(203 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 described as a marker for radiographic marking and future medical procedures, not for treating or preventing disease.
No
The device is a marker for radiographic marking and future medical procedures, not for diagnosing conditions.
No
The device description clearly states it is an "implantable radiopaque marker comprised of a bioabsorbable PLA component and a permanent component (titanium)". This indicates a physical, implantable hardware device, not a software-only device.
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 for future medical procedures. This is a physical marking function within the body, not a test performed on samples taken from the body.
- Device Description: The device is an implantable marker. IVDs are typically reagents, instruments, or systems used to examine specimens (like blood, urine, tissue) in vitro (outside the body).
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, detection of substances, or diagnosis based on in vitro testing.
The BioZorb Marker is a medical device used for imaging and procedural guidance, not for diagnosing conditions through laboratory testing.
N/A
Intended Use / Indications for Use
The BioZorb 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 Marker is an implantable radiopaque marker comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 or more years and a permanent component (titanium). The BioZorb 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
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
Performance data included:
- Pyrogenicity, LAL (USP Pharmacopeia ) .
- MR compatibility (ASTM 2052-14, ASTM F2213-06, ASTM 2182-11a, . ASTM F2119-07) and,
- Shelf life testing (ASTM D4169, ASTM F2096, ASTM F88/F88M, . ASTM F1980, ISO 11607-1).
The Focal BioZorb Marker performance is identical to the predicate device (K113202).
Key Metrics
Not Found
Predicate Device(s)
Mixed Media Marker (K102506), Focal Therapeutics BioZorb Tissue Marker (K113202)
Reference Device(s)
Civco Suture-type Marker (K071614)
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.
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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. The seal features the department's name encircling a stylized image of an eagle with three human profiles incorporated into its design. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2015
Focal Therapeutics Mr. George Hermann Official Correspondent 4370 Alpine Road, #101 Portola Valley, California 94028
Re: K143484
Trade/Device Name: BioZorb Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: May 22, 2015 Received: May 28, 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 (reporting of medical
1
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 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) K143484
Device Name BioZorb Marker
Indications for Use (Describe) The BioZorb 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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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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: | June 23, 2015 |
| 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 Marker |
| COMMON NAME: | Implantable Radiographic Marker |
| CLASSIFICATION NAME: | Implantable Clip, 21 CFR, 878.4300, 892.5050 |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODE | NEU |
| PREDICATE DEVICES: | Mixed Media Marker (K102506) |
| Civco Suture-type Marker [reference predicate] (K071614) | |
| Focal Therapeutics BioZorb Tissue Marker (K113202) |
Substantially Equivalent To:
The BioZorb Marker is substantially equivalent in intended use, principal of operation and technological characteristics to the Mixed Media Marker (K 102506), Suture-type Marker (K071614) and the BioZorb Tissue Marker (K113202).
Description of the Device Subject to Premarket Notification:
The BioZorb Marker is an implantable radiopaque marker comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 or more years and a permanent component (titanium).
The BioZorb Marker is provided sterile for single use and is implantable.
Indication for Use:
The BioZorb 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.
Technical Characteristics:
The BioZorb Marker has similar physical and technical characteristics to the predicate devices, as illustrated in the table below.
| Subject device | Primary | Primary | Reference | |
|---|---|---|---|---|
| Predicate | Predicate | Predicate | ||
| Focal | Focal | Cortex | Civco Medical | |
| BioZorb | BioZorb | Mixed Media | Suture-type | |
| Marker | Tissue | Marker | Marker | |
| Marker | (K102506) | (K071614) | ||
| (K113202) | ||||
| Overall | Radiographically | SAME | Radiographically | SAME |
| Technological | visible | visible | ||
| Characteristics | permanent | permanent | ||
| marker | marker | |||
| element(s) in | element(s) with | |||
| bioabsorbable | or without | |||
| polymer spacer | polymer | |||
| Principle of | Marker is | SAME | SAME | SAME |
| Operation | positioned into | |||
| tissue site for | ||||
| radiographic | ||||
| visualization of | ||||
| tissue site | ||||
| Visualization | Mammography | SAME | SAME | X-Ray |
| Compatibility | Ultrasound | CT | ||
| X-Ray | (presumed) | |||
| CT | ||||
| Materials of | Titanium, | SAME | Gold, titanium or | Gold. |
| Construction | bioabsorbable | PEEK polymer, | bioabsorbable | |
| polymer | stainless steel | polymer | ||
| (spacer) | (suture) | |||
| Overall Device | 2-5 cm | SAME | 1 mm x ~ 20 mm | >5 cm (with |
| Length | suture) | |||
| Typical | Soft tissue | |||
| Anatomical | including breast | SAME | SAME | breast |
| Treatment Site | ||||
| Method of | Manual, | SAME | Manual, | SAME |
| Marker | open surgical | percutaneous | ||
| Deployment | ||||
| Marker | Sutured in place | Tissue | Tissue retention | SAME |
| Stability | retention | |||
| Provided sterile | Yes | Yes | Yes | Yes |
| Steriliz. method | Radiation | SAME | Unknown | Unknown |
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Performance Data:
Performance data included:
- Pyrogenicity, LAL (USP Pharmacopeia ) .
- MR compatibility (ASTM 2052-14, ASTM F2213-06, ASTM 2182-11a, . ASTM F2119-07) and,
- Shelf life testing (ASTM D4169, ASTM F2096, ASTM F88/F88M, . ASTM F1980, ISO 11607-1).
The Focal BioZorb Marker performance is identical to the predicate device (K113202).
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 is determined by Focal Therapeutics to be substantially equivalent to existing legally marketed devices.