ADC PEDIATRIC

K012750 · Agfa Corp. · MQB · Nov 14, 2001 · Radiology

Device Facts

• Record ID: K012750
• Device Name: ADC PEDIATRIC
• Applicant: Agfa Corp.
• Product Code: MQB · Radiology
• Decision Date: Nov 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ADC Pediatric is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Pediatric is intended to be used in pediatric imaging applications.

Device Story

ADC Pediatric is a computed radiography (CR) imaging system; utilizes photo-stimulatable storage phosphor imaging plates to capture X-ray latent images. System scans plates with laser; converts latent image to digital bit stream; stores data locally or transmits to PACS via DICOM. Device is identical in hardware/software to ADC Compact (K974597); adds a data file containing preselected image processing parameters mapped to pediatric age and exam types. User selects exam/age; system automatically applies optimized processing parameters, replacing manual parameter entry. Used in clinical settings; operated by radiology staff. Benefits include standardized, optimized image quality for pediatric patients based on European Guidelines on Quality Criteria for Diagnostic Radiographic Images in Paediatrics.

Clinical Evidence

Bench testing only. Testing conducted in two hospitals to refine and optimize image processing parameter sets for pediatric applications, following recommendations from the European Guidelines on Quality Criteria for Diagnostic Radiographic Images in Paediatrics.

Technological Characteristics

Computed radiography system; utilizes photo-stimulatable storage phosphor imaging plates; laser scanning mechanism; digital output; DICOM connectivity. Hardware and software are identical to the predicate device. No specific materials or ASTM standards cited.

Indications for Use

Indicated for pediatric patients requiring diagnostic radiographic imaging to aid in physician diagnosis.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• ADC Compact (K974597)

Submission Summary (Full Text)

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NOV 1 4 2001

510(k) Summarv

K012750

3

# ADC Pediatric

Common/Classification Name: Computed Radiography, 21 CFR 892.1680

Agfa Corporation 10 South Academy Street Greenville, SC 25602-9048

Contact: Jeff Jedlicka, Prepared: June 22, 2001

#### A. LEGALLY MARKETED PREDICATE DEVICES

The predicate device is the crevious version of the same device, namely the ADC Compact, which was cleared by FDA on 09 March 1998 as K974597.

#### DEVICE DESCRIPTION 8.

The ADC Compact, the predicate device, is a computed radiography imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plats is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.

The ADC Pediatric is identical in hardware and software to the ADC Compact. The only difference is in a data file that is provided that is accessed by the (unchanged) suftware, where preselected image processing parameters are paired with typical pediatric exposure parameters by age and exam type (assuming that the exposures follow the European Guidelings on Quality Criteria for Diagnostic Radiographic Images in Pacdiatrics). Rather than entering the exposure parameters manually. as would be the case for pediatric exams using the ADC Compact, the user would simply select the exam and patient age, and the proper image processing parameters would be selected automatically and applied to the image.

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# C. INTENDED USE

The ADC Pediatric is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Pediatric is intended to be used in pediatric imaging applications.

## D. SUBSTANTIAL EQUIVALENCE SUMMARY

The ADC Pediatric has the same indications for use as the legally marketed predicate device except for the explicit inclusion of pediatric applications. This change does not affect the intended diagnostic effect. The ADC Pediatric has the same (identical) technological characteristics as the predicate device. This premarket notification has described the characteristics of the ADC Pediatric in sufficient detail to assure substantial equivalence.

## E. TECHNOLOGICAL CHARACTTER'STICS

The technological characteristics are identical in the proposed and predicate devices.

### F. TESTING

The ADC Pediatric was tested in two hospitals to refine the image processing parameter sets for pediatric applications. Images were exposed according to the recommendations of the European Guidelines on Quality Criteria for Diagnastic Rediographic Images in Paediatrics. and the parameter sets were optimized for those exposures.

#### G. CONCLUSIONS

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Public Health Service

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

Agfa Corporation % T. Whit Athev. Ph.D. Senior Consultant C. L. McIntosh 12300 Twinbrook Pkwy, Suite 625 ROCKVILLE MD 20850

AUG 2 3 2013

Re: K012750

Trade/Device Name: ADC Pediatric Computed Radiographic (CR) Medical Imaging Device

Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 16, 2001 Received: August 16, 2001

Dear Dr. Athey:

This letter corrects our substantially equivalent letter of November 14, 2001.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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,

Janine M. Morris

Acting 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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NOV 1 4 2001

K012750

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

The ADC Pediatric is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Pediatric is intended to be used in pediatric imaging applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Manavic Broolin

(Division Sign-Off)
Division of lepreductive, Abdominal,
and Radiological Devices K012750

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