(39 days)
The RSVP Phantom™ Pelvis is designed for use in a variety of radiation therapy applications including, final quality verification of therapy dose delivery and for comparing the delivered dose profiles for different treatment plans. It is also used for periodic quality assurance evaluations and acceptance testing and to perform reevaluations after equipment or software upgrades.
The RSVP Phantom™ Pelvis provides isodose distribution and verification information for both conventional and intensity modulated radiation therapy machines. The life-size pelvic shape is formed from CAB material and filled with water to simulate the radiation absorption and scatter of human soft tissue.
Here's an analysis of the provided 510(k) summary for the RSVP Phantom™ Pelvis, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance for RSVP Phantom™ Pelvis
Based on the provided document, the RSVP Phantom™ Pelvis is a medical device phantom used for quality assurance in radiation therapy. Its primary function is to simulate human tissue for dose verification.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | The RSVP Phantom™ Pelvis "duplicates the functions of the predicate device" (RSVP Phantom™ K954634). It is designed to "evaluate maximum delivered dose to an identified location for radiation therapy machines." |
| Simulation of Human Tissue (Radiation Absorption & Scatter) | Both the RSVP Phantom™ Pelvis and the predicate device are "formed from CAB material and filled with water to simulate human tissue, and mimic actual patient absorbed dosages." |
| Material Integrity & Absence of Leaks | "Numerous measurements and pressure leak tests were conducted" during prototype creation as part of the development process. |
| Accuracy of Radiation Measurements / Dose Distribution | "Physicist Charles W. Coffey, II, Ph.D. of Vanderbilt University, conducted additional radiation measurements to verify the functions of the phantom compared to the predicate device." The phantom provides "isodose distribution and verification information." |
| Anthropomorphic Design for Pelvic Studies | The RSVP Phantom™ Pelvis offers an "anthropomorphic pelvic form [which] is more effective for pelvic studies" compared to the predicate device. This implies an acceptance criterion for anatomical accuracy relevant to its intended use. |
| Manufacturing Quality | Manufactured in accordance with "The Phantom Laboratory's ISO 9001:2000 registered quality system." Measurement equipment used was "calibrated with traceability to NIST." |
Study Details:
The primary study mentioned is a comparative verification study against a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a numerical value in terms of "cases" or "test samples." The document refers to "numerous measurements and pressure leak tests" for prototypes and "additional radiation measurements" conducted by the physicist. This suggests a series of experiments and tests rather than a single fixed "test set."
- Data Provenance: The testing was conducted during the device's development process and by a U.S. academic institution (Vanderbilt University). The nature of the measurements suggests prospective experimental data rather than retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: One expert is explicitly named: "Physicist Charles W. Coffey, II, Ph.D. of Vanderbilt University."
- Qualifications of Experts: Ph.D. holder and a physicist at Vanderbilt University. While "physicist" is mentioned, his specific specialization (e.g., medical physicist, radiation physicist) is not detailed, but is implied by the context of radiation therapy measurements.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable or not explicitly detailed. The verification work appears to have been performed by a single expert (Dr. Coffey) comparing the new device against the predicate device's known functions and performance standards. There is no mention of multiple reviewers adjudicating discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a phantom for calibrating and verifying radiation therapy machines, not an imaging or diagnostic device requiring human interpretation of medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: This concept is not directly applicable to a physical phantom. The phantom itself is a tool. Its "performance" is its ability to accurately simulate tissue properties for radiation dose measurements. The verification measurements performed by Dr. Coffey would be considered the assessment of the phantom's standalone performance in its intended function. There is no "algorithm" in the typical sense for this device.
7. The Type of Ground Truth Used:
- Ground Truth: The ground truth for evaluating the RSVP Phantom™ Pelvis was primarily based on:
- Benchmarking against a legally marketed predicate device (K954634): The predicate device's established performance and "functions" served as a "gold standard" for functional equivalence.
- "Actual patient absorbed dosages" simulation: The phantom is designed to mimic these, suggesting general physical principles and known dosimetric properties as part of the ground truth.
- Calibrated measurements with traceability to NIST: This ensures the accuracy and reliability of the measurement equipment used during testing.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set." It is a physical phantom.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
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RSVP Phantom™ Pelvis, 510(k) Summary
| JUL 29 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 | June 6, 2008 |
| Device Name: | Trade Name - RSVP Phantom™ PelvisClassification Name - Accelerator, linear, medical(892.5050, Product Code IYE) |
| Equivalent Device: | RSVP Phantom™, 510(k) submission number K954634 |
| Device Description: | The RSVP Phantom™ Pelvis provides isodose distributionand verification information for both conventional andintensity modulated radiation therapy machines. The life-size pelvic shape is formed from CAB material and filledwith water to simulate the radiation absorption and scatterof human soft tissue. |
| Intended Use: | The RSVP Phantom™ Pelvis is designed for use in avariety of radiation therapy applications including, finalquality verification of therapy dose delivery and forcomparing the delivered dose profiles for differenttreatment plans. It is also used for periodic qualityassurance evaluations and acceptance testing and toperform reevaluations after equipment or softwareupgrades. |
| Technological Comparison: | The RSVP Phantom™ Pelvis and the predicate device,RSVP Phantom™, are both designed to evaluate maximumdelivered dose to an identified location for radiationtherapy machines. Both phantoms are formed from CABmaterial and filled with water to simulate human tissue, andmimic actual patient absorbed dosages. |
| Testing Conclusions: | During the creation of prototypes for the RSVP Phantom™Pelvis, as part of the development process, numerousmeasurements and pressure leak tests were conducted inaccordance with the Phantom Laboratory's ISO 9001:2000 |
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registered quality system. The measurement equipment used was calibrated with traceability to NIST.
During the development of the RSVP Phantom™ Pelvis, physicist Charles W. Coffey, II, Ph.D. of Vanderbilt University, conducted additional radiation measurements to verify the functions of the phantom compared to the predicate device. The RSVP Phantom™ Pelvis duplicates the functions of the predicate device, however, the anthropomorphic pelvic form is more effective for pelvic studies.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2008
Mr. Joshua R. Levy President The Phantom Laboratory, Inc. PO Box 511 SALEM NY 12865
Re: K081760
Trade/Device Name: RSVP Phantom™ Pelvis Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy Regulatory Class: II Product Code: IYE Dated: June 6, 2008 Received: June 20, 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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/cdrb/industry/support/index.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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Indications for Use
510(k) Number (if known): K081760
Device Name: RSVP Phantom™ Pelvis
Indications For Use:
The RSVP Phantom™ Pelvis is designed for use in a variety of radiation therapy applications including, final quality verification of therapy dose delivery and for comparing the delivered dose profiles for different treatment plans. It is also used for periodic quality assurance evaluations and acceptance testing and to perform reevaluations after equipment or software upgrades.
Prescription Use AND/OR 801 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081760
§ 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.