(27 days)
Not Found
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 or ML.
No.
The device is indicated for radiographic marking of soft tissue sites for visualization or future medical procedures. It does not provide any therapeutic benefit or treatment.
No
The device is described as an implantable radiographic marker used to facilitate visualization of a soft tissue site for future medical procedures. It does not diagnose conditions, but rather marks a location for subsequent procedures.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiographic marking of sites in soft tissue" and "marking for future medical procedures." This describes a device used in vivo (within the body) for visualization and procedural guidance, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The device is described as an "implantable radiopaque marker." This confirms its use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for marking and visualization within the body.
N/A
Intended Use / Indications for Use
The BioZorb SP Marker is indicated for radiographic marking of sites in addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The BioZorb SP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb SP 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 SP 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
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 testing has been performed for the subject BioZorb SP Marker to ensure substantial equivalence to the predicate device and demonstrate the device performs as intended.
Performance data with regards to imaging assessment and MR compatibility are provided in support of the substantial equivalence.
The BioZorb SP Marker met all specified input criteria and did not raise new safety or performance questions.
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 26, 2019
Focal Therapeutics Dhaval Saraiya Principal Regulatory Affairs Specialist 1010 Stewart Drive Sunnyvale, California 94085
Re: K192371
Trade/Device Name: BioZorb SP Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: August 29, 2019 Received: August 30, 2019
Dear Dhaval Saraiya:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192371
Device Name BioZorb® SP Marker
Indications for Use (Describe)
The BioZorb SP Marker is indicated for radiographic marking of sites 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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510(k) SUMMARY
Date: August 29, 2019
I. SUBMITTER
Focal Therapeutics A Hologic Company 1010 Stewart Drive Sunnyvale, CA 94085
Contact person: Dhaval Saraiya Phone: 508.263.8823 Email: Dhaval.saraiya@hologic.com
II. DEVICE
Name of the device: BioZorb® SP Marker Common or usual name: Implantable Radiographic Marker Regulation name: Implantable Clip Regulation Number: 21 CFR 878.4300 Product Code: NEU Classification: Class II Panel: General and Plastic Surgery
- III. PREDICATE DEVICE BioZorb Marker (K143484) BioZorb LP Marker (K152070) These cleared products have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The BioZorb SP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb SP 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 SP Marker is provided sterile for single use and is implantable.
- V. INDICATIONS FOR USE The BioZorb SP 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.
TECHNICAL CHARACTERISTICS
The BioZorb SP Marker has similar physical and technical characteristics as the predicate devices. The shape of the implant is identical to the current BioZorb (K143484) and the titanium clips (i.e. markers) are identical to those cleared in the BioZorb LP Marker (K152070).
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VI. PERFORMANCE DATA
All necessary testing has been performed for the subject BioZorb SP Marker to ensure substantial equivalence to the predicate device and demonstrate the device performs as intended.
Performance data with regards to imaging assessment and MR compatibility are provided in support of the substantial equivalence.
The BioZorb SP Marker met all specified input criteria and did not raise new safety or performance questions.
- VII. DETERMINATION OF SUBSTANTIAL EQUIVALENCE BASIS FOR The Indication/Intended Use and the fundamental scientific technology of the subject device have not been changed and are the same as those described in the predicate devices. The BioZorb SP Marker device is found to have a safety and effectiveness profile that is substantially equivalent to the predicate devices.