BioZorb Marker GOLD / LP Marker GOLD

K171467 · Focal Therapeutics · IYE · Nov 9, 2017 · Radiology

Device Facts

• Record ID: K171467
• Device Name: BioZorb Marker GOLD / LP Marker GOLD
• Applicant: Focal Therapeutics
• Product Code: IYE · Radiology
• Decision Date: Nov 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

Device Story

Implantable radiopaque marker; consists of gold marker elements within bioabsorbable polymer spacer. Implanted into soft tissue (e.g., breast) via manual, open surgical procedure. Serves as permanent radiographic fiducial for target localization in stereotactic radiosurgery and radiotherapy. Visualized via mammography, ultrasound, X-ray, CT, and MRI. Provides stable reference frame for clinicians to guide radiation therapy planning and delivery. Benefits patient by enabling accurate target localization for radiation treatment.

Clinical Evidence

Bench testing only. Performance data included simulated use, device integrity, imaging assessment, and MR compatibility. Device met all specified criteria.

Technological Characteristics

Implantable marker comprising gold elements and bioabsorbable polymer spacer. Dimensions: 2-4 cm length. Visualization compatibility: Mammography, Ultrasound, X-Ray, CT, MRI. Deployment: Manual, open surgical. Stability: Sutured in place. Sterilization: Radiation.

Indications for Use

Indicated for patients requiring implantation of a radiopaque marker into soft tissue (including breast) to visualize and provide a reference frame for stereotactic radiosurgery and radiotherapy target localization.

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 Suture-type Marker (K071614)
• Focal Therapeutics BioZorb Marker (K143484)
• BioZorb LP Marker (K152070)
• BiomarC Fiducial Marker (K132708, K110772)

Submission Summary (Full Text)

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November 9, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Focal Therapeutics, Inc. % Mr. George Hermann President 1010 Stewart Drive SUNNYVALE CA 94085

Re: K171467

Trade/Device Name: BioZorb Marker GOLD / LP Marker GOLD Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 18, 2017 Received: October 19, 2017

Dear Mr. Hermann:

We have reviewed vour 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 device-related 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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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.

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,

Robert Oaks

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) K171467

Device Name BioZorb Marker GOLD / LP Marker GOLD

Indications for Use (Describe)

The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

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

| <input checked="true" 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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### 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Focal Therapeutics |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 21, 2017 |
| CONTACT PERSON: | George Hermann<br>Focal Therapeutics<br>1010 Stewart Drive<br>Sunnyvale, CA 94085<br>Phone: [phone]<br>Fax: [phone] |
| TRADE NAME: | BioZorb Marker GOLD / LP Marker GOLD |
| COMMON NAME: | Implantable Radiographic Fiducial Marker |
| CLASSIFICATION<br>NAME: | Accelerator, Linear, Medical, 21 CFR 892.5050 |
| DEVICE<br>CLASSIFICATION: | Class II |
| PRODUCT CODE: | IYE |
| PREDICATE DEVICES: | Civco Suture-type Marker (K071614) (Primary Predicate)<br>Focal Therapeutics BioZorb Marker (K143484) and BioZorb<br>LP Marker (K152070)<br>BiomarC Fiducial Marker (K132708, K110772) |

#### Substantially Equivalent To:

The BioZorb Marker GOLD/LP Marker GOLD is substantially equivalent in intended use, principal of operation and technological characteristics to the Civco Suture-type Marker (K071614), Focal Therapeutics BioZorb Marker (K143484), BioZorb LP Marker (K152070), and the BiomarC Fiducial Marker (K132708, K110772).

## Description of the Device Subject to Premarket Notification:

The BioZorb Marker GOLD / LP Marker GOLD is an implantable radiopaque marker comprised of a bioabsorbable component and a permanent component.

The BioZorb Marker GOLD / LP Marker GOLD is provided sterile for single use and is implantable.

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### Indication for Use:

The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

### Technical Characteristics:

The BioZorb Marker GOLD / LP Marker GOLD has similar physical and technical characteristics to the predicate devices. In particular, the Marker and the predicate devices are comprised of the same primary components and the component materials are substantially equivalent.

| | Focal<br>BioZorb Marker<br>GOLD / LP Marker<br>GOLD | Civco Medical<br>Suture-type<br>Marker<br>(K071614,<br>IYE)<br>(Primary Predicate) | Focal<br>BioZorb Marker<br>(K143484) &<br>BioZorb LP<br>Marker<br>(K152070) (NEU) | Carbon Medical<br>Technologies<br>BiomarC Fiducial<br>Marker<br>(K132064, IYE,<br>K110772, NEU) |
|---------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Overall<br>Technological<br>Characteristics | Radiographically<br>visible permanent<br>marker element(s) in<br>bioabsorbable polymer<br>spacer | SAME | SAME | SAME |
| Principle of<br>Operation | Marker is positioned<br>into tissue site for<br>radiographic<br>visualization of tissue<br>site | SAME | SAME | SAME |
| Visualization<br>Compatibility | Mammography<br>Ultrasound<br>X-Ray<br>CT<br>MRI | X-Ray<br>CT<br>(presumed) | SAME | Mammography<br>Ultrasound<br>X-Ray<br>MRI<br>Fluoroscopy<br>kV<br>CT |
| Materials of<br>Construction | Gold,<br>bioabsorbable polymer<br>(spacer) | Gold,<br>bioabsorbable<br>polymer (suture) | Titanium,<br>bioabsorbable<br>polymer<br>(spacer) | Pyrolytic carbon<br>coated zirconium<br>oxide |
| Overall Device<br>Length | 2-4 cm | >5 cm (with<br>suture) | 2-5 cm | 2 mm x 4 mm |
| Typical<br>Anatomical<br>Treatment Site | Soft tissue including<br>breast | breast | SAME | SAME |
| Method of<br>Marker<br>Deployment | Manual,<br>open surgical | SAME | SAME | Manual,<br>percutaneous |
| Marker Stability | Sutured in place | SAME | SAME | Tissue retention |
| Provided sterile | Yes | Yes | Yes | Yes |
| Steriliz. method | Radiation | Unknown | SAME | EO |

## Performance Data:

All necessary verification and validation testing has been performed for the BioZorb Marker GOLD / LP Marker GOLD to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended.

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Performance data included:

- Simulated Use ●
- Device Integrity ●
- . Imaging Assessment
- MR Compatibility

The BioZorb Marker GOLD / LP Marker GOLD met all specified criteria and did not raise new safety or performance questions.

## Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the BioZorb Marker GOLD / LP Marker GOLD is determined by Focal Therapeutics to be substantially equivalent to existing legally marketed devices.