(120 days)
No
The summary describes a physical implantable marker and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a tissue marker used for radiographic visualization, not for treatment or therapy.
No
The device is a marker used to facilitate visualization of a site in soft tissue, not to diagnose a condition. Its purpose is to make a site visible for radiographic marking, which aids in subsequent procedures or monitoring, rather than providing diagnostic information itself.
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 only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- BioZorb Tissue Marker Function: The BioZorb Tissue Marker is an implantable device used to mark a site within soft tissue for radiographic visualization. It is a physical marker, not a test performed on a sample.
- Intended Use: The intended use clearly states "radiographic marking of sites in soft tissue," which is a procedural aid for imaging, not a diagnostic test on a biological sample.
The information provided describes a medical device used in conjunction with imaging, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The BioZorb™ Tissue Marker is indicated for radiographic marking of sites in soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The BioZorb Tissue Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb Tissue Marker is comprised of a bioabsorbable component and a permanent component.
The BioZorb Tissue Marker is provided sterile for single use and is disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
All necessary verification and validation testing has been performed for the BioZorb Tissue Marker to assure substantial equivalence to the predicate devices, including image based verification.
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.
K062528, K072913, K011402, K032217
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.
Not Found
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
§ 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.
0
6. 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: | February 28, 2012 |
| CONTACT PERSON: | George Hermann |
| Focal Therapeutics | |
| 4370 Alpine Rd. #101 | |
| Portola Valley, CA 94028 | |
| Phone: 650.530.2394 | |
| Fax: 650.530.2397 | |
| TRADE NAME: | BioZorb™ Tissue Marker |
| COMMON NAME: | Implantable Radiographic Marker |
| CLASSIFICATION | |
| NAME: | Implantable Clip, 21 CFR, 878.4300 |
| DEVICE | |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | NEU |
| PREDICATE DEVICES: | Hologic/Suros Tissue Site Marking System |
| (K062528, K072913); | |
| Bard/SenoRx GelMark Ultra (K011402); | |
| Devicor/Artemis CorMARK Marker (K032217) |
Substantially Equivalent To:
The Focal Therapeutics BioZorb™ Tissue Marker is substantially equivalent in intended use, principal of operation and technological characteristics to the Hologic/Suros Tissue Site Marking Systems (K062528, K072913), the Bard/SenoRx GelMark Ultra (K011402), and the Devicor/Artemis CorMARK (K032217) devices.
Description of the Device Subject to Premarket Notification:
The BioZorb Tissue Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb Tissue Marker is comprised of a bioabsorbable component and a permanent component.
The BioZorb Tissue Marker is provided sterile for single use and is disposable.
Indication for Use:
The BioZorb Tissue Marker is indicated for radiographic marking of sites in soft tissue.
1
Technical Characteristics:
The BioZorb™ Tissue Marker has similar physical and technical characteristics to the predicate devices. In particular the BioZorb Tissue Marker and the predicate devices are comprised of the same primary components and the component materials are substantially equivalent.
Performance Data:
All necessary verification and validation testing has been performed for the BioZorb Tissue Marker to assure substantial equivalence to the predicate devices, including image based verification.
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 Tissue Marker is determined by Focal Therapeutics, to be substantially equivalent to existing legally marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Focal Therapeutics, Inc. % Mr. George Hermann President 4370 Alpine Road #101 Portola Valley, California 94028 .
FEB 2 8 2012
Re: K113202
Trade/Device Name: BioZorb™ Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 22, 2012 Received: February 23, 2012
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
3
Page 2 - Mr. George Hermann
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours. Mark N. Melkerso
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: BioZorb™ Tissue Marker
Indications for Use:
The BioZorb™ Tissue Marker is indicated for radiographic marking of sites in soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X_ (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
Page of of _
Division Size: Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113202