(91 days)
The IntraOs 70 (with Autoset Timer) is intended for the dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth. Such a device makes use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.
IntraOs 70 is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. For such application, a peak voltage of 70 kVp has been demonstrated to give a high quality film with a good film quality/risk ratio.
The beam-limiting device is formed by a circular cone, which grants a source skin distance of 20cm and has a round output field of 6cm diameter. The weight of the tubehead is 6.4 kg. The certified components may be assembled in different configurations in terms of arms and mounting.
Exposure times are microprocessor controlled, assuring a high constancy and also repeatability. The operator may choose exposure times from 60 ms to 3,2 s by object selection. Manual setting possibility or exposure time from 60 ms to 3,2 s (plus or minus, 18 steps: 0.06; 0.08; 0.10; 0.12; 0.16; 0.20; 0.25; 0.32; 0.40; 0.50; 0.64; 0.80; 1.00; 1.25; 1.60; 2.00; 2.50; 3.20 s) if required.
Timer and hand switch can be remotely mounted. The hand-switch is provided with a 3 m-coiled cord.
This entry describes an X-ray system, IntraOs 70, for dental radiographic examination. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, the following information, particularly regarding acceptance criteria, performance data, and detailed study methodologies, is not available within the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document is a 510(k) summary establishing substantial equivalence, not a detailed performance study with specific acceptance criteria and reported results. It highlights technological characteristics of the IntraOs 70 compared to the predicate device Explor-X 70.
| Acceptance Criteria | Reported Device Performance (IntraOs 70) |
|---|---|
| Not specified in document | Not specified in document |
The summary does provide a comparison of technological characteristics with the predicate device, which implicitly serves as the "performance" benchmark for substantial equivalence. Key characteristics include:
- Intended Use: Extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth (Matches predicate).
- High Voltage value: 70 kVp (Matches predicate).
- Tube current: 7mA (Predicate: 8 mA).
- Tube insert: OCX 70-G / RF8G070 (Predicate: CEI OCX 70-G).
- H.V. type: Single phase, self rectifying (Matches predicate).
- X-Ray exposure time control: Microprocessor Controlled (Matches predicate).
- Compensation of Line Voltage Fluctuations: Yes, automatically by software algorithm (Matches predicate).
- Safety features: Dead man command, Safety backup timer (Matches predicate).
- Signaling devices: Acoustic and visual signal, Optional remote signaling (Matches predicate).
The summary explicitly states: "The main differences of the IntraOs 70 with respect to SE device are mainly aesthetics; the functionality and technology are similar."
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) application, which typically focuses on technical specifications and comparison to a predicate device for substantial equivalence, rather than a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical performance study with a test set requiring ground truth established by experts is described in this 510(k) summary.
4. Adjudication method for the test set
Not applicable. No clinical performance study with a test set requiring adjudication is described in this 510(k) summary.
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
Not applicable. This device is an X-ray generator, not an AI-powered diagnostic tool, and the document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray generator, not an algorithm, and the document does not describe any standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth definition is mentioned as part of a performance study in this 510(k) summary.
8. The sample size for the training set
Not applicable. This device is an X-ray generator; there is no mention of an algorithm or training set in this 510(k) summary.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no discussion of how ground truth would be established for it.
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Annex 1- 510(k) Summary for IntraOs 70
JUL 0 8 2003
.
{1}------------------------------------------------
Kenny
| Date: | March 18, 2003 |
|---|---|
| Applicant | Blue X Imaging Srl. |
| Via Idiomi 3/16 | |
| 20090 Assago -- Milan - Italy | |
| Phone: + 39-0245712171 | |
| Fax: + 39-0246703385 | |
| Contact Person | Giuseppe Giacomini - CEO & |
| General Manager | |
| Device Name: | IntraOs 70 |
| Common Name: | X-Ray |
| Classification Name: | Unit, X-Ray, Extraoral |
| Legally Marketed device to which | Explor-X 70 |
| firm is claiming equivalence: | |
| Description of the Device: | IntraOs 70 is a Dental X-Ray |
| generator; its primary use is for | |
| intra oral image receptor radiology. | |
| For such application, a peak voltage | |
| of $70 kV_p$ has been demonstrated to | |
| give a high quality film with a good | |
| film quality/risk ratio. | |
| The beam-limiting device is formed | |
| by a circular cone, which grants a | |
| source skin distance of 20cm and | |
| has a round output field of 6cm | |
| diameter. The weight of the | |
| tubehead is 6.4 kg. The certified | |
| components may be assembled in | |
| different configurations in terms of | |
| arms and mounting. | |
| Exposure times are microprocessor | |
| controlled, assuring a high | |
| constancy and also repeatability. | |
| The operator may choose exposure | |
| times from 60 ms to 3,2 s by object | |
| selection. Manual setting | |
| possibility or exposure time from | |
| 60 ms to 3,2 s (plus or minus, 18 | |
| steps: 0.06; 0.08; 0.10; 0.12; 0.16; | |
| 0.20; 0.25; 0.32; 0.40; 0.50; 0.64; | |
| 0.80; 1.00; 1.25; 1.60; 2.00; 2.50; | |
| 3.20 s) if required. | |
| Intended use of the device: | Timer and hand switch can be remotely mounted. The hand-switch is provided with a 3 m-coiled cord. |
| IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. |
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x 16111117
Summary of the Technological characteristics of IntraOs 70 compared to the predicate device Explor-X 70
| Explor-X 70 | IntraOs 70 | |
|---|---|---|
| Intended Use | Extra oral source X-ray system fordental radiographicexamination anddiagnosis of diseasesof the teeth | Extra oral source X-ray system fordental radiographicexamination anddiagnosis of diseasesof the teeth |
| High Voltage value | 70 kVp | 70 kVp |
| Tube current | 8 mA | 7mA |
| Tube insert | CEI OCX 70-G | OCX 70-G /RF8G070 |
| H.V. type: | Single phase, selfrectifying | Single phase, selfrectifying |
| X-Ray exposuretime control | MicroprocessorControlled | MicroprocessorControlled |
| Compensation ofLine VoltageFluctuations | Yes, automaticallyby softwarealgorithm | Yes, automaticallyby softwarealgorithm.This function canoptionally beactivated duringinstallation. |
| Safety features | Dead man commandSafety backup timer | Dead man commandSafety backup timer |
| Signaling devices | Acoustic and visualsignalOptional remotesignaling | Acoustic and visualsignalOptional remotesignaling |
The main differences of the IntraOs 70 with respect to SE device are mainly aesthetics; the functionality and technology are similar.
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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing left. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 8 2003
Blue X Imaging Srl. % Mr. Al Sosa President Chicago X-Ray Systems, Inc. 251 E. Dundee Road Suite #6 WHEELING IL 60090
Re: K031118
Trade/Device Name: IntraOs 70 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system
Regulatory Class: II Product Code: 90 EHD Dated: March 18, 2003 Received: April 9, 2003
Dear Mr. Sosa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance 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 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can 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) regulation (21 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) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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510 (k) NUMBER (if KNOWN): DEVICE NAME: IntraOS 70 INDICATIONS FOR USE:
K 031118
The IntraOs 70 (with Autoset Timer) is intended for the dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth. Such a device makes use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.
(PLEASE DO NOT WRITE BELOW-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter-Use(Optional Formay 1-2-96) |
|---|---|---|---|
| ------------------------------------------ | -------------- | ---- | -------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | N031118 |
§ 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.