(149 days)
The SignalMark Breast Marker is intended to provide accuracy in marking a surgical site and/or a biopsy location for visualization during surgical resection.
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.
The provided document, a 510(k) summary for the SignalMark Breast Marker, describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study designed to prove the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Therefore, a table of acceptance criteria and reported device performance in those terms is not available from this document.
However, the document does detail other aspects of the testing performed, which can be extracted and summarized.
No clinical studies involving human patients, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance studies are described in this 510(k) summary, as it focuses on non-clinical (bench and animal) testing. The device is a physical marker and not an AI/algorithm-based diagnostic tool, so certain sections of your request (e.g., effect size of human readers improving with AI, standalone performance, training set details) are not applicable.
1. A table of acceptance criteria and the reported device performance
As mentioned, this document does not provide a table of acceptance criteria for diagnostic performance or clinical effectiveness, nor does it report device performance against such criteria. The testing focused on demonstrating equivalence to predicate devices through physical and biological testing.
The document lists the following non-clinical tests performed:
| Test Category | Specific Tests | Reported Device Performance and Acceptance Criteria |
|---|---|---|
| Biocompatibility | ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing with a risk management process | Patient-contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1. This implies the device met the requirements of this standard. |
| Performance (Bench) | Visual Inspection of the Applicator | Not explicitly stated, but implied to meet internal specifications for visual quality. |
| Applicator Deployment Test | Not explicitly stated, but implied to meet internal specifications for proper deployment. | |
| Applicator Dimensional Inspection | Not explicitly stated, but implied to meet internal specifications for dimensions. | |
| Applicator Stroke Length Test | Not explicitly stated, but implied to meet internal specifications for stroke length. | |
| Applicator Compression Test | Not explicitly stated, but implied to meet internal specifications for compression limits. | |
| Applicator Tensile Test | Not explicitly stated, but implied to meet internal specifications for tensile strength. | |
| Visual Inspection of the Marker Pad | Not explicitly stated, but implied to meet internal specifications for visual quality. | |
| Marker Pad Diameter | Not explicitly stated, but implied to meet internal specifications for diameter. | |
| Marker Pad Hydration | Not explicitly stated, but implied to meet internal specifications for hydration properties and expansion. | |
| Marker Pad Ultrasound Visual Test | The document states both the subject device and predicate are visible under ultrasound, implying the test confirmed this visibility. | |
| Labeling wipe test with 70% IPA | Not explicitly stated, but implied to meet internal specifications for labeling durability. | |
| Packaged Contents Verification | Not explicitly stated, but implied to meet internal specifications for package integrity and contents. | |
| Performance (Animal) | Biodistribution in rodents | Not explicitly stated, but implied to demonstrate acceptable biodistribution without adverse effects or to be comparable to predicate. |
| Safety and efficacy in porcine | Not explicitly stated, but implied to demonstrate safety and function in an animal model, comparable to predicate. | |
| Biologic response in porcine | Not explicitly stated, but implied to demonstrate an acceptable biological response in an animal model. |
Note: The document states, "No FDA performance standards have been established for the SignalMark Breast Marker." This indicates that the equivalence was demonstrated against the predicate's known performance for these non-clinical aspects, rather than against specific regulatory performance metrics for this type of device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes for each of the bench and animal tests. It only lists the types of tests conducted. For example, for "Biodistribution in rodents" and "Safety and efficacy in porcine," the specific number of animals used is not provided.
- Data Provenance: The document does not mention the country of origin of the data. The studies were non-clinical (bench and animal), so the terms "retrospective" or "prospective" as they apply to human clinical studies are not directly relevant. These were experimental studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes non-clinical (bench and animal) testing, not a diagnostic accuracy study requiring expert establishment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the document describes non-clinical (bench and animal) testing, not a diagnostic accuracy study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The SignalMark Breast Marker is a physical implantable marker, not an AI or imaging diagnostic device. No MRMC study or AI assistance is mentioned or relevant to this device's 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The SignalMark Breast Marker is a physical implantable marker, not an algorithm, and therefore does not have "standalone performance" in the context of AI or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- For Biocompatibility, the ground truth is adherence to the ISO 10993-1 standard.
- For Bench Performance tests (e.g., dimensional inspection, deployment, hydration, ultrasound visibility), the ground truth would be the pre-defined engineering specifications, material properties, and expected physical behaviors of the device, often compared to the predicate device's characteristics.
- For Animal Performance tests (biodistribution, safety, efficacy, biologic response), the ground truth is derived from the observed biological reactions, histology, and functional outcomes in the animal models, compared to established norms or the predicate device's effects.
8. The sample size for the training set
This section is not applicable. The SignalMark Breast Marker is a physical medical device, not a machine learning or AI model, and therefore does not have a "training set" in that context. The device's design and manufacturing processes are developed through traditional engineering and material science principles.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
{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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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
{5}------------------------------------------------
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.
§ 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.