(87 days)
Not Found
Not Found
No
The summary focuses on mechanical enhancements for improved accuracy and repeatability, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
Explanation: The device is a patient support and positioning table used for radiation therapy and simulation. It does not directly provide therapy but rather supports the patient during the therapeutic process.
No
The device description states it is a "patient treatment support and positioning table for radiation therapy and simulation use" and enhances existing devices for "improved directional accuracy and repeatability to provide for easier and more efficient patient set up." This indicates a tool for treatment delivery and patient setup, not for diagnosis.
No
The device description explicitly states it is a "Treatment Table," which is a physical hardware device used for patient support and positioning. While it might have software components for control or positioning, the core device is hardware.
Based on the provided information, the Precise™ Treatment Table is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "patient treatment support and positioning table for radiation therapy and simulation use." This describes a device used on a patient for treatment and positioning, not a device used to test samples from a patient in a lab setting.
- Device Description: The description focuses on its function as a table for patient support and positioning, highlighting improvements in accuracy and repeatability for patient setup. This aligns with a treatment support device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the Precise™ Treatment Table falls under the category of a medical device used for patient support and positioning during radiation therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Precise™ Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.
Product codes
90 JAI
Device Description
The Precise™ Treatment Table is an enhancement to the previously reported EOS RAM and Pedestal devices that have been cleared for commercial distribution. This enhancement offers improved directional accuracy and repeatability to provide for easier and more efficient patient set up. The Precise™ Treatment Table is further considered as an enhancement to the RAM and Pedestal devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.
0
SUMMARY OF SAFETY & EFFECTI JAN 1 5 1999
Elekta Oncology Systems Ltd hereby provides the following material, summarising information on the safety and effectiveness information of the Elekta Oncology Systems Precise™ Treatment Table. This information is summarised as follows:
- The Precise™ Treatment Table is an enhancement to the previously 1. reported EOS RAM and Pedestal devices that have been cleared for commercial distribution. These devices have established and proven track records for safety. This enhancement offers improved directional accuracy and repeatability to provide for easier and more efficient patient set up. The Precise™ Treatment Table is further considered as an enhancement to the RAM and Pedestal devices.
-
- Accompanying documents provided for the user contain comprehensive information to ensure safe and effective use. Past experience with substantially equivalent predicate devices have shown them to be both safe, and effective when used as directed by such accompanying documents provided to the user.
- It is our opinion that the Precise™ Treatment Table does not have 3. technological characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing EOS RAM and Pedestal devices.
- The Precise™ Treatment Table is subject to compliance testing as defined in 4. the internationally recognised safety standards of IEC 60601-1 and IEC 60601-2-1.
-
- The Precise™ Treatment Table is designed to bear the CE mark affirming compliance with all relevant European Directives in force, particularly the European Medical Device Directive, and the European Electromagnetic Compatibility Directive. Consequently, products may be sold freely without restriction throughout the entire European Union.
-
- As the Precise™ Treatment Table contains no executable software, the design ensures "Year 2000" conformity, and additionally ensures that the integrity of "Year 2000" Conformity Compliance is not compromised for systems in which the Precise™ Treatment Table may be used.
-
- Elekta Oncology Systems is a registered medical device manufacturer of assessed capability against the requirements of ISO 9001, EN 46001, and the Medical Device Directive 93/42/EEC Annex II.
| REF: 804/ | Summary of Safety & Effectiveness Information | N.C. 4513 361 2152 | |
|---|---|---|---|
| PC52MAO8468 | for the Elekta Oncology Systems | Attachment No: 14 | |
| MO8QA062 | Precise™ Treatment Table | Page 1 of 2 | 14/10/98 |
| © 1998 Elekta Oncology Systems Ltd. All rights reserved | |||
| ELEKTA ONCOLOGY SYSTEMS LTD, CRAWLEY. UK. |
1
- K483678 The Quality System of Elekta Oncology Systems has been established to 8. satisfy the requirements of ISO 9001, EN 46001, the Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820. Elekta Oncology Systems has developed the Precise™ Treatment Table using this established and documented Quality Management System.
- In accordance with the above requirements, all parts of the Quality System 9. are subject to periodic and systematic internal Quality Audits. Trained personnel not having direct responsibilities in the functions being audited perform these audits.
-
- The Quality System is further subject to regular, planned and documented quality system audits conducted by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
-
- Elekta Oncology Systems has conducted hazard analyses on the Precise™ Treatment Table. Although the Precise™ Treatment Table does not contain software, Elekta Oncology Systems has employed the Guidance for the Content of Pre-Market Notification Submissions of Medical Devices Containing Software and, in doing so, has concluded the level of concern appropriate to the device is "Higher".
-
- It is our opinion that the device does not raise new types of safety or effectiveness considerations.
Signature
P.A. Hart Vice President Research & Development
Signature
P.J. Gaccione Vice President Field Support
Signature
Abdorninal, ENTM.A. Osborne dical Dr Regulatory Affairs & Standardisation Manager
| REF: 804/ | Summary of Safety & Effectiveness Information | N.C. 4513 361 2152 | |
|---|---|---|---|
| PC52MAO8468 | for the Elekta Oncology Systems | Attachment No: 14 | |
| MO8QA062 | Precise™ Treatment Table | Page 2 of 2 | 14/10/98 |
| © 1998 Elekta Oncology Systems Ltd. All rights reserved | |||
| ELEKTA ONCOLOGY SYSTEMS LTD, CRAWLEY. UK. |
2
Public Health Service
JAN 1 5 1999
Electra Instruments, Inc.
3155 Northwoods Parkway, NW
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: Director, Regulatory Affairs & Quality Assurance
K983678 Precise™ Treatment Table Dated: October 19, 1998 Received: October 20, 1998 Regulatory class: II 21 CFR 892.5770/Procode: 90 JAI
Dear Mr. Sumner:
Norcross, GA 30071
Paul L. Sumner
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (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 the Electronic Product 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 (301) 594-4613. 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" (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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D.
Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Precise™ Treatment Table
Device Name:
Indication for Use:
The Precise™ Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.
(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 __
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiolasit
and Radiological Dev 510(k) Number