PLANMED NUANCE DIGIGUIDE

K121963 · Planmed OY · MUE · Nov 21, 2012 · Radiology

Device Facts

• Record ID: K121963
• Device Name: PLANMED NUANCE DIGIGUIDE
• Applicant: Planmed OY
• Product Code: MUE · Radiology
• Decision Date: Nov 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Intended Use

Planmed Nuance DigiGuide is an optional system for stereotactic biopsy. It consists of a needle guidance unit attached to Planmed Nuance or Planmed Nuance Excel digital mammographic Xrav units. The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.

Device Story

Planmed Nuance DigiGuide is a stereotactic biopsy system accessory for Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. It comprises a needle guidance unit and the Nuance Manager 3 software module. The system acquires mammographic images, calculates lesion coordinates, and facilitates needle biopsy. Used in clinical settings by healthcare professionals, the device eliminates the need to move the detector between stereo exposures and removes the requirement to manually mark references in images, resulting in faster, more accurate procedures. The output is displayed on an acquisition workstation, assisting clinicians in targeting breast tissue for sampling. Benefits include improved procedural efficiency and accuracy compared to previous manual reference methods.

Clinical Evidence

Clinical study conducted at a mammography screening facility using 20 stereotactic biopsies. Comparison against the predicate device demonstrated that image quality was at least equal to the old system and the device was accurate and reliable in clinical use.

Technological Characteristics

System consists of a needle guidance unit and Nuance Manager 3 software module. Integrates with Planmed Nuance/Nuance Excel FFDM X-ray units. Features include automated coordinate determination and fixed-detector stereo imaging. No specific materials or ASTM standards provided.

Indications for Use

Indicated for needle sampling of breast tissue in women for examination. Use restricted to supervision by a healthcare professional.

Regulatory Classification

Identification

A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.

Predicate Devices

• Planmed Sophie & Sophie Classic (with Digispot and Cytoguide) (K021945)

Submission Summary (Full Text)

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# Planm K121963

### 510K) SUMMARY

DATE October 12, 2012 NOV 2 1 2012

### PRODUCT, CLASSIFICATION NAME

Trade name: Planmed Nuance DigiGuide Common name: Stereotactic biopsy for Full Field Digital Mammography (FFDM) System Classification: MUE, Class II Regulation number: 21 CFR 892.1715

### MANUFACTURER

Planmed Oy Asentajankatu 6 / Sorvaajankatu 7 FI-00880 Helsinki, Finland Phone: [phone] Fax: [phone] Contact person: Lars Moring

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

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

### INTENDED USE

Planmed Nuance DigiGuide is an optional system for stereotactic biopsy. It consists of a needle guidance unit attached to Planmed Nuance or Planmed Nuance Excel digital mammographic Xrav units.

The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.

### PRODUCT DESCRIPTION

Planmed Nuance DigiGuide is a digital biopsy imaging system. This system is compatible with Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. .

The Planmed Nuance DigiGuide system consists of the FFDM X-ray unit (Planmed Nuance or Planmed Nuance Excel) that is equipped with the needle guidance unit and the acquisition workstation (AWS), including a personal computer with the Nuance Manager 3 software, which is used for acquiring mammographic images, determining the lesion coordinates, and taking the biopsy.

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### SUBSTANTIAL EQUIVALENCE

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

K021945 Planmed Sophie & Sophie Classic (with Digispot and Cytoguide) = Planmed DigiGuide

The biopsy procedure is the same in both systems. Also the needle guidance unit and its control are the same. The main technical difference between the two systems is the detector used. The new system removes 1) the need to move the detector between the stereo exposures, and 2) also the need to mark the reference in the images, making the procedure faster and more accurate.

The nonclinical verification tests made at the factory and accuracy tests conducted by a 3ª party show compliance with set specifications.

The clinical tests were conducted at a mammography screening facility, which already had long experience in using the previous Planmed DigiGuide system. The comparison study included 20 stereotactic biopsies. The end result was that the image quality scored was at least equal with the old system. The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use.

The comparison of characteristics supports substantial equivalence. Planmed Nuance DigiGuide is as safe and effective as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services, featuring three curved lines emanating from a central point.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2012

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

Re: K121963

Trade/Device Name: Planmed Nuance DigiGuide Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: MUE Dated: October 12, 2012 Received: October 17, 2012

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 (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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely Yours,

## Robert A. Ochs

Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

### 510(k) Number (if known): K121963

Device Name: Planmed Nuance DigiGuide

Indications for Use:

Planmed Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planned Nuance or Planmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software.

The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR

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 In Vitro Diagnostics and Radiological Health (OIR)

Robert A. Ochs 2012.11.21 10:46:32 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

. 510(k)

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