PHILIPS EASYDIAGNOST ELEVA

K031535 · Philips Medical Systems North America Co. · KPR · Jun 17, 2003 · Radiology

Device Facts

• Record ID: K031535
• Device Name: PHILIPS EASYDIAGNOST ELEVA
• Applicant: Philips Medical Systems North America Co.
• Product Code: KPR · Radiology
• Decision Date: Jun 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Philips EasyDiagnost Eleva intended use is for the following applications: as a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. This includes the following examples: Routine Examinations Colon examinations Examinations of the digestive tract Lung fluoroscopy Examinations of the gall bladder Thorax examinations Skeleton imaging Pediatric examinations Special Applications (might require special accessories and technique) Angiography Myelography Phlebography Arthrography Bronchography Tomography Sialography Hysterosalpingography

Device Story

Philips EasyDiagnost Eleva is a multi-functional R/F system comprising a floor-mounted tilting patient support table and a spot-film device with image intensifier and TV camera. System integrates with Philips Velara generators, digital spot-film cameras, and ViewForum workstation. Operates via motorized tabletop movement (longitudinal/lateral) and spot-film device tilting/positioning. Employs Grid Controlled Fluoroscopy (GCF) with SRM grid-switched X-ray tube for dose reduction and pulse control. Used in clinical settings by physicians/technicians for diagnostic imaging and interventional procedures. Output includes fluoroscopic and radiographic images displayed on monitors for clinical assessment. Supports hospital IT integration via bidirectional RIS coupling, dose calculation, and automated image transfer. Benefits include improved image quality, reduced radiation dose, and streamlined workflow.

Clinical Evidence

Bench testing only. Hazard analysis and verification measures were performed to ensure safety and efficiency equivalent to the predicate device. No clinical data provided.

Technological Characteristics

Multi-functional R/F system with tilting patient support table, image intensifier, and TV camera. Features Grid Controlled Fluoroscopy (GCF) with SRM metal grid-switched X-ray tube. Complies with UL 2601, IEC 60601-1, IEC 60601-2-7, and federal X-ray standards (CFR 1020.30, .31, .32). Supports digital imaging, bidirectional RIS coupling, and automated dose/image management. Software is classified as minor level of concern.

Indications for Use

Indicated for patients requiring general R/F, fluoroscopy, radiography, angiography, and specialized interventional procedures including pediatric examinations. Procedures include routine, digestive, lung, gall bladder, thorax, skeletal, and specialized contrast studies (e.g., myelography, angiography, arthrography).

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

• Philips EasyDIAGNOST (K970640)
• Philips MultiDiagnost Eleva (K023441)

Submission Summary (Full Text)

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JUN 1 7 2003

# Ko31 535 510 (k) Summary

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

| COMMANY NAME: | Philips Medical Systems North America Company | |
|----------------------|-------------------------------------------------------------------------------------|--|
| ADDRESS: | 22100 Bothell Everett Highway<br>P.O. Box 3003<br>Bothell, WA 98021-3003, USA | |
| CONTACT PERSON: | Lynn Harmer | |
| Telephone No.: | 425-487-7312 | |
| DATE PREPARED: | May 15,2003 | |
| CLASSIFICATION NAME: | Table 21CFR 892.1980 (90IXR)<br>Spot-film Device 21CFR 892.1670 (90IXL)<br>Class II | |
| COMMON/USUAL NAME: | R/F System (R/F Table) | |
| DEVICE (Trade) NAME: | PHILIPS EasyDiagnost Eleva | |
| REGISTRATION No. | 1217116 | |

# PERFORMANCE STANDARDS:

This device complies with the federal X-Ray performance standards (CFR 1020.30, .31, .32) as well as with the relevant national and international standards for Electrical and Mechanical Safety (UL 2601, IEC 60601-1, IEC 60601-2-7).

# SYSTEM DESCRIPTION:

The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Velara familiy, with digital spot film cameras from the Philips DI family, and with a Philips ViewForum workstation. The system comes with a 4-mode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Ultramark 400C) can also be added.

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inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.

Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy. The system supports system-wide application-oriented presets and can be equipped with options for better integration into the hospital IT environment (bidirectional RIS coupling), advanced X-ray control techniques (in-pulse control), dose awareness (dose calculation or measurement, automatic prefilter setting), image handling (automatic iamge transfer to integrated viewing workstation), and postprocessing (overview image reconstruction).

#### PREDICATE DEVICE:

The Philips EasyDiagnost Eleva is a modification of, and substantially equivalent to, the Philips EasyDIAGNOST manufactured by Philips Medical Systems. The EasyDIAGNOST received 510(k) clearance March 21, 1997 ( see 510(k) K970640). The Eleva control concept was cleared by the FDA for the Philips MultiDiagnost Eleva (see 510(k) K023441). The intended use of the Philips EasyDiagnost Eleva is the same as for the Philips EasyDIAGNOST. Both systems make use of equivalent technology.

# GENERAL SAFETY INFORMATION:

The Philips EasyDiagnost Eleva uses mature technology and is designed to be in compliance with National and International safety standards.

A hazard analysis on the changes to the previous device identified measures necessary to ensure that the new device is as safe and efficient as the previous device. Those measures are implemented and have been verified.

The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per the August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems North America 22100 Bothell Everett Highway Post Office Box 3003 98041-3003 BOTHELL WA 98021-8431

Re: K031535

Trade/Device Name: Phillips EasyDiagnost Eleva Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulation Number: 21 CFR 892.1670 Regulation Name: Spot-film device Regulation Number: 21 CFR 892.1980 Regulation Name: Tilting Radiographic table Regulatory Class: II Product Code: JAA, KPR, IXL, and IXR Dated: May 15, 2003 Received: May 19, 2003

Dear Ms. Harmer:

This letter corrects our substantially equivalent letter of June 17, 2003.

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Chefosate) to legant manated to the Medical Device Amendments of to commerce prior to May 20, 1976, the enaonance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the PM MA - Very may devices that have been recrassified in acceeders of a premarket approval (PMA). You may.
and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). T and Cosmetic Act (Act) that do not require approvisions of the Act. The general therefore, market the device, subject to the generals for annual registration, listing of devices, controls provisions of the received readers and prohibitions against misbranding and adulteration.

Image /page/2/Picture/11 description: The image shows a circular seal with the letters "FDA" in the center. The seal also contains the word "Centennial" below the letters "FDA". The text "THE N.Y.C." is above the letters "FDA". The seal has a dotted border.

Protecting and Promoting Public Health

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

David A. Ingram

for

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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# ıdications for Use Statement

210(k) Number (if known)

1031535

Device Name Philips EasyDiagnost Eleva

Indications for Use

The Philips EasyDiagnost Eleva intended use is for the following applications: as a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. This includes the following examples:

> Routine Examinations Colon examinations Examinations of the digestive tract Lung fluoroscopy Examinations of the gall bladder Thorax examinations Skeleton imaging Pediatric examinations Special Applications (might require special accessories and technique) Angiography Myelography Phlebography Arthrography Bronchography Tomography Sialography Hysterosalpingography

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>✓</div> | OR | Over-The-Counter Use |
|-----------------------|--------------|----|----------------------|
| (Per 21 CFR 801. 109) | | | |

David A. Agrom
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K031535 |
|---------------|---------|
|---------------|---------|