(99 days)
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Not Found
No
The summary describes a tissue marker and a system for its non-imaging detection, with no mention of AI, ML, or image processing beyond basic imaging guidance for placement.
No
The device is a tissue marker used to temporarily mark a lumpectomy site for surgical removal, which is a diagnostic or localization aid, not a therapeutic intervention. Its intent is to help locate and remove target tissue, not to treat a disease.
No
Explanation: The device is a tissue marker intended for marking a lumpectomy site for surgical removal, not for diagnosing a condition or disease. It aids in locating tissue to be removed, not in identifying a medical condition.
No
The device description and intended use clearly describe a physical tissue marker and a system for its detection, indicating hardware components are involved.
Based on the provided information, the Cianna Medical SGS Tissue Marker 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "Tissue Marker" intended to be "placed percutaneously in the breast" to mark a surgical site. It is a physical object implanted in the body.
- Intended Use: The intended use is to mark a surgical site for removal, not to analyze a sample taken from the body.
- No Mention of Sample Analysis: The description does not mention any analysis of biological samples.
Therefore, the Cianna Medical SGS Tissue Marker is a medical device used in vivo (within the body) for surgical guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cianna Medical SGS Tissue Marker is intended to be placed percutaneously in the breast to temporarily (
§ 878.4670 Internal tissue marker.
(a)
Identification. An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated.
(3) Performance data must demonstrate the sterility of the device.
(4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life.
(5) Labeling must include:
(i) A warning that the device must not be used on a non-sterile surface prior to use internally.
(ii) An expiration date/shelf life.
(iii) Single use only labeling must be labeled directly on the device.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Cianna Medical, Inc. % Mr. Gary Mocnik V.P. Regulatory Affairs and Quality Systems 6 Journev. Suite 125 ALISO VIEJO CA 92656
Re: K141318
Trade/Device Name: SGS Tissue Marker and System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PBY Dated: May 25, 2016 Received: June 1, 2016
Dear Mr. Mocnik.
This letter corrects our substantially equivalent letter of August 27, 2014.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Office of In Vitro Diagnostics and Radiological Health] Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Ciagnna Medical SGS Tissue Marker and System
Indications for Use (Describe)
The Cianna Medical SGS Tissue Marker is intended to be placed percutaneously in the breast to temporarily ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."