The FibermarX™ Radiopaque Tissue Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. In addition, the markers are indicated in situations where tissue needs to be marked for future medical procedures such as IMRT/IGRT.

Device Description

The device is a sterile, single-patient-use, barium sulfate infused non-absorbable polymer monofilament that is visible on standard radiographs (x-ray, CT, mammography). FibermarX™ is passed through soft tissue and tied into place during open, percutaneous, or arthroscopic/laparoscopic/endoscopic procedures and standard surgeon's knots or a continuous running outline are used to quickly mark the soft tissue for subsequent imaging or for radiotherapy target localization.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the FibermarX™ Radiopaque Tissue Marker. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data that would typically include detailed acceptance criteria and performance metrics of the new device in a standalone clinical trial.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study that proves the device meets those criteria in the context of a comparative effectiveness study, standalone AI algorithm performance, or using experts to establish ground truth. The submission focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of what can be extracted or inferred from the document based on the standard 510(k) submission process:

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

The document does not provide a formal table of acceptance criteria and reported device performance in the manner one would see for a clinical trial or AI algorithm validation. Instead, it describes non-clinical tests conducted to support substantial equivalence. The "performance" is generally demonstrated by showing that the device is comparable to the predicate device in specific aspects.

Inferred "Acceptance Criteria" (based on non-clinical tests) and "Reported Device Performance":

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary from submission)
Biocompatibility: No cytotoxicity, irritation, sensitization, systemic toxicity, and non-pyrogenic.	Passed ISO 10993 biocompatibility testing (cytotoxicity, Intracutaneous irritation, sensitization, intramuscular implantation, pyrogenicity, and acute systemic toxicity) and toxicological risk assessment of extractables.
Material Safety: Extractables are within safe limits.	Extractables analyzed using GC-MS, LC-MS, and ICP-MS showed safety.
Sterility: Achieve a Sterility Assurance Level (SAL) of 10^-6.	Sterilization resistance and bioburden testing determined proper EO parameters to achieve 10^-6 SAL.
Radiographic Visibility: Visible on standard radiographs (x-ray, CT, mammography) and comparable to predicate.	CT/x-ray radiographic imaging at low, medium, and high doses and mammography showed substantially equivalent radiographic visualization to the predicate device.
Shelf-Life & Packaging Integrity: Maintain performance over shelf-life and packaging suitable.	Packaging validation and post shelf-life performance testing conducted.
Radiation Impact: Mechanical properties, visibility, and cytotoxicity unaffected by radiation exposure (for radiotherapy applications).	Evaluation of radiation impact on mechanical properties, visibility, and cytotoxicity showed no negative impacts.

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

Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical samples of the device used for non-clinical testing (e.g., individual markers for biocompatibility, imaging, and radiation impact). The specific number of physical units tested is not detailed, but it would have been sufficient for the conducted non-clinical tests.
Data Provenance: Not applicable as this is non-clinical testing of the device itself, not human data. The tests were performed by the manufacturer or a contracted lab.

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)

Number of Experts: Not applicable. Ground truth, in the context of clinical or AI studies, is not established for non-clinical device testing. The results of the physical tests are the "ground truth" for the device's characteristics.

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

Adjudication Method: Not applicable. This concept applies to expert review of clinical data, which is not part of this 510(k) non-clinical submission.

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

MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not conducted and is not mentioned. This type of study would be relevant for evaluating diagnostic imaging devices or AI-assisted systems reading images from human patients, which is not the nature of this device or its submission.

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

Standalone Performance: No, a standalone algorithm performance study was not done. This device is a physical tissue marker, not an algorithm.

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

Type of Ground Truth: For the non-clinical tests, the "ground truth" is derived from objective, quantitative measurements and laboratory analyses (e.g., chemical analysis results for extractables, physical measurements for mechanical properties after radiation, optical/imaging assessments of visibility).

