The Attain™ LDS 6216A 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, adjustable hemostasis valves 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.

The Attain LDS 6216A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

The key changes being made to the system are the addition of Tungsten Carbidefilled polyether block amide material to the guide catheter distal tip segment and the addition of extra slitters and adjustable hemostasis valves in a revised system configuration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Attain™ LDS 6216A Left-heart delivery system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or not present in this document. The focus of this 510(k) is on in vitro testing and demonstrating that the new device is functionally the same as an already approved device.

Here's a breakdown of the information that is available or can be inferred, along with explanations for the missing information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical performance criteria.	The device meets all of its design and performance requirements based on in vitro testing, supporting substantial equivalence to the predicate device.
Biocompatibility (ISO 10993-1)	All materials were found to be biocompatible.
Sterilization validation (100% Ethylene Oxide)	Appropriate processes for sterilizing the devices were validated.

Explanation: For a 510(k) submission, the "acceptance criteria" are generally that the new device performs as intended and is as safe and effective as the predicate device. Specific quantitative performance metrics with defined pass/fail thresholds, as would be seen in a clinical trial for a novel device, are typically not required or presented in this type of document. The "reported device performance" refers to the successful completion of the indicated tests.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "representative samples" for biocompatibility testing but does not quantify them. For in vitro mechanical testing, an exact sample size is generally not provided in the summary.
Data Provenance: The document does not specify country of origin for the in vitro testing. It is conducted by the manufacturer, Medtronic, Inc., which is based in Minneapolis, MN, USA (submitter address). The testing is in vitro, not involving human subjects, so retrospective/prospective distinction is not applicable in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as this submission is based on in vitro physical and material performance testing, not on clinical data requiring expert interpretation (e.g., image analysis, diagnosis). The "ground truth" here is adherence to engineering specifications and approved testing standards.

4. Adjudication method for the test set

This information is not applicable as the testing is in vitro and does not involve human readers or complex interpretations that would require adjudication.

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

This information is not applicable. This is a medical device for delivery of catheters and leads, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the in vitro testing and biocompatibility is established by engineering specifications, recognized standards (e.g., ISO 10993-1 for biocompatibility), and manufacturing quality control parameters. It's based on objective measurements and established scientific principles for material and device performance, not on clinical outcomes, pathology, or expert consensus in the diagnostic sense.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and performance are based on engineering principles and in vitro validation.

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

Not applicable, as there is no "training set" for this device.

Summary

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MAY 3 0 2002

CONFIDENTIAL May not be reproduced without written permission from Medtronic, Inc.

510(K) Summary of Substantial Equivalence

Date prepared	May 13, 2002
Submitter:	Medtronic, Inc.Parkmore Business Park WestGalway, Ireland.
Submission Correspondent:	Karen Reidt, RACSr. Product Regulation Manager7000 Central Avenue N.E.Minneapolis, MN 55432
Telephone:	(763) 514-3914
Fax:	(763) 514-6424
E-Mail:	karen.reidt@medtronic.com
Proprietary Name:	Attain™ LDS 6216A Left-heart deliverysystem
Common Name:	Catheter, Percutaneous
Device Classification:	Class II, 21 CFR § 870.1250
Product Code:	74 DQY

Performance Standard

Performance standards do not currently exist for these devices. None established under Section 514.

Device Description

The Attain LDS 6216A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

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CONFIDENTIAL

May not be reproduced without written permission from Medtronic, Inc.

Indications for Use

The intended use of the Medtronic Attain LDS 6216A 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

Substantially Equivalent Devices

Attain LDS 6216ALeft-heartDelivery SystemDevice	Predicate Device	Predicate Device Manufacturer	Predicate 510(k)
40 cm and 45 cmGuide Catheters	Medtronic Attain LDS 6216Left-heart Delivery System	Medtronic, Inc.Minneapolis, MN 55432	K012130
Guide CatheterDilator	Medtronic Attain LDS 6216Left-heart Delivery System	Medtronic, Inc.Minneapolis. MN 55432	K012130
AdjustableHemostasis Valve	Medtronic Attain LDS 6216Left-heart Delivery System	Medtronic, Inc.Minneapolis, MN 55432	K012130
120 cm GuideWires	Medtronic Attain Access6218 Left-heart DeliverySystem	Medtronic, Inc.Minneapolis, MN 55432	K012083
4 Fr and 6 FrGuide CatheterSlitters	Medtronic Attain LDS 6216Left-heart Delivery System	Medtronic, Inc.Minneapolis, MN 55432	K012130
Guide Wire Clip	Class I device, exempt from premarket notification

Attain LDS 6216A Left-heart Delivery System Predicate Devices

Summary of Studies

In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain LDS 6216A meets all of its design and performance requirements.

Biocompatibility Information

Biocompatibility testing was performed on representative samples of Attain product. Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible.

Sterilization Validation

The Attain LDS 6216A Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated.

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CONFIDENTIAL

May not be reproduced without written permission from Medtronic, Inc.

Conclusion (Statement of Equivalence)

Through the data and information presented, as well as similarities to a legally Through the data and thronic, Inc. considers the Attain LDS 6216A Left-heart marketed dotho, medically equivalent to the previously discussed legally marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a symbol consisting of three stylized human figures, depicted in a flowing, abstract manner. The figures are arranged in a row, with each figure slightly overlapping the previous one.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2002

Ms. Karen Reidt Principal Regulatory Affairs Specialist Cardiac Rhythm Management Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432

Re: K021587

Trade Name: Attain™ LDS 6216A Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 13, 2002 Received: May 15, 2002

Dear Ms. Reidt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined 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. Karen Reidt

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,

Da Carter

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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CONFIDENTIAL May not be reproduced without written permission from Medtronic, Inc.

Indications for Use Statement

510(k) Number (if known):	N/A
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Device Name:

Attain™ LDS 6216A Left-heart delivery system

Indications For Use:

The Attain™ LDS 6216A 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)

Over-The-Counter Use_

Division of Cardiovascular & Respiratory Devices
510(k) Number K021587

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).