The Modified 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. The Modified Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 6F.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Modified Acumen Single-Lumen Delivery Sheath". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data as would be found in a PMA.

Therefore, the requested information regarding acceptance criteria and performance data for an AI-powered device, involving sample sizes, expert ground truth, MRMC studies, and standalone performance, is not applicable to this 510(k) submission.

This submission is for a physical medical device (a catheter introducer sheath), not an AI/software as a medical device (SaMD). The "testing" mentioned refers to in-vitro testing of the physical device's components and does not involve AI performance metrics.

Here's a breakdown of why each requested point is not present or applicable:

A table of acceptance criteria and the reported device performance: Not applicable. The document states "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide a table of these specifications or detailed performance metrics. This is typical for a 510(k) of this nature, where adherence to internal design specifications and equivalence to a predicate device are the primary focus.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to physical in-vitro tests, not an AI test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as there is no AI algorithm being evaluated against expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no AI algorithm and no expert adjudication process described.
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 physical medical device, not an AI-assisted diagnostic tool.
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 AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there is no AI algorithm that requires ground truth for its evaluation as per the provided document. The "ground truth" for the device's function would be its ability to physically introduce leads and catheters, assessed through engineering and bench testing.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary from the provided documents:

Device Type: Catheter Introducer Sheath (physical medical device)
Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Acumen Single-Lumen Delivery Sheath K053400).
Primary Evidence: In-vitro testing (details not provided beyond "met the required specifications") and comparison of materials, intended use, method of operation, and construction to the predicate device.
Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Summary

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5. 510(k) Summary

General Information

Date Compiled	February 9, 2007	MAY 22 2007
Classification	Class II
Trade Name	Modified Acumen Single-Lumen Delivery Sheath
Submitter	Acumen Medical, Inc.275 Santa Ana CourtSunnyvale CA 94085Tel: 408-530-1810Fax: 408-530-1811
Contact	Marybeth Gamber
Intended Use	The Modified Acumen Single-Lumen Delivery Sheath is indicated for the introduction of varioustypes of pacing or defibrillator leads and catheters.

Predicate Devices Acumen Single-Lumen Delivery Sheath Manufactured by Acumen Medical, Inc.

K053400

Device Description

Materials

All materials used in the manufacture of the Acumen Single-Lumen Delivery Sheath are identical to the predicate device.

Testing

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

Summary of Substantial Equivalence

Acumen Medical, Inc. believes the Modified 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 cxisting legally marketed predicate products.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2007

Acumen Medical, Inc. c/o Marybeth Gamber 275 Santa Ana Court Sunnyvale, CA 94085

Re: K070396

Trade/Device Name: Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 11, 2007 Received: May 14, 2007

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.

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. 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 promated 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) 276-0120. 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,

Brimmer for

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

Enclosure

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4. Indications for Use Statement

510(k) Number (if known):	K070396
Device Name:	Modified Acumen Single-Lumen Delivery Sheath
Indications for Use:	The Modified Acumen Single-Lumen Delivery Sheath isintended for the introduction of various types of pacing cdefibrillator 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)

Bhimma

(Division Sign-Om) Division of Cardlov 510(k) Number

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).