(116 days)
The Elekta Beam Modulator is an X-ray collimator, designed to be used in a linear accelerators and intended to assist a licensed practitioner in the delivery of radiation to defined treatment volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fraction delivery of radiation in all areas of the body where such treatment is indicated.
The provided document is a Summary of Safety & Effectiveness for the Elekta Beam Modulator™ and an FDA 510(k) clearance letter. It does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the format typically expected for AI/software device performance.
Instead, the document focuses on regulatory compliance, substantial equivalence to predicate devices, and general safety assurances in the context of a physical medical device (a multileaf collimator for radiation therapy).
Therefore, I cannot extract the requested information as it is not present in the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance (in terms of specific metrics like accuracy, sensitivity, specificity, etc., which would be relevant for software/AI).
- Sample sizes for test sets, data provenance, or expert qualifications.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies.
- Standalone performance studies.
- Types of ground truth.
- Training set sample size or how its ground truth was established.
Summary of what the document does state regarding safety and effectiveness:
- Device Type: The Beam Modulator™ is an enhancement to previously reported MLCs (Multileaf Collimators) and is a physical component of a radiation therapy system.
- Predicate Devices: K904124 (MLCi), K990085 (Varian Millennium MLC), and K030609 (Tarritom Moduleaf). The document states these have an "established and proven track record for safety."
- Purpose: To provide more precise conformance to desired treatment volume by offering a leaf pitch of 4 millimetres.
- Safety & Effectiveness Rationale:
- Does not raise additional types of safety or effectiveness considerations compared to predicate devices.
- Considered an "enhancement" to previously cleared Elekta devices.
- User documents provide comprehensive information for safe and effective use.
- Compliance testing to IEC 60601-1 and IEC 60601-2-1.
- Designed to bear the CE mark (European compliance).
- Developed under an ISO 9001, ISO 13485, and MDD 93/42/EEC Annex II compliant Quality Management System (QMS).
- Hazard analysis concluded no new safety/effectiveness hazards.
- Level of concern for the device is "Major" as per FDA guidance for devices containing software (though the document doesn't detail what "software" is involved or its function).
- Intended Use (from FDA letter): Used in linear accelerators to assist licensed practitioners in delivering radiation to defined treatment volumes (e.g., tumors) while sparing normal tissue. Intended for single fraction or multi-fraction delivery in all body areas.
In conclusion, this document is a regulatory submission for a physical medical device enhancement based on substantial equivalence and compliance with established safety standards, not a performance study for an AI or software-driven diagnostic or prognostic device.
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SUMMARY OF SAFETY & EFFECTIVENESS Ko42794 JAN 3 1 2005
page 1 of 2
Elekta Limited hereby provides the following material summarising safety and Elekta Elimited for the Beam Modulator™. This information is summarised as follows: -
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- The Beam Modulator™ is an enhancement to the previously reported MLC The Deam Houdlator - D.C. Number K904124, and the MLCi, multileaf collimator, matthear commater, 24. Other predicate devices are the Millennium multileaf collimator from Varian Assoc. Inc., D.C. number K990085 and the Moduleaf committeer from Tarritom MRC Systems GmbH, D.C. number K030609.
These devices have an established and proven track record for safety. The primary I hese devices in roduction of this product is to provide more precise conformance to desired treatment volume by providing a leaf pitch of 4 millimetres. The Beam Modulator™ does not raise additional types of safety or effectiveness considerations.
- The Beam Modulator™ is an enhancement to the previously reported MLC The Deam Houdlator - D.C. Number K904124, and the MLCi, multileaf collimator, matthear commater, 24. Other predicate devices are the Millennium multileaf collimator from Varian Assoc. Inc., D.C. number K990085 and the Moduleaf committeer from Tarritom MRC Systems GmbH, D.C. number K030609.
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- It is our opinion that the Beam Modulator™ does not have technological characteristics that raise additional types of safety or effectiveness questions, and that we consider it an enhancement to the previously cleared devices within the Elekta product range.
