(71 days)
The ANA-BEL and ANA-BEL CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray all employ X-ray tube with maximum rated peak tube potential of 90 kV.
The provided document describes a 510(k) submission for the ANA-BEL and ANA-BEL CM X-ray systems, seeking substantial equivalence to predicate devices (Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray).
The document does not contain detailed information about specific acceptance criteria or a dedicated study report proving the device meets those criteria in a quantitative sense. Instead, the equivalence is established by comparing the new device's indications for use and technological characteristics to those of the predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document uses the concept of "substantial equivalence" as its acceptance overarching criterion. The performance is assessed by confirming that the new device shares the same intended use and similar technological characteristics with existing legally marketed devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (ANA-BEL and ANA-BEL CM) |
|---|---|
| Same Indications for Use | Yes, "Generation of radiographic images of the dento-maxilofacial region for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures." This matches the predicate devices. |
| Same Technological Characteristics (Design, Materials, etc.) | Yes, employs an X-ray tube with a maximum rated peak tube potential of 90 kV, similar to predicate devices. (A detailed comparison table is referenced but not provided in the excerpt). |
| New characteristics do not affect safety and effectiveness | No, asserted that new characteristics do not affect safety and effectiveness. |
| New characteristics do not raise new types of safety or effectiveness questions | No, asserted that new characteristics do not raise new questions. |
| Acceptable scientific methods exist for assessing effects of new characteristics | Yes, asserted. |
| Performance data available to assess effects of new characteristics | Yes, asserted. |
| Performance data demonstrate equivalence | Yes, asserted. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" or provide details on data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The basis for clearance is demonstrating equivalence to predicate devices, not through a separate clinical performance study with a distinct test set in the traditional sense. The phrase "performance data available to assess effects of new characteristics" is generic and not further elaborated on to describe specific testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts or the establishment of ground truth for a test set. The regulatory decision is based on a review of the device's specifications and comparison to predicates by the FDA, not on a human-readability study or expert consensus for image interpretation.
4. Adjudication Method for the Test Set:
Since there is no described test set or expert evaluation, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or at least not described in this document. The submission is for substantial equivalence, which often relies on technical specifications and functional comparisons rather than comparative clinical performance trials.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study (e.g., for an AI algorithm) was not done. This document pertains to an X-ray imaging device, which is hardware, not an AI algorithm.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI or diagnostic accuracy studies is not applicable or mentioned in this context. The basis for equivalence relies on comparing the device's functional and design characteristics to those of predicate devices, and its ability to "Generate radiographic images" for diagnosis, rather than the accuracy of image interpretation against a definitive ground truth.
8. Sample Size for the Training Set:
Not applicable. This document describes an X-ray imaging device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set mentioned, this information is not provided.
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SUBSTANTIAL EQUIVALENCE SUMMARY JUN - 2 2004
This summary follows the format of the FDA 510(k) Substantial Equivalence Decision Making Process document.
| EQUIVALENT (PREDICATE) DEVICE #1: | X-Caliber Model 1000, X-Caliber CMModel 2000 |
|---|---|
| 510(k) Number | K900681 |
| Manufactured By: | TAKARA BELMONT USA, Inc.Somerset, New Jersey |
| EQUIVALENT (PREDICATE) DEVICE #2: | PLANMECA 2002 CC Proline PanoramicX-ray |
| 510(k) Number | K970812 |
| Manufactured By: | PLANMECA OYAsentajankatu 6Helsinki, FI 00880 |
A. Do the X-Ray Imaging Device have the same indications statements?
Yes. ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray are intended for the following use:
- Generation of radiographic images of the dento-maxilofacial region for . dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
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Do the X-Ray Imaging Device have the same technological characteristics, B.
e.g., design, materials, etc.?
Yes. ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray all employ X-ray tube with maximum rated peak tube potential of 90 kV. Please refer to the comparison table for specifications.
- C. Could the new characteristics affect safety and effectiveness? No.
- Do the new characteristics raise new types of safety or effectiveness D. questions?
No.
-
Do acceptable scientific methods exist for assessing effects of the new E. characteristics?
Yes. -
Are performance data available to assess the effects of new characteristics? r. Yes.
G. Do performance data demonstrate equivalence?
Yes.
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CONCLUSION:
The ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA
2002 CC Proline Panoramic X-ray are substantially equivalent.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2004
Takara Belmont USA % Mr. Jean-Claude Amar Official Correspondent Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL NJ 07006 Re: K040748 Trade/Device Name: ANA-BEL and ANA-BEL CM Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II
Product Code: 90 EHD Dated: May 13, 2004 Received: May 14, 2004
Dear Mr. Amar:
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 such 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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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you vo organizatial equivalence of your device of your device to a legally promaticated predicated." The 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 spoolite 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 Other of Complanos at (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. Bryden
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Device Name:
Not assigned yet ANA-BEL and ANA-BEL CM
Indications for Use:
. . . . .
The ANA-BEL and ANA-BEL CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Prescription Use
(Per 21 CFR 801 Subpart D)
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. Swanson
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices KOHOT 510(k) Number
SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ
JC C:\Documents and Settings\Jean-Claude Amar\My Documents\TakaraBelmont\ANA-BEL\2004-03-15-Ana-Bel510k.doc
§ 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.