ AFocus II™, 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
K0427
page 1
Confidential
Special 510(k)
NOV - 4 2004 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.
1. Submitter's name, address, telephone number, contact person, and date summary prepared:
| a. | Submitter: | Irvine Biomedical, Inc.
2375 Morse Avenue
Irvine, CA 29612
Tel. (949) 851-3053 |
|----|-----------------|--------------------------------------------------------------------------------------------|
| b. | Contact Person: | Bonnie Bishop
Director, Regulatory Affairs and Quality Assurance
Tel. (949) 851-3053 |
- Date Summary Prepared: June 18, 2004 C.
2. Name of device, including trade name and classification name:
| a. | Trade/Proprietary Name: | InquiryTM AFocusTM, InquiryTM AFocus IITM, or
InquiryTM OptimaTM Steerable Electrophysiology
Catheter |
|----|-------------------------|-------------------------------------------------------------------------------------------------------------|
| b. | Classification names: | Catheter, Electrode Recording |
3. 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 |
| 510(k): | K010471 |
| Date Cleared: | June 6, 2001 |
| Company: | Irvine Biomedical, Inc. |
| Device: | IBI-1100 Inquiry™ Steerable Electrophysiology Catheter System |
| 510(k): | K961924 |
| Date Cleared: | April 11, 1997 |
1
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™ AFocus™, Inquiry™ AFocus IITM, or Inquiry™ Optima™ 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 loon 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 shaft and/or loop is 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.
5. Statement of intended use:
The Inquiry™ AFocus™, Inquiry™ AFocus IITM, or Inquiry™ Optima™ Steerable Electrophysiology Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheter is designed to map the 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™ AFocus™, Inquiry™ AFocus II™, or Inquiry™ Optima™ 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.
7. Brief summary of nonclinical tests and results:
The test plan for the Inquiry™ AFocus™, Inquiry™ AFocus II™, 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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2004
Irvine Biomedical, Inc. c/o Ms. Bonnie Bishop Director, Regulatory Affairs and Quality Assurance 2375 Morse Avenue Irvine, CA 92614
Re: K042775
K042773
Trade Name: Inquiry" AFocus™ Steerable Electrophysiology Catheter
Trade Name: Inquiry" AFocusII™ Steerable Electrophysiology Catheter Inquiry " Optima" Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: October 1, 2004 Received: October 6, 2004
Dear Ms. Bishop:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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). and Cosmette Herefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelove, manes as 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 rr your de vice to such additional controls. Existing major regulations affecting your device can thay be subject to basil adall 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. Bonnie Bishop
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat 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 premainer netition on "ceresults 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 may be obtained from the Ourision 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,
Bhimmerfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Irvine Biomedical, Inc.
Inquiry™ AFocus™, AFocus II™ & Optima™ Electrophysiology Catheter | Confidential
Special 510(k) |
| ---------------------------------------------------------------------------------------------- | -------------------------------- |
|---|
Indications for Use Statement
| 510(k) Number (if known): | K042775 | Page 1 of 1 |
|---|---|---|
| Device Name: | Inquiry™ AFocus™ Steerable Electrophysiology Catheter | |
| Inquiry™ AFocus II™ Steerable Electrophysiology Catheter | ||
| Inquiry™ Optima™ Steerable Electrophysiology Catheter |
Indications for Use:
The Steerable Electrophysiology Catheter is used for electrogram recording and cardiac
stimulation during diagnostic electrophysiologic studies. The catheter is indicated for mapping
the atrial regions of the heart.
| Prescription Use
| (Per 21 CFR 801.109) | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | ---------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bmmuna
(Division Sign-Off)
(Division of Cardiovasculiar Devices
Division of Cardiovasculiar Devices
510(k) Number_______________________________________________________________________________________