K Number
K012083
Device Name
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
Manufacturer
Date Cleared
2001-08-28

(56 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Attain Access 6218 Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Device Description
The left-heart delivery system features two guide wires to facilitate venous access, an adjustable hemostasis valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field. A steerable 7 French or smaller intracardiac catheter is recommended for use to assist in placing guiding catheters to access cardiac veins via the coronary sinus. The Attain Access 6218 is intended for single use only and will be distributed independently for use with current and future leads. The Attain Access Model 6218 combines components that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.
More Information

Not Found

No
The summary describes a mechanical delivery system with no mention of AI or ML capabilities.

No
The device is described as a delivery system for introducing other devices (balloon catheters, leads) into the heart, rather than providing a direct therapeutic effect itself.

No

The device is a delivery system for introducing catheters and leads into the heart, not for diagnosing a condition. Its function is interventional, not diagnostic.

No

The device description explicitly lists multiple hardware components (guide wires, valve, catheters, dilator, slitters, clip) and describes a physical delivery system for introducing other physical devices (balloon catheters, leads). There is no mention of software as the primary or sole component.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for introducing balloon catheters or leads into the left heart via the coronary sinus. This is a surgical/interventional procedure performed directly on the patient's body.
  • Device Description: The device components (guide wires, catheters, dilators, slitters, etc.) are all designed for facilitating access and delivery within the circulatory system.
  • Lack of Diagnostic Function: There is no mention of this device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are specifically designed for testing samples outside of the body to diagnose diseases or conditions.

This device is clearly intended for in vivo use, meaning it is used within a living organism, rather than in vitro, which means "in glass" or outside of the body.

N/A

Intended Use / Indications for Use

The intended use of the Medtronic Attain Access 6218 Left-heart delivery system is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus

Product codes (comma separated list FDA assigned to the subject device)

74 DQY

Device Description

The left-heart delivery system features two guide wires to facilitate venous access, an adjustable hemostasis valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

A steerable 7 French or smaller intracardiac catheter is recommended for use to assist in placing guiding catheters to access cardiac veins via the coronary sinus. The Attain Access 6218 is intended for single use only and will be distributed independently for use with current and future leads.

The Attain Access Model 6218 combines components 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

left heart, coronary sinus, cardiac veins

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)

Compatibility Testing, incoming inspection of final packaged device and package qualification testing was performed to support substantial equivalence to the predicate devices. Attain Access passed all of the in vitro specified requirements, and ensures that the Attain Access 6218 meets all of its design and performance requirements.

The Attain Access 6218 was included in two (2) Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain Access 6218 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K950490, K003731, K950179, K990707, K965167, K895580, K963320

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Attachment E

510(K) Summary of Substantial Equivalence

Date preparedJuly 2, 2001
Submitter:Medtronic, Inc.
7000 Central Avenue N.E.
Minneapolis, MN 55432
Contact:Karen Reidt, RAC
Sr. Product Regulation Manager
Telephone:(763) 514-3914
Fax:(763) 514-6424
E-Mail:karen.reidt@medtronic.com
Proprietary Name:Attain™ Access 6218 Left-heart delivery system
Common Name:Catheter, Percutaneous
Device Classification:Class II, 21 CFR § 870.1250
Product Code:74 DQY

Device Description

The left-heart delivery system features two guide wires to facilitate venous access, an adjustable hemostasis valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

A steerable 7 French or smaller intracardiac catheter is recommended for use to assist in placing guiding catheters to access cardiac veins via the coronary sinus. The Attain Access 6218 is intended for single use only and will be distributed independently for use with current and future leads.

The Attain Access Model 6218 combines components 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 intended use of the Medtronic Attain Access 6218 Left-heart delivery system is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus

1

Substantially Equivalent Devices
------------------------------------

Attain Access 6218 Left-heart Delivery System Predicate Devices

| Attain Access
Model 6218 Left-
heart Delivery

System DevicePredicate DevicePredicate Device ManufacturerPredicate 510(k)
45 cm and 50 cm
Guide CathetersMedtronic GC IV Coronary
Guiding CatheterMedtronic Interventional
Vascular (MIV)
Danvers, MA 01923K950490
SafeSheath MSP (Same as
SafeSheath CSG)Thomas Medical
Malvern, PA 19355K003731
GC III (Vector, Vector X)
Coronary Guiding CatheterMedtronic Interventional
Vascular (MIV)
Danvers, MA 01923K950179
Zuma Guiding CatheterMedtronic Interventional
Vascular (MIV)
Danvers, MA 01923K990707
Guide Catheter
DilatorPercutaneous Introducer Kit
(Component)MedAmicus
Minneapolis, MN 55447K965167
SafeSheath MSP (Same as
SafeSheath CSG)Thomas Medical
Malvern, PA 19355K003731
Adjustable
Hemostasis ValveY-Adaptor W/Touhy Borst
ValveAngeion Corp
Plymouth, MN 55441K895580
120 cm Guide
WiresTFX Medical Guide WireTFX Medical Group
Jaffrey, NH 03452K963320
4 Fr and 6 Fr
Guide Catheter
SlittersPercutaneous Introducer Kit
(Component)MedAmicus
Minneapolis, MN 55447K965167
Guide Wire ClipClass I device, exempt from premarket notification

Summary of Studies

Compatibility Testing, incoming inspection of final packaged device and package qualification testing was performed to support substantial equivalence to the predicate devices. Attain Access passed all of the in vitro specified requirements, and ensures that the Attain Access 6218 meets all of its design and performance requirements.

The Attain Access 6218 was included in two (2) Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain Access 6218 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.

2

Biocompatibility Information

Biocompatibility testing was performed on the materials which are blood contacting. Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible.

Sterilization Validation

The Attain Access 6218 Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated.

Conclusion

Through the data and information presented, as well as similarities to legally marketed devices, Medtronic Inc, considers the Attain Access 6218 Left-heart delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2001

Ms. Karen Reidt Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K012083

Trade Name: Attain Access 6218 Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II (two) Product Code: 74 DQY Dated: July 2, 2001 Received: July 3, 2001

Dear Ms. Reidt:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your becally is substantially equivalent (for the indications for use above and we nere acterine as a marketed predicate devices marketed in interstate commerce stated in une encrosare) to tegally markets of the Medical Device Amendments, or to devices that prior to may 20, 1978, and in the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act. The Act. The general controls provisions of the Act include requirements for annual provisions of the Frea - Frices, 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 (Frenancer Ippe of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 mspootions, the Food and may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

4

Page 2 - Ms. Karen Reidt

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 regulations.

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 nredicate 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) 594-4646. 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 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,

Dalla Mela

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Preliminary Information

Indications for Use

510(k) Number (if known):N/A K012083
Device Name:Attain™ Access 6218 Left-heart delivery system
Indications For Use:The Attain Access 6218 Left-heart delivery system is intended 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 K612083

Meditronic confidential