(25 days)
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are intended to be used only for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.
The EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) is intended to be used for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system. The EnVision Intraoral Dental X-Ray Machine is a highly efficient user-friendly Constant-potential radiation system that produces, clear, sharp radiography with minimal elapsed exposure time. Includes 2 versions- integrated and remote, that are compatible to open to open to and the (30 cm round, and equipped with rectangular SSD's available as optional).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Flow X-Ray Corporation's EnVision Intraoral Dental X-Ray Machines:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, no specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or performance metrics are stated for the EnVision Intraoral Dental X-Ray Machine. The document focuses on establishing substantial equivalence to a predicate device, not on meeting specific, quantifiable performance targets for diagnostic accuracy.
The reported device performance, therefore, is primarily in relation to its equivalence to the predicate:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K#896024, MDT/Castle Model HDX Dental X-Ray Machine) in intended use and technology. | The EnVision and HDX Dental X-Ray Machines are "virtually identical" in regard to intended use and technology. Bench testing and software validation demonstrate no differences in technological characteristics, raising no new issues of safety or effectiveness. |
| Compliance to applicable voluntary standards (IEC 60601-1, IEC 60601-2-7, ISO 14971:2000 for Risk Assessment) | The device demonstrates compliance to these standards. |
| Ability to minimize potential operator errors in selecting x-ray exposure times. | A new feature of preset anatomical manual exposure time settings was added to reduce errors in selecting proper exposure times. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document states that "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical test set was used to evaluate the device's diagnostic performance.
- Data Provenance: Not applicable. As no clinical tests were performed, there's no data provenance to report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Since no clinical tests were performed, no experts were used to establish ground truth for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical test set was used that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done? No. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable," indicating no clinical studies were conducted, including MRMC studies.
- Effect Size: Not applicable. Without an MRMC study, there is no effect size to report.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done? No. This device is an X-ray machine (hardware), not an algorithm. Its performance is evaluated through bench testing and its ability to achieve substantial equivalence to a predicate device, not through an "algorithm only" study.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable for diagnostic performance. The "ground truth" in this submission relates to the device meeting engineering and safety standards and replicating the functionality of a predicate device. This is primarily established through bench testing and software validation, which confirm its technical specifications and operational safety.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is an x-ray machine, not an AI or machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable. As it's not an AI/ML device, there's no training set or associated ground truth for a training set.
Summary of Study Type:
The submission for the EnVision Intraoral Dental X-Ray Machines is a substantial equivalence (SE) submission. This means the primary "study" involved demonstrating that the new device is as safe and effective as a legally marketed predicate device (K#896024, MDT/Castle Model HDX Dental X-Ray Machine) that is already on the market. This demonstration was achieved through:
- Bench Testing: To confirm technical specifications and performance.
- Software Validation: To ensure the proper functioning of the machine's control software, particularly with the new preset exposure time feature.
- Compliance with Voluntary Standards: Adherence to established safety and risk management standards (IEC 60601-1, IEC 60601-2-7, ISO 14971:2000).
No clinical studies, diagnostic performance studies, or AI/ML specific evaluations (like training sets or standalone performance) were conducted or reported in this 510(k) summary.
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Exhibit #2
SEP 2 7 2005
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in This Summary of Sickly Safety ents of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K052422
Submitter's Identification: 1.
Flow X-Ray Corporation 420 Hempstead Turnpike W. Hempstead, NY 11562 Tel: 516-485-7000
Contact: Mr. Peter Mitropoulos
Date Summary Prepared: August 31, 2005
Name of the Device: 2.
EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)
Common or Usual Name:
Intraoral Dental X-Ray Unit
Predicate Device Information: 3.
K#896024, MDT/Castle Model HDX Dental X-Ray Machine; MDT Diagnostic Co., Rochester, NY
Device Description: 4.
The EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) is intended to be used for intraoral radiography of dental anatomy for diagnostic intended to be acou for nr fessionally trained and licensed personnel on the use purposes porformously porte that the intended use of the EnVision Machine, as described in the labeling, has not changed as a result of the modification.
The reason for the modification is to minimize the potential error(s) an operator may make in selecting the desired x-ray exposure time(s) for different speed
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image receptors, different teeth, different size patients, and different length cones.
The EnVision Intraoral Dental X-Ray Machine is a highly efficient user-friendly The Envision Intraoral Bontal liation system that produces, clear, sharp Constant-potchildi output A faciallex of sure time. Includes 2 versions- integrated fradiography with minimal Stapsed on various line voltages, and and remote, that are comigated to open to open to and the (30 cm round, and equipped with rectangular SSD's available as optional).
Intended Use: 5.
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are The Envision Intraoral radiography of dental anatomy of dental anatomy for intended to be assu only for intrass professionally trained and licensed personnel on the use of the system.
Comparison to Predicate Devices: 6.
The EnVision and HDX Dental X-Ray Machines (Wall Mounted and Mobile) are The ENVISION and HDA Donathe intended use and technology. In addition to virtually identioun'in rogard to the MDX, a new feature of preset anatomical manual exposure time settings had been added to the EnVision Machine to reduce the exposure time octings had beselecting the proper exposure time for different teeth.
Discussion of Non-Clinical Test Performed for Determination of 7. Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes IEC 60601-1 and IEC Compliano to applicable Totalition, ISO 14971: 2000, "Medical Devices -Application of Risk Management to Medical Devices Standard" was used for our Risk Assessment.
Discussion of Clinical Tests Performed: 8.
Not Applicable
Conclusions: 9.
The subject device, the EnVision Intraoral Dental X-Ray Machine (Wall Mounted The Subject Gevice, the Envisions for use as the original MDT/Castle Model HDX Dental X-Ray Machine. The bench testing and software validation documentation contained in our submission demonstrates that there are no
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differences in their technological characteristics, thereby not raising any new differences in their lechnological J.Thus, the EnVision Intraoral Dental X-Ray Issues of Salety of enectiveneos. "This, the Envision in the predicate devices.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Flow X-Ray Corporation % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
Re: K052422
Trade/Device Name: EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) Regulation Number: 21 CFR 872.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP Dated: September 1, 2005 Received: September 2, 2005
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to make the device referenced in we have reviewed your Section 710(x) premaint invinced (for the indications for use stated in above and nave determined the do needicate devices marketed in interstate commerce prior to the enclosure) to legally maneted predical Device Amendments, or to devices that have been May 26, 1970, the chacinem and of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act that the reclassmed in accordaties with and proval application (PMA). You may, therefore, market the do not require approval of a premance approval special controls provisions of the Act. device, subject to the general connois provisions 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 (Premarket If your device is classified (see above) into entrols. Existing major regulations affecting your Approval), It may of subject to such adations, Title 21, Parts 800 to 898. In addition, FDA device can of found in the Obacents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEase be advised marr 271 s issumise of evice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administer of registration and listing (21 CFR Part 807); labeling Act s requirements, metading bactive minited to reguirements as set forth in the quality systems (QS) (21 CFR Part 801); 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)
1992) 1 This letter will allow you to begin harketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA initing of substantial of a loves 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
r the regulation of the for a tool on to the courshers, becad on the regul If you desire specific advice for your device on our labering regarities.
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "visoranante" of your cases in the Act from the 807.97). You may obtain other gelleral information on your september Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
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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Exhibit B
1 Page -
510(k) Number (if known): KD52422
Device Name: EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile)
Indications For Use:
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)
The EnVision Intractal in transal redications were anatomy The Envision Intraoral Dental >> R&F Machaeling of dental anatomy
are intended to be used only for intractal radiography topingd and licensed are intended to be used only for intrueral radiography f
for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.
Prescription Use _ X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-C Division of Reproduct 510(k) Numb
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.