CHRYSALIS

K080655 · Meta Imaging Solutions, LLC · KPR · May 9, 2008 · Radiology

Device Facts

• Record ID: K080655
• Device Name: CHRYSALIS
• Applicant: Meta Imaging Solutions, LLC
• Product Code: KPR · Radiology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

These devices are intended to accessorize stationary X Ray Systems.

Device Story

Chrysalis is a medical imaging accessory designed for use with stationary X-ray systems. It consists of vinyl-coated polyester, 1/4 inch polyurethane foam headliner, poly-pro webbing, and 2-inch side-release plastic buckles. The device functions as a mechanical aid for breast displacement during imaging, intended to decrease radiation exposure to the breasts and improve image quality. It is designed for professional use in clinical settings, applied externally over hospital garments without direct patient skin contact.

Clinical Evidence

No clinical data; bench testing and safety evaluations were deemed unnecessary due to lack of patient exposure.

Technological Characteristics

Materials: vinyl-coated polyester, 1/4 inch polyurethane foam headliner, poly-pro webbing, plastic side-release buckles. Mechanical accessory; no energy source; non-patient contacting.

Indications for Use

Indicated for breast displacement during imaging procedures to reduce radiation dose to breasts and/or improve image quality. Reusable device used external to hospital garb; does not contact patient skin.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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K080655

### 510K SUMMARY

Device Name: " Chrysalis"

VII

Legally marketed device: These devices accessorize the current approved medical imaging devices, eg Stationary X ray Systems

Device description: Chrysalis is composed of vinyl-coated polyester, 1/4 inch polyurethane foam headliner, poly-pro webbing, Buckles: 2" side-release plastic buckles

Intended Use: These devices are intended to accessorize stationary X Ray Systems.

## Assessment of Performance Standards: Not Applicable

- の Non-Clinical Testing: Biocompatibility testing and safety evaluations were deemed to be unnecessary due to a lack of patient exposure to the device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

META Imaging Solutions % Mr. Robert J. Staab Official Consultant Regulatory and Technical Associates, Inc. 30 Neck Road OLD LYME, CT 06371

Re: K080655

Trade/Device Name: Accessory to Stationary X Ray System (Chrysalis) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: March 3, 2008 Received: March 14, 2008

### Dear Mr. Staab:

We have reviewed vour 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, 1796, 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 art 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 Crampliance promo 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 yours,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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**CENTER FOR DEVICES AND RADIOLOGICAL HEALTH**

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# Indications for Use

510(k) Number (if known):

A. Device Name: Device Name: Accessory to Stationary X Ray System Proposed trade name: Chrysalis.

Common name: Medical Imaging Accessory

Indications for Use:

The device described here is an accessory to imaging devices previously approved. In general, the intended professional application is described as follows:

Breast displacement for imaging purposes with the intention of decreasing radiation dose to the breasts and/or improving image quality. The Chrysalis device is reusable and used external to hospital garb; it does not touch the patient's body.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page iii of

(Posted November 13, 2003)

Center for Devices and Radiological Health / CDRH

Amuth Whang
(Division Sign-Off)

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