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- 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.
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- The Beam Modulator™ is subject to compliance testing as defined in the internationally recognised safety standards IEC 60601-1 and IEC 60601-2-1.
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- The Beam Modulator™ is designed to bear the CE mark affirming compliance with all relevant European Directives in force, in particular the European Medical Device Directive. As a result of this, products may be sold freely without restriction throughout the entire European Union.
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- The Elekta Limited Quality Management System has been established to satisfy the requirements of ISO 9001, ISO 13485, the Medical Device Directive 93/42/EEC Annex II and US 21 CFR 820. Elekta Limited has developed the Beam Modulator™ using an established and documented Quality Management System.
| REF.: PH3RA006 | Summary of Safety & Effectiveness Informationfor the Beam Modulator™ | N.C. 4513 361 2036Attachment No: 6Page 1 of 2 2004/09/27 |
|---|---|---|
| © 2004 Elekta Limited. All rights reserved | ||
| ELEKTA LIMITED, CRAWLEY. UK. |
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SUMMARY OF SAFETY & EFFECTIVENESS
Koppar
fixwiz
1042794
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- Elekta Limited is a registered medical device manufacturer of assessed capability ERKTa Elimited 13 a registered meators 150 13485 and the Medical Device Directive 93/42/EEC Annex II.
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- In accordance with the above requirements all parts of the Quality System are subject to periodic and systematic internal Quality Audits. These audits are subject to personnel not having direct responsibilities in the functions being audited.
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- The quality system is subject to regular, planned and documented GMP audits I he quand by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
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- Elekta Limited has conducted hazard analysis on the Beam Modulator™ and has concluded that it does not introduce hazards that raise new types of safety or effectiveness considerations. After considering the Guidance for the Content of Pre-Market Notification Submissions of Medical Devices Containing Software Elekta Limited has concluded the level of concern appropriate to the device is "Major".
ture
P.D. Hart
29 Sep 2004
Signature
Peter Hart, Vice President, Research & Development
Datudbi........................ Date
29.9.04
Signature
Dee Mathieson, Vice President, Product Management
Signature
Mark A Osborne, Regulatory Affairs Manager
................. Date .........
. Date
zalaA
N.C. 4513 361 2036 Summary of Safety & Effectiveness Information for the Beam Modulator™ Attachment No: 6 REF.: PH3RA006 Page 2 of 2 2004/09/27 © 2004 Elekta Limited. All rights reserved ELEKTA LIMITED, CRAWLEY. UK.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or other bird with outstretched wings. The bird is facing left and has a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2005
Mr. Peter Stegagno Vice President, Regulatory Affairs and Quality Assurance ELEKTA Ltd. 4775 Peachtree Industrial Boulevard Building 300, Suite 300 NORCROSS GA 30092
Re: K042794
Trade/Device Name: Elekta Beam Modulator™ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IYE and IXI Dated: January 5, 2005 Received: January 6, 2005
Dear Mr. Stegagno:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 May 20, 1778, and clance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include reguirements 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 Apple can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statues and regulations administered by other Federal agencies. You must comply with all the roderal batered and lig, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogin mantening of substantial equivalence of your device to a legally premarket nothleation: "The PDF Intentig of our 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), please 11 you desire specific advice for your as rest to following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation econoral information on your responsibilities under the Act from the 807.77). Tou may ooually curers, International and Consumer Assistance at its toll-free number (800) DWNslor of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K04C794
510(k) Number (if known):
Device Name ......................
Beam Modulator™
Indication for Use:
The Elekta Beam Modulator is an X-ray collimator, designed to be used I he Elekta Deant Modulator i in a linear accelerators and intended to with the Dicensed practitioner in the delivery of radiation to defined assist a nechsed practions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single ernical organo from delivery of radiation in all areas of the body where such treatment is indicated.
Prescription Use __- YES (Per 21 CFR 801.109 Subpart D) AND/OR Over-The-Counter Use - NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 3 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
§ 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.