(84 days)
The RSVP Half Sphere Phantom™ is designed for verification of therapy dose delivery in radiation therapy machines, specifically the Leksell™ Gamma Knife sterotactic radiosurgery system. The phantom can also be used for periodic quality assurance evaluations and acceptance testing, and to perform reevaluations after equipment or software upgrades. The phantom works in conjunction with commercially available ion chambers, which are not manufactured by the Phantom Laboratory.
The RSVP Half Sphere PhantomTM was developed to provide localization and dose verification for radiation therapy machines, specifically the LeksellTM Gamma Knife stereotactic radiosurgery system. The phantom's design provides full simulation of the localization and irradiation sequences. The hemi-spherical shape is formed from a urethane material and filled with water to simulate the radiation absorption and scatter of human soft tissue.
Based on the provided 510(k) summary, here's an analysis of the acceptance criteria and the study conducted for the RSVP Half Sphere PhantomTM:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics like accuracy, precision, or reproducibility. Instead, it relies on the device's design, manufacturing controls, and a scientific paper to demonstrate substantial equivalence and fitness for intended use.
However, based on the narrative, the implicit acceptance criteria relate to:
- Ability to simulate radiation absorption and scatter of human soft tissue: Achieved through the urethane material and water-filled design.
- Suitability for localization and dose verification in radiation therapy machines (specifically Leksell Gamma Knife): Demonstrated by comparison to the predicate device and the referenced study.
- Ease of position reproducibility for consistency monitoring: A stated advantage of the geometric shape.
- Manufacturing quality and calibration traceability: Ensured by adherence to ISO 9001:2000 and NIST traceability.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Simulates radiation absorption and scatter of human soft tissue. | The hemi-spherical shape is formed from a urethane material and filled with water "to simulate the radiation absorption and scatter of human soft tissue." |
| Suitable for localization and dose verification for radiation therapy machines (Gamma Knife). | "The RSVP Half Sphere PhantomTM was developed to provide localization and dose verification for radiation therapy machines, specifically the LeksellTM Gamma Knife stereotactic radiosurgery system." The phantom's design "provides full simulation of the localization and irradiation sequences." The device is intended for "verification of therapy dose delivery." |
| Enables simpler theoretical calculations and easier position reproducibility for QA. | "The geometric shape of the RSVP Half Sphere Phantom™ has the advantage, compared to the predicate device, of simpler theoretical calculations and easier position reproducibility which makes it ideal for consistency monitoring through periodic QA testing." |
| Manufactured according to quality standards and calibrated measurement equipment. | "During the creation of prototypes for the RSVP Half Sphere Phantom™ , as part of the development process, numerous measurements and pressure leak tests were conducted in accordance with the Phantom Laboratory's ISO 9001:2000 registered quality system. The measurement equipment used was calibrated with traceability to NIST." |
| Functionally equivalent to the predicate device for evaluating maximum delivered dose. | "The RSVP Half Sphere PhantomTM and the predicate device, RSVP PhantomTM , are both designed to evaluate maximum delivered dose to an identified location for radiation therapy machines. Both phantoms are formed from materials selected for strength and tissue like absorbency, filled with water to simulate human tissue, and mimic actual patient absorbed dosages." "This 510(k) application draws on conclusions made from the research and corresponding paper, 'Calibration of the Gamma Knife using a new phantom following the AAPM TG51 and TG21 protocols' by R. E. Drzymala and R. C. Wood." (Implies the phantom's utility in established calibration protocols). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" in the context of clinical data for algorithmic performance. The validation relies on measurements taken during prototype development and the conclusions drawn from the referenced scientific paper. The number of measurements and pressure leak tests conducted during prototype creation is described as "numerous," but a specific numerical sample size is not provided.
- Data Provenance: The directly referenced study, "Calibration of the Gamma Knife using a new phantom following the AAPM TG51 and TG21 protocols" by R. E. Drzymala and R. C. Wood, would presumably be from a research setting, likely academic or institutional. The document does not specify the country of origin of this research or whether it was retrospective or prospective. The internal testing during prototype creation by The Phantom Laboratory would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the device is a physical phantom for calibration and quality assurance, not a diagnostic or AI-driven interpretative device. Therefore, clinical "ground truth" established by experts in the typical sense (e.g., radiologists interpreting images) is not applicable or discussed for this type of device. The "ground truth" for a phantom would be its physical properties and performance against established dosimetry protocols, which are typically verified by medical physicists or engineers. The referenced paper's authors (R.E. Drzymala and R.C. Wood) are presumably experts in medical physics or a related field, given the subject matter (AAPM TG51 and TG21 protocols).
