LANTIS TREATSTATION

K972275 · Siemens Medical Solutions USA, Inc. · IYE · Sep 8, 1997 · Radiology

Device Facts

• Record ID: K972275
• Device Name: LANTIS TREATSTATION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYE · Radiology
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the LANTIS TREATSTATION is to allow the radiation therapist to deliver treatment to the patient using the MEVATRON and all available accessories. This entails selecting a patient, selecting today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, LANTIS TREATSTATION supports intensity modulation (IM), a process of shaping, modifying, and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

Device Story

LANTIS TREATSTATION functions as a record and verify radiation treatment system module; replaces sequencing/VMI module of Impac Sequencer. Input: treatment data from verification and record system. Operation: downloads treatment fields/segments to linear accelerator control; supports auto-sequencing and intensity modulation (IM) for beam shaping/modification. Output: controlled delivery of radiation treatment; recorded treatment data. Used in clinical radiation oncology settings; operated by radiation therapists. Benefits: maximizes dose to target while minimizing dose to normal structures; ensures sequential delivery without manual intervention.

Clinical Evidence

Bench testing only. Performance tests conducted to verify device operation within design parameters and equivalence to the predicate device.

Technological Characteristics

Software-based record and verify system for radiation therapy. Integrates with MEVATRON linear accelerators. Supports auto-sequencing and intensity modulation (IM). No significant changes in materials or energy source compared to predicate.

Indications for Use

Indicated for patients undergoing radiation therapy requiring treatment delivery via MEVATRON linear accelerators, including auto-sequencing of treatment fields and intensity-modulated radiation therapy (IMT).

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

• Impac Medical Systems' Sequencer (K913612)

Submission Summary (Full Text)

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SEP - 8 1997

K972a275

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. | Submitter's Information: | Dated: June 9, 1997 |
|----|-----------------------------|---------------------------------------------------------|
| | Siemens Medical Systems | |
| | Oncology Care Systems Group | |
| | 4040 Nelson Avenue | |
| | Concord, CA 94520 | |
| | Contact Person: | Kathryn B. Dodd |
| | | Vice President Regulatory Affairs and Quality Assurance |
| 2. | Common or Usual Name: | Record and Verify Radiation Treatment System |
| | Proprietary Name: | LANTIS TREATSTATION |
| | Classification Names: | Record and Verify Radiation Treatment System |
| | | 21 CFR § 892.5710 |

Class II, Product Code: RA 90 IYE

Impac Medical Systems' Sequencer (K913612) 3. Predicate Device:

- Description of Device: LANTIS TREATSTATION is a direct replacement for the 4. sequencing/VMI module of the Impac Sequencer Record and Verify Radiation Treatment System. The TREATSTATION coexists with the LANTIS Commander application on the target platform to allow the user access to the information system's other functions and provide the complete spectrum of required functionality.
- Statement of intended use: The intended use of the LANTIS TREATSTATION is to allow the પં radiation therapist to deliver treatment to the patient using the MEVATRON and all available accessories. This entails selecting a patient, selecting today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, LANTIS TREATSTATION supports intensity modulation (IM), a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures. The intended use is the same as the predicate device.
- Statement of technological characteristics: The LANTIS TREATSTATION software does not 6. have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
- Differences: The minor configuration and specification differences between the LANTIS 7. TREATSTATION and Impac's Sequencer does not alter the intended use or affect the safety and effectiveness of the LANTIS TREATSTATION when used as labeled.
- Performance Evaluation: Performance tests were conducted and the results indicated that the 8. device consistently performed within the design parameters and equivalently to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 8 1997

Kathryn B. Dodd Vice President Regulatory and Affairs and Quality Assurance Siemens Medical Systems, Inc. 4040 Nelson Avenue Concord, CA 94520

Re: K972275 Lantis Treatstation Dated: June 9, 1997 Receivced: June 18, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Dodd:

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 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 requirement, 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 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/dsmamain.html".

Sincerely yours,

h.Liau Yu-

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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Page 1 of 1

510(k) Number (if known): K972275

Device Name: LANTIS TREATSTATION

Indications For Use:

The intended use of the LANTIS TREATSTATION is to allow the radiation the intendta deliver treatment to the patient using the MEVATRON and all This entails selecting a patient, selecting available accessories. today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user In addition, LANTIS TREATSTATION supports intensity intervention. modulation (IM), a process of shaping, modifying, and moving the modulation (11), a t to maximize the dose at the target and minimize the dose to all normal structures.

The intended use is the same as the predicate device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972275 |

Prescription Use (Per 21 CFR 801 109)

CR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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