(149 days)
No
The device description and performance studies focus on the physical components and biological interactions of a hydrogel marker and applicator, with no mention of AI/ML algorithms for image analysis, diagnosis, or any other function.
No.
The device's intended use is to mark a surgical site or biopsy location for visualization during surgical resection, not to treat a disease or condition. It is a marker, not a therapeutic agent.
No
The device is a marker intended to "mark" the location of a biopsy or surgical site for visualization during surgical resection, not to diagnose a medical condition.
No
The device description explicitly states it consists of two physical components: an applicator made of plastic and stainless steel, and a marker pad made of hydrogel and microspheres. This indicates it is a hardware device, not software-only.
Based on the provided information, the SignalMark Breast Marker is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The SignalMark Breast Marker is a device that is implanted into the human body to mark a location. It does not analyze or test any biological samples.
- The intended use is to mark a surgical site/biopsy location for visualization during surgical resection. This is a procedural aid, not a diagnostic test performed on a sample.
- The device description clearly states it is an "implantable hydrogel marker". This is a medical device, not an IVD.
Therefore, the SignalMark Breast Marker falls under the category of a medical device, specifically an implantable marker, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SignalMark Breast Marker is intended to provide accuracy in marking a surgical site and/or a biopsy location for visualization during surgical resection.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The SignalMark Breast Marker is a medical device used by a physician to percutaneously place a small implantable hydrogel marker in breast tissue to "mark" the location of the biopsy or surgical site. It is intended to be used on adults undergoing open surgical breast biopsy or percutaneous breast biopsy, in a surgical setting, such as a hospital or medical clinic with operating suites. The SignalMark Breast Marker consists of two components:
- . Applicator: Component made of plastic and stainless steel that pushes the marker into the tissue.
- Marker Pad: Component made of USP-grade porcine gelatin-based hydrogel with methylene blue-colored silicon dioxide microspheres. The marker aids in the visualization of tissue allowing surgeons to readily locate the biopsy site for subsequent tissue or tumor resection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast tissue
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician, in a surgical setting, such as a hospital or medical clinic with operating suites.
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)
No FDA performance standards have been established for the SignalMark Breast Marker.
Patient-contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing with a risk management process.
The following tests were performed to demonstrate equivalence to the predicate device:
- Performance testing (Bench)
- Visual Inspection of the Applicator
- Applicator Deployment Test
- Applicator Dimensional Inspection
- Applicator Stroke Length Test
- Applicator Compression Test
- Applicator Tensile Test
- Visual Inspection of the Marker Pad
- Marker Pad Diameter
- Marker Pad Hydration
- Marker Pad Ultrasound Visual Test
- Labeling wipe test with 70% IPA
- Packaged Contents Verification
- Performance testing (Animal)
- Biodistribution in rodents
- Safety and efficacy in porcine
- Biologic response in porcine
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 14, 2019
View Point Medical, Inc. % Michelle Rubin-Onur Regulatory Specialist AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave Suite B-257 San Diego, California 92110
Re: K190689
Trade/Device Name: SignalMark Breast Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: July 16, 2019 Received: July 17, 2019
Dear Michelle Rubin-Onur:
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
1
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,
David Krause, Ph.D. Acting Division Director Division of Infection Control and Plastic Surgery Devices 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) K190689
Device Name SignalMark Breast Marker
Indications for Use (Describe)
The SignalMark Breast Marker is intended to provide accuracy in marking a surigcal site and/or a biopsy location for visualization during surgical resection.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
View Point
MEDICAL
510(k) Summary
DATE PREPARED
July 16, 2019
MANUFACTURER AND 510(k) OWNER
View Point Medical, Inc. 5621 Palmer Way, Suite F Carlsbad, CA 92010, USA Telephone: +1 (760) 707-7901 Official Contact: Thomas Kane, Vice President of Regulatory Affairs and Quality Assurance
REPRESENTATIVE/CONSULTANT
Michelle Rubin-Onur, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: mrubin@acknowledge-rs.com Website: https://www.acknowledge-rs.com/
PROPRIETARY NAME OF SUBJECT DEVICE
SignalMark Breast Marker
COMMON NAME
Biopsy site marker
DEVICE CLASSIFICATION
Implantable clip (Product code NEU, Class II) 21 CFR 878.4300 Implantable clip
INDICATIONS FOR USE
The SignalMark Breast Marker is intended to provide accuracy in marking a surgical site and/or a biopsy location for visualization during surgical resection.
DEVICE DESCRIPTION
The SignalMark Breast Marker is a medical device used by a physician to percutaneously place a small implantable hydrogel marker in breast tissue to "mark" the location of the biopsy or surgical site. It is intended to be used on adults undergoing open surgical breast biopsy or percutaneous breast biopsy, in a surgical setting, such as a hospital or medical clinic with operating suites. The SignalMark Breast Marker consists of two components:
- . Applicator: Component made of plastic and stainless steel that pushes the marker into the tissue.
4
510(k) Summary
- Marker Pad: Component made of USP-grade porcine gelatin-based hydrogel with methylene blue-colored silicon dioxide microspheres. The marker aids in the visualization of tissue allowing surgeons to readily locate the biopsy site for subsequent tissue or tumor resection.
PREDICATE DEVICE IDENTIFICATION
SignalMark Breast Marker is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K060769 | HydroMark Biopsy Site Marker / | |
| Biopsy Sciences, Inc. | ✓ | |
| K180175 | SignalMark Lung Biopsy Site Marker / | |
| View Point Medical, Inc. | (Reference device) |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the SignalMark Breast Marker.
Patient-contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing with a risk management process.
The following tests were performed to demonstrate equivalence to the predicate device:
- Performance testing (Bench) ●
- Visual Inspection of the Applicator O
- o Applicator Deployment Test
- Applicator Dimensional Inspection O
- Applicator Stroke Length Test O
- O Applicator Compression Test
- Applicator Tensile Test O
- Visual Inspection of the Marker Pad O
- O Marker Pad Diameter
- Marker Pad Hydration O
- Marker Pad Ultrasound Visual Test O
- Labeling wipe test with 70% IPA O
- Packaged Contents Verification O
- Performance testing (Animal) ●
- O Biodistribution in rodents
- Safety and efficacy in porcine o
- Biologic response in porcine O
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510(k) Summary
View Point
MEDICAL
EQUIVLANCE TO PREDICATE DEVICE
The SignalMark Breast Marker is substantially equivalent to the predicate device based on the information summarized here:
The subject device has the same intended use and uses similar materials as the device cleared in K060769; namely, both are meant to mark a biopsy location in breast tissue and both use an absorbable hydrogel that expands on fluid contact. Additionally, both devices are visible under ultrasound.
The subject device also has a similar design and dimensions and uses identical materials as the device cleared in K180175. Key technological characteristics of the subject device and reference device (K180175) remain identical; in particular the Applicator and chemical composition of the USP-grade porcine gelatin-based hydrogel Marker Pad with methylene blue-colored, silicon dioxide microspheres. The main difference is that the subject device is provided in two formats (three 1.0 cm pads or one 3.0 cm pad) whereas the reference device is only provided in one format (one 3.0 cm pad). This new format has been added to allow physicians more control over how they place the device in breast tissue, though the total volume of the implant remains the same as the device cleared in K180175.
CONCLUSION
Based on the testing performed, including biocompatibility and non-clinical performance testing (bench and animal), it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed SignalMark Breast Marker are assessed to be substantially equivalent to the predicate devices.