MODIFICATION TO FOCUS

• K Number: K022630
• Device Name: MODIFICATION TO FOCUS
• Manufacturer: INSTRUMENTARIUM CORP.
• Date Cleared: 2002-10-09 ( 63 days)
• Product Code: EHD
• Regulation Number: 872.1800
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K001828 , K001729
• Predicate For: N/A

Intended Use

Focus is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Device Description

The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm.

AI/ML Overview

The provided text describes the 510(k) summary for the "Focus" intra-oral x-ray unit, which includes an AEC option. However, it does not contain detailed acceptance criteria, a specific study proving the device meets those criteria with performance metrics, or information about AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Focus K001729) and verifying the modified Focus functions as intended and provides images of equivalent diagnostic capability.

Therefore, many of the requested details cannot be extracted from this document. I will fill in the available information and explicitly state what is not present.

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Acceptance Criteria and Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Functions as intended	Verification and validation testing was successfully performed to confirm that the modified Focus functions as intended.
Provides images of equivalent diagnostic capability to predicate device	It was also shown that modified Focus is able to provide images of equivalent diagnostic capability to that of predicate device.
As safe and effective as the predicate device	Modified Focus is as safe and effective as the predicate device.
Substantially equivalent to predicate device (Focus K001729)	The technological characteristics of Focus are essentially equivalent to the technological characteristics of predicate device; the only difference is the AEC option, which can be used with Sigma sensor. The intended uses of the devices are equivalent.

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Detailed Study Information (Based on Available Text):

1. Sample size used for the test set and the data provenance: Not specified. The document only mentions "Verification and validation testing."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
4. 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 unit, not an AI-based diagnostic tool. The document does not mention AI assistance or MRMC studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The performance evaluation is related to the imaging capabilities of the x-ray unit itself.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document refers to "equivalent diagnostic capability to that of predicate device," implying a comparison based on image quality suitable for diagnosis. However, the specific method for establishing this "diagnostic capability" (e.g., by expert review, comparison to known clinical outcomes) is not detailed.
7. The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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Summary of what is known:

The submission focuses on demonstrating substantial equivalence to a previously cleared device (Focus K001729) and confirming that the modifications (primarily the AEC option) do not alter the diagnostic capability, safety, or effectiveness. The term "performance data" refers to verification and validation testing, but the specifics of these tests are not provided in this 510(k) summary. The comparison is against the predicate device's established performance, implying that the new device meets similar standards.

Summary

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29 July 2002

K022630

510(K) SUMMARY

PRODUCT CLASSIFICATION NAME:

OCT 0 9 2002

Focus System, x-ray, extraoral source, / EHD Regulation number: 872.1800

MANUFACTURER:

Instrumentarium Corp. Imaging Division P.O.Box 20 (Street Address: Nahkelantie 160) FIN-04301 Tuusula, Finland Phone: [phone] Fax: [phone]

Contact person: Kaija Jokela

UNITED STATES SALES REPRESENTATIVE (US DESIGNATED AGENT):

Instrumentarium Imaging Inc. 300 West Edgerton Avenue Milwaukee, Wisconsin 53207

Phone: [phone] Fax: [phone]

Contact person: Mark Mason

INTENDED USE:

Focus is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Instrumentarium Imaging (Nahkelantie 160) P.O. Box 20 • FIN-04301 TUUSULA • Tel. + 358 10 394 6500 • Fax [phone] [e-mail]• [e-mail]• [e-mail] http://www.instrumentarium.com/imaging Instrumentarium Corporation · FIN-00031 INSTRUMENTARIUM · Trade Reg. No.12.570 · VAT FI01092226

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29 July 2002

DESCRIPTION:

The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm.

SUBSTANTIAL EQUIVALENCE:

We consider this product is similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:

Focus

K001729

The technological characteristics of Focus are essentially equivalent to the technological characteristics of predicate device; the only difference is the AEC option, which can be used with Sigma sensor (manufactured by Instrumentarium Imaging, #K001828). The intended uses of the devices are equivalent.

PERFORMANCE DATA:

Verification and validation testing was successfully performed to confirm that the modified Focus functions as intended. It was also shown that modified Focus is able to provide images of equivalent diagnostic capability to that of predicate device. Modified Focus is as safe and effective as the predicate device.

Instrumentarium Corp. Imaging Division

Kaija Jokela

Regulatory Affairs tel. [phone], fax. [phone] e-mail. [e-mail]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the edge. Inside the circle is a stylized symbol that resembles three bird-like shapes stacked on top of each other. The logo is black and white and appears to be from a document.

Food and Drug Administrat 0 Corporate Boulevaro ville MD 20850

OCT 09 2002

Instrumentarium Corp. Imaging Division -% Mr. Mark Mason Instrumentarium Imaging, Inc. 300 West Edgerton Avenue MILWAUKEE WI 53207

Re: K022630

Trade/Device Name: Focus with AEC option Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: July 29, 2002 Received: August 7, 2002

Dear Mr. Mason:

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 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 this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx :	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancv 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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29 July 2002

022630

Indications for Use

510(k) Number (if known):

)
—
+

Focus

Device Name:

Indications for Use:

Focus is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Instrumentarium Corp. Imaging Division

Kaija Jokela
Regulatory Affairs

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

David C. Leymann

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number .

(Optional Format 3-10-98)

Instrumentarium Imaging (Nahkelantie 160) P.O. Box 20 • FIN-04301 TUUSULA • Tel. + 358 10 394 6500 • Fax [phone] [e-mail] • [e-mail] • [e-mail] http://www.instrumentarium.com/imaging Instrumentarium Corporation · FIN-00031 INSTRUMENTARIUM · Trade Reg. No.12.570 · VAT FI01092226

Regulation Number and Section

§ 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.