(124 days)
Not Found
Not Found
No
The summary describes a mechanical system for tissue resection and manipulation, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML involvement.
No.
The device is designed for the removal of lesions, which is a surgical procedure, not a therapeutic treatment of a disease.
Yes
The 'FTRD System' is explicitly described as an "Instrument designed for diagnostic tissue acquisition".
No
The device description clearly indicates the FTRD System is an "Instrument designed for flexible endoscopy" and includes components like a "Marking Probe" and "Grasper," which are physical instruments, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an instrument for flexible endoscopy used for diagnostic tissue acquisition and full-thickness resection of lesions in the colon and rectum. This is a surgical or interventional procedure, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: While the description is "Not Found," the names of the components (FTRD System, FTRD Marking Probe, FTRD Grasper) strongly suggest instruments used during an endoscopic procedure.
- Anatomical Site: The device is used directly on the colon and rectum, which is an in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) in vitro to provide diagnostic information. The "diagnostic tissue acquisition" is for obtaining a sample for subsequent analysis, but the device itself is not performing the diagnostic test.
IVD devices are typically used to examine samples like blood, urine, tissue biopsies, etc., in a laboratory setting to diagnose diseases or conditions. This device is used in vivo to remove tissue.
N/A
Intended Use / Indications for Use
FTRD System: Instrument designed for flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum. The FTRD System is indicated for the resection of lesions
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
Ovesco Endoscopy AG % Martina Krautwald Consultant Novineon CRO & Consulting Ltd Dorfackerstrasse 26 Tuebingen, 72074 De Germany
Re: K170867 Trade/Device Name: FTRD System Set (Set contains FTRD System, FTRD Marking Probe and FTRD Grasper) Regulation Number: 21 CFR& 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL, FDI, KNS, OCZ Dated: June 12, 2017 Received: June 13, 2017
Dear Martina Krautwald:
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.
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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); medical device reporting (reporting of medical devicerelated 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" (21 CFR 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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170867
Device Name
FTRD System Set (Set contains FTRD System, FTRD Marking Probe and FTRD Grasper)
Indications for Use (Describe)
FTRD System:
Instrument designed for flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum.
The FTRD System is indicated for the resection of lesions 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."