(9 days)
The NOMAD™ DENTAL X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental x-ray source to produce x-ray images using intraoral image receptors.
NOMAD™ Dental is a portable dental x-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The x-ray tubehead, x-ray controls, and power source are assembled into a single handtubenoud, A ray controlage includes spare batteries, a battery charger, and a backscatter shield.
The provided text describes a 510(k) summary for the NOMAD™ Dental X-ray System, establishing its substantial equivalence to a predicate device (Portable HDX Intraoral X-ray system, K021378). The document focuses on regulatory approval based on comparison with existing technology rather than on detailed performance studies with acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific acceptance criteria in a table format with corresponding reported device performance for clinical outcomes or image quality as would be expected for a detailed clinical study report. Instead, it compares the technical specifications of the NOMAD™ Dental X-ray System to its predicate device to argue for substantial equivalence. The "performance" mentioned relates to physical and electrical specifications meeting regulatory standards rather than clinical diagnostic performance.
| Feature Type | Acceptance Criteria (Implied by Predicate) | Reported NOMAD™ Performance |
|---|---|---|
| X-RAY PERFORMANCE (Standards) | Meets 21 CFR 1020.30 | Meets 21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7 |
| Timer Accuracy | ±(10% + 1ms) (from predicate) | ±(10% + 1ms) |
Missing Information: There are no explicit acceptance criteria for clinical performance (e.g., diagnostic accuracy, image quality scores, etc.) and no reported device performance against such criteria. The "Conclusion" states: "The only significant technological difference, DC battery power versus AC line voltage, has no bearing on safety or effectiveness of the new device. Since the new device operates without an AC line voltage, it is substantially equivalent to the predicate device." This indicates the primary "proof" relies on demonstrating that the new power source does not negatively impact the established safety and effectiveness of the predicate device, which is usually demonstrated through bench testing and compliance with relevant standards.
2. Sample Size for Test Set and Data Provenance
Missing Information: The document does not describe a clinical test set, nor does it provide sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The approval is based on a comparison of technical specifications and compliance with electrical and X-ray performance standards, not a clinical study involving a test dataset for diagnostic performance.
3. Number of Experts and Qualifications for Ground Truth
Missing Information: Since no clinical test set or diagnostic performance study is described, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication Method
Missing Information: Not applicable, as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Missing Information: No MRMC study is mentioned. This approval is based on substantial equivalence to a predicate device through technical comparison and compliance with standards, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Missing Information: This device is an X-ray system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The document describes the performance of the hardware device itself.
7. Type of Ground Truth Used
Missing Information: No clinical ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for the assessment described in the provided text. The "ground truth" implicitly referred to is the established safety and effectiveness of the existing predicate device and the adherence to relevant industry standards (e.g., 21 CFR, IEC standards).
8. Sample Size for Training Set
Missing Information: Not applicable. This document describes a physical X-ray device, not an AI model that requires a training set.
9. How Ground Truth for Training Set Was Established
Missing Information: Not applicable. This document describes a physical X-ray device, not an AI model.
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Image /page/0/Picture/1 description: The image shows the logo and contact information for ARIBEX. The logo features the company name in bold, black letters with a stylized graphic element. Below the logo is the company website, www.aribex.com. The contact information includes the address: 754 South 400 East, Orem, Utah 84097, USA, as well as the phone number: 801.226.5522 and fax number: 801.434.7233.
Tab 4
JUL 1 4 2005
510(k) Summary
NOMAD™ Dental Portable X-ray System June 13, 2005
-
- Company:
| Name: | Aribex, Inc. |
|---|---|
| Address: | 754 South 400 EastOrem, UT 84651 |
Official Correspondent: D. Clark Turner, PhD, CEO
Telephone No: 801-226-5522 801-434-7233 FAX No:
| 2. Proprietary – Trade Name: | NOMAD™ Dental X-ray System |
|---|---|
| Classification Name: | Extraoral source x-ray system (per 21CFR section 872.1800) |
| Common/Usual Name: | Portable Dental X-ray System |
-
- Predicate Device: Portable HDX Intraoral X-ray system, (K021378), manufactured by Flow X-Ray. Literature included at Tab 11.
