(175 days)
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.
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.
The provided text does not contain information about the acceptance criteria or a detailed study proving the device meets specific performance metrics. It primarily focuses on the FDA's regulatory approval process for the BioZorb Marker GOLD / LP Marker GOLD, establishing its substantial equivalence to predicate devices. Therefore, I cannot fulfill most of the requested table and answer many of the specific questions about studies and ground truth.
However, I can extract the general types of performance data that were reviewed and a very high-level statement about meeting criteria.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional / Device Integrity | Met all specified criteria. |
| Imaging Compatibility (Radiographic Visibility) | Met all specified criteria. |
| MR Compatibility | Met all specified criteria. |
| Simulated Use | Met all specified criteria. |
| Safety (No new safety questions) | Did not raise new safety or performance questions. |
Missing Information for the table: Specific quantitative or qualitative acceptance criteria for "Simulated Use", "Device Integrity", "Imaging Assessment", and "MR Compatibility" are not provided. The document only states that the device "met all specified criteria."
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 specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Simulated Use," suggesting some lab-based or non-clinical testing, but no details are given.
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)
- Not specified. The document does not describe the use of experts for establishing ground truth in a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- No MRMC comparative effectiveness study is mentioned. This device is an implantable marker, not an AI-powered diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (an implantable marker), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The document does not describe the establishment of "ground truth" as would be relevant for an AI or diagnostic device evaluation. Instead, it refers to performance testing of a physical marker.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
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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 (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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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 HermannFocal Therapeutics1010 Stewart DriveSunnyvale, CA 94085Phone: 408.962.7010Fax: 408.962.7020 |
| TRADE NAME: | BioZorb Marker GOLD / LP Marker GOLD |
| COMMON NAME: | Implantable Radiographic Fiducial Marker |
| CLASSIFICATIONNAME: | Accelerator, Linear, Medical, 21 CFR 892.5050 |
| DEVICECLASSIFICATION: | Class II |
| PRODUCT CODE: | IYE |
| PREDICATE DEVICES: | Civco Suture-type Marker (K071614) (Primary Predicate)Focal Therapeutics BioZorb Marker (K143484) and BioZorbLP 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.
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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.
| FocalBioZorb MarkerGOLD / LP MarkerGOLD | Civco MedicalSuture-typeMarker(K071614,IYE)(Primary Predicate) | FocalBioZorb Marker(K143484) &BioZorb LPMarker(K152070) (NEU) | Carbon MedicalTechnologiesBiomarC FiducialMarker(K132064, IYE,K110772, NEU) | |
|---|---|---|---|---|
| OverallTechnologicalCharacteristics | Radiographicallyvisible permanentmarker element(s) inbioabsorbable polymerspacer | SAME | SAME | SAME |
| Principle ofOperation | Marker is positionedinto tissue site forradiographicvisualization of tissuesite | SAME | SAME | SAME |
| VisualizationCompatibility | MammographyUltrasoundX-RayCTMRI | X-RayCT(presumed) | SAME | MammographyUltrasoundX-RayMRIFluoroscopykVCT |
| Materials ofConstruction | Gold,bioabsorbable polymer(spacer) | Gold,bioabsorbablepolymer (suture) | Titanium,bioabsorbablepolymer(spacer) | Pyrolytic carboncoated zirconiumoxide |
| Overall DeviceLength | 2-4 cm | >5 cm (withsuture) | 2-5 cm | 2 mm x 4 mm |
| TypicalAnatomicalTreatment Site | Soft tissue includingbreast | breast | SAME | SAME |
| Method ofMarkerDeployment | 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.
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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.
§ 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.