CLEARVUE PRONE BREAST TREATMENT TABLE

K090349 · Orbital Therapy, LLC · IYE · Mar 9, 2009 · Radiology

Device Facts

• Record ID: K090349
• Device Name: CLEARVUE PRONE BREAST TREATMENT TABLE
• Applicant: Orbital Therapy, LLC
• Product Code: IYE · Radiology
• Decision Date: Mar 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

ClearVue Prone Breast Treatment Table, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and re-position patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.

Device Story

ClearVue is a prone-breast table top attachment for radiation therapy; provides multi-angle access to treatment anatomy. Device placed on existing treatment or imaging modality couch; compatible with mainstream linear accelerators and most CT/MR scanners. Construction uses carbon-fiber to minimize thickness and radiation absorption; includes soft cushion lining for patient comfort and variable inserts for left/right breast patients. Optional support cushion available for patient tilting. Device is non-motorized; rests on couch via high-friction feet or optional locking fixture. Used by radiation therapy staff to stabilize and position patients during imaging and treatment delivery; facilitates accurate radiation targeting by maintaining consistent patient geometry.

Clinical Evidence

Bench testing only.

Technological Characteristics

Carbon-fiber table top attachment; non-motorized; dimensions 18-30 cm height; weight 28 lbs; high-friction feet or optional locking mechanism for couch attachment; compatible with linear accelerators, CT, and MR scanners.

Indications for Use

Indicated for patients undergoing breast radiation therapy requiring positioning and repositioning on medical linear accelerators, CT, or MR scanners for treatment planning.

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

• Bionix RT-6025 Prone Breast System (K905007)

Submission Summary (Full Text)

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KC90349

·

MAR - 9 2009

:

# 510(k) Summary

| Date prepared | February 10, 2008 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner | Orbital Therapy, LLC<br>8 Alfred Circle<br>Bedford, MA 01730 |
| | Phone: [phone]<br>Fax: [phone] |
| Contact | Natalya Koshnitsky, Manager, Regulatory Affairs |
| Trade name | ClearVue Prone Breast Treatment Table |
| Common name | Breast radiation therapy patient support |
| Classification Name | Medical charged-particle radiation therapy system |
| Regulation: | 21 CFR 892.5050 |
| Product code: | IYE |
| Predicate device | Bionix RT-6025 Prone Breast System, which was cleared to market<br>in 510(k) # K905007 |
| Device description | ClearVue is a prone-breast table top attachment, which allows for<br>multi-angle access to the treatment anatomy. This device is<br>compatible with mainstream linear accelerators as well as<br>compatible with most existing CT scanners. ClearVue is placed on<br>top of the existing treatment or imaging modality couch. ClearVue<br>does not have motors for mechanical motion. ClearVue is<br>compatible with both left and right breast patients by the use of<br>variable inserts. An optional support cushion is used should one<br>find it necessary to tilt the patient. ClearVue passes through a<br>standard CT opening with the patient on top (these range from 70 to<br>85 cm in diameter). The distance between the layer on which the<br>patient rests and the layer which rests on the therapy system couch<br>is 18 to 30 cm to accommodate most breast sizes. The table is<br>made from carbon-fiber to minimize thickness and radiation<br>absorption. A soft, cushion lining is attached to the patient layer for<br>comfort. |

Y ﮩﺴ

:

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## Intended use

Clear Vue Prone Breast Treatment Table, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and re-position patients for breast radiation therapy. Clear Vue may be used with CT and MR scanners to acquire images for radiation therapy planning.

### Comparison to the predicate device

| Characteristic | ClearVue | Bionix RT-6025 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Connection to<br>accelerator patient<br>table | Rests on table with<br>high friction feet to<br>prevent movement.<br>An optional fixture<br>locks to the table. | Locks to table |
| Prone position for<br>breast treatment | Same | Same |
| Patient cushion | Cushioned body and<br>head support | Massage-style face<br>cushion supports the<br>head with openings<br>for air flow. |
| Contralateral breast<br>protection | Same | Same |
| Comfortable foam<br>support during<br>treatment | Same | Same |
| Height | 7" to 12" | 9" |
| Weight | 28 pounds | 18 pounds |

#### Conclusion

The Clear Vue is substantially equivalent to the Bionix RT-6025 Prone Breast System with respect to intended use, safety, and effectiveness.

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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 caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2009

Orbital Therapy, LLC % Mr. Chas Burr President Chas Burr Q/R Services, Inc. 11 Mystic Avenue WINCHESTER MA 01890

Re: K090349

Trade/Device Name: ClearVue Prone Breast Treatment Table Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 10, 2009

Received: February 11, 2009

#### Dear Mr. Burr:

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. Iisting 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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Manufactures. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K 090349

Device Name: ClearVue Prone Breast Treatment Table

Indications for Use:

ClearVue, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and reposition patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.

Prescription Use X (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 OF NEEDED) .

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulin Perner

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

10(k) Number

ClearVue 510(k)

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