(175 days)
Not Found
No
The summary describes a physical implantable marker for imaging and localization, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a marker intended for visualization in radiosurgery and radiotherapy target localization, not for treating a disease or condition itself.
No
The device is described as an implantable radiopaque marker for visualizing and localizing targets in stereotactic radiosurgery and radiotherapy. It does not state that it is used to diagnose a disease or condition, but rather to aid in the treatment of one.
No
The device description explicitly states it is an "implantable radiopaque marker comprised of a bioabsorbable component and a permanent component," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization." This describes a device used in vivo (within the living body) for imaging and treatment guidance.
- Device Description: The description confirms it is an "implantable radiopaque marker comprised of a bioabsorbable component and a permanent component." This further reinforces its use within the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the living body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any analysis of biological specimens.
Therefore, this device falls under the category of an implantable medical device used for imaging and treatment guidance, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
IYE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Mammography
Ultrasound
X-Ray
CT
MRI
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
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.
Key Metrics
Not Found
Predicate Device(s)
Civco Suture-type Marker (K071614), Focal Therapeutics BioZorb Marker (K143484), BioZorb LP Marker (K152070), BiomarC Fiducial Marker (K132708, K110772)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
| Focal Therapeutics | |
| 1010 Stewart Drive | |
| Sunnyvale, CA 94085 | |
| Phone: 408.962.7010 | |
| Fax: 408.962.7020 | |
| TRADE NAME: | BioZorb Marker GOLD / LP Marker GOLD |
| COMMON NAME: | Implantable Radiographic Fiducial Marker |
| CLASSIFICATION | |
| NAME: | Accelerator, Linear, Medical, 21 CFR 892.5050 |
| DEVICE | |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | IYE |
| PREDICATE DEVICES: | Civco Suture-type Marker (K071614) (Primary Predicate) |
| Focal Therapeutics BioZorb Marker (K143484) and BioZorb | |
| LP Marker (K152070) | |
| 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.
4
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
BioZorb Marker
GOLD / LP Marker
GOLD | Civco Medical
Suture-type
Marker
(K071614,
IYE)
(Primary Predicate) | Focal
BioZorb Marker
(K143484) &
BioZorb LP
Marker
(K152070) (NEU) | Carbon Medical
Technologies
BiomarC Fiducial
Marker
(K132064, IYE,
K110772, NEU) |
|---------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Overall
Technological
Characteristics | Radiographically
visible permanent
marker element(s) in
bioabsorbable polymer
spacer | SAME | SAME | SAME |
| Principle of
Operation | Marker is positioned
into tissue site for
radiographic
visualization of tissue
site | SAME | SAME | SAME |
| Visualization
Compatibility | Mammography
Ultrasound
X-Ray
CT
MRI | X-Ray
CT
(presumed) | SAME | Mammography
Ultrasound
X-Ray
MRI
Fluoroscopy
kV
CT |
| Materials of
Construction | Gold,
bioabsorbable polymer
(spacer) | Gold,
bioabsorbable
polymer (suture) | Titanium,
bioabsorbable
polymer
(spacer) | Pyrolytic carbon
coated zirconium
oxide |
| Overall Device
Length | 2-4 cm | >5 cm (with
suture) | 2-5 cm | 2 mm x 4 mm |
| Typical
Anatomical
Treatment Site | Soft tissue including
breast | breast | SAME | SAME |
| Method of
Marker
Deployment | Manual,
open surgical | SAME | SAME | Manual,
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.
5
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.