The BioZorb LP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

Device Description

The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.

AI/ML Overview

The information provided is a 510(k) premarket notification for the BioZorb LP Marker. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria for device performance. Medical devices cleared via 510(k) often rely on non-clinical data (e.g., bench testing) to demonstrate equivalence if their technology and intended use are similar to existing devices.

Based on the provided text, here's what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance

The document states that "The modified BioZorb Marker met all specified criteria and did not raise new safety or performance questions" for the listed tests. However, the specific acceptance criteria (e.g., quantitative thresholds for mechanical integrity) are not detailed in this summary. The performance is generally stated as meeting criteria.

Acceptance Criterion	Reported Device Performance
Simulated Use	Met all specified criteria
Mechanical Integrity	Met all specified criteria
Imaging Assessment	Met all specified criteria
MR Compatibility	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)

This information is not provided in the document. The tests listed (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility) are typically non-clinical bench or lab tests, not clinical studies involving human patients. Therefore, terms like "test set" in the context of patient data, data provenance, or retrospective/prospective would not apply here.

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)

This information is not provided or applicable to the type of testing described. The tests are non-clinical, and thus do not involve expert interpretation of images or other data for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided or applicable. Adjudication methods are typically used in clinical trials involving expert review of patient data, which is not described here.

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

There is no mention of an MRMC study or AI assistance. This device is a physical implantable marker, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a physical marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility), the "ground truth" would be established by engineering specifications, material properties, and objective measurements during the testing process, not by expert consensus, pathology, or outcomes data in the clinical sense. The specific details of how ground truth was established for each test are not provided.

8. The sample size for the training set

This is not applicable as the device is a physical marker and there is no mention of a training set in the context of machine learning or AI.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as above.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of a stylized human figure in profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circular seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 26, 2015

Focal Therapeutics Mr. George Hermann President 4370 Alpine Road #101 Portola Valley, California 94028

Re: K152070

Trade/Device Name: BioZorb LP Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: July 24, 2015 Received: July 27, 2015

Dear Mr. Hermann:

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. 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K152070

Device Name BioZorb LP Marker

Indications for Use (Describe)	The BioZorb LP Marker is indicated for radiographic marking of sites in soft tissue.
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In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

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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1. 510(k) Summary

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

APPLICANT:	Focal Therapeutics
DATE PREPARED:	08/14/15
CONTACT PERSON:	George HermannFocal Therapeutics4370 Alpine Rd. #101Portola Valley, CA 94028Phone: 650.530.2394Fax: 650.530.2397
TRADE NAME:	BioZorb™ LP Marker
COMMON NAME:	Implantable Radiographic Marker
CLASSIFICATIONNAME:	Implantable Clip, 21 CFR, 878.4300
DEVICECLASSIFICATION:	Class II
PRODUCT CODE	NEU

PREDICATE DEVICES: (primary) BioZorb Marker (K143484)

Substantially Equivalent To:

The modified BioZorb Marker (BioZorb LP Marker) is substantially equivalent in intended use, principal of operation and technological characteristics to the BioZorb Marker cleared under premarket notification K143484.

Description of the Device Subject to Premarket Notification:

Indication for Use:

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Technical Characteristics:

The modified BioZorb Marker has the same or similar physical and technical characteristics as the predicate device. Low profile markers have been added to the BioZorb product family.

	Subject device	Predicate device
	BioZorb Marker,Modified	BioZorb Marker(K143484)
Overall TechnologicalCharacteristics	SAME	Radiographically visible permanent markerelement(s) in bioabsorbable polymer spacer
Principle of Operation	SAME	Marker is positioned into tissue site forradiographic visualization of tissue site
VisualizationCompatibility	SAME	MammographyUltrasoundX-RayCTMR
Device Shape	Low Profile (circular, oval)	Spiral
Materials ofConstruction	SAME	Titanium (marker clip),bioabsorbable polymer (spacer)
Overall Device Length	SAME	2-5 cm
Typical AnatomicalTreatment Site	SAME	Soft tissue including breast
Method of MarkerDeployment	SAME	Manual, open surgical
Marker Stability	SAME	Sutured in place
Provided sterile	SAME	Yes
Sterilization method	SAME	Radiation

Performance Data:

All necessary testing has been performed for the modified BioZorb Marker to assure substantial equivalence to the predicate device and demonstrate the device performs as intended.

The device design was qualified through the following tests:

Simulated Use
Mechanical Integrity
. Imaging Assessment
MR Compatibility

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

Basis for Determination of Substantial Equivalence:

The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified BioZorb Marker device is found to have a safety and effectiveness profile that is the same as the predicate device and is determined by Focal Therapeutics to be substantially equivalent to the BioZorb Marker (K143484).

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.