The Acumen Lead Delivery Sheath with Stylet is a single-use percutaneous catheter intended to The Acumen Lead Delivery Birean West villator leads and catheters. The Acumen Lead Delivery Sheath with Stylet has a guidewire lumen and a lumen for introduction of leads. The Acumen Silean with Stylet was a gurdential be packaged with a stylet to aid in positioning of the device in the vasculature.

AI/ML Overview

This document, K070197, describes a 510(k) premarket notification for the "Acumen Lead Delivery Sheath with Stylet." The information provided is a summary of the device's intended use, description, and a statement of substantial equivalence to a predicate device. It does not contain the kind of detailed study data, acceptance criteria, and performance results that would be expected for a typical medical device performance study, especially for AI/ML devices.

Based on the provided text, here's what can be extracted and what information is not available:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of specific performance metrics or thresholds.	"Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (No specific quantitative results or metrics provided).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document broadly states "Appropriate testing has been performed" without detailing the nature or scope of this testing, including sample sizes for any test sets.
Data Provenance: Not specified.

3. 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)

Number of Experts: Not applicable. This device is a medical instrument (lead delivery sheath), not an AI/ML diagnostic or prognostic tool that would typically involve expert-established ground truth from image or other medical data. The testing mentioned would likely involve engineering and biocompatibility tests, not expert reviews of diagnostic interpretations.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. As this is not an AI/ML diagnostic or prognostic device, adjudication methods related to expert consensus on diagnostic interpretations are not relevant.

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

MRMC Study: No. This is a medical instrument, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies are not relevant.
Effect Size: Not applicable.

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

Standalone Study: No. This device is a component used in a medical procedure, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable in the context of an AI/ML device. For a physical medical device like this, "ground truth" would refer to established engineering specifications, material properties, and biological compatibility standards. The document only mentions "required specifications for the completed tests."

8. The sample size for the training set

Sample Size for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" in the machine learning sense.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary of what is present:

The submission highlights the device's intended use (introduction of pacing/defibrillator leads and catheters) and states its substantial equivalence to a predicate device (Acumen Lead Delivery Sheath, K062145). The substantial equivalence is based on "identical or substantially equivalent" factors in intended use, method of operation, construction, and materials. The document confirms that "appropriate testing has been performed" and that the device "met the required specifications," but it does not provide any details about these tests, the specific specifications, or the results.

This type of 510(k) submission for a non-AI physical medical device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a combination of engineering testing, materials analysis, and comparison of design features. Detailed performance metrics and study designs, as requested in your prompt (which are common for AI/ML devices), are generally not included in this high-level summary for traditional medical devices.

Summary

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K070197

FEB 2 3 2007

Acumen Lead Delivery Sheath January 19, 2007

Acumen Medical, Inc.

510(k) Summary 5.

General Information

Date Compiled	January 19 2007
Classification	Class II,
Trade Name	Acumen Lead Delivery Sheath with Stylet
Submitter	Acumen Medical, Inc.

275 Santa Ana Court Sunnyvale, CA 94085

Tel: 408-530-1810 Fax: 408-530-1811

Contact

Marybeth Gamber Director, Regulatory Affairs

Intended Use

The Acumen Lead Delivery Sheath with Stylet is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Predicate Devices
Acumen Lead Delivery Sheath	K062145
Manufactured by Acumen Medical, Inc.

Device Description

Materials

MI materials used in the manufacture of the Acumen Lead Delivery Sheath with Stylet are suitable for this use and have been used in numerous previously cleared products.

Testing

Appropriate 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 Acumen Lead Delivery Sheath with Stylet is substantially equivalent to the predicate product. The intended use, method of operation, methods of ounstruction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings, and a wavy line representing its tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2007

Acumen Medical, Inc. C/O Marybeth Gamber 275 Santa Ana Court Sunnyville, CA 94085

Re: K070197

Trade/Device Name: Acumen Lead Delivery Sheath with Stylet Regulation Number: 21 CFR 870.1340 Regulation Name: Regulatory Class: Class II Product Code: DYB Dated: January 19, 2007 Received: January 23, 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. Iisting 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 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) 276-0120. 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,

BHummar fr

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.

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

Acumen Lead Delivery Sheath with Stylet Device Name:

Indications for Use:

The Acumen Lead Delivery Sheath with Stylet is indicated 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)

House Hotel Color State Childer Hotel Comment He School Collection Child Children Children Children Children Children Children Children Children Children Children Children

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Hummer

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ 270197

Confidential

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).