The SightSure® Operation Indicator is indicated for use as an accessory to a dual lumen gastrointestinal sump tube with an air vent lumen which allows for a visual monitor of proper functioning of the tube during medical use.

Device Description

The device is characterized by a chamber that is filled with sterile water prior to use. Negative pressure provided by a functioning dual lumen medical tube vent lumen is applied to the chamber through a tube linking the vent (sump) lumen to the sealed chamber. Atmospheric equilibration of the chamber is provided through a capillary vent that has its distal end in the liquid media. Equilibration of the chamber results in flow of atmospheric air into the capillary tube and subsequent egress of bubbles in the liquid media of the device indicates proper functioning of the dual lumen tube.

AI/ML Overview

Here's an analysis of the provided text regarding the SightSure Operation Indicator, breaking it down by your requested categories:

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

Based on the provided text, the device's function is purely mechanical and visual. There are no explicit quantitative acceptance criteria or reported performance metrics in the way one might see for diagnostic algorithms (e.g., sensitivity, specificity, or accuracy). Instead, the acceptance is based on the demonstration of proper functioning as a visual indicator.

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Monitoring: The device successfully provides a visual indication (bubbling) of proper functioning of a dual lumen medical tube vent lumen.	The design states: "Egress of bubbles in the liquid media of the device indicates proper functioning of the dual lumen tube." The FDA's 510(k) clearance implies that MEDevices, Inc. demonstrated to the agency's satisfaction that the device does perform this intended function. No specific numerical performance data (e.g., success rate of bubbling) is provided.
Safety: The device is safe for its intended use.	"The SightSure Operation Indicator is non-patient contact and does not require testing per ISO 10993." This implies that its design inherently addresses biological safety by avoiding direct patient interaction. Its mechanical design is presumed safe.
Materials: The materials used are appropriate for the device's intended use and do not pose a known risk.	"The product is manufactured with components primarily made of styrene and vinyl." This is a statement of fact about the materials, not a specific performance metric.

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

The provided document does not contain any information about a "test set" in the context of a statistical study with a specific sample size. The device is a mechanical indicator, not an AI or diagnostic algorithm, so traditional clinical study methodologies for device performance (like those for diagnostic accuracy) are not described. The evaluation appears to be based on engineering design, material safety, and functional demonstration rather than a data-driven test set.

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 applicable and not present in the provided document. Since there is no "test set" in the sense of patient data requiring expert interpretation, there's no mention of experts establishing a ground truth for such a set.

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

This information is not applicable and not present. There is no "test set" or adjudication method described for the evaluation of this 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 device is a simple mechanical indicator, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed for this product.

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 purely mechanical, visual indicator and does not involve an algorithm. Its "performance" is purely its ability to visually bubble, and it inherently requires a human to observe that bubbling.

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

The "ground truth" for this device is effectively its mechanical function and observed visual output.

Mechanical Functionality: The core ground truth is whether the vent lumen is providing negative pressure, leading to atmospheric air flowing into the capillary tube and causing bubbles, as designed.
Observed Visual Output: The "ground truth" for indicating proper functioning is the presence of bubbles. If bubbles are observed, the device is indicating proper function. If bubbles are not observed, it's indicating a lack of proper function. This is a direct, observable, and unambiguous physical phenomenon.

There is no complex medical "ground truth" (like a pathology report for diagnosing cancer) associated with this simple mechanical indicator.

8. The sample size for the training set

This information is not applicable and not present. As a mechanical device, there is no "training set" in the context of machine learning or statistical modeling. Its design and manufacturing are based on engineering principles.

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

This information is not applicable and not present. Since there is no training set, there is no method for establishing ground truth for it. The device's "ground truth" relates to its fundamental physical operation and is established by design and engineering verification.

Summary

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Summary of Safety and Effectiveness 11.0

MAR 1 5 2000

Submitter Name and Address:	MEDevices, Inc.1840 Industrial Drive, Suite 210Libertyville, Illinois 60048
Contact Person:Telephone Number:	Michele H. Vovolka847-856-0355
Date Summary Prepared:	October 3, 1999
Proprietary Name:	SightSure Operation Indicator
Common Name:	Dual Lumen Tube Operation Indicator
Classification Name:	Gastrointestinal Tube and Accessories
Device Classification:	Class II per 21 CFR 876.5980
Panel Code:	78
Procodes:	KNT
Predicate Devices:	Nasal FlowmeterThrope Tube Flowmeter

Product Design:

Intended Uses/Indications:

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Physical/ Mechanical Specifications:

Biological Specifications:

This SightSure Operation Indicator is non-patient contact and does not require testing per ISO 10993.

Materials:

The product is manufactured with components primarily made of styrene and vinyl.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, facing left. The eagle is enclosed in a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2000

MEDevices, Inc. c/o Ms. Michele H. Vovolka President Vantage Consulting International, Ltd. P.O. Box 848 Grayslake, IL 60030

Re: K993358 SightSure Operation Indicator - for use with a dual lumen gastrointestinal sump tube Dated: January 21, 2000 Received: January 24, 2000 Requlatory Class: II 21 CFR §876.5980/Procode: 78 KNT

Dear Ms. Vovolka:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 reclassfied in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in viteg diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel C. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): K993358

SightSure Operation Indicator Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)		OR		Over -The-Counter Use
				(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K993358
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Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.