EXPLORER 3D

K991815 · Our Scientific Intl., Inc. · MUJ · Aug 13, 1999 · Radiology

Device Facts

• Record ID: K991815
• Device Name: EXPLORER 3D
• Applicant: Our Scientific Intl., Inc.
• Product Code: MUJ · Radiology
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Device Story

Explorer 3D is a software application for stereotactic irradiation planning. It imports CT images to identify target locations; defines and visualizes treatment beam paths; and calculates/visualizes radiation dose distribution relative to target and surrounding anatomical structures. Used by clinicians in a clinical setting to assist in radiation therapy planning for intracranial pathologies. Output aids in precise targeting and dose delivery planning, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based treatment planning system for stereotactic irradiation. Functions include CT image import, target localization, beam definition, and dose visualization. Operates as a standalone software application.

Indications for Use

Indicated for intracranial diseases including gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• pReference TPS (K970464)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 13 1999

Mario Caballero Manager, Quality Systems Our Scientific Int'l, Inc. 5870 Stoneridge Drive Pleasantville, California 94588 Re:

K991815

Explorer 3D Stereotactic Irradiation Software Dated: May 5, 1999 Received: May 27, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 MUJ

Dear Mr. Caballero:

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 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 redassified 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 III (Special Controls) or dass 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,

APT Daniel G. Schultz, M.D. Acting 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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## Section D - Statement of Indications for Use

Page of

K9918/5
510 (k) Number (if known): (new product)

Device Name:_ Explorer 3D

Indications For Use:

The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Seaym

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices,
510(k) Number K991815

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)