PINPOINT

K974513 · Philips Medical Systems (Cleveland), Inc. · JAK · May 20, 1998 · Radiology

Device Facts

• Record ID: K974513
• Device Name: PINPOINT
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: JAK · Radiology
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Device Story

PinPoint is a CT system accessory for interventional procedure planning; consists of a stereotactic arm mounted on a CT gantry, flat panel monitor, cabling, biopsy phantom, and software. Device maps patient CT image volume to the physical target field; enables radiologist to simulate and initiate interventions. Used in clinical settings by trained healthcare professionals. Output displayed on monitor to guide biopsy, drainage, brachytherapy, or bone pinning. Benefits include improved accuracy in planning interventional procedures.

Clinical Evidence

No clinical data provided. Effectiveness established through internal development evaluation and adherence to design specifications and safety standards.

Technological Characteristics

Stereotactic arm mounted on CT gantry; includes flat panel monitor, cabling, biopsy phantom, and software. Complies with UL 187 and IEC 601-1 safety standards. Operates as an accessory to CT systems for image-to-target registration.

Indications for Use

Indicated for radiologists to simulate and initiate interventional procedures by relating CT image volumes to the target field. Applicable to any body region, including head, spine, and abdomen. Primary use cases include planning biopsies of abdominal organs, drainage of abdominal fluid collections, brachytherapy, and bone pinnings.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Picker 510(k) Notice
K974513
MAY 20 1998
PinPoint

# Summary of Safety and Effectiveness

This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (ODE), specifically DRAERD of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3).

The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel video monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Preliminary functional specifications and operator's instructions are included in the Attachments "B" and "C" respectively. Final documentation will be provided with production units.

The PinPoint is substantially equivalent to legally marketed devices and is under control of health care professionals who are trained and responsible for computed tomography examinations. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.

Picker adheres to FDA 21 CFR 820, 1020.30, and 33, and voluntary standards for safety and effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). In addition, the system is designed to conform to IEC 601-1.

Effectiveness is established by Picker's evaluation throughout all phases of the PinPoint development. The product will perform in accordance with the development specifications. The PinPoint represents the current state-of-the-art technology, therefore, is equivalent to legally marketed devices.

Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the PinPoint. In addition, all information contained in this 510(k) Notice is accurate and complete.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 20 1998
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Robert L. Turocy
Regulatory Affairs and Compliance Manager
Picker International, Inc.
595 Miner Road
Cleveland, Ohio 44143

Re: K974513
PinPoint CT Accessory
Dated: April 3, 1998
Received: April 6, 1998
Regulatory Class: II
21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Turocy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(K) Number (if known): K97 4513

Device Name: **PinPoint**

Indications for Use:

The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

PinPoint is not limited to any particular region of the body. It is equally viable for planning head and spine interventions as it is in the abdomen. It is expected that its major use will be in the planning biopsies of abdominal organs and drainage of fluid collections in the abdomen. However, more complicated procedures such as Brachy therapy and bone pinnings will be planned using the PinPoint.

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