MODIFICATION TO FOCUS

K022630 · Instrumentarium Corp. · EHD · Oct 9, 2002 · Dental

Device Facts

• Record ID: K022630
• Device Name: MODIFICATION TO FOCUS
• Applicant: Instrumentarium Corp.
• Product Code: EHD · Dental
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

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

Device Story

Focus is a microprocessor-controlled intra-oral x-ray unit featuring a Load Matching Frequency (LMF) DC generator. It produces dental images on digital or film media. For digital imaging, the unit connects to a Sigma USB terminal linked to a PC, which reads data from a sensor and displays images on a monitor. Electronics are integrated into the horizontal arm for serviceability. Used in dental clinical settings by trained professionals to capture diagnostic radiographs; output assists clinicians in evaluating oral structures and dentition, facilitating diagnosis and treatment planning.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed the device functions as intended and provides images of equivalent diagnostic capability to the predicate device.

Technological Characteristics

Microprocessor-controlled intra-oral x-ray unit; Load Matching Frequency (LMF) DC generator; integrated electronics in horizontal arm; connectivity via USB terminal to PC; digital or film media compatibility; AEC option.

Indications for Use

Indicated for patients requiring diagnostic x-ray imaging of dentition, jaws, and oral structures. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Focus (K001729)

Reference Devices

• Sigma sensor (K001828)

Submission Summary (Full Text)

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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

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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