(61 days)
No
The 510(k) summary describes a passive barrier envelope for dental imaging plates and makes no mention of AI or ML.
No
The device prevents contamination of the imaging plate with bodily fluids; it does not directly treat or diagnose a disease or condition.
No
The device is a barrier envelope designed to prevent contamination of imaging plates with bodily fluids, not to diagnose medical conditions. Its function is protective, not diagnostic.
No
The device description clearly states it is a "single-use pouch" and describes physical characteristics like being "opaque on one side," indicating it is a physical barrier and not software.
Based on the provided information, the DenOptix Barrier Envelope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination of an imaging plate with bodily fluids during intra-oral dental x-ray procedures. This is a barrier function for a medical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on its physical properties as a pouch for protecting an imaging plate.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information based on biological markers.
The device is clearly intended to be a barrier accessory for a digital imaging system used in dental procedures.
N/A
Intended Use / 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.
Product codes
IXK, EHD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Physical testing was performed to demonstrate performance relative to light protection. Biocompatibility testing was conducted in accordance with ISO 10993.
Key Metrics
Not Found
Predicate Device(s)
Kodak ClinAsept Barrier Envelope, 510(k) K884827
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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
3
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.
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.
(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)
✓
OR
Over-the-Counter Use
(Optional Format 1-2-96)