(28 days)
No
The device description and performance studies focus on the physical properties and visibility of the marker, with no mention of AI or ML for image analysis or other functions.
No
The device is described as a radiopaque tissue marker intended for visualizing and localizing targets for radiosurgery and radiotherapy, or for future medical procedures. It does not provide any therapeutic effect itself but aids in procedures that may be therapeutic.
No
This device is a marker intended to be implanted into the body to visualize and localize target tissues for future medical procedures and radiotherapy. It does not perform diagnostic functions itself but aids in the visualization for diagnostic or therapeutic purposes.
No
The device description clearly states it is a physical, sterile, single-patient-use polymer monofilament intended for implantation, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- FibermarX™ Function: The FibermarX™ Radiopaque Tissue Marker is a device that is implanted into the body. Its purpose is to be a physical marker visible on imaging modalities to guide future procedures like radiosurgery or radiotherapy. It does not perform any diagnostic test on a sample taken from the body.
The device description clearly states it is "implanted into the body" and is a "monofilament that is visible on standard radiographs." This is the function of a surgical implant used for marking, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE, NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Mammography, X-ray, CT
Anatomical Site
Soft Tissue, including breast
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)
Non-clinical testing was performed as a basis for substantial equivalence. This included:
- Failure Mode Effects Analysis (FMEA)
- Extractables analysis (Gas Chromatograph-Mass Spectrometry, Liquid Chromatograph-Mass Spectrometry, and Inductively Coupled Plasma-Mass Spectrometry) and toxicological risk assessment.
- ISO 10993 biocompatibility testing (cytotoxicity, Intracutaneous irritation, sensitization, intramuscular implantation, pyrogenicity, and acute systemic toxicity) which showed the device is biocompatible and non-pyrogenic.
- Sterilization resistance and bioburden testing to determine proper ethylene oxide parameters for achieving a sterilization assurance level of 10-6.
- CT/x-ray radiographic imaging at low, medium, and high doses and mammography of implanted subject and predicate devices to show substantially equivalent radiographic visualization.
- Packaging validation and post shelf-life performance testing.
- Additional testing evaluating the impact of radiation on mechanical properties, visibility, and cytotoxicity of the device when used for radiotherapy target localization. Results showed no negative impacts.
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
§ 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.
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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.
1
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:
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.
4
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
Radiopaque Tissue
Marker | CIVCO Medical
suture-type marker
(K071614, IYE)
(Primary Predicate) | Radiopaque Tissue
Marker (K170026, NEU,
reference) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------|
| Overall
Technological
Characteristics | Radiographically visible
metal-based permanent
marker element(s)
closely attached to a
polymer | SAME | SAME |
| Principle of
Operation | Marker is positioned into
tissue site for
radiographic
visualization of tissue
site | SAME | SAME |
| Visualization
Compatibility | Mammography
X-ray
CT | (Mammography)-unknown
X-Ray
CT | SAME |
| Materials of
Construction | Barium sulfate,
nonabsorbable polymer
(monofilament) | Gold, bioabsorbable
polymer (suture
monofilament) | SAME |
| Typical
Anatomical
Treatment Site | Soft Tissue, including
breast | SAME | SAME |
| Method of
Marker
Deployment | Manual, open surgical or
laparoscopically | Manual, open
surgical | SAME |
| Marker
Stability | Sutured in place (knots or
running outline) | Sutured in place | SAME |
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| Provided
| Sterile | Yes | Yes | Yes |
|---|---|---|---|
| Sterilization | |||
| 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.