The Optivus Technology, Inc.'s 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 Description

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 treatment rooms. This complete, turnkey system consists of seven major 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Optivus Proton Beam Therapy System (PBTS). The submission seeks to demonstrate substantial equivalence to a predicate device, the Loma Linda University Medical Center (LLUMC) PBTS, which was already cleared for marketing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The report does not define explicit quantitative "acceptance criteria" through specific performance metrics like sensitivity, specificity, accuracy, or other benchmark values. Instead, the basis for approval is establishing substantial equivalence to a predicate device. This means the Optivus PBTS must demonstrate that it is as safe and effective as the LLUMC PBTS.

The "reported device performance" is presented through a comparison matrix, highlighting the technological characteristics of the Optivus PBTS and showing them to be the "Same as LLUMC PBTS" or having comparable specifications.

Characteristic	LLUMC PBTS (Predicate Device)	Optivus PBTS (Proposed Device)	Acceptance Criteria (Implied)	Reported Performance
Accelerator	Synchrotron, approx. 20 ft. diameter	Same as LLUMC PBTS	Functionally and structurally equivalent to predicate accelerator.	Synchrotron, approx. 20 ft. diameter (Same as LLUMC PBTS)
Particle	Protons	Same as LLUMC PBTS	Uses protons for therapy.	Protons (Same as LLUMC PBTS)
Energy	Continuously variable from 70-250 MeV, corresponding to a water depth of 3 cm to 38 cm.	Same as LLUMC PBTS	Capable of delivering doses within the same energy range.	70-250 MeV, 3 cm to 38 cm water depth (Same as LLUMC PBTS)
Total Cycle Time	2 seconds nominal	1.5-10.0 seconds (2.2 sec nominal)	Comparable cycle time. Nominal time is close to predicate.	2.2 sec nominal (within range, close to predicate's nominal)
Spill Time	1 second	0.1-9.0 seconds (0.5 sec nominal)	Comparable spill time.	0.5 sec nominal (within range, comparable to predicate's nominal)
Cycle Completion Time	0.5 seconds	0.1-9.0 second (1 sec nominal)	Comparable cycle completion time.	1 sec nominal (within range, comparable to predicate's nominal)
Beam Intensity	> 1.5x10^11 protons per pulse	A variable beam intensity in ten steps over range (1x10^9 to 3x10^10 protons per pulse).	Sufficient beam intensity for therapeutic use.	Variable, 1x10^9 to 3x10^10 protons per pulse (Different but acceptable range)
Proton Source	40 keV duoplasmatron	40 keV duoplasmatron (nominal)	Same type of proton source.	40 keV duoplasmatron (nominal) (Same type)
Injector Type	Radio Frequency Quadrupole	Same as LLUMC PBTS	Same type of injector.	Radio Frequency Quadrupole (Same as LLUMC PBTS)
Injection Energy	1.7 MeV	2 MeV (nominal)	Comparable injection energy.	2 MeV (nominal) (Close to predicate)
Treatment Facilities	3 treatment rooms with isocentric gantries, one treatment room with fixed horizontal beam, and a fixed-beam dedicated to calibration and non-patient use.	At least one isocentric gantry treatment room and one fixed-beam treatment room.	Provide sufficient treatment capabilities; configuration may vary but core functionality is maintained.	At least one isocentric gantry and one fixed-beam (subset of predicate's configuration)

2. Sample size used for the test set and the data provenance:

Sample Size: This 510(k) submission does not describe a test set or clinical study involving patient data. The "study" is a comparison of two device specifications.
Data Provenance: Not applicable, as no external data set (patient or otherwise) is mentioned for performance evaluation beyond the device specifications themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This question is not applicable. The "ground truth" here is the established and accepted specifications and performance of the predicate device (LLUMC PBTS). There's no mention of external experts being used to establish a "ground truth" for a test set for the Optivus PBTS. The FDA review process implicitly relies on the agency's experts to evaluate the technical comparison.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This question is not applicable. There is no "test set" in the context of a clinical study that would require an adjudication method. The comparison is based on documented specifications of the two devices.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. The device is a proton beam therapy system, not an imaging analysis AI or diagnostic aid that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. The device is a physical radiation therapy system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the established and regulatory-cleared specifications and performance characteristics of the predicate device (LLUMC PBTS), which has been legally marketed. The submission's core argument is that the proposed device shares the same fundamental technological characteristics and principles of operation as this already-cleared device.

8. The sample size for the training set:

This question is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring training data. The device is hardware.

9. How the ground truth for the training set was established:

This question is not applicable. As there is no training set, there isn't a method for establishing its ground truth.

Summary

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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: (909) 799-8300

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.diameter	Same as LLUMC PBTS
Particle	Protons	Same as LLUMC PBTS
Energy	Continuously variable from 70-250 MeV, corresponding to awater depth of 3 cm to 38 cm.	Same as LLUMC PBTS
Total Cycle Time	2 seconds nominal	1.5-10.0 seconds (2.2 secnominal)
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 tensteps over range ( $1x1019$ to3x1010 protons per pulse).
Proton Source	40 keV duoplasmatron	40 keV duoplasmatron(nominal)
Injector Type	Radio Frequency Quadrupole	Same as LLUMC PBTS
Injection Energy	1.7 MeV	2 MeV (nominal)
Treatment Facilities	3 treatment rooms withisocentric gantries, onetreatment room with fixedhorizontal beam, and a fixed-beam dedicated to calibrationand non-patient use.	At least one isocentric gantrytreatment room and one fixed-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 (301) 594-4591. Additionally, for questions on the promotion and diagnosite devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-5597 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	✓	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

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.