(185 days)
No
The summary describes a mechanical catheter system and does not mention any AI or ML components or functionalities.
No.
The device description states it is "indicated to provide a pathway through which diagnostic and therapeutic devices are introduced," indicating it is an accessory device, not a therapeutic device itself.
No
The "Intended Use" states that the device is "to provide a pathway through which diagnostic and therapeutic devices are introduced," indicating it's a delivery system for other devices, not a diagnostic device itself.
No
The device description clearly outlines multiple physical components (needle, syringe, guide wire, catheter, dilator, slitters) and describes mechanical and biocompatibility testing, indicating it is a hardware-based medical device.
Based on the provided information, the Medtronic Model 10600 Deflectable Catheter System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide a pathway for introducing diagnostic and therapeutic devices within the body (chambers and coronary vasculature of the heart, coronary sinus, vessels of the left heart). IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details components used for accessing and navigating within the body (needle, syringe, guide wire, catheter, dilator, slitters). This aligns with an invasive medical device used for procedures, not for analyzing samples in a lab.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Medtronic Model 10600 Deflectable Catheter System is an invasive medical device used for facilitating procedures within the heart and associated vessels.
N/A
Intended Use / Indications for Use
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.
Product codes
74 DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers and coronary vasculature of the heart, coronary sinus, vessels of the left heart
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
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.
Key Metrics
Not Found
Predicate Device(s)
K012130, K012083, K950179, K974683, K003731, K931794
Reference Device(s)
K893658, K965167, K012130, K012083
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Premarket Notification Attachment C
Model 10600 Deflectable Catheter System
K
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, RAC | |
| Product Regulation Manager | ||
| Telephone: | ||
| Facsimile: | ||
| E-mail: | (763) 514-4189 | |
| (763) 514-6424 | ||
| kristina.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 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.
Indications for Use
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.
1
510(k) Premarket Notification Attachment C
Substantially Equivalent Devices
Medtronic Model 10600 Deflectable Catheter System Predicate Devices
| Medtronic Model 10600
Deflectable Catheter
System | Predicate Device | Predicate Device
Manufacturer | 510(k) |
|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------|---------|
| Guide Catheter | Model 6216 Medtronic Attain
LDS Left-heart delivery system | Medtronic, Inc.
Minneapolis, MN 55432 | K012130 |
| | Model 6218 Medtronic Attain
Access Left-heart delivery
system | Medtronic, Inc.
Minneapolis, MN 55432 | K012083 |
| | GCIII (Vector, Vector X)
Coronary Guiding Catheter | Medtronic Interventional
Vascular (MIV)
Danvers, MA 01923 | K950179 |
| | Cardima Naviport Deflectable
Guiding Catheter | Cardima
Fremont, CA 94538 | K974683 |
| | SafeSheath CSG (Same as
SafeSheath MSP) | Thomas Medical
Malvern, PA 19355 | K003731 |
| | Marinr Series EP Diagnostic
Catheters | Medtronic CardioRhythm
Minneapolis, MN 55432 | K931794 |
| Guide Catheter Dilator
Adjustable Hemostasis
Valve
Guide Wire
Guide Catheter Slitters
Guide Catheter
Percutaneous Introducer | Model 6216 Medtronic Attain
LDS Left-heart delivery system | Medtronic, Inc.
Minneapolis, MN 55432 | K012130 |
| | Model 6218 Medtronic Attain
Access Left-heart delivery
system | 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 Venous
Introducer | 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 6218
Left-heart delivery system | Medtronic, Inc.
Minneapolis, MN 55432 | K012083 |
Ironic confiderial
..............................................................................................................................................................................
2
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.
3
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.
4
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
5
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)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013517
editronic confideral
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