(30 days)
Not Found
No
The summary describes a passive implantable marker and does not mention any computational or analytical functions, let alone AI/ML.
No
The device is described as an implantable radiopaque marker for visualization and marking of soft tissue sites. Its intended use is for radiographic marking and preparation for future medical procedures, not for treating a disease or condition.
No
The device is a marker used for radiographic marking of sites in soft tissue to facilitate visualization for future medical procedures. It does not perform any diagnostic function itself, but rather aids in the visualization step of a diagnostic or interventional procedure.
No
The device description explicitly states it is an "implantable radiopaque marker" comprised of physical components (PLA and titanium), indicating it is a hardware device, not software-only.
Based on the provided information, the BioZorb LP Marker 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 outside the body (in vitro).
- BioZorb LP Marker Function: The BioZorb LP Marker is an implantable device used to mark soft tissue sites within the body for future medical procedures and 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" and "marking for future medical procedures." This describes a physical marking function, not a diagnostic test.
- Device Description: The description details the physical components of the implantable marker.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the BioZorb LP Marker falls under the category of an implantable medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Mammography
Ultrasound
X-Ray
CT
MR
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
The device design was qualified through the following tests:
- Simulated Use
- Mechanical Integrity
- . Imaging Assessment
- MR Compatibility
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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. |
|---|---|
| -------------------------------- | -------------------------------------------------------------------------------------- |
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 Hermann |
| Focal Therapeutics | |
| 4370 Alpine Rd. #101 | |
| Portola Valley, CA 94028 | |
| Phone: 650.530.2394 | |
| Fax: 650.530.2397 | |
| TRADE NAME: | BioZorb™ LP Marker |
| COMMON NAME: | Implantable Radiographic Marker |
| CLASSIFICATION | |
| NAME: | Implantable Clip, 21 CFR, 878.4300 |
| DEVICE | |
| CLASSIFICATION: | 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:
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.
Indication for Use:
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.
4
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 Technological | ||
| Characteristics | SAME | Radiographically visible permanent marker |
| element(s) in bioabsorbable polymer spacer | ||
| Principle of Operation | SAME | Marker is positioned into tissue site for |
| radiographic visualization of tissue site | ||
| Visualization | ||
| Compatibility | SAME | Mammography |
| Ultrasound | ||
| X-Ray | ||
| CT | ||
| MR | ||
| Device Shape | Low Profile (circular, oval) | Spiral |
| Materials of | ||
| Construction | SAME | Titanium (marker clip), |
| bioabsorbable polymer (spacer) | ||
| Overall Device Length | SAME | 2-5 cm |
| Typical Anatomical | ||
| Treatment Site | SAME | Soft tissue including breast |
| Method of Marker | ||
| Deployment | 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).