FibermarX Radiopaque Tissue Marker

K190155 · Viscus Biologics, LLC · IYE · Feb 27, 2019 · Radiology

Device Facts

• Record ID: K190155
• Device Name: FibermarX Radiopaque Tissue Marker
• Applicant: Viscus Biologics, LLC
• Product Code: IYE · Radiology
• Decision Date: Feb 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

Device is a sterile, single-patient-use, barium sulfate-infused non-absorbable polymer monofilament; functions as a radiopaque tissue marker. Implanted into soft tissue via open, percutaneous, arthroscopic, laparoscopic, or endoscopic procedures; secured using surgeon's knots or continuous running outline. Provides a reference frame for stereotactic radiosurgery, radiotherapy target localization, and IMRT/IGRT. Visible on standard radiographs including X-ray, CT, and mammography. Used by surgeons in clinical settings to mark tissue sites for subsequent imaging or radiation therapy planning. Benefits patient by enabling accurate target localization for radiation treatment.

Clinical Evidence

Bench testing only. Testing included FMEA, biocompatibility (cytotoxicity, irritation, sensitization, intramuscular implantation, pyrogenicity, acute systemic toxicity), sterilization validation (EO, SAL 10^-6), and shelf-life/packaging validation. Radiographic performance was verified via CT, X-ray, and mammography imaging. Radiation impact on mechanical properties, visibility, and cytotoxicity was evaluated to confirm suitability for radiotherapy target localization.

Technological Characteristics

Barium sulfate-infused non-absorbable polymer monofilament. Radiopaque marker element. Sterile, single-use. Sterilization via ethylene oxide (EO). Compatible with X-ray, CT, and mammography. Manual deployment via surgical knotting or running suture technique.

Indications for Use

Indicated for patients requiring soft tissue marking for stereotactic radiosurgery, radiotherapy target localization, or future medical procedures such as IMRT/IGRT.

Regulatory Classification

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.

Predicate Devices

• CIVCO Medical Suture-Type Marker (K071614)

Reference Devices

• Viscus Biologics Radiopaque Tissue Marker (K170026)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <input checked="" type="checkbox"/> | Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------|----------------------------------------------|
| <input type="checkbox"/> | 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: [phone] - 2740
## Submitted by and Contact Person

Justin Baker Viscus Biologics, LLC 10000 Cedar Avenue Cleveland, OH 44106 Tel: [phone] - 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:

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.

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## 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. There are absolutely no changes in materials or design in the subject device from the reference device K170026.

# 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.

| | FibermarXTM<br>Radiopaque Tissue<br>Marker | CIVCO Medical<br>suture-type marker<br>(K071614, IYE)<br>(Primary Predicate) | Radiopaque Tissue<br>Marker (K170026, NEU,<br>reference) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------|
| Overall<br>Technological<br>Characteristics | Radiographically visible<br>metal-based permanent<br>marker element(s)<br>closely attached to a<br>polymer | SAME | SAME |
| Principle of<br>Operation | Marker is positioned into<br>tissue site for<br>radiographic<br>visualization of tissue<br>site | SAME | SAME |
| Visualization<br>Compatibility | Mammography<br>X-ray<br>CT | (Mammography)-unknown<br>X-Ray<br>CT | SAME |
| Materials of<br>Construction | Barium sulfate,<br>nonabsorbable polymer<br>(monofilament) | Gold, bioabsorbable<br>polymer (suture<br>monofilament) | SAME |
| Typical<br>Anatomical<br>Treatment Site | Soft Tissue, including<br>breast | SAME | SAME |
| Method of<br>Marker<br>Deployment | Manual, open surgical or<br>laparoscopically | Manual, open<br>surgical | SAME |
| Marker<br>Stability | Sutured in place (knots or<br>running outline) | Sutured in place | SAME |

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| Provided<br>Sterile | Yes | Yes | Yes |
|-------------------------|-----|---------|-----|
| Sterilization<br>Method | 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.