The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, 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. The Insight is intended for use in the right heart only.

Device Description

The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, 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 text states that "additional device testing was not required" and does not describe any specific studies conducted for this 510(k) submission. Instead, it relies on substantial equivalence to predicate devices (K042381, K062084, K992631). Therefore, information regarding acceptance criteria, study design elements (sample size, ground truth, expert qualifications, adjudication methods), or AI-specific details (MRMC studies, standalone performance, training set) is not available in the given document.

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

No acceptance criteria or reported device performance data are provided in the document from a new study. The submission relies on substantial equivalence to predicate devices based on identical or substantially equivalent intended use, method of operation, construction, and materials.

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

Not applicable. No new device performance study was conducted as stated in the document: "As there is no change in the design of the device, additional device testing was not required."

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)

Not applicable. As no new device performance study was conducted.

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

Not applicable. As no new device performance study was conducted.

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 device is a medical catheter for visualization and delivery, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

Not applicable. This device is a medical catheter and does not involve an algorithm with standalone performance.

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

Not applicable. As no new device performance study was conducted.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set.

Summary

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Insight™ Endocardial Visualization System, K070051

510(k) Summary 5. General Information

Date Compiled	April 5, 2007
Classification	Class II
Trade Name	Acumen Insight Endocardial Visualization System
Submitter	Acumen Medical, Inc.275 Santa Ana CourtSunnyvale, CA 94085
	Tel: 408-530-1810Fax: 408-530-1811
	Contact

Intended Use

Predicate Devices
Acumen Insight Endocardial Visualization SystemManufactured by Acumen Medical, Inc.	K042381, K062084
AcuNav Diagnostic Ultrasound CatheterManufactured by Acuson Corporation	K992631

Device Description

Materials

All materials used in the manufacture of the Acumen Insight Endocardial Visualization System are suitable for this use, are identical to the those used in the predicate devices, and have been used in numerous previously cleared products

Testing

As there is no change in the design of the device, additional device testing was not required.

Summary of Substantial Equivalence

Acumen Medical, Inc. believes the Acumen Insight Endocardial Visualization System is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = $ 2007

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

Re: K070051

Trade/Device Name: Acumen Insight Endocardial Visualization System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: March 7, 2007 Received: March 8, 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. 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 vours.

Bfimmerman 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.

510(k) Number (if known):	K070051
Device Name:	Acumen Insight Endocardial Visualization System
Indications for Use:	The Insight Endocardial Visualization System is intended toaid in the visualization of the coronary sinus, foramen ovaleand other venous and cardiac anatomy, provide temporaryocclusion during a venogram, and to provide a pathway fordelivery of transvenous devices to the coronary sinus andcoronary vasculature of the heart. The Insight is intended foruse in the right heart only.

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)

B.A.mumo

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).