The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.

Device Description

The VereSure Bell is a single-use device used during gynecologic laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate housing containing a sealable port for introduction of standard Veress needles and a stopcock for attachment to a sterile standard hospital vacuum line.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "VereSure Bell," and the FDA's clearance letter for it. This document focuses on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the detailed information a study proving acceptance criteria for an AI/CADe device would typically include.

Specifically, the "VereSure Bell" is a physical medical device (a single-use device for laparoscopic procedures), not an AI or software-as-a-medical-device (SaMD). Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/CADe performance metrics (like sensitivity, specificity, AUC) are not applicable here.

However, I can extract the information that is present regarding "test results" and "substantial equivalence" as it relates to this traditional medical device.

Here's a breakdown based on the provided text, highlighting what is present and what is missing due to the nature of the device and document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) nor does it report specific numerical performance data against such criteria. This is because it's a physical device, and the evaluation for 510(k) clearance focuses on safety and substantial equivalence, not AI performance metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for Intended Use (implied from 510(k) process for traditional devices)	"Results of animal and clinical testing demonstrate that the VereSure Bell is safe and effective for its intended use." (From 510(k) Summary)
Substantial Equivalence to Predicate Devices	"Based on the intended use, product, performance and clinical information provided in this notification the subject device has been shown to be substantially equivalent to the currently marketed predicate devices." (From 510(k) Summary)
	"We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (From FDA Clearance Letter)

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

The document mentions "animal and clinical testing" but does not provide specific sample sizes for these tests, nor does it detail data provenance (e.g., country of origin, retrospective/prospective).

Sample Size (Test Set): Not specified.
Data Provenance: "Animal and clinical testing" (retrospective/prospective not specified, origin not specified).

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

This information is not applicable and not present. Ground truth, in the context of AI/CADe, involves expert labeling of data. For a physical device, testing focuses on functionality, materials, and clinical outcomes, not expert-labeled datasets.

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

This information is not applicable and not present for a physical device.

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 applicable and not present. The VereSure Bell is a physical device, not an AI or CADe system designed to assist human readers.

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

This information is not applicable and not present. The device is a physical tool, not an algorithm.

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

For this physical device, "ground truth" would relate to the successful establishment of pneumoperitoneum, safety outcomes (e.g., no adverse events), and effectiveness in facilitating the laparoscopic procedure. The document broadly states "animal and clinical testing" demonstrated safety and effectiveness, implying clinical outcomes data was assessed, but details are not provided.

8. The sample size for the training set:

This information is not applicable and not present. "Training sets" are relevant for AI/machine learning models, not for traditional physical medical devices.

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

This information is not applicable and not present.

Summary

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JUL 2 1 2006

510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: July 15, 2006

510(k) number: _______________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________

Applicant Information:

VereSure Inc. 900 Welch Road Palo Alto, CA 94304

Contact Person

Robert Chin. Ph.D. Phone Number: (650) 593-5225 rjchin@pacbell.net E-mail: and the comments of the country

Device Information:

Trade Name:	VereSure Bell
Classification:	Class II
Classification Name:	Laparoscopic Insufflator and Accessories

Physical Description:

Intended Use:

The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.

Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the Taut insufflation Needle (K003703), the EndoPath Ultra Veress Needle (K983925), and the Allis Tissue Forceps (K852726).

Test Results:

Results of animal and clinical testing demonstrate that the VereSure Bell is safe and effective for its intended use.

Summarv:

Based on the intended use, product, performance and clinical information provided in this notification the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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JUL 2 1 2006

VereSure, Inc. % Robert J. Chin, Ph.D. Regulatory Consultant 25 Hartford Avenue SAN CARLOS CA 94070

Re: K061387

Trade/Device Name: VereSure Bell Regulation Number: 21 CFR 884.1730 Regulation Name: Laproscopic insufflator Regulatory Class: II Product Code: HIF Dated: May 12, 2006 Received: May 18. 2006

Dear Dr. Chin:

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 (Premarket Approval), 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.

Image /page/1/Picture/9 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-2006" are printed in a smaller font size. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The entire logo is surrounded by a dotted circle.

noting Public Gr

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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 $10/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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon
Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: VereSure Bell

Indications for Use:

The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Szymanski
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1061387

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Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.