(29 days)
Not Found
No
The summary describes a physical catheter and its mechanical features for recording electrical signals. There is no mention of software analysis, algorithms, or any terms related to AI/ML.
No
The device is described as being used for "recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies" and to "map the atrial regions of the heart", which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies."
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" and "to map the atrial regions of the heart." This involves direct interaction with the patient's body to gather electrical signals from the heart.
- Device Description: The description details a physical catheter inserted into the body with electrodes for recording and stimulation.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVDs are designed to perform tests on these types of samples in a laboratory setting.
This device is an invasive medical device used for diagnostic procedures within the patient's body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Inquiry Optima Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima catheters are to be used to map the atrial regions of the heart.
Product codes
DRF
Device Description
The Inquiry Optima PLUS 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 shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop and on the shaft of the catheter 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The test plan for the Inquiry Optima PLUS Steerable Electrophysiology Catheter was based on the guidance document "Electrode Recording Catheter Preliminary Guidance, Draft Version", March 1995. The test results indicated reliable performance when the device was used in accordance with the Instructions for Use. The Inquiry Optima PLUS catheter does not raise new issues of safety, effectiveness, or performance of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
: | | | | 1 0 2006 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.
- Submitter's name, address, telephone number, contact person, and date summary l. prepared:
Submitter: Irvine Biomedical, Inc. 2375 Morse Avenue Irvine, CA 92614 Tel. (949) 851-3053
Contact: Dennis Hong Regulatory Affairs Manager Tel. (949) 271-1134 March 18, 2006 Date:
- Name of device, including trade name and classification name:
| a. | Trade/Proprietary Name: | Inquiry™ Optima™ PLUS Steerable
Electrophysiology 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 Optima Steerable Electrophysiology Catheter 510(k): K042775 Date Cleared: November 4, 2004
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
page 1 of 3
1
K ctc"fst Page 2
- 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 Optima PLUS 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 shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop and on the shaft of the catheter 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:
The Inquiry Optima Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima catheters are to be used to map the atrial regions of the heart.
- Statement of intended use:
-
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.
The Inquiry Optima and Inquiry Optima PLUS Steerable Electrophysiology Catheters are intended for electrogram recording and stimulation during electrophysiological studies. The modification in additional electrodes on the shaft of the Inquiry Optima PLUS catheter does not affect the intended use or scientific technology of the device. -
- Brief summary of non-clinical tests and results:
The test plan for the Inquiry Optima PLUS Steerable Electrophysiology Catheter was based on the guidance document "Electrode Recording Catheter Preliminary Guidance, Draft Version", March 1995. The test results indicated reliable performance when the device was used in accordance with the Instructions for Use. The Inquiry Optima PLUS catheter does not raise new issues of safety, effectiveness, or performance of the product.
- Brief summary of non-clinical tests and results:
page 2 of 3
2
The Inquiry Optima Steerable EP Catheter and the Inquiry Optima PLUS Steerable EP catheter are both intended to be used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. In comparison to the Inquiry Optima Steerable EP Catheter, the Inquiry Optima PLUS Steerable EP Catheter has 4 additional electrodes. The similarities and differences between these catheters are tabularized below.
Choorg
| Product Description | Inquiry Optima Steerable EP
Catheter (K042775) | Inquiry Optima PLUS Steerable
EP Catheter |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Variable loop, steerable diagnostic
catheter | Same |
| Size | 7Fr Shaft, 4-5Fr Loop | Same |
| Usable Length | 110cm | Same |
| Electrode Number on
Loop | 10 - 20 electrodes | 20 electrodes |
| Size (width, diameter) of
Electrode on Loop | 0.6 mm - 1.0 mm width
4 Fr - 5 Fr diameter | 1.0 mm width
5 Fr diameter |
| Electrode Number on
Shaft | None | 4 electrodes |
| Size (width, diameter) of
Electrode on Shaft | None | 1 mm width
7 Fr diameter |
| Distal Tip Electrode
(length, diameter) | 1 mm - 2 mm length,
4 Fr - 5 Fr diameter | 1mm length
5 Fr diameter |
| Electrodes Material | Platinum / Iridium | Same |
| Electrode Profile | Each band has adhesive applied on
both ends of the electrode | Same |
| Type of Curve | The catheter has a uni-direction 0-
180° deflectable distal end, SM
curve and an adjustable loop | Same |
| Loop Size | Adjustable, minimum is 15mm
diameter, maximum is 25mm
diameter | Same |
| Type of Catheter Outer
Shaft | 7 Fr size, non braided on distal,
braided on proximal | Same |
| Material of Catheter
Outer Shaft | Pebax | Same |
| Handle and Connector | The handle has a push/pull
mechanism to steer the distal
deflection curve and a rotating
knob to adjust the distal loop
diameter. The handle has a
connector with 10 to 24 pins
attached at the back of the handle. | The handle has a push/pull
mechanism to steer the distal
deflection curve and a rotating
knob to adjust the distal loop
diameter. The handle has a
connector with 24 pins attached at
the back of the handle. |
| Type of Conductor Wire | Electrodes use a Copper / Nickel
Alloy | Same |
| Single Use or Usable | Single Use only | Same |
Page 3 of 3
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
Irvine Biomedical, Inc. c/o Mr. Dennis Hong Regulatory Affairs Manager 2375 Morse Avenue Irvine, CA 92614
Re: K060757
Trade Name: Inquiry™ Optima™ PLUS Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: March 20, 2006 Received: March 21, 2005
Dear Mr. Hong:
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.
4
Page 2 - Mr. Dennis Hong
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Bhimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO60757
Indications for Use
KOBO757 510(k) Number: Inquiry Optima PLUS Steerable Electrophysiology Catheter Device Name: The Inquiry Optima Catheter is a steerable electrophysiology Indications for Use: catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima catheters are to be used to map the 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)
Blumina
(Division Sig
Division of Cardio vascular Devices
510(K) Number: K060757
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