PROTON BEAM THERAPY SYSTEM (PBTS)

K992414 · Optivus Technology, Inc. · LHN · Jul 21, 2000 · Radiology

Device Facts

• Record ID: K992414
• Device Name: PROTON BEAM THERAPY SYSTEM (PBTS)
• Applicant: Optivus Technology, Inc.
• Product Code: LHN · Radiology
• Decision Date: Jul 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optivus Proton Beam Therapy System (PBTS) is an integrated facility designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that protects people from unnecessary exposure to radiation and other hazards.

Device Story

Integrated facility for proton radiation therapy; delivers predetermined radiation dose to target volume. System components: 70-250 MeV proton synchrotron; beam transport system; fixed beam delivery systems; isocentric gantries; patient positioning system; integrated facility control and safety systems. Operated by clinical staff in a specialized facility. System accelerates protons via synchrotron; transports beam to treatment rooms; directs beam to patient target. Integrated control and safety systems manage dose delivery and radiation protection. Output is a controlled proton beam for therapeutic radiation. Benefits include precise dose delivery to target volume while minimizing unnecessary radiation exposure.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison to the predicate device.

Technological Characteristics

Facility-based proton radiation therapy system. Components: 70-250 MeV proton synchrotron, beam transport system, isocentric gantries, fixed beam delivery, patient positioning system. Proton source: 40 keV duoplasmatron. Injector: Radio Frequency Quadrupole. Energy range: 70-250 MeV (3-38 cm water depth). Beam intensity: 1x10^9 to 3x10^10 protons per pulse. Integrated facility control and safety systems. Standalone facility infrastructure.

Indications for Use

Indicated for patients requiring proton radiation therapy for the delivery of a predetermined radiation dose to a target volume.

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

• Loma Linda University Medical Center (LLUMC) PBTS (K872369)

Submission Summary (Full Text)

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## JUL 2 1 2000

### 510(k) SUMMARY

### For

OPTIVUS PROTON BEAM THERAPY SYSTEM

K992414
Page 1 of 3

#### COMPANY NAME/ADDRESS 1.

1.1 Sponsor Contact

Optivus Technology, Inc. P.O. Box 608 Loma Linda, CA 92354 Contact Person: Clark Taylor Telephone: [phone]

1.2 Sponsor Manufacturing Address

Optivus Technology, Inc. 1475 South Victoria Court San Bernardino, CA 92408

Date Prepared: July 19, 1999

#### 2. DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name:

Proton Beam Therapy System (PBTS) Proton Beam Therapy System Medical Charged-Particle Radiation Therapy System

#### 3. PREDICATE DEVICES

The Optivus Proton Beam Therapy System (PBTS) is substantially equivalent to the Loma Linda University Medical Center (LLUMC) PBTS. The LLUMC PBTS was cleared for marketing in the United States in the premarket notification, K872369.

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#### 4. DEVICE DESCRIPTION

K992414
Page 2 of 3

The Optivus Proton Beam Therapy System (PBTS) is an integrated facility designed to deliver radiation treatment. Optivus' proposed facility is essentially the same as the facility that is currently operating at LLUMC. Both facilities consists of three major functional blocks; the accelerator, the beam transport system, and the This complete, turnkey system consists of seven major treatment rooms. subsystems:

- 70 - 250 MeV proton synchrotron;
- beam transport system;
- . one or more fixed beam delivery systems;
- . one or more isocentric gantries;
- patient positioning system;
- integrated facility control system; and .
- integrated facility safety system.

#### INTENDED USE ട.

The Optivus Proton Beam Therapy System (PBTS) is an integrated facility designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that protects people from unnecessary exposure to radiation and other hazards. This is the same intended use as the LLUMC PBTS.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Optivus PBTS has the same technological characteristics as the LLUMC PBTS. The comparison matrix for the LLUMC PBTS and the Optivus PBTS is summarized below.

