PLANMED SOPHIE NUANCE CLASSIC

K042671 · Planmed OY · IZH · Nov 19, 2004 · Radiology

Device Facts

• Record ID: K042671
• Device Name: PLANMED SOPHIE NUANCE CLASSIC
• Applicant: Planmed OY
• Product Code: IZH · Radiology
• Decision Date: Nov 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.

Device Story

Conventional mammography x-ray system using films and cassettes; produces radiographs of human breast. Modification of previous Planmed Sophie/Sophie Classic models; features updated lower shelf construction for improved serviceability/assembly, new Flex AEC (Automatic Exposure Control) system, and modernized design. Used in clinical settings by trained radiology personnel. Output consists of radiographic images for diagnostic evaluation by clinicians. System serves as base for future field digital imaging upgrades. Spot mammography functionality restricted to stereotactic needle biopsy guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Conventional mammography x-ray system; utilizes film/cassette imaging. Features Flex AEC (Automatic Exposure Control) system. Design modifications include improved lower shelf construction for serviceability and updated ergonomics. System is designed for future upgradeability to full-field digital imaging.

Indications for Use

Indicated for producing radiographs of the human breast for diagnostic purposes. Spot mammography is indicated only when used in combination with stereotactic needle biopsy guidance.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Planmed Sophie (K904953)
• Planmed Sophie with Cytoguide (K923471)
• Planmed Sophie modification (K951883)
• Planmed Sophie Classic (K962105)
• Planmed Sophie Classic with Cytoguide (K973493)
• Planmed Sophie modification (K983659)
• Planmed Sophie with Maxview (K991826)
• Planmed Sophie modification (K013656)
• Planmed Sophie with Digiguide (K021945)

Submission Summary (Full Text)

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NOV 1 9 2004

Image /page/0/Picture/1 description: The image shows the word "Planned" in large, bold, white letters against a black background. Below the word "Planned" are the words "ENCLOSURE 12" and "P. 12-1" in a smaller font size. The words "ENCLOSURE 12" and "P. 12-1" are also in black.

### 510K) SUMMARY

K04 2671

#### DATE

November 16, 2004

## PRODUCT, CLASSIFICATION NAME

Trade name: Planmed Sophie Nuance Classic Common name: Mammographic x-ray system Classification: 90 IZH, Class II Regulation number: 892.1710

#### MANUFACTURER

Planmed Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: [phone] Fax: [phone] Contact person: Lars Moring

### UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)

Planmed USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: [phone] Fax: [phone] Contact person : Bob Pienkowski

#### INTENDED USE

The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.

#### PRODUCT DESCRIPTION

The Planmed Sophie Nuance Classic is a conventional mammography x-ray system utilizing films and cassettes. This product is a modification of the previous devices Planmed Sophie and Planmed Sophie Classic, where the changes made are concentrated on the lower shelf construction (with easier assembly and better serviceability), a new Flex AEC system, more modern overall design and enhanced user friendliness. The modification also serves as a base to an easy upgradeability to full field digital imaging use in the future.

#### SUBSTANTIAL EQUIVALENCE

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

Planmed Sophie # K904953

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Image /page/1/Picture/0 description: The image shows the word "Planned" in large, bold, white letters against a black background. Below the word "Planned" are the words "ENCLOSURE 12" and "P. 12-2" in a smaller font size. The text is centered.

| # K923471 | Planmed Sophie with Cytoguide |
|-----------|---------------------------------------|
| # K951883 | Planmed Sophie modification |
| # K962105 | Planmed Sophie Classic |
| # K973493 | Planmed Sophie Classic with Cytoguide |
| # K983659 | Planmed Sophie modification |
| # K991826 | Planmed Sophie with Maxview |
| # K013656 | Planmed Sophie modification |
| # K021945 | Planmed Sophie with Digiguide |

The comparison of characteristics supports substantial equivalence. Planmed Sophie Nuance Classic is as safe and effective as the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 9 2004

Planmed Ov % Mr. Bob Pienkowski Managing Director Planmed USA, Inc. 100 North Gary Avenue, Suite A ROSELLE IL 60172

Re: K042671 Trade/Device Name: Planmed Sophie Nuance Classic Regulation Number: 21 CFR 892.1710 Regulation Name: Mammograhpic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: September 17, 2004 Received: September 29, 2004

Dear Mr. Pienkowski:

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 (Premarket Approval), 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and your he FDA finding of substantial equivalence of your device to a legally premated notificated on " 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 If you don't openite at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 7 // 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

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

510(k) Number (if known):_K042671

Device Name: Planmed Sophie Nuance Classic

Indications For Use:

The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Hodgson

(Division Sign-Off) Division of Reproductive and Radiological Devic 510(k) Number

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