PHILIPS SLI SERIES LINEAR ACCELERATOR

K963624 · Philips Medical Systems, Inc. · IYE · Dec 6, 1996 · Radiology

Device Facts

• Record ID: K963624
• Device Name: PHILIPS SLI SERIES LINEAR ACCELERATOR
• Applicant: Philips Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

The Philips SLi Series Linear Accelerators and MLCi products are radiotherapy systems designed for cancer treatment. They function as improvements to the existing Philips SL Series Linear Accelerators and Philips MLC products. The system delivers radiation therapy, with the MLCi (Multi-Leaf Collimator) component providing beam shaping. Operated by trained clinical staff in a radiotherapy setting, the device uses established radiation delivery principles to treat patients. The system is designed to maintain safety and effectiveness standards consistent with its predecessors. Clinical benefit is derived from the delivery of controlled radiation to target tissues, with the device's performance and safety profile supported by compliance with international standards and a documented quality management system.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1, IEC 601-2-1, IEC 950, and UL 1950 standards. Hazard analysis conducted; no new hazards identified.

Technological Characteristics

Linear accelerator system with Multi-Leaf Collimator (MLCi). Compliance with IEC 601-1, IEC 601-2-1, IEC 950, and UL 1950. Software developed under ISO 9001, EN 46001, and 21 CFR 820 GMP. Moderate level of concern for software.

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

• Philips SL Series Linear Accelerators
• Philips MLC products

Submission Summary (Full Text)

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Dec. 6, 1996 K963624

Philips Medical Systems - Radiotherapy, hereby provide the following material summarising safety and effectiveness information for the Philips SLi Series Linear Accelerators and MLCi products. This information is summarised as follows:-

1) The SLi Series Linear Accelerators and MLCi products are improvements of the existing SL Series and the Philips MLC products which have previously been cleared for commercial distribution. These devices have an established and proven track record for safety. The SLi Series Linear Accelerators and MLCi products do not raise additional types of safety or effectiveness considerations when compared against the existing functions provided by the Philips SL Series fitted with MLC.

2) The accompanying documents provided for the user contain comprehensive information to ensure safe and effective use. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed by the accompanying documents provided for the user.

3) It is our opinion that the Philips SLi Series Linear Accelerators and MLCi products do not have technological characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing SL Series Linear Accelerators and MLC products.

4) The SLi Series Linear Accelerators and MLCi products have been subject to compliance testing as defined in the internationally recognised safety standards IEC 601-1 and IEC 601-2-1. As appropriate, proprietary information technology equipment is procured to the internationally recognised standards IEC 950 and/or UL 1950.

5) All products bear the CE mark affirming compliance with all relevant European Directives in force. In particular compliance has been assured to the European Medical Device Directive and the European Electromagnetic Compatibility Directive. Additionally the total system is subject to the provision of the Code of Federal Regulations, Title 21: Food and Drugs.

6) The SLi Series Linear Accelerators and MLCi products have been designed to ensure that compliance to the above standards is maintained.

| REF: 804/PC52MA06926QA6M0100 | SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION FOR THE PHILIPS SLi SERIES LINEAR ACCELERATORS | N.C. 4513 364 1752
Attachment No: 26 |
| --- | --- | --- |
| | | Sht. 1 29.08.96 |

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PHILIPS RADIO THERAPY SYSTEMS OWN THE COPYRIGHT OF THIS DOCUMENT WHICH IS SUPPLIED IN CONFIDENCE. WHICH MUST NOT BE USED FOR ANY PURPOSE OTHER THAN THAT FOR PHILIPS REPRODUCED IN THE COPYRIGHT HOLDERS.

7) PMS-R is a Department of Health GMP registered medical device manufacturer of assessed capability, against the requirements of ISO 9001, EN 46001, and the UK Department of Health GMP. This Software Quality System has been established to satisfy the requirements of ISO 9001, EN 46001, the UK Department of Health GMP and the US 21 CFR 820 GMP. Philips Medical Systems - Radiotherapy has developed the SLi Series Linear Accelerators and the MLCi products using an established and documented Software Quality Management System.

8) In accordance with the above requirements all parts of the Quality System are subject to periodic and systematic internal Quality Audits. These audits are performed by trained personnel not having direct responsibilities in the functions being audited.

9) Additionally the quality system is subject to regular, planned and documented GMP audits conducted by external auditors from the UK Department of Health, SGS Yarsley and the FDA.

10) PMS-R has conducted hazard analysis on the Philips SLi Series Linear Accelerators and the MLCi products and have concluded that it introduces no new hazards and that the level of concern appropriate to the SLi Series Linear Accelerators and the MLCi products is moderate.

Signature: 
Development Director

Signature: 
Company Marketing Manager

Signature: 
Quality Assurance Manager

| REF: 804/
PC52MA06926
QA6M0100 | SUMMARY OF SAFETY AND EFFECTIVENESS
INFORMATION FOR THE PHILIPS
SLi SERIES LINEAR ACCELERATORS | N.C. 4513 364 1752
Attachment No: 26 | |
| --- | --- | --- | --- |
| | | Sht. 2 | 29.08.96 |