(63 days)
Not Found
No Reference Device(s) K/DEN number are present in the text.
No
The device description and intended use focus on physical components and mechanical function for breast displacement, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML involvement.
No.
The device's purpose is to displace the breast for imaging, not to treat any medical condition or directly interact with the patient's body for therapeutic benefit. Its function is to facilitate imaging, not therapy.
No
Explanation: The device is described as an accessory for breast displacement during imaging, aiming to decrease radiation dose or improve image quality. It does not mention any function related to identifying, detecting, or classifying diseases or conditions, which are characteristic functions of a diagnostic device.
No
The device description explicitly lists physical components like vinyl-coated polyester, foam, webbing, and buckles, indicating it is a physical accessory, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an accessory to imaging devices used for breast displacement. It is used external to the patient's body and does not involve testing any biological samples.
- Intended Use: The intended use is to improve imaging quality and potentially reduce radiation dose, not to diagnose a disease or condition based on a biological sample.
Therefore, the Chrysalis device, as described, falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KPR, MQB
Device Description
Chrysalis is composed of vinyl-coated polyester, 1/4 inch polyurethane foam headliner, poly-pro webbing, Buckles: 2" side-release plastic buckles
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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)
Non-Clinical Testing: Biocompatibility testing and safety evaluations were deemed to be unnecessary due to a lack of patient exposure to the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
0
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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body, representing the department's mission to promote health and well-being.
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.
2
Page 2
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 (800) 638-2041 or (240) 276-3150 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
3
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle on the left and the text "Department of Health and Human Services" on the right. The text is stacked vertically, with "Department of" on the top line, "Health and" on the second line, and "Human Services" on the third line. The logo is black and white.
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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)
ivision of Reproducti Radiological De 510/11 Numbo