The DenOptix Barrier Envelope is a single-use device intended for use with the DenOptix Digital Imaging System (K955643) to prevent contamination of the phosphor imaging plate with saliva and other bodily fluids.

Device Description

The DenOptix Barrier Envelope is a single-use pouch available in sizes corresponding to standard intra-oral imaging plate dimensions. Imaging plates used for intraoral dental x-ray procedures are sealed inside the envelope before being placed into the patient's mouth. The envelope is opaque on one side to protect the imaging plate from ambient light.

AI/ML Overview

This document describes the DenOptix Barrier Envelope, a dental barrier envelope. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding AI device testing is not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for performance as it's a substantial equivalence submission for a physical barrier. Instead, it relies on demonstrating that the new device is essentially the same as a legally marketed predicate and performs equivalently or better in relevant aspects.

Instead of a table with specific performance metrics against acceptance criteria, the document states:

Acceptance Criteria (Implied): The DenOptix Barrier Envelope must perform equivalently to the Kodak ClinAsept Barrier Envelope (K884827) in preventing contamination of imaging plates and provide light protection.
Reported Device Performance:
- "Physical testing was performed to demonstrate performance relative to light protection." (No specific quantitative results are provided in the summary).
- "Biocompatibility testing was conducted in accordance with ISO 10993." (No specific results are provided in the summary).

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

This information is not provided in the summary. The "physical testing" and "biocompatibility testing" mentioned likely involved specific sample sizes for their respective tests, but these details are not included in the 510(k) summary. Given the nature of the device (a physical barrier), it's highly unlikely this involved a clinical test set with data provenance in the context of AI studies, but rather laboratory testing of materials and design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is a physical barrier envelope and not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a physical barrier envelope and not an AI or diagnostic device requiring expert interpretation for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable. The device is a physical barrier envelope; no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical barrier envelope; no algorithm is involved.

7. The Type of Ground Truth Used

This information is not applicable in the context of AI or diagnostic device performance. For a physical device, "ground truth" would relate to objective measurements of its physical properties (e.g., light blocking, material integrity, biocompatibility), which would be established through standard engineering and materials testing.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical barrier envelope and does not involve a training set as would be used for an AI algorithm.

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

This information is not applicable. The device is a physical barrier envelope and does not involve a training set or its associated ground truth establishment.

Summary of the Study and Conclusion from the Provided Text:

The study proving the device meets its (implied) acceptance criteria is a demonstration of substantial equivalence to an existing predicate device, the Kodak ClinAsept Barrier Envelope (K884827).

The rationale for substantial equivalence is based on:

Same Indications for Use: Both the DenOptix Barrier Envelope and the predicate device share the same intended purpose: prevention of contamination of phosphor imaging plates.
Equivalent Materials and Manufacturing: The new device is manufactured by the same contract manufacturer using equivalent materials, manufacturing processes, and inspection/test procedures as the predicate.
Minor Difference: The only difference is the addition of a blue colorant to one side of the DenOptix Barrier Envelope for ambient light protection.
Testing Performed:
- Physical Testing: "Physical testing was performed to demonstrate performance relative to light protection." (No specific results are detailed in the summary).
- Biocompatibility Testing: "Biocompatibility testing was conducted in accordance with ISO 10993." (No specific results are detailed in the summary).

The Conclusion states that the DenOptix Barrier Envelope was found to be substantially equivalent to the predicate device, with the added benefit of ambient light protection due to the opaque colorant. This implies that the testing performed confirmed the device's ability to provide light protection and ensured biocompatibility, thereby meeting the necessary safety and effectiveness requirements for a substantially equivalent device.

Summary

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K980543

Attachment 11: 510(k) Summary of Safety and Effectiveness DenOptix Barrier Envelope

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

APR 1 4 1998

DENTSPLY International, Inc. Submitter: DENTSPLY Gendex 901 West Oakton Street Des Plaines, IL 60018-1884
Daniel P. Murphy Contact Person: Director of Engineering, OA, & Regulatory Affairs phone: (847) 640-4908 (847) 640-4970 fax:
Date Prepared: ..... FEBRUARY 9, 1998
DenOptix Barrier Envelope Device Name:
Dental Barrier Envelope Common Name:

Classification Name: Electrostatic X-ray Imaging System, IXK, 892.1630

Kodak ClinAsept Barrier Envelope, 510(k) K884827 Predicate Device:

Product Description: The DenOptix Barrier Envelope is a single-use pouch available in sizes corresponding to standard intra-oral imaging plate dimensions. Imaging plates used for intraoral dental x-ray procedures are sealed inside the envelope before being placed into the patient's mouth. The envelope is opaque on one side to protect the imaging plate from ambient light.
Indications for Use: The DenOptix Barrier Envelope is a single-use device intended for use with the DenOptix Digital Imaging System (K955643) to prevent contamination of the phosphor imaging plate with saliva and other bodily fluids.

Rationale for Substantial Equivalence

The DenOptix Barrier Envelope shares the same indications for use as the predicate device. It is manufactured by the same Contract Manufacturer with equivalent materials, manufacturing process, and inspection and test procedures. The difference between the DenOptix Barrier Envelope and the predicate device is the addition of a blue colorant to one side of the envelope in order to provide protection against ambient light. Biocompatibility of materials has been demonstrated.

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510(k) Summary of Safety and Effectiveness

Safety and Effectiveness Information:

There are no differences between the design or manufacture of the DenOptix Barrier Envelope and the predicate device that could affect effectiveness relative to the intended use. Physical testing was performed to demonstrate performance relative to light protection. Biocompatibility testing was conducted in accordance with ISO 10993.

Conclusion:

The DenOptix Barrier Envelope was found to be substantially equivalent to the predicate device. The DenOptix Barrier Envelope is identical to the predicate device except that the DenOptix Barrier Envelope provides protection from ambient light for phosphor imaging plates through the addition of an opaque colorant to one side of the envelope.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and head facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1998

Daniel P. Murphy Director Engineering, Quality Assurance & Regulatory Affairs Gendex Dental X-Ray Division Dentsply International Inc. 90 West Oakton Street Des Plaines, IL 60018-1884

Re:

K980543 DenOptix™ Barrier Envelope Dated: January 9, 1998 Received: February 12, 1998 Regulatory class: II 21 CFR 872.1800 Procode: 90 EHD

Dear Mr. Murphy:

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 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). 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 (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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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" (21 CFR 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) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification 510(k) for the DenOptix Barrier Envelope

Section 3: Intended Use

510(k) Number (if known):

Device Name:

Indications for Use:

DENTSPLY International, Inc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra-Pags
(Division Sign-Off)

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

Prescription Use
(Per 21 CFR 801.109)
✓

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.