(84 days)
Not Found
No
The summary describes a physical phantom used for calibrating and verifying radiation therapy equipment. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies reference a paper on calibration protocols and physical testing of the phantom's design and construction.
No
The device is a phantom used for quality assurance and verification of radiation therapy machines, not for treating patients.
No
The device is designed for verification of therapy dose delivery and quality assurance of radiation therapy machines, not for diagnosing medical conditions in patients.
No
The device description clearly states the device is a physical phantom made of urethane and filled with water, designed for use with ion chambers. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "verification of therapy dose delivery in radiation therapy machines," "periodic quality assurance evaluations," and "acceptance testing." These are all related to the performance and calibration of a medical device (the radiation therapy machine), not to the diagnosis or monitoring of a patient's health condition using samples from the human body.
- Device Description: The device is a phantom designed to simulate human tissue for radiation absorption and scatter. It's used in conjunction with ion chambers to measure radiation dose. This is a tool for calibrating and testing equipment, not for analyzing biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample from a patient.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment decisions. This phantom does not fit that description.
N/A
Intended Use / 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 stereotactic 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The RSVP Half Sphere Phantom™ was developed to provide localization and dose verification for radiation therapy machines, specifically the Leksell™ 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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.5050 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.
0
510(k) Summary
.
.
DEC 2 3 2008
| 510(k) Owner/Applicant: | The Phantom Laboratory, Incorporated
Joshua 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 PhantomTM
Classification 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 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. |
| Intended Use: | The RSVP Half Sphere PhantomTM is designed for
verification of therapy dose delivery in radiation therapy
machines, specifically the LeksellTM Gamma Knife
stereotactic 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. |
| Technological Comparison: | 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. |
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:
:
1
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.
2
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
4
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
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