(15 days)
The Render-Plan 3-D® is intended to be used for planning the dosimetry of treatments in radiation therapy. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
The Render-Plan 3-D® is an enhancement to the Render-Plan 3-D 1) (Formerly known as Renner-Plan) which has previously been cleared for (Formerly Known as Renner-Frish) winest (1999). This enhancement to Render-Plan 3-De does not raise additional types of safety of effectiveness considerations.
The provided document is limited to a summary of safety and effectiveness, and the FDA clearance letter for a device called "Render-Plan 3-D®". It appears to be a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies for effectiveness.
Based on the provided text, the following information can be extracted regarding the device and its assessment:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, accuracy, or any clinical outcomes. This submission focuses on demonstrating substantial equivalence and adherence to quality systems and regulations.
2. Sample size used for the test set and the data provenance
No information is provided about a specific "test set" with a defined sample size or data provenance. The submission states that the Render-Plan 3-D® is an "enhancement to the Render-Plan 3-D (Formerly known as Renner-Plan) which has previously been cleared for (1999)." This implies that the current device is being compared to its predicate, and effectiveness is asserted largely based on the predicate's prior clearance and the lack of new safety/effectiveness concerns.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
No information is provided about experts establishing ground truth for a test set. This type of detail is typically found in documentation for clinical trials or performance studies, which are not detailed here.
4. Adjudication method for the test set
No information is provided about an adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study is mentioned. The device is a "Render-Plan 3-D®" intended for "planning the dosimetry of treatments in radiation therapy," which processes inputs for dose setting. It is not described as an AI-assisted diagnostic or interpretative tool that would typically involve human reader performance comparisons.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone performance study for the algorithm is described. The device's function is described as processing inputs for dosimetry planning, implying it's a tool used by a healthcare professional rather than a standalone diagnostic.
7. The type of ground truth used
No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as being used for performance evaluation in this summary. The submission relies on affirming compliance with directives and the safety and effectiveness profile of its predicate device.
8. The sample size for the training set
No information is provided about a "training set" or its sample size. This suggests the device's development did not involve a machine learning approach that requires such a set.
9. How the ground truth for the training set was established
Since no training set is mentioned, there is no information on how its ground truth might have been established.
Summary of what is provided:
The document focuses on demonstrating that the Render-Plan 3-D® is an enhancement to a previously cleared predicate device, the Render-Plan 3-D (formerly Renner-Plan). The core argument for safety and effectiveness rests on:
- The new device being an enhancement to a predicate and not raising additional types of safety or effectiveness considerations.
- The device bears the CE mark and complies with relevant European Directives (e.g., Medical Device Directive 93/42/EEC Annex II).
- The manufacturer (PTI) operates under a Quality Management System compliant with ISO 9001.
- Risk analysis was conducted, concluding the device does not introduce new hazards and the level of concern is "Major" for software.
- The FDA determined the device is substantially equivalent to legally marketed predicate devices.
The submission is primarily a regulatory filing demonstrating equivalence and compliance with quality standards, rather than a detailed report of a performance study with specific acceptance criteria and outcome data for the device itself.
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SUMMARY OF SAFETY & EFFECTIVENESS
Precision Therapy International Inc. (PTI) hereby provides the following
Plan Precision Therapy International The (12) Information for PTI Render-Plan
material summarising safety and offectiveness information for PTI Render-Plan 3-D. This information is summarised as follows:
- The Render-Plan 3-D® is an enhancement to the Render-Plan 3-D 1) (Formerly known as Renner-Plan) which has previously been cleared for (Formerly Known as Renner-Frish) winest (1999). This enhancement to Render-Plan 3-De does not raise additional types of safety of effectiveness considerations.
- contain the uscr The accompanying documents provided for 2) comprehensive information to ensure safe and effective use. Past comprehensive "intornation" to valuent predicate devices has shown our experience with substantially equive used as directed by the accompanying documents provided for the user.
- It is our opinion that the Render-Plan 3-D does not have technological ਤੇ। characteristics that raise additional types of safety or effectiveness characteristics that we consider them an enhancement to the existing Render-Plan 3-D".
- The Render-Plan 3-Dªis designed to bear the CE mark affirming 4) The Relider-1 lan '5 D 10 - assignone Directives in force, in particular compliatice with an relevant Directive. As a result of this, products may be sold freely without restriction throughout the entire European Union.
- PTI is a registered medical device establishment of assessed capability ਟ) against the requirements of ISO 9001 and the Medical Device Directive 93/42/EEC Annex II.
- PTI Quality System has been established to satisfy the requirements of ୧) ISO 9001, the Medical Device Directive 93/42/EEC Annex II, and 150 7001, the Medical Developed the Render-Plan 3-D" using an escablished and documented Quality Management System.
- In accordance with the above requirements, all parts of the Quality 7) 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.
| REF:DRC140-2030-01 | Summary of Safety & Effectiveness Informationfor the PTI Render-Plan 3-D® | Page 1 of 2 | 08/20/99 |
|---|---|---|---|
| © 1999 Precision Therapy International Inc. All rights reserved | |||
| PRECISION THERAPY INTERNATIONAL INC. NORCROSS GA. USA |
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- PTI has conducted risk analysis on the Render-Plan 3-D* and has 8) 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 PTI has concluded the level of concern appropriate to the device is "Major".
- The Quality System is subject to regular, planned and documented 9) quality system audits conducted by external auditors from BSI (UK Notified Body) and the FDA.
Signature
Mark Symons
President
Signature
William Z. King
William Joy
Quality Engineer
| REF: DRC140-2030-01 | Summary of Safety & Effectiveness Information for the PTI Render-Plan 3-D |
|---|---|
| Page 2 of 2 08/20/99 | |
| © 1999 Precision Therapy International Inc. All rights reserved | |
| PRECISION THERAPY INTERNATIONAL INC. NORCROSS GA. USA |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is arranged on a single line. The text appears to be part of a document or letterhead.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
lagga SEP ರಿ
Paul L. Sumner Director, Regulatory Affairs and Quality Assurance Precision Therapy International 3155 Northwoods Parkway, NW Norcross, GA 30071
Re:
Render-Plan 3-D Dated: August 25, 1999 Received: August 25, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 MUJ
Dear Mr. 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 redassilied 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 requirements, 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 verily 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,
BART Daniel J. Scheidt, M.D.
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
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INDICATIONS FOR USE
Render-Plan 3-D®
510(k) Number (if known):
Device Name:
Indication for Use:
The Render-Plan 3-D® is intended to be used for planning the dosimetry of treatments in radiation therapy. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
(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)
Daniel A. Skymm
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological De 510(k) Number
OR
Over-The-Counter Use _________
(Optional Format 1-2-96)
011
§ 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.