The Medtronic Model 9210 delivery catheter is designed to provide a pathway through which Medtronic transvenous devices, such as leads or catheters, are introduced into the venous vessels and chambers of the heart.

The delivery catheter features two lumens. The large lumen is used for passing Medtronic leads or other Medtronic transvenous devices. The small lumen is designed to accept a stylet; the stylet facilitates passage and placement of the delivery catheter. The proximal opening of the small lumen features a stylet guide on the proximal end of the delivery catheter. This delivery catheter is intended for temporary use (contemplated implant duration of eight hours or less).

The catheter will be introduced into the patient via standard cut down or percutaneous technique, maneuvered through the vasculature using a stylet in the small lumen and appropriately positioned in the heart for the introduction of devices through the larger lumen.

AI/ML Overview

Device Name: Medtronic Model 9210 Delivery Catheter
Device Description: The Medtronic Model 9210 delivery catheter is designed to provide a pathway for Medtronic transvenous devices (leads or catheters) into the venous vessels and chambers of the heart. It features two lumens: a large lumen for device passage and a small lumen for a stylet to facilitate passage and placement. It is intended for temporary use (eight hours or less).
Predicate Device: Medtronic Vector Vector X Guide Catheter (K950179).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details various tests performed to ensure the Model 9210 Delivery Catheter conforms to design specifications and reliability intent. However, it does not explicitly state quantitative acceptance criteria or specific numerical performance results for these tests. Instead, it states that the tests were performed "to assure" conformity. We can infer the areas of performance based on the tests conducted.

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Integrity & Steerability:
Ability to prevent stylet perforation	Tested ("dry stylet perforation") to assure conformity to design specification.
Ability to prevent stylet bottoming	Tested ("dry stylet bottoming") to assure conformity to design specification.
Compatibility with Medtronic leads/devices	Tested ("catheter compatibility") to assure conformity to design specification. Functionality with typical Medtronic leads was "demonstrated through bench testing."
Sufficient torsional strength	Tested ("composite torsional strength") to assure conformity to design specification.
Sufficient tensile strength	Tested ("composite tensile strength") to assure conformity to design specification.
Biocompatibility:
Biocompatibility of tissue-contacting materials	Tested according to FDA Blue Book Memorandum #G95-1 and ISO Standard 10993-1. Materials for both the Model 9210 and predicate (GC III) were "fully tested for biocompatibility; therefore, any potential risks due to biocompatibility have been mitigated."
Functional Equivalence to Predicate:
Overall functionality for indications for use	"The functionality of the Model 9210 catheter for use with typical Medtronic leads has been demonstrated thorough bench testing." The differences in design from the predicate "do not require comparative testing" and were determined substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the numerical sample sizes for the "bench testing" or "qualification testing" studies. It only lists the types of tests performed.
Data Provenance: The studies were conducted by Medtronic, Inc. as part of their 510(k) submission. The data is retrospective in the sense that it pertains to laboratory testing conducted for regulatory clearance. There is no information regarding the country of origin of the data beyond Medtronic's Minneapolis, MN location. No clinical data or human subject data is mentioned for these specific tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The studies mentioned are primarily bench/laboratory tests of physical and material properties, not diagnostic or clinical performance requiring expert ground truth assessment in the typical medical imaging or diagnostic sense.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The tests are objective physical and material property tests. There is no indication of human interpretation or adjudication required for the results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes bench testing and biocompatibility assessments, not a study involving human readers or clinical cases. The comparison is made to a predicate device based on design differences and functional equivalence proved by bench testing, not a comparative effectiveness study with human readers.

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical medical catheter, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance described relates to the physical and material properties of the catheter itself.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluations appears to be based on:

Design Specifications: The tests were performed to "assure the Model 9210 Delivery Catheter conforms to design specification and reliability intent."
Regulatory Standards: Biocompatibility testing was conducted "according to FDA Blue Book Memorandum #G95-1, and ISO Standard 10993-1."
Functional Equivalence: The device's functional equivalence to its predicate for its intended use was demonstrated through bench testing.

8. The Sample Size for the Training Set:

Not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The studies are for product qualification and regulatory submission.

9. How the Ground Truth for the Training Set was Established:

Not applicable/provided. As there is no training set for an AI algorithm, this question is not relevant to the information provided.