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no training set in the conventional sense.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Viscus Biologics, LLC % Mr. Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. WARREN NJ 07059

March 4, 2019

Re: K190155

Trade/Device Name: FibermarX Radiopaque Tissue Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: February 18, 2019 Received: February 19, 2019

Dear Mr. Yungvirt:

This letter corrects our substantially equivalent letter of February 27, 2019.

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

FibermarXTM Radiopaque Tissue Marker

Indications for Use (Describe)

FibermarX™ Radiopaque Tissue Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. In addition, the markers are indicated in situations where tissue needs to be marked for future medical procedures such as IMRT/IGRT.

Type of Use (Select one or both, as applicable)

	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

Justin Baker Viscus Biologics, LLC 10000 Cedar Avenue Cleveland, OH 44106 Tel: +1 216 744 - 2744

CONTACT PERSON:	Justin Baker
DATE PREPARED:	January 28, 2019
TRADE NAME:	FibermarX™ Radiopaque Tissue Marker
COMMON NAME:	Implantable Radiographic Tissue Marker
CLASSIFICATION NAME:	Accelerator, Linear, Medical
REGULATION:	21 CFR 892.5050
PRODUCT CODE:	IYE, NEU
CLASS:	Class II

PREDICATE DEVICES:

CIVCO Medical Suture-Type Marker (primary predicate)(K071614)

REFERENCE DEVICE(s):

Viscus Biologics Radiopaque Tissue Marker (K170026)

INDICATIONS FOR USE:

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DEVICE DESCRIPTION:

TECHNOLOGICAL CHARACTERISTICS:

The FibermarX™ Radiopaque Tissue Marker is identical to Radiopaque Tissue Marker (K170026) except the indications for use are in accordance with CIVCO Medical Suture-type Marker (K071614). The FibermarX™ Radiopaque Tissue Marker is substantially equivalent to the predicate and reference devices in terms of physical and technical characteristics. The subject and predicate devices are composed of a radiopaque metal element and are either embedded within or attached to a polymer monofilament element and have identical intended use.

	FibermarXTMRadiopaque TissueMarker	CIVCO Medicalsuture-type marker(K071614, IYE)(Primary Predicate)	Radiopaque TissueMarker (K170026, NEU,reference)
OverallTechnologicalCharacteristics	Radiographically visiblemetal-based permanentmarker element(s)closely attached to apolymer	SAME	SAME
Principle ofOperation	Marker is positioned intotissue site forradiographicvisualization of tissuesite	SAME	SAME
VisualizationCompatibility	MammographyX-rayCT	(Mammography)-unknownX-RayCT	SAME
Materials ofConstruction	Barium sulfate,nonabsorbable polymer(monofilament)	Gold, bioabsorbablepolymer (suturemonofilament)	SAME
TypicalAnatomicalTreatment Site	Soft Tissue, includingbreast	SAME	SAME
Method ofMarkerDeployment	Manual, open surgical orlaparoscopically	Manual, opensurgical	SAME
MarkerStability	Sutured in place (knots orrunning outline)	Sutured in place	SAME

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ProvidedSterile	Yes	Yes	Yes
SterilizationMethod	EO	Unknown	EO

NON-CLINICAL TESTING BASIS FOR SUBSTANTIAL EQUIVALENCE:

We performed a Failure Mode Effects Analysis (FMEA) on the Radiopaque Tissue Marker when used in accordance with the IYE indications for use. 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 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.

Additional testing evaluating the FibermarX™ Radiopaque Tissue Marker when used for radiotherapy target localization was performed and the impact of the radiation on the mechanical properties, visibility, and cytotoxicity of the device was evaluated. Results showed no negative impacts that would prevent the FibermarX™ Radiopaque Tissue Marker from substantially equivalent safe and effective use for the proposed indications for use.

CONCLUSION

Viscus Biologics, LLC believes that the FibermarX™ Radiopaque Tissue Marker as described in this submission and as evidenced by the results of testing and the similar technological characteristics and intended use described above, does not raise any new or significant questions of safety and efficacy and is substantially equivalent to existing legally marketed devices.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.