RSVP PHANTOM PELVIS, MODEL TLP260

K081760 · The Phantom Laboratory, Inc. · IYE · Jul 29, 2008 · Radiology

Device Facts

• Record ID: K081760
• Device Name: RSVP PHANTOM PELVIS, MODEL TLP260
• Applicant: The Phantom Laboratory, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jul 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

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.

Device Story

RSVP Phantom™ Pelvis is a life-size, anthropomorphic pelvic phantom used in radiation therapy clinics. Constructed from CAB material and water-filled to simulate human soft tissue radiation absorption and scatter. Used by medical physicists/technicians to verify dose delivery, compare treatment plan profiles, perform acceptance testing, and validate equipment/software upgrades. Device provides physical medium for radiation measurements; output is physical dose distribution data used to ensure accuracy of linear accelerators and treatment planning systems. Benefits patient by ensuring radiation therapy equipment delivers prescribed doses accurately.

Clinical Evidence

Bench testing only. Prototype measurements and pressure leak tests conducted under ISO 9001:2000 quality system. Radiation measurements performed by a physicist to verify phantom function against the predicate device.

Technological Characteristics

Material: CAB (cellulose acetate butyrate); water-filled. Form factor: Anthropomorphic pelvic shape. Principle: Tissue-equivalent phantom for radiation absorption/scatter simulation. Connectivity: None (mechanical/physical device). Sterilization: Not applicable.

Indications for Use

Indicated for use in radiation therapy quality assurance, including dose delivery verification, treatment plan profile comparison, acceptance testing, and post-upgrade reevaluations. No specific patient population; device is a physical phantom used for equipment calibration and verification.

Regulatory Classification

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.

Predicate Devices

• RSVP Phantom™ (K954634)

Submission Summary (Full Text)

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K017600

## RSVP Phantom™ Pelvis, 510(k) Summary

| | JUL 29 2008 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner/Applicant: | The Phantom Laboratory, Incorporated<br>Joshua R. Levy, President |
| Mailing Address: | P.O. Box 511, Salem, NY 12865 |
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Date | June 6, 2008 |
| Device Name: | Trade Name - RSVP Phantom™ Pelvis<br>Classification Name - Accelerator, linear, medical<br>(892.5050, Product Code IYE) |
| Equivalent Device: | RSVP Phantom™, 510(k) submission number K954634 |
| Device Description: | The RSVP Phantom™ Pelvis provides isodose distribution<br>and verification information for both conventional and<br>intensity modulated radiation therapy machines. The life-<br>size pelvic shape is formed from CAB material and filled<br>with water to simulate the radiation absorption and scatter<br>of human soft tissue. |
| Intended Use: | The RSVP Phantom™ Pelvis is designed for use in a<br>variety of radiation therapy applications including, final<br>quality verification of therapy dose delivery and for<br>comparing the delivered dose profiles for different<br>treatment plans. It is also used for periodic quality<br>assurance evaluations and acceptance testing and to<br>perform reevaluations after equipment or software<br>upgrades. |
| Technological Comparison: | The RSVP Phantom™ Pelvis and the predicate device,<br>RSVP Phantom™, are both designed to evaluate maximum<br>delivered dose to an identified location for radiation<br>therapy machines. Both phantoms are formed from CAB<br>material and filled with water to simulate human tissue, and<br>mimic actual patient absorbed dosages. |
| Testing Conclusions: | During the creation of prototypes for the RSVP Phantom™<br>Pelvis, as part of the development process, numerous<br>measurements and pressure leak tests were conducted in<br>accordance 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 [phone] or [phone] 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