(29 days)
Not Found
No
The summary describes a physical medical device (catheter) used for recording electrical signals. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The device's function is purely mechanical steering and electrical signal recording.
No
The device is described as a "Steerable Diagnostic Catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies" and to "map the atrial regions of the heart", indicating its use for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies." This directly indicates its diagnostic purpose.
No
The device description clearly details a physical catheter with electrodes, a connecting cable, a handle for steering, and a pre-formed shape, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing happens outside the body (in vitro).
- Device Function: The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is used inside the body (in vivo) to record electrical signals and stimulate the heart during a diagnostic procedure. It is a tool used directly on the patient's anatomy, not for analyzing samples taken from the patient.
Therefore, based on the provided information, the Inquiry™ H-Curve TV Steerable Diagnostic Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The H-Curve TV catheters are to be used to map the atrial regions of the heart."
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
"The Inquiry™ H-Curve TV Steerable Diagnostic 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 which is parallel to catheter body. The loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
"The test plan for the Inquiry™ H-Curve TV Steerable Diagnostic Catheter was based on the quidance 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 (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
K082061
page 1/2
AUG 1 9 2008
Section 16
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 1. summary prepared:
| a. | Submitter: | Irvine Biomedical, Inc. |
|---|---|---|
| a St. Jude Medical Company | ||
| 2375 Morse Avenue | ||
| Irvine, CA 92614 | ||
| Tel. (949) 769-5000 |
b. Contact Person: Jeanette Hendrickson, RAC Regulatory Affairs Specialist Tel. (949) 769-5006
- C. Date Summary Prepared: July 18, 2008
Name of device, including trade name and classification name: 2.
- Trade/Proprietary Name: Inquiry™ H-Curve TV Steerable Diagnostic a. Catheter
- b. Classification names: Catheter, Electrode Recording
3. ldentification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
Company: Irvine Biomedical, Inc. Inquiry™ Optima™ Steerable Electrophysiology Catheter Device: 510(k): K042775 Date Cleared: November 4, 2004
-
- A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at
- A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
1
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text appears to be a combination of letters and numbers, with the first line reading "K082061". The second line reads "page 2/2", indicating that this is the second page of a document. The handwriting is somewhat stylized, with distinct letterforms and spacing.
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 which is parallel to catheter body. The loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. 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™ H-Curve TV Steerable Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The H-Curve TV catheters are to be used to map the atrial regions of the heart.
6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.
The Inquiry TM H-Curve TV Steerable Diagnostic Catheter Inquiry™ and its predicate device 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™ H-Curve TV Steerable Diagnostic Catheter was based on the quidance 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2008
Irvine Biomedical, Inc. c/o Ms. Jeanette Hendrickson, RAC Regulatory Affairs Specialist 2375 Morse Ave. Irvine CA 92614
Re: K082061
Trade/Device Name: Inquiry H-Curve TV Steerable Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Codc: DRF Dated: July 18, 2008 Received: July 21, 2008
Dear Ms. Hendrickson:
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.
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
3
Page 2 - Ms. Jeanette Hendrickson, RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known); K082061 .
Device Name: Inquiry™ H-Curve TV Steerable Diagnostic Catheter
Indications for Use:
The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The H-Curve TV 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)
ell
vision of Cardiovascular Devices
Page I of I
K082061 510(k) Number_