(28 days)
The Elekta Synergy™ System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
The Elekta Synergy™ System is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SL/SLi Series, D.C. K963624) and its commercially available options.
The provided text describes the Elekta Synergy™ System as an enhancement to a previously reported device (Precise Treatment Systems Digital Accelerator, K963624) and its commercially available options. However, it does not include detailed information regarding specific acceptance criteria, device performance, a study conducted to prove it meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods in the way typically expected for a detailed product validation.
Instead, the document focuses on:
- Safety and Effectiveness Justification: Stating that the device does not raise new safety or effectiveness concerns compared to its predicate device and is considered an enhancement.
- Compliance with Standards: Highlighting compliance with international safety standards (IEC 60601-1, IEC 60601-2-1), CE mark, ISO 9001, ISO 13485, Medical Device Directive 93/42/EEC Annex II, and US 21 CFR 820.
- Quality Management System: Describing established and documented Quality Management System, internal audits, and external GMP audits by SGS Yarsley and FDA.
- Hazard Analysis: Concluding that the device does not introduce new hazards, and the level of concern for the device is "Major."
- Substantial Equivalence: The FDA letter confirms the device's substantial equivalence to legally marketed predicate devices, allowing it to be marketed.
Given the information, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values for performance metrics. The document generally asserts safety and effectiveness without providing quantitative clinical study results for the new components of the Elekta Synergy™ system.
Therefore, many sections of your request cannot be fulfilled due to the absence of this information in the provided text.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied/General) | Reported Device Performance (Summary) |
|---|---|
| Safety Profile | Device does not raise additional types of safety considerations compared to predicate. |
| Effectiveness | Device does not raise additional types of effectiveness considerations; considered an enhancement to predicate. |
| Compliance with Standards | Complies with IEC 60601-1, IEC 60601-2-1, CE mark, ISO 9001, ISO 13485, MDD 93/42/EEC Annex II, US 21 CFR 820. |
| Hazards | Hazard analysis concluded no new types of safety or effectiveness considerations. |
| Quality Management | Established and documented QMS, subject to internal and external audits. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe a specific test set or clinical study for the new device components, but rather relies on the predicate device's established safety and effectiveness and compliance with regulatory standards.
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)
- Not provided. No explicit "ground truth" establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No test set or adjudication method is described.
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
- Not provided. This is not an AI-assisted device; it's a radiation therapy system. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This isn't an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated for the "Elekta Synergy™ System" components. The safety and effectiveness are based on the proven track record of the predicate device (Precise Treatment Systems Digital Accelerator) and compliance with regulatory/quality standards.
8. The sample size for the training set
- Not applicable / Not provided. The document doesn't describe a machine learning model with a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. The document doesn't describe a machine learning model with a training set or ground truth establishment for it.
In summary, the provided text is a summary of safety and effectiveness for a 510(k) submission, emphasizing regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance metrics from a comparative clinical trial for a novel device.
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SUMMARY OF SAFETY & EFFECTIVENESS
OCT 2 3 2003
Elekta Limited hereby provide the following material summarising safety and effectiveness information for the Elekta Synergy™ System. This information is summarised as follows: -
-
- The Elekta Synergy™ System is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SL/SLi Series, D.C. K963624) and its commercially available options.
These devices have an established and proven track record for safety. The primary reason for the introduction of this product is to improve information available to allow the set up of the patient position as part of the treatment process. The Elekta Synergy " System does not raise additional types of safety or effectiveness considerations.
- The Elekta Synergy™ System is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SL/SLi Series, D.C. K963624) and its commercially available options.
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- It is our opinion that the Elekta Synergy™ System 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 components of the Elekta Synergy™ System are 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 components of the Elekta Synergy™ System are 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 Elekta Synergy™ System using an established and documented Quality Management System.
| REF.: PH2RA006 | |
|---|---|
| Summary of Safety & Effectiveness Information for the Elekta Synergy™ System | |
| N.C. 4513 341 3467 | |
| Attachment No: 6 | |
| Page 1 of 2 | 2003/09/01 |
© 2003 Elekta Limited. All rights reserved
ELEKTA LIMITED, CRAWLEY. UK.
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SUMMARY OF SAFETY & EFFECTIVENESS
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- Elekta Limited is a registered medical device manufacturer of assessed capability against the requirements of ISO 9001, ISO 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 performed by trained 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 conducted by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
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- Elekta Limited has conducted hazard analysis on the elements of the Elekta Synergy "" System 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".
Signature
D.H. Hart
Signature
Vice President Research & Development
Signature
Atauds
Director Product Management
. Date .
. Date
..................... Date
12 SEP 2003
.................
.12. Sept. 2003
A. Ataide
Director Product Management
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Signature
Regulatory Affairs Manager
| REF.: PH2RA006 | Summary of Safety & Effectiveness Informationfor the Elekta Synergy™ System | N.C. 4513 341 3467Attachment No: 6 |
|---|---|---|
| Page 2 of 2 2003/09/01 | ||
| © 2003 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 & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2003
Elekta Oncology Systems, Ltd. % Mr. Peter Stegagno Elekta, Inc. 4775 Peachtree Industrial Boulevard Building 300, Suite 300 NORCROSS GA 30092
Re: K032996
Trade/Device Name: Elekta Synergy™ System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II
Product Code: 90 IYE Dated: September 12, 2003 Received: September 25, 2003
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 reclassified in accordance 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 requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, 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) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
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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510(k) Number (if known):
Device Name ..................................................... Elektem
Indication for Use:
The Elekta Synergy™ System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ______________________________________________________________________________________________________________________________________________________________________________ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
David C. Egnor
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
(Optional Format 1-2-96)
§ 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.