(39 days)
Not Found
No
The summary describes a physical phantom used for radiation therapy quality assurance and verification. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on physical measurements and comparisons to a predicate device.
No
This device is a phantom used for quality assurance and verification of radiation therapy equipment, not for direct therapeutic treatment of patients.
No
The device is described as a phantom used for quality assurance and verification of radiation therapy dose delivery, not for diagnosing patient conditions.
No
The device description explicitly states the device is a physical phantom made from CAB material and filled with water, simulating human tissue for radiation therapy verification. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for quality assurance and verification of radiation therapy dose delivery. This is a quality control tool for medical equipment, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device simulates human tissue for radiation absorption and scatter. It's a physical phantom used in a radiation therapy setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
Therefore, the RSVP Phantom™ Pelvis is a medical device used in radiation therapy quality assurance, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis
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)
During the creation of prototypes for the RSVP Phantom™ Pelvis, 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
RSVP Phantom™ Pelvis, 510(k) Summary
| JUL 29 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 | June 6, 2008 |
| Device Name: | Trade Name - RSVP Phantom™ Pelvis |
| Classification 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 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. | |
| Intended 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. | |
| Technological Comparison: | The RSVP Phantom™ Pelvis and the predicate device, |
| RSVP Phantom™, are both designed to evaluate maximum | |
| delivered dose to an identified location for radiation | |
| therapy machines. Both phantoms are formed from CAB | |
| material and filled with water to simulate human tissue, and | |
| mimic actual patient absorbed dosages. | |
| Testing Conclusions: | During the creation of prototypes for the RSVP Phantom™ |
| Pelvis, as part of the development process, numerous | |
| measurements and pressure leak tests were conducted in | |
| accordance with the Phantom Laboratory's ISO 9001:2000 |
.
2
.
1
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.
3
2
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.
3
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
4
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