(319 days)
No
The device description and performance studies focus on the physical components and biological interaction of a biopsy site marker, with no mention of AI/ML algorithms for image analysis, prediction, or other functions.
No.
The device is used to mark a biopsy location for visualization during surgical resection, which is a diagnostic or procedural aid rather than a direct treatment for a disease or condition.
No
The device is used to mark a biopsy location for visualization during surgical resection, aiding surgeons in locating a site that has already been biopsied. It does not provide information about the presence, absence, or state of a disease or condition.
No
The device description clearly outlines physical components (Applicator made of plastic and stainless steel, Marker made of hydrogel and microspheres) and performance testing related to these physical components (dimensional inspection, tensile test, hydration, etc.), indicating it is a hardware device, not software-only.
Based on the provided information, the SignalMark Lung Biopsy Site 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 to provide information for diagnosis, monitoring, or screening.
- SignalMark's Function: The SignalMark device is used in vivo (within the living body) to physically mark a location within the lung tissue. It is a physical marker for surgical guidance, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "marking a biopsy location for visualization during surgical resection." This is a procedural aid, not a diagnostic test.
- Device Description: The description details a physical applicator and a hydrogel marker placed directly into the tissue. This aligns with an implantable or procedural device, not an IVD.
Therefore, the SignalMark Lung Biopsy Site Marker falls under the category of a surgical or procedural device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The SignalMark Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
Product codes
GDW
Device Description
The SignalMark Lung Biopsy Site Marker is a medical device used by a physician to percutaneously place a small implantable hydrogel marker in lung tissue biopsy to "mark" the location of the biopsy site. It is intended to be used on adults undergoing percutaneous lung biopsies, in surgical settings, such as hospitals or medical clinics with operating suites. The SignalMark Lung Biopsy Site Marker consists of two components:
- Applicator: Component made of plastic and stainless steel that pushes the marker into the tissue.
- Marker: 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
lung tissue biopsy
Indicated Patient Age Range
adults
Intended User / Care Setting
physician; surgical settings, such as hospitals or medical clinics 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
The following performance testing was completed in order 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 Length
- Marker Pad Hydration
- Marker Pad Ultrasound Visual Test
- 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
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-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 two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
December 7, 2018
ViewPoint Medical, Inc. Thomas Kane Vice President, Regulatory Affairs & Quality Assurance 1235 Puerta del Sol #600 San Clemente, California 92673
Re: K180175
Trade/Device Name: SignalMark Lung Biopsy Site Marker Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 2, 2018 Received: November 6, 2018
Dear Thomas Kane:
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cynthia Chang -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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)
K180175
Device Name
SignalMark Lung Biopsy Site Marker
Indications for Use (Describe)
The SignalMark Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
Type of Use (Select one or both, as applicable)
즈 Prescription Use (Part 21 CFR 801 Subpart D)
_Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Image /page/3/Picture/1 description: The image shows the logo for View Point Medical. The words "View Point" are in a large, blue, sans-serif font. Below that is a logo consisting of a stylized letter "L" with a yellow circle in the upper left corner. To the right of the logo is the word "MEDICAL" in a smaller, blue, sans-serif font.
510(k) Summary K180175
DATE PREPARED
December 6, 2018
MANUFACTURER AND 510(k) OWNER
View Point Medical Inc. 5621 Palmer Way, Suite F Carlsbad, CA 92010, U.S.A. Telephone: (760) 707-7901 Official Contact: Thomas Kane, Vice President of Regulatory Affairs and Quality Assurance
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
SignalMark Lung Biopsy Site Marker
COMMON NAME
Biopsy site marker
DEVICE CLASSIFICATION
Staple, Implantable (Product code GDW, Class II) 21 CFR 878.4750 Implantable staple
INDICATIONS FOR USE
The SignalMark Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
DEVICE DESCRIPTION
The SignalMark Lung Biopsy Site Marker is a medical device used by a physician to percutaneously place a small implantable hydrogel marker in lung tissue biopsy to "mark" the location of the biopsy site. It is intended to be used on adults undergoing percutaneous lung biopsies, in surgical settings, such as hospitals or medical clinics with operating suites. The SignalMark Lung Biopsy Site Marker consists of two components:
4
510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for View Point Medical. The words "