The NAVIPORT is a sterile, single use only, dual lumen, deflectable tip, guiding catheter with various curve reach configurations. NAVIPORT device is torquable and has a steering mechanism (control knob) in the handle. The control knob allows the catheter tip to be curved or to be straightened while the NAVIPORT is being routed to the desired location. The control knob is connected to an anchor ring located at the distal tip of the guiding catheter by a stainless steel pull wire. The pull wire runs from the control knob through a small closed lumen which terminates at the anchor ring. The anchor ring function is to allow the tip of the catheter to be deflected from the handle. A large central continuous lumen with a female luer at the proximal end and the deflectable tip at the distal end serves as a conduit for medical devices to the cardiovascular system.

AI/ML Overview

This document describes a 510(k) premarket notification for the Cardima NAVIPORT™ Deflectable Tip Guiding Catheter, which primarily relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints. Therefore, many of the requested elements for a study proving device meets acceptance criteria are not directly applicable or explicitly stated in this type of submission.

However, I can extract and infer information about the evaluation process.

Acceptance Criteria and Reported Device Performance

The submission focuses on establishing equivalence and safety through various types of testing, rather than reporting quantifiable performance metrics against specific "acceptance criteria" in the way a clinical trial would for performance claims. The "acceptance criteria" here are largely implied by compliance with existing guidance documents and successful completion of the described tests.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with relevant ISO standards and FDA guidance	Testing conducted; results found acceptable.
Reliability	Durability and consistent function over intended use cycles	Testing conducted; results found acceptable.
Mechanical Properties	Strength, flexibility, deflection mechanism functionality, etc.	Testing conducted; results found acceptable for intended use.
Sterilization	Sterility Assurance Level (SAL) per ANSI/AAMI/ISO 11137	Sterilized at minimum 25 kGy gamma radiation; validated process.
Packaging	Maintenance of sterility and physical integrity	Uses same validated materials and process as cleared predicate (VENAPORT).
Functionality (Animal Study)	Ability to access cardiovascular system and deliver devices without trauma	Performance acceptable when placed into heart chambers.
Substantial Equivalence	Similarities in intended use, design, and physical characteristics to predicate devices.	Determined to be substantially equivalent to Medtronic's Marinr™ Steerable Intracardiac Electrode Catheter (K931794) and Sherpa Guiding Catheter (K955651).

Study Details

Given this is a 510(k) submission and not a traditional clinical trial comparing performance against specific numerical endpoints for a device with novel performance claims, the requested study details are largely absent or not applicable in the way they would be for a direct performance study.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set: Not explicitly stated as a separate "test set" for performance evaluation in a clinical sense. The "testing" involved biocompatibility, reliability, mechanical, and animal studies.
- Animal Studies: The number of animals or specific procedures is not detailed.
- Bench Testing: The number of units tested for mechanical properties, reliability, etc., is not provided.
Data Provenance: Not specified, but generally, 510(k) bench and animal studies are conducted internally by the manufacturer or by contract research organizations (CROs) in the country of origin (implied to be the USA for Cardima, Inc., based on the address). These are prospective tests performed specifically for the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in this context would be defined by the inherent properties of the materials and device design (for bench testing) or by veterinary assessment of animal health and trauma (for animal studies). No human expert "ground truth" was established for a clinical test set in this submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or multi-reader assessment requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a guiding catheter, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Bench Testing: Physical measurements, engineering specifications, material properties, and comparison against established industry standards.
For Animal Studies: Direct observation of access, device delivery, and assessment of trauma by trained veterinary personnel or researchers.

7. The sample size for the training set

Not applicable. There is no machine learning or AI component requiring a training set described in this 510(k) submission.

8. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, no ground truth establishment method for it is relevant.

Summary

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Summary of Safety and Effectiveness

Trade Name:

Cardima NAVIPORT™ Deflectable Tip Guiding Catheter

Manufacturer :

Cardima, Inc. 4 % 66 Benibia Street Fremont, CA 94538-7330 Contact: Shelley Trimm Establishment Registration Number: 29-51-009

Classification Name:

Catheter Percutaneous (21 CFR 870.1250)

Device Classification:

Class II (21 CFR 870.1250) Panel: Circulatory System Devices Panel, DCRND

Intended Use and Product Description:

The Cardima NAVIPORT Deflectable Tip Guiding Catheter (here after referred to as NAVIPORT) is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

Sterilization, Packaging and Pyrogenicity:

Cardima follows the guidelines of ANSI/AAMI/ISO 11137 for sterilization validation and routine control of the radiation sterilization process for all Cardima products. The minimum sterilization dose of 25 kGy is supported per ISO TR 13409 "Sterilization of health care products -Radiation sterilization -Substantiation of 25kGy as a sterilization dose for small or infrequent production batches" (12-15-96). All NAVIPORT product will be sterilized in the same facility using identical gamma

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radiation parameters (minimum 25kGy dose) as other similar Cardima products. The NAVIPORT design, manufacturing materials, and environment does not introduce any new or unique challenges to the current validated sterilization program.

The NAVIPORT is individually packaged in a Paperboard-SBS polyethylene coated (in-side only) tray and inserted into a standard Tyvek/EETpolyethylene pouch. The pouch is heat-sealed to provide a microbial barrier. The NAVIPORT catheter utilizes the same packaging materials and packaging process as Cardima VENAPORT (K951603, cleared) . . .

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Substantial Equivalence:

turing a WIND II Deflectable Tip Buiding Catheter is substantially equivalent to Medtronic's Marinr™ Steerable Intracardiac Electrode Catheter (K931794, Decision Date 6/6/94) and Sherpa Guiding Catheter (K955651, Decision Date 1/22/96). Establishment of equivalence is based on similarities of intended use, design, and physical characteristics as evaluated by physical bench testing, biocompatibility and animal studies.

Summary of Safety and Effectiveness:

Safety and effectiveness were evaluated through biocompatibility testing, reliability testing, mechanical testing, and animal studies. Testing was conducted on sterilized NAVIPORT Catheters with quidance in part from "Electrode Recording Catheter Preliminary Guidance", March 1995; "Catheter Guidance" by Carroll O'Neill, May 1991; "GUIDANCE ON PREMARKET NOTIFICATION {510(K)} SUBMISSIONS FOR SHORT AND LONG-TERM INTRAVASCULAR CATHETERS" April, 1993. The tests were used to assess the mechanical properties of the NAVIPORT catheter and testing results were found to be acceptable for the stated intended use.

Animal studies were conducted to evaluate the ability of NAVIPORT guiding catheter to access the cardiovascular system and to deliver medical devices ( i.e. EP catheters) to the heart chambers without inducing trauma to the blood vessels or to the surface of the endocardium. The NAVIPORT performance was acceptable when placed into the heart chambers.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of snakes.

Public Health Service

JUL 2 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jack P. Douglas, Ph.D. Director of Regulatory Affairs Cardima, Inc. 47266 Benicia Street P.O. Box 14172 Fremont, CA 94538-7330

K974683 Re : NAVIPORT™ Deflectable Guiding Catheter Regulatory Class: II (Two) Product Code: DOY Dated: April 21, 1999 Received: April 23, 1999

Dear Dr. Douglas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Jack P. Douglas, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callehan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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።

5 1 0(k) Number (if known): K974683

NAVIPORT Deflectable Guiding Catheter Device Name:

Indications For Use:

The NAVIPORT deflectable guiding catheter is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher Ahn for Callahan

Prescription Use
(Per 21 CFR 801. 109)
✓

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).