The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Acumen Single-Lumen Delivery Sheath". This type of submission is a declaration that a new device is "substantially equivalent" to one or more legally marketed predicate devices, rather than a study proving performance against acceptance criteria in the way one might for a novel AI device.

Therefore, many of the requested categories related to AI device studies (like sample size for test/training sets, expert ground truth adjudication, MRMC studies, or standalone performance of an algorithm) are not applicable to this submission.

Here's a breakdown of the information provided in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Suitable for intended use (introduction of pacing/defibrillator leads and catheters)	"In-vitro and animal testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."
Materials suitable for use in medical devices	"All materials used in the manufacture of the Acumen Single-Lumen Delivery Sheath are suitable for this use and have been used in numerous previously cleared products."
Substantially equivalent to predicate devices (SafeSheath, Attain Access 6216, Attain Access 6218) in terms of intended use, method of operation, construction, and materials.	"Acumen Medical, Inc. believes the Acumen Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products."

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is not a clinical trial or AI performance study, but rather a premarket submission demonstrating substantial equivalence to existing devices through a combination of:

In-vitro testing: Performed to ensure the device components, subassemblies, and the full device meet required specifications.
Animal testing: Also performed to ensure the device components, subassemblies, and the full device meet required specifications.
Material compatibility assessment: Confirming that all materials are suitable for medical use and have a history of use in previously cleared products.
Comparison to Predicate Devices: A detailed comparison of the new device's intended use, method of operation, construction, and materials to those of the predicate devices.

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

Not Applicable. This is not an AI device study requiring a traditional "test set" from a dataset of images or clinical cases. The testing involved in-vitro and animal studies, which are typically defined by the specific test protocols and models used, rather than a "sample size" of patient data.
Data Provenance: The document does not specify the country of origin for the in-vitro or animal testing. It also doesn't explicitly state if the testing was retrospective or prospective, though in-vitro and animal studies for device clearance are typically prospective.

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

Not Applicable. This is not an AI device study involving expert human review for ground truth establishment. The "ground truth" here is compliance with engineering specifications and functional performance in in-vitro and animal models.

4. Adjudication method for the test set

Not Applicable. No expert adjudication method (like 2+1, 3+1) is mentioned or relevant for this type of device submission.

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 not an AI device. No MRMC study was conducted.

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

Not Applicable. This is not an AI device. No standalone algorithm performance was assessed.

7. The type of ground truth used

For the in-vitro and animal testing: The ground truth would be engineering specifications, functional performance metrics, and safety outcomes as defined by the test protocols.
For the substantial equivalence claim: The "ground truth" is the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI device, so there is no training set mentioned or relevant.

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

Not Applicable. As no training set exists for an AI model, this question is not relevant.

Summary

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General Information

510(k) Summary

JUN 19 2006

K053400
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Date Compiled	December 1, 2005
Classification	Class II
Trade Name	Acumen Single-Lumen Delivery Sheath
Submitter	Acumen Medical, Inc.275 Santa Ana CourtSunnyvale CA 94085Tel: 408-530-1810Fax: 408-530-1811
Contact	Marybeth GamberE-mail: MGamber@acumen-medical.com

Intended Use

The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Predicate Devices

SafeSheath	K003731
	Manufactured by Thomas Medical Products
Attain Access 6216 Left Heart Delivery SystemManufactured by Medtronic, Inc.	K012130

Attain Access 6218 Left Heart Delivery System K012083 Manufactured by Medtronic, Inc.

Device Description

Materials

All materials used in the manufacture of the Acumen Single-Lumen Delivery Sheath are suitable for this use and have been used in numerous previously clearcd products.

Testing

In-vitro and animal testing has been performed and all components, subassemblics, and/or fuil devices met the required specifications for the completed tests.

Summary of Substantial Equivalence

Acumen Medical, Inc. believes the Acumen Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of

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Acumen Medical, Inc.

053400
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construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

(Division Sign-Off)
Division of Cardiovascular
510(k) Number
E053/80

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acumen Medical, Inc c/o Ms. Marybeth Gamber Director, Regulatory Affairs

275 Santa Ana Court Sunnyvale, CA 94085

Re: K053400

Device Name: Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: June 7, 2006 Received: June 8, 2006

Dear Ms. Gamber:

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.

JUN 19 2006

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. Marybeth Gamber

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), please contact the Office of Compliance at (240) 276- 1020. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Indications for Use Statement 4.

510(k) Number (if known): This application

Device Name: Acumen Single-Lumen Delivery Sheath

Indications for Use:

The Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.

Prescription Use _X (Per 21 CFR 801 Subpart D)

. .

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhummunon
(Division Sign-Off)

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Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).