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K992414
Page 3 of 3

# Table 1: Comparison matrix between the Optivus PBTS and the Loma Linda University Medical Center PBTS

| Characteristic | LLUMC PBTS | Optivus PBTS |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Accelerator | Synchrotron, approx. 20 ft.<br>diameter | Same as LLUMC PBTS |
| Particle | Protons | Same as LLUMC PBTS |
| Energy | Continuously variable from 70-<br>250 MeV, corresponding to a<br>water depth of 3 cm to 38 cm. | Same as LLUMC PBTS |
| Total Cycle Time | 2 seconds nominal | 1.5-10.0 seconds (2.2 sec<br>nominal) |
| Spill Time | 1 second | 0.1-9.0 seconds (0.5 sec nominal) |
| Cycle Completion Time | 0.5 seconds | 0.1-9.0 second (1 sec nominal) |
| Beam Intensity | > 1.5x1011 protons per pulse | A variable beam intensity in ten<br>steps over range ( $1x1019$ to<br>3x1010 protons per pulse). |
| Proton Source | 40 keV duoplasmatron | 40 keV duoplasmatron<br>(nominal) |
| Injector Type | Radio Frequency Quadrupole | Same as LLUMC PBTS |
| Injection Energy | 1.7 MeV | 2 MeV (nominal) |
| Treatment Facilities | 3 treatment rooms with<br>isocentric gantries, one<br>treatment room with fixed<br>horizontal beam, and a fixed-<br>beam dedicated to calibration<br>and non-patient use. | At least one isocentric gantry<br>treatment room and one fixed-<br>beam treatment room. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**JUL 21 2000**

Optivus, Inc. c/o James R. Veale Vice President, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K992414 Optivus Proton Beam Therapy System (PBTS) Dated: April 28, 2000 Received: May 1, 2000 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN

Dear Mr. Veale:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have deemined the We have reviewed your Section 5 fincile in the enclosure) to legally in the enclosure) to legally marketed predicate devices and device is substantialy equivalent (for the novel on the states in the encline of the American of to devices that maketed in interstate commerce proct to way 20, 1910, the that have and Cosmetic Act (Act). You may, therefore,
have been reclassified in accordance with the provisions of t nave been recalssited in accordance will the provisions of the Act. The general controls provisions of the Activate market the device, subject to the gelleral control provisions of the golling and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) in the Corporal). it nay be subject (o If your device is classified (see above) into eller Class in (the Code of Frederal Regulations) Title 21,
such additional controls. Existing major regulations affecting your ട്രിറ്റ് ഓസ്റ്റ് - Extonig high legolations and only in the Current Cool Mandfacturing Practice Parts 800 to 895. A substantally equivalen described incr. Co enclares (o ocenter couldion (21 CFR Pat 820) and requirements, as set form in the Quality System regulation (FDA) will verify such assumptions. Faire to ormply with that, through periodic US inspections, the Food and Drug Forming announcements concerning your device in the GMP regulation may result in regulation. In addition of the mission does not affect any oligation you might the Federal Register. Please for the Response to your premainst nations of any of the Clecific on tother Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) pemarket notification. The FDA finding of i his letter will allow you to begilly marketing your device in your virus promotive 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 80010 for in vitro If you desie spealic abite for your device of Canading of [phone]. Additionally, for questions on the promotion and diagnosite devices, please contact the Office of Compliance at [phone]. Also, please note the regulation under advertising of your device, please collice of Complanes of (or ) or rest information on your resorgeibilities under the ender he "Misolanding by release to peniance noticles from the reserved in the former [phone] or [phone] r or at its internet address "http://www.fda.gov/odch/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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992414 510(k) Number (if known):

Device Name: Proton Beam Therapy System

Indications for Use:

The Optivus Technology, Inc.'s Proton Beam Therapy System (PBTS) is an integrated The Optivas Technology, the. 5 Procession treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that a protection from unnecessary exposure to radiation and other hazards.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K992414 |

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use | |
|----------------------|--------------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |

| Optivus Technology, Inc. 510(k) | 7/19/99 | CONFIDENTIAL |
|---------------------------------|---------|--------------|
| Proton Beam Therapy System | | Page vii |