Summary

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Medtronic Model 9210 Delivery Catheter

510(k) Premarket Notification 510(k) Summary

FEB 2 8 2002

510(K) SUMMARY

KD13963

Date Prepared:	October 19, 2001
Submitter:	Medtronic, Inc.7000 Central Ave. N.E.Minneapolis, MN 55432
Contact:	Mary Ellen BestSenior Product Regulation ManagerTelephone: (763) 514-4846Facsimile: (763) 514-6424E-mail: mary.ellen.best@medtronic.com
Trade / Proprietary Name:	Medtronic Model 9210 Delivery Catheter
Common Name:	Catheter, Percutaneous
Device Classification:	Class II, 21 CFR 870.1250
Product Code:	74 DOY

Device Description

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Indications for Use

The Medtronic Model 9210 Delivery Catheter is intended for device passage and placement within the venous vessels and chambers of the heart. .

Substantially Equivalent Device

The Medtronic Model 9210 catheter is substantially equivalent to the Medtronic Vector Vector X Guide Catheter submitted under the name Medtronic GCIII Coronary Guiding Catheter (K950179, cleared 7/25/95).

The Model 9210 Delivery Catheter contains two lumens; the Vector/Vector X contains one lumen. The large lumen of the Model 9210 is used for passing Medtronic leads or other Medtronic transvenous devices. The small lumen is designed to accept a stylet and is lined with an MP35N coil. The stylet adds stiffness to the catheter and allows it to be steered through the vasculature. The Vector/VectorX catheter is also steerable; however, the shaft of the Vector/Vector X catheter contains stainless steel braid to increase the stiffness of the catheter, allowing it to be steered through the vasculature. The use of stylets to introduce pacemaker and internal defibrillator leads through the vasculature has been proven to be safe and effective. These products have been legally marketed for a number of years. Many of these leads contain a lumen lined with an MP35N coil through which the stylets are guided. Therefore, no additional risks are presented due to this design feature.

The main body of the Model 9210 and GC III (Vector/Vector X) catheters are both composed of Pebax. Acrylamide is polymerized onto the surface of the main lumen of the Model 9210 catheter whereas the inner lumen of the Vector/Vector X is coated with MDX4-4159. Functionally, the hubs of both catheter designs allow for mating of standard Luer fittings, although the material of the hubs is different. The materials for both catheters have been fully tested for biocompatibility; therefore, any potential risks due to biocompatibility have been mitigated. The functionality of the Model 9210 catheter for use with typical Medtronic leads has been demonstrated thorough bench testing.

The differences in design between the Model 9210 and the Vector/Vector X are fully described in this submission and do not require comparative testing. Performance and biocompatibility testing for the Model 9210 Delivery Catheter is described in this submission. Qualification testing was performed to assure the Model 9210 Delivery Catheter conforms to design specification and reliability intent.

Summary of Studies

The following tests were performed to assure the Model 9210 Delivery Catheter conform to design specification and reliability intent: dry stylet perforation, dry stylet bottoming, catheter compatibility, composite torsional strength, and composite tensile strength.

The Model 9210 Delivery Catheter tissue contacting materials were tested according to FDA Blue Book Memorandum #G95-1, and ISO Standard 10993-1, Biological Evaluation of Medical Devices Part 1: Guidances and Selection of Tests.

Image /page/1/Picture/12 description: The image shows a logo with the word "Microtronic" in bold, sans-serif font. To the left of the word is a stylized graphic, and to the right is the word "CONFIDENTIAL" in a smaller, sans-serif font. The logo appears to be for a company or organization named Microtronic, and the presence of the word "CONFIDENTIAL" suggests that the image is related to sensitive or proprietary information.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2002

Ms. Mary Ellen Best Medtronic, Inc. 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K013963 Model 9210 Guiding Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: November 30, 2001 Received: December 3, 2001

Dear Ms. Best:

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 any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Mary Ellen Best

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

le
Peter Zuckerman, M.D.

ram Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Indications for Use

Indications for Use

510(k) Number (if known):	N/A K013963
Device Name:	Model 9210 Guiding Catheter
Indications For Use:	The Medtronic Model 9210 Delivery Catheter is intended for device passage and placement within the venous vessels and chambers of the heart.
Contraindications:	The delivery catheter is contraindicated for patients with sepsis or a hypercoagulable state.The delivery catheter is contraindicated for right ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart valve.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
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Over-The-Counter Use
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(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013465

Mechatronic solutions

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).