-
- Description: NOMAD™ Dental is a portable dental x-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The x-ray tubehead, x-ray controls, and power source are assembled into a single handtubenoud, A ray controlage includes spare batteries, a battery charger, and a backscatter shield.
-
- Intended Use: The NOMAD™ Dental X-ray System is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
| Feature | Portable HDXIntraoral X-rayK021378 | NOMAD™ DentalX-ray System |
|---|---|---|
| INTENDED USE: | Both systems are intended as extraoral x-ray sources to be used withintraoral image receptors for diagnostic imaging by dentists or dentaltechnicians. |
- Comparison with predicate device: 6.
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6. Comparison (continued)
| Feature | Portable HDXIntraoral X-rayK021378 | NOMAD™ DentalIntraoral X-ray Source |
|---|---|---|
| MECHANICAL: | ||
| Size: Body | 5.5"H x 8.25" W x 8" D | 13"L x 11.5"H x 5.5"W |
| Weight | 11.7 lbs. | 8.5 lbs. |
| Source to skin distance | 20 cm | 20 cm |
| Cone diameter | 6.3 cm | 6 cm |
| User Interface | Up-down buttons for exposuretime selections with display | Up-down buttons for exposuretime selection, with timer display |
| Backscatter radiationprotection | Circular scatter shield | 6.75" dia. Pb-filled acrylic plasticscatter shield |
| Exposure switch | On tubehead assembly, or atcontrol panel | On tubehead assembly/ controlpanel |
| Tubehead mounting | Handheld, or on a tripod | Handheld |
| ELECTRICAL: | ||
| Energy Source | 120 V 50/60 Hz or 240 V 50/60Hz AC | Rechargeable 14.4 V DC NiCdbattery pack |
| Exposure Time | 0.01 – 2.00 seconds in 0.01increments | 0.01 - 0.99 seconds in 0.01increments |
| Timer Accuracy | ±(10% + 1ms) | ±(10% + 1ms) |
| mA | 7 mA fixed | 2.3 mA fixed |
| kVp | 65 kVp fixed | 60 kVp fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:60 | 1:60 |
| Electrical SafetyStandards | UL 2601, CSA 601-M90,EN60601-1: 1990+A1+A2 | IEC60601-1, UL60601-1,EN60601-1 |
| EMI Standards | IEC60601-1-2 | IEC60601-1-2 |
| X-RAYPERFORMANCE: | ||
| Performance Standard | 21 CFR 1020.30 | 21 CFR 1020.30, 1020.31IEC60601-1-3IEC60601-2-7 |
7. Conclusion:
The only significant technological difference, DC battery power versus AC line voltage, has no bearing on safety or effectiveness of the new device. Since inte voltage, has no boaining on balely in is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2005
Aribex, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169
Re: K051795 Trade/Device Name: NOMAD™ Dental X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 1, 2005 Received: July 5, 2005
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w one reviewed 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 the cholors, to e enactment date of the Medical Device Amendments, or to devices that have been reay 20, 1970, all clares 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 do not require approvisions 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 (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your I tpp. o an 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.
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) (2) CFR Part 820); 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)
The States will and and on the best of a location at the squice to a legally This letter will allow you to begin maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, p premarket notification. The PDA miding of Substantial off.
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 If you desire specific advice for your device on our laboring regionation (
contact the Office of Compliance at one of the following numbers, based on the regulation number a 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, "firstnation on your responsibilities under the Act from the 807.97). You may obtain other geleral information on your repeared its toll-free number (800) Division or (301) 443-6597 or at its Internet address 058-2041 of (501) vicdrh/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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Tab 3
Indications For Use
510(k) Number:________________________________________________________________________________________________________________________________________________________________
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Device Name: NOMAD™ DENTAL X-ray System
Indications for Use: The NOMAD™ DENTAL X-ray System is indicated for use Indications for USe. The NOM/ - Dental technician for both adult and the only by a trained and qualified dentist of dontal coomist.
pediatric subjects as an extraoral diagnostic dental x-ray source to produce x-ray images using intraoral image receptors.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051795
Prescription Use_X (per 21CFR801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.