(238 days)
No
The summary describes a physical electrode catheter for sensing and recording electrical signals, with no mention of AI/ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is used for sensing, recording, and stimulating the heart (diagnostic functions), not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheters are for "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," which are diagnostic activities. Additionally, the predicate devices are named "Diagnostic Electrode Catheter."
No
The device description clearly describes a physical, steerable catheter with electrodes, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias." This describes a device used within the body (in vivo) to interact with and measure electrical activity of the heart.
- Device Description: The description details a steerable catheter with electrodes designed to be inserted into the heart. This is consistent with an in vivo device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a person's health. The provided information does not mention any interaction with biological specimens outside the body.
Therefore, the Bard Electrophysiology's steerable diagnostic electrode catheters, including the Orbiter PV, are not IVD devices. They are considered medical devices used for in vivo diagnostic and therapeutic procedures.
N/A
Intended Use / Indications for Use
Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardial sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Product codes
DRF
Device Description
The Orbiter PV Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter PV catheter will be offered in 7.5F diameter (7F shaft with a 5F tip) with 1-24 electrodes with a variety of inter-electrode spacings. The distal curve is capable of forming a 360-degree loop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Orbiter ST Diagnostic Electrode catheter
Reference Device(s)
K971265, Preamendment device
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
OCT 2 3 2003
BARD
p / / 2
510(k) SUMMARY FOR THE ORBITER PV VI. DIAGNOSTIC ELECTRODE CATHETER
C.R. Bard, Inc.
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.
Submitter's Information A.
Name: Address:
Phone: Fax: Contact Person:
Date of Preparation:
Device Name: B.
Trade Name:
Common/Usual Name: Classification Name:
55 Technology Drive, Suite 1 Lowell, MA 01851 (978) 323-2216 (Direct Line) (978) 323-2222 Deborah L. Herrington Requlatory Affairs Manager February 26, 2003
Orbiter PV Diagnostic Electrode Catheter Electrode Recording Catheter Electrode Recording Catheter
Predicate Device Name(s): C.
Orbiter ST Diagnostic Electrode Catheter Viking Diagnostic Electrode Catheter Bard Woven Electrode Catheter
Image /page/0/Picture/16 description: The image shows the logo for Bard Electrophysiology. The logo consists of a square with a stylized heart shape inside it. To the right of the square, the word "Bard" is written in a bold, sans-serif font. Below "Bard", the word "electrophysiology" is written in a smaller, italicized, sans-serif font.
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D. Device Description/Indications for Use:
Description
The Orbiter PV Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter PV catheter will be offered in 7.5F diameter (7F shaft with a 5F tip) with 1-24 electrodes with a variety of inter-electrode spacings. The distal curve is capable of forming a 360-degree loop.
Indications:
Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Technological Characteristics/Performance Data Summary ய்
1992372 The predicate device for this 510(k) Premarket Notification is the currently marketed Bard Orbiter ST Diagnostic Electrode catheter. Where appropriate, other Bard devices are referenced as supplemental predicate devices including the Viking catheter (K971265/FDA concurrence October 23, 1997) and the Woven catheter (Preamendment device).
Refer to Appendix 4 for the Instructions for Use for the predicate device and the supplemental predicate devices.
Appendix 5 contains the information demonstrating Preamendment Status for the Bard Woven Electrode Catheter.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2003
Bard Electrophysiology c/o Ms. Deborah L. Herrington Manager, Regulatory Affairs C.R. Bard, Inc. 55 Technology Drive Lowell, MA 01851
Re: K030627
Trade Name: Orbiter PV Diagnostic Electrode Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: DRF Dated: September 18, 2003 Received: September 22, 2003
Dear Ms. Herrington:
We have reviewed your Section 510(k) premarket notification of intent to market the device refe:enced 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. Deborah L. Herrington
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 (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 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Dng Hemku for
B. Zaleski, MD
Bram D. Zuckerman, M.I Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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D. INDICATIONS FOR USE
Diagnostic Electrode Catheter
Device Name: Orbiter PV Diagnostic Electrode Catheter Device Name. - Orbiter FV Blagnoons ff.com in both the 14-pole and 24-pole design.
Indications for Use: Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardial sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Contraindications: The catheter should not be used in conditions where manipulation of the catheter would be unsafe (e.g. Intracardiac mural thrombus).
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
The retrograde transaortic approach is contraindicated due to the risk of entrapping the tip in the left ventricle.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dno Xumler
10(k) Number
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-the-Counter Use _