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

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.

Predicate Devices

K001729

Reference Devices

K001828

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard microprocessor-controlled x-ray unit and image display system without mentioning any AI or ML components or functionalities.

Therapeutic

No
The device is described as an intra-oral x-ray unit used for producing diagnostic x-ray radiographs, which means it is used for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures." Additionally, the "Summary of Performance Studies" mentions the device's ability to "provide images of equivalent diagnostic capability."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
• Device Function: The FOCUS device is an x-ray unit used to produce images of dental and oral structures. It works by emitting radiation that passes through the body and is captured on a sensor or film.
• No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It directly images the patient's anatomy.

Therefore, the FOCUS device falls under the category of imaging devices rather than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

EHD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-ray

Anatomical Site

dentition, jaws and other oral structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K001729

Reference Device(s)

K001828

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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