The Medtronic Model 10600 Deflectable Catheter System is indicated to provide a pathway through which diagnostic and therapeutic devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Device Description

The Medtronic Model 10600 Deflectable Catheter System features a percutaneous needle and syringe to access the venous insertion site, a guide wire to access the vein, an adjustable hemostasis valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a deflectable catheter dilator to facilitate deflectable catheter passage, and slitters to remove the deflectable catheter.

The Model 10600 Deflectable Catheter System is provided STERILE and is intended for single use only.

The Model 10600 Deflectable Catheter System combines devices that are either cleared for market distribution via 510(k) or are exempt from Premarket notification because of Class I designation.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Medtronic Model 10600 Deflectable Catheter System. This notification focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria in the way a new, novel AI or diagnostic device would.

Therefore, many of the typical acceptance criteria and study details requested (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission. The submission relies on engineering and integrity testing to show that the new device performs comparably to established devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test Type	Reported Device Performance / Outcome
Device Integrity	Environmental Conditioning	Met specified requirements
	Mechanical Testing	Met specified requirements
	Compatibility Testing	Met specified requirements
	Package/Shelf Life Testing	Met specified requirements
Biocompatibility	ISO 10993-1	All blood-contacting materials found to be biocompatible
Sterilization	100% Ethylene Oxide (EtO) sterilization process	Validated process used

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

Sample Size: Not explicitly stated for specific tests. The "Summary of Studies" indicates that "Device integrity testing was conducted," but does not provide details on the number of units tested.
Data Provenance: Not applicable in the context of clinical data for a diagnostic/AI device. The testing described is laboratory-based engineering and material testing performed by the manufacturer, Medtronic, Inc.

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

Not Applicable. This submission is for a medical catheter system, not a diagnostic or AI device that requires expert-established ground truth from clinical data. The "ground truth" for this device relates to meeting engineering specifications and biocompatibility standards.

4. Adjudication Method for the Test Set

Not Applicable. As there is no clinical data or expert interpretation involved, no adjudication method would be used.

5. 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 is a hardware medical device (catheter system), not an AI or diagnostic imaging device. Therefore, no MRMC study would be performed, nor would there be human readers, AI assistance, or an effect size for improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware medical device; there is no algorithm or AI component to test in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, recognized standards (like ISO 10993-1 for biocompatibility), and validated processes (for sterilization). The device is deemed acceptable if it meets these predetermined technical and safety requirements.

8. The Sample Size for the Training Set

Not Applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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510(k) Premarket Notification Attachment C

Model 10600 Deflectable Catheter System

510(k) Summary of Substantial Equivalence

Date Prepared:	October 19, 2001
Submitter:	Medtronic, Inc.7000 Central Ave. N.E.Minneapolis, MN 55432
Contact:	Kristy K. Mollner, RACProduct Regulation ManagerTelephone:Facsimile:E-mail:	(763) 514-4189(763) 514-6424kristina.mollner@medtronic.com
Trade / Proprietary Name:	Medtronic Model 10600 Deflectable Catheter System
Common Name:	Catheter, Percutaneous
Device Classification:	Class II, 21 CFR 870.1250
Product Code:	74 DQY

Device Description

The Model 10600 Deflectable Catheter System is provided STERILE and is intended for single use only.

The Model 10600 Deflectable Catheter System combines devices that are either cleared for market distribution via 510(k) or are exempt from Premarket notification because of Class I designation.

Indications for Use

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510(k) Premarket Notification Attachment C

Substantially Equivalent Devices

Medtronic Model 10600 Deflectable Catheter System Predicate Devices

Medtronic Model 10600Deflectable CatheterSystem	Predicate Device	Predicate DeviceManufacturer	510(k)
Guide Catheter	Model 6216 Medtronic AttainLDS Left-heart delivery system	Medtronic, Inc.Minneapolis, MN 55432	K012130
	Model 6218 Medtronic AttainAccess Left-heart deliverysystem	Medtronic, Inc.Minneapolis, MN 55432	K012083
	GCIII (Vector, Vector X)Coronary Guiding Catheter	Medtronic InterventionalVascular (MIV)Danvers, MA 01923	K950179
	Cardima Naviport DeflectableGuiding Catheter	CardimaFremont, CA 94538	K974683
	SafeSheath CSG (Same asSafeSheath MSP)	Thomas MedicalMalvern, PA 19355	K003731
	Marinr Series EP DiagnosticCatheters	Medtronic CardioRhythmMinneapolis, MN 55432	K931794
Guide Catheter DilatorAdjustable HemostasisValveGuide WireGuide Catheter SlittersGuide CatheterPercutaneous Introducer	Model 6216 Medtronic AttainLDS Left-heart delivery system	Medtronic, Inc.Minneapolis, MN 55432	K012130
	Model 6218 Medtronic AttainAccess Left-heart deliverysystem	Medtronic, Inc.Minneapolis, MN 55432	K012083

Additionally, the sterilization process and biocompatibility of the Medtronic 10600 Deflectable Catheter System is substantially equivalent to the following devices:

MedAmicus, Inc. Percutaneous Introducer(also known as Solotrak)	MedAmicus, Inc.Plymouth, MN 55447	K893658
MedAmicus, Inc. Percutaneous VenousIntroducer	MedAmicus, Inc.Plymouth, MN 55447	K965167
Medtronic Attain LDS Model 6216 Left-heart delivery system	Medtronic, Inc.Minneapolis, MN 55432	K012130
Medtronic Attain Access Model 6218Left-heart delivery system	Medtronic, Inc.Minneapolis, MN 55432	K012083

Ironic confiderial

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510(k) Premarket Notification Attachment C

Summary of Studies

Device integrity testing was conducted to support that the Medtronic Model 10600 Deflectable Catheter System is equivalent to the predicate devices. Testing included: Environmental Conditioning, Mechanical Testing, Compatibility Testing, Package/Shelf Life Testing. All device test results for the Medtronic Model 10600 Deflectable Catheter System met specified requirements.

Biocompatibility Information

Biocompatibility testing was conducted on all blood contacting materials. The testing performed on this product was done in accordance with ISO 10993-1 and results demonstrate that all materials were found to be biocompatible.

Sterilization Validation

The Medtronic Model 10600 Deflectable Catheter System is sterilized using a validated 100% Ethylene Oxide (EtO) sterilization process.

Conclusion

Through the data and information presented, numerous similarities support a determination of substantial equivalence and therefore market clearance of the Medtronic Model 10600 Deflectable Catheter System through this 510(k) Pre-market Notification.

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Image /page/3/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 an abstract caduceus, with three lines curving upwards and a wavy line at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2002

Ms. Kristy K. Mollner, RAC Product Regulation Manager Cardiac Rhythm Management Medtronic, Inc. 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K013517

Trade Name: Model 10600 Deflectable Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: February 1, 2002 Received: February 4, 2002

Dear Ms. Mollner:

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.

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Page 2 - Ms. Kristy K. Mollner, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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,

Sincerely, years,

Donna-Bea Tillman, Ph.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

Model 10600 Deflectable Catheter System K

INDICATIONS FOR USE

510(k) Number (if known):

N/A K013517

Device Name:

Indications For Use:

Model 10600 Deflectable Catheter System

The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

(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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013517

editronic confideral

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).