The SMART Dilator is a sterile, single use disposable esophageal dilator. The SafeStitch endoscope guide dilator consists of a graduated tube with a center endoscope channel, a tapered tip and a safety handle. The flexible endoscope has a relative rigidity and in combination with the dilator will provide sufficient axial integrity for dilation. The handle provides feedback to indicate how much axial force is being placed on the device and subsequently, the esophagus.

AI/ML Overview

Here’s an analysis of the provided text regarding the SafeStitch SMART Dilator (K082995):

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary only mentions that "Bench testing was performed to verify the SMART Dilator's performance to internal specifications." It also states that "bench testing was also performed to demonstrate that the SMART Dilator is substantially equivalent to both the Savory-Gilliard Dilator and the Optical DVS Esophageal Dilator."

However, the document does not explicitly list specific acceptance criteria (e.g., tensile strength, flexibility, force feedback accuracy with threshold, etc.) nor the detailed results of these tests. Therefore, I cannot populate a table with specific acceptance criteria and their corresponding reported performance values. The information available is very high-level.

2. Sample Size Used for the Test Set and Data Provenance

The document only refers to "bench testing." It does not specify:

The sample size for any test set.
The data provenance (e.g., country of origin, retrospective or prospective). Given it's bench testing, it would be laboratory data rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the provided text describes bench testing comparing device performance to internal specifications and predicate devices, not studies requiring expert-established ground truth on clinical data (e.g., image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation or diagnostic accuracy studies, to establish a reference standard when multiple experts disagree.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as described in the provided document. The submission focuses on bench testing for substantial equivalence, not a clinical study involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this medical device. The SMART Dilator is a physical medical device (esophageal dilator), not an algorithm or AI system. Its performance inherently involves a human user (a clinician). Therefore, there is no "standalone" algorithm-only performance to assess.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be established by:

Internal specifications: The device's performance was compared against predetermined engineering or design specifications.
Predicate device characteristics: The SMART Dilator's performance was compared against the known characteristics and performance of the Savory-Gilliard Dilators and the Optical DVS Esophageal Dilator to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. The SMART Dilator is a physical medical device. It does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing are based on established engineering principles and materials science.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8. There is no concept of a "training set" or "ground truth" for a training set for this type of device.

Summary

{0}------------------------------------------------

K082995

SAFESTITCH
MEDICAL

Premarket Notification Submission 510(k) -- Dilator

Safestitch SMART Dilator 510(k) Summary

Company:	SafeStitch Medical, LLC.	FEB - 6 2009
Contact:	Mario ArbesuDirector, Quality Assurance and Regulatory AffairsSafeStitch Medical, LLC.4400 Biscayne BoulevardMiami, FL 33137Phone 305.575.4631Fax 305.575.4130
Trade Name:	SMART Dilator
Device Type:	Esophageal Dilator
Classification Regulation:	876.5365
Class:	II
Panel:	Gastroenterology/Urology
Product Code:	KNQ
Predicate Devices:	Savary-Gilliard Dilators (K851955)Optical DVS Esophageal Dilator (K031147)
Device Description:	The SMART Dilator is a sterile, single use disposableesophageal dilator. The SafeStitch endoscope guidedilator consists of a graduated tube with a centerendoscope channel, a tapered tip and a safety handle.The flexible endoscope has a relative rigidity and incombination with the dilator will provide sufficient axialintegrity for dilation. The handle provides feedback toindicate how much axial force is being placed on thedevice and subsequently, the esophagus.
Indications For Use:	The SMART Dilator is indicated for dilation of stricturesof the esophagus under endoscopic visualization in adults18 years or older.
Technological Characteristics:	The SMART Dilator is similar to the predicate devices indesign and operation. The primary differences are the

Page 1 of 2

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

. 1

{1}------------------------------------------------

K082995.

SAFESTITCH

MEDICAL -

Premarket Notification Submission 510(k) — Dilator

handle that provides the user with feedback as to how much force he/she is applying.

Bench testing was performed to verify the SMART Dilator's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the SMART Dilator is substantially equivalent to both the Savory-Gilliard Dilator and the Optical DVS Esophageal Dilator.

Performance Data:

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2009

Mr. Mario Arbesu Director, Quality Assurance and Regulatory Affairs SafeStitch Medical, LLC 4400 Biscayne Blvd., Suite 670 MIAMI FL 33137

Re: K082995

Trade/Device Name: SMART Dilator Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: January 15, 2009 Received: January 15, 2009

Dear Mr. Arbesu:

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.

{3}------------------------------------------------

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 os 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 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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/cdrb/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Premarket Notification Submission 510(k) - Dilator

Image /page/4/Picture/1 description: The image shows the word "SAFESTITCH" in a stylized, blocky font. The letters are outlined and filled with a pattern that resembles small squares or pixels. Below the word, there is a horizontal line, suggesting that there may be additional text or information associated with the logo.

Indications for Use

510(k) Number (if known): K082995

Device Name: SMART Dilator

Indications for Use:

The SMART Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization in adults 18 years or older.

Prescription Use X (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)

Lozuh Whay
(Division Sign-Off)

Division of Reproductive, Apgominal a Radiological Devices 510(k) Number

Page 3

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.