The 7F Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Device Description

The 7F Acumen Coronary Sinus Visualization System (CSVS) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

AI/ML Overview

The provided document K062084 for the Acumen Medical, Inc. 7F Acumen Coronary Sinus Visualization System is a 510(k) summary and an FDA clearance letter. It states that appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests to demonstrate substantial equivalence to its predicate device (Acumen Coronary Sinus Visualization System, K042381). However, the document does not provide specific details about the acceptance criteria, study design, or performance metrics.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the details about sample sizes, ground truth establishment, or specific study types. The document explicitly states that the new device is "either identical or substantially equivalent to existing legally marketed predicate product" in terms of its intended use, method of operation, methods of construction, and materials.

To answer your questions based only on the provided text:

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

This information is not explicitly provided in the document. The document states: "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, the specifications themselves are not detailed.

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

This information is not provided in the document.

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):

This information is not provided in the document. The testing mentioned appears to be related to meeting required specifications for a medical device's components and functionality, rather than a clinical study requiring expert ground truth for interpretation.

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

This information is not provided in the document.

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 provided in the document. The device is a "Coronary Sinus Visualization System," a physical catheter, not an AI-assisted diagnostic tool for image interpretation.

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

This information is not provided in the document. As mentioned, this is a physical catheter, not an algorithm.

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

This information is not provided in the document. The testing described appears to be engineering/performance testing for a physical device rather than a diagnostic accuracy study.

8. The sample size for the training set:

This information is not provided in the document. This is a physical device, and the concept of a "training set" for an algorithm is not applicable here.

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

This information is not provided in the document.

Summary

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K062084
p. 1 of 2

Acumen Medical, Inc.

AUG 1 8 2006

510(k) Summary 5.

General Information

Date Compiled Classification Trade Name

Submitter

July 18, 2006

Class II

7F Acumen Coronary Sinus Visualization System

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

Predicate Devices

Acumen Coronary Sinus Visualization System K042381 Manufactured by Acumen Medical, Inc.

Device Description

Materials

All materials used in the manufacture of the 7F Acumen Coronary Sinus Visualization System are suitable for this use, are identical to the those used in the predicate device, 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 7F Acumen Coronary Sinus Visualization System is substantially equivalem to the predicate product. The imended use, method of operation,

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Acumen Medical, Inc.

and the same of the same of the states of the states of the states

methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.

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Confidential

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

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

Re: K062084

Trade Name: 7F Acumen Coronary Sinus Visualization System, Model (CSVS) Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 9, 2006 Received: July 21, 2006

Dear Ms. Gamber:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surver to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer to province of the ) 2011-07-12 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 I va may, atteres, and 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. 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) 276-0120. 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.

Q.B.M.

FOR 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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Acumen Medical, Inc.

Indications for Use Statement 4. ﭗ ﮨﺎ

510(k) Number (if known):	This application
Device Name:	7F Acumen Coronary Sinus Visualization System
Indications for Use:	The 7F Acumen Coronary Sinus Visualization System isintended to aid in the visualization of the coronary sinus,provide temporary occlusion during a venogram, and toprovide a pathway for delivery of transvenous devices to thecoronary sinus and coronary vasculature of the heart.

Prescription Use __X (Per 21 CFR 801 Subpari D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q.S.M.

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number -Ko 62084

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).