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.

AI/ML Overview

This document is a 510(k) summary for a medical device called a "Radiopaque Tissue Marker." It outlines the device's characteristics, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance metrics for the device. Instead, it describes non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The performance is assessed against the predicate device, not against specific, pre-defined numerical thresholds for accuracy, sensitivity, or specificity.

However, based on the non-clinical testing mentioned, we can infer performance aspects:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device is safe for implantation and does not cause adverse biological reactions.	Biocompatibility: Showed that the subject device is biocompatible and non-pyrogenic, based on ISO 10993 testing (cytotoxicity, intracutaneous irritation, sensitization, intramuscular implantation, pyrogenicity, and acute systemic toxicity) and toxicological risk assessment of extractables.
Sterility: Device is sterile at the time of use.	Sterility: Ethylene oxide sterilization parameters were determined to achieve a sterilization assurance level of 10^-6, supported by sterilization resistance and bioburden testing.
Radiographic Visualization: Device is visible under standard radiological imaging (x-ray, mammography).	Radiographic Visualization: CT/x-ray radiographic imaging at low, medium, and high doses and mammography of implanted subject and predicate devices showed "substantially equivalent radiographic visualization" to the Cassi Beacon Tissue Marker.
Mechanical Properties (Implied for Suture): Sufficient tensile strength for placement and knot tying.	Mechanical Properties: Polypropylene was chosen as the polymer base due to its "ability to be extruded and processed to increase tensile strength, which is required for placement and knot tying." (This is a design choice to meet a functional requirement, rather than a direct test result).
Shelf-Life and Packaging Integrity: Device maintains performance and sterility over its shelf life and is protected by its packaging.	Shelf-Life and Packaging Integrity: Packaging validation and post shelf-life performance was also tested. (No specific results provided, only that it was tested).
Chemical Composition/Safety of Extractables: No harmful leachable substances.	Chemical Composition/Safety of Extractables: Extractables were analyzed using GC-MS, LC-MS, and ICP-MS, and a toxicological risk assessment was performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical laboratory testing. It does not mention a "test set" in the context of patient data, nor does it specify any sample sizes for patients or data provenance (country of origin, retrospective/prospective). The testing involved physical devices and materials, not patient data in the way one would analyze for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the study described. The study involves non-clinical testing of a physical device. There is no "ground truth" establishment in the context of expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the study described. There is no "test set" of patient data requiring adjudication of ground truth by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed. The device is a physical radiopaque tissue marker, not an AI algorithm. Therefore, an "effect size of human readers improve with AI vs without AI assistance" is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. The device is a physical radiopaque tissue marker, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable for the study described. The "ground truth" for non-clinical device testing would be the physical and chemical properties of the materials and their behavior under controlled laboratory conditions, as measured by standard testing methods (e.g., ISO 10993 for biocompatibility, specific imaging protocols for radiopacity). It is not based on expert consensus, pathology, or outcomes data related to patient diagnosis.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable. There is no AI algorithm or training set associated with this device.

Summary

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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.

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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

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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)

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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.

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DEVICE DESCRIPTION:

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

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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).

Regulation Number and Section

§ 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.