4. Adjudication Method for the Test Set
This information is not applicable as the device is a physical phantom for calibration, not a device requiring human interpretation or consensus for its "ground truth" in the way a diagnostic AI would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not relevant here. This device is a passive phantom used for calibrating and verifying radiation therapy machines, not an AI for image analysis or diagnosis that would assist human readers.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical phantom, not an algorithm. Therefore, "standalone" algorithmic performance is not applicable. Its "performance" is based on its physical properties and how accurately it facilitates dosimetry measurements when used with an ion chamber (which is a separate, commercially available product).
7. Type of Ground Truth Used
The "ground truth" implicitly used for the phantom's validation is based on:
- Physical principles and dosimetry protocols: Specifically, the AAPM TG51 and TG21 protocols mentioned in the referenced paper.
- Traceability to national standards: "Measurement equipment used was calibrated with traceability to NIST."
- Comparison to predicate device: Functional equivalence to the RSVP PhantomTM.
- Material properties: Selection of urethane and water to mimic human soft tissue radiation absorption and scatter.
8. Sample Size for the Training Set
Not Applicable. This device is a physical phantom and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this question is not relevant.
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510(k) Summary
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DEC 2 3 2008
| 510(k) Owner/Applicant: | The Phantom Laboratory, IncorporatedJoshua R. Levy, President |
|---|---|
| Mailing Address: | P.O. Box 511, Salem, NY 12865 |
| Telephone:Fax: | (518) 692-1190(518) 692-3329 |
| Date | September 26, 2008 |
| Device Name: | Trade name - RSVP Half Sphere PhantomTMClassification name - Accelerator, linear, medical(892.5050, Product Code IYE) |
| Equivalent Device: | RSVP PhantomTM , 510(k) submission number K954634. |
| Device Description: | The RSVP Half Sphere PhantomTM was developed toprovide localization and dose verification for radiationtherapy machines, specifically the LeksellTM Gamma Knifestereotactic radiosurgery system. The phantom's designprovides full simulation of the localization and irradiationsequences. The hemi-spherical shape is formed from aurethane material and filled with water to simulate theradiation absorption and scatter of human soft tissue. |
| Intended Use: | The RSVP Half Sphere PhantomTM is designed forverification of therapy dose delivery in radiation therapymachines, specifically the LeksellTM Gamma Knifestereotactic radiosurgery system. The phantom can also beused for periodic quality assurance evaluations andacceptance testing, and to perform reevaluations afterequipment or software upgrades. The phantom works inconjunction with commercially available ion chambers,which are not manufactured by The Phantom Laboratory. |
| Technological Comparison: | The RSVP Half Sphere PhantomTM and the predicatedevice, RSVP PhantomTM , are both designed to evaluatemaximum delivered dose to an identified location forradiation therapy machines. Both phantoms are formedfrom materials selected for strength and tissue likeabsorbency, filled with water to simulate human tissue, andmimic actual patient absorbed dosages. |
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Testing Conclusions:
This 510(k) application draws on conclusions made from the research and corresponding paper, "Calibration of the Gamma Knife using a new phantom following the AAPM TG51 and TG21 protocols" by R. E. Drzymala and R. C. Wood.
The geometric shape of the RSVP Half Sphere Phantom™ has the advantage, compared to the predicate device, of simpler theoretical calculations and easier position reproducibility which makes it ideal for consistency monitoring through periodic QA testing.
During the creation of prototypes for the RSVP Half Sphere Phantom™ , as part of the development process, numerous measurements and pressure leak tests were conducted in accordance with the Phantom Laboratory's ISO 9001:2000 registered quality system. The measurement equipment used was calibrated with traceability to NIST.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2008
Mr. Joshua R. Levy President The Phantom Laboratory, Inc. PO Box 511 SALEM NY 12865
Re: K082909
Trade/Device Name: RSVP Half Sphere Phantom™ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 28, 2008 Received: September 30, 2008
Dear Mr. Levy:
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 adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx. | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
hope Mr. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: RSVP Half Sphere Phantom™
Indications For Use:
The RSVP Half Sphere Phantom™ is designed for verification of therapy dose delivery in radiation therapy machines, specifically the Leksell™ Gamma Knife sterotactic radiosurgery system. The phantom can also be used for periodic quality assurance evaluations and acceptance testing, and to perform reevaluations after equipment or software upgrades. The phantom works in conjunction with commercially available ion chambers, which are not manufactured by the Phantom Laboratory.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene Remmer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of
§ 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.