The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical DVS is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical DVS to allow for visualization at the stricture site.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Optical DVS Esophageal Dilator:

Summary of Device and Context:

The Optical DVS (Dual Vector Shearing) Esophageal Dilator is a sterile, single-use, disposable device designed for dilating esophageal strictures. Its key differentiating feature from its predicate device (Savary-Gilliard Dilators) is that it allows for visualization of strictures with an endoscope, whereas the predicate device does not. This 510(k) submission (K031147) was cleared by the FDA on January 12, 2004.

Acceptance Criteria and Device Performance:

Based on the provided document, the device's acceptance criteria primarily revolve around its equivalency to a predicate device in terms of "dilation performance" and its general safety and effectiveness for its intended use. However, the document does not explicitly state quantitative or qualitative acceptance criteria in a structured table format with corresponding performance data for the Optical DVS Esophageal Dilator itself.

The document states:

"Bench testing was performed to verify dilation performance. These data, combined with descriptive intended use and design information, indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator."

This implies that the acceptance criteria were inherently linked to demonstrating substantial equivalence to the predicate device, particularly in its ability to dilate esophageal strictures. The "dilation performance" was verified through bench testing.

Therefore, we can infer the following:

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Dilation Performance	Ability to effectively dilate esophageal strictures.	Verified through "Bench testing." The data "indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator."
Safety	Safe for its intended use (implied by 510(k) clearance based on substantial equivalence).	Not explicitly detailed, but implied by regulatory clearance.
Effectiveness	Effective for its intended use (dilation of esophageal strictures under endoscopic visualization).	Not explicitly detailed, but implied by regulatory clearance.
Technological Equivalence	Similar design and function to the predicate device, with the added benefit of endoscopic visualization.	"The Optical DVS is similar to the predicate device with respect to design. The Optical DVS allows for visualization of strictures with the use of an endoscope where as the predicate device does not."

Details of the Supporting Study:

Sample size used for the test set and the data provenance:
- The document mentions "Bench testing was performed to verify dilation performance." It does not specify the sample size for this bench testing.
- The data provenance is not specified (e.g., country of origin, retrospective/prospective). Bench testing typically takes place in a laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the involvement of experts for establishing ground truth as this was a bench test verifying "dilation performance." For such physical performance tests, ground truth is typically based on objective measurements against engineering specifications or physical properties.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading). Since this was "bench testing" of dilation performance, an adjudication method is not applicable and therefore not mentioned.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (an esophageal dilator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, questions about human reader improvement with/without AI assistance are not relevant to this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a physical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "bench testing" verifying "dilation performance," the ground truth would most likely be based on objective physical measurements and engineering specifications related to the device's ability to mechanically dilate a given material or simulate a stricture. It would not typically involve expert consensus, pathology, or outcomes data, which are more common for diagnostic or therapeutic efficacy studies involving patients.
The sample size for the training set:
- This question is not applicable as there is no mention of machine learning or an "algorithm" that would require a training set for this device.
How the ground truth for the training set was established:
- This question is not applicable as there is no mention of machine learning or an "algorithm" and thus no training set for this device.

Summary

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JAN 1 2 2004

K031147

Page 1 of 1

Optical DVS (Dual Vector Shearing) Esophageal Dilator 510(k) Summary of Safety and Effectiveness

Company

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

Contact

Kimberly Shoemaker Senior Regulatory Affairs Associate

Date Prepared:

April 8, 2003

Name of Device

Trade Name: Optical DVS (Dual Vector Shearing) Esophageal Dilator Classification Name: Esophageal Dilator

Predicate Devices:

Savary-Gilliard Dilators cleared under K851955 on 07/25/85

Device Description

Indications for Use

The Ontical DVS is indicated for dilation of strictures of the esophagus under endoscopic visualization.

Technological Characteristics

The Optical DVS is similar to the predicate device with respect to design. The Optical DVS allows for visualization of strictures with the use of an endoscope where as the predicate device does not.

Performance Data

Bench testing was performed to verify dilation performance. These data, combined with descriptive intended use and design information, indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator.

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird, with a wavy line below representing the tail.

JAN 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kimberly Shoemaker Sr. Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. A Johnson & Johnson Co. 4545 Creek Road CINCINNATI OH 45242-2839

Re: K031147

Trade/Device Namc: OPTICAL DVS (Dual Vector Shearing) Esophageal Dilator Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: 78 KNQ Dated: October 13, 2003 Received: October 14, 2003

Dear Ms. Shoemaker:

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 usc 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 Fedcral 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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 Fedcral 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 practicc 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hantes of substantial equivalence of your device to a legally prematication. The PDF intems to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on increase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by reference to premarked nonitode (21 cm 4ct may be obtained from the Division of Small information on your responsionalises and consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collection 115-11-11-11-11-11-11-11-11-11-11-11

Sincerely yours,

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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: OPTICAL DVS (Dual Vector Shearing) Esophageal Dilator

Indications for Use:

The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 876.5365 Esophageal dilator.

(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.