(150 days)
No
The device description and performance studies focus on the radiopaque properties of a physical suture for marking tissue, with no mention of AI or ML for image analysis or other functions.
No
Explanation: The device is used for radiographically marking soft tissue for imaging purposes, not for treating a disease or condition. It aids in diagnosis and surgical planning rather than providing therapy.
No
The device is described as a "Radiopaque Tissue Marker" used to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures." Its function is to make tissue visible on imaging for evaluation, not to diagnose a condition.
No
The device description explicitly states it is a "sterile, single-patient-use, barium sulfate infused polypropylene suture," which is a physical hardware component.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Radiopaque Tissue Marker is a physical device (a suture) that is implanted into soft tissue during or for future surgical procedures. Its purpose is to be visible on radiographic images to mark the location of the tissue.
- No Sample Analysis: The device itself does not analyze any biological samples from the patient. It is a marker, not a diagnostic test performed on a sample.
The device's function is to aid in the visualization of tissue location using imaging techniques, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Radiopaque Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The device is a sterile, single-patient-use, barium sulfate infused polypropylene suture that is radiopaque using standard radiographs (x-ray, mammography). The device is placed into soft tissue sites during open, percutaneous, or endoscopic procedures and standard surgeon's knots are tied to quickly and inexpensively mark the soft tissue so that the integrity and location of the marked soft tissue can be evaluated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard radiographs (x-ray, mammography)
Anatomical Site
soft tissue sites
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)
CT/x-ray radiographic imaging at low, medium, and high doses and mammography of implanted subject and predicate devices was performed to show substantially equivalent radiographic visualization of the tissue markers. Packaging validation and post shelf-life performance was also tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
Viscus Biologics, LLC Ms. Leslie Clark Director, Quality 10000 Cedar Ave Cleveland, Ohio 44106
Re: K170026
Trade/Device Name: Radiopaque Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: May 18, 2017 Received: May 19, 2017
Dear Ms. Clark:
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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.
1
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
Sincerely,
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Jennifer R. Stevenson -ਟੇਤ For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170026
Device Name Radiopaque Tissue Marker
Indications for Use (Describe)
The Radiopaque Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
SECTION 5 510(K) SUMMARY
TRADITIONAL 510(k)
Submitter- Manufacturer: Viscus Biologics, LLC, 10000 Cedar Avenue Cleveland, OH 44106, USA. Tel: +1 216 744 - 2740
Submitted by and Contact Person
Rebecca Clark Viscus Biologics, LLC 10000 Cedar Avenue Cleveland, OH 44106 Tel: +1 216 744 – 2742
| CONTACT PERSON: | Rebecca Clark |
|---|---|
| DATE PREPARED: | December 29, 2016 |
| TRADE NAME: | Radiopaque Tissue Marker |
| COMMON NAME: | Implantable Radiographic Marker |
| CLASSIFICATION NAME: | Implantable Clip |
| REGULATION | 21 CFR 878.4300 |
| PROCODE and CLASS | General and Plastic Surgery, NEU, Class II |
PREDICATE DEVICE:
Cassi Beacon Tissue Marker (K140835)
REFERENCE DEVICE(s):
Focal Therapeutics BioZorb Marker (K143484)
INDICATIONS FOR USE:
The Radiopaque Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
4
DEVICE DESCRIPTION:
The device is a sterile, single-patient-use, barium sulfate infused polypropylene suture that is radiopaque using standard radiographs (x-ray, mammography). The device is placed into soft tissue sites during open, percutaneous, or endoscopic procedures and standard surgeon's knots are tied to quickly and inexpensively mark the soft tissue so that the integrity and location of the marked soft tissue can be evaluated.
TECHNOLOGICAL CHARACTERISTICS:
The Radiopaque Tissue Marker is substantially equivalent to the Cassi Beacon Tissue Marker by Scion Medical Technologies (K140835) in terms of intended use/indications for use, composition, biocompatibility, sterility and use, and performance. The predicate and subject device have identical indications for use. The subject and predicate device both utilize a barium sulfate (BaSO2) composition to achieve radiopacity that is infused into a polymer base. The Cassi Beacon Tissue Marker uses barium sulfate as a radiocontrast agent with polyetherketone (PEKK) as a polymer base, while the Radiopaque Tissue Marker uses barium sulfate with polypropylene as its polymer base due to polypropylene's ability to be extruded and processed to increase tensile strength, which is required for placement and knot tying. The subject device underwent biocompatibility testing according to ISO 10993. Both devices are supplied as sterile, single patient use. While the predicate device uses a specific delivery system as part of the device, the subject device can be used with any general suture passer or may be used without a suture passer depending on the physician's preference and the tissue to be marked. This difference is not critical to the intended use and does not affect the safety and effectiveness of the device.
NON-CLINICAL TESTING BASIS FOR SUBSTANTIAL EQUIVALENCE:
Extractables from Radiopaque Tissue Marker were analyzed using Gas Chromatograph-Mass Spectrometry, Liquid Chromatograph-Mass Spectrometry, and Inductively Coupled Plasma-Mass Spectrometry and a toxicological risk assessment was performed that along with ISO 10993 biocompatibility testing (cytotoxicity, Intracutaneous irritation, sensitization, intramuscular implantation, pyrogenicity, and acute systemic toxicity) showed that the subject device is biocompatible and non-pyrogenic. Sterilization resistance and bioburden testing was performed to determine the proper ethylene oxide
5
parameters for achieving a sterilization assurance level of 10° in order to ensure sterility. CT/x-ray radiographic imaging at low, medium, and high doses and mammography of implanted subject and predicate devices was performed to show substantially equivalent radiographic visualization of the tissue markers. Packaging validation and post shelf-life performance was also tested.
CONCLUSION
Viscus Biologics, LLC believes that the Radiopaque Tissue Marker as described in this submission and as evidenced by the results of testing and the similar technological characteristics described above, does not raise any new or significant questions of safety and efficacy and is substantially equivalent to the predicate Scion Medical technologies, LLC Cassi Beacon Tissue Marker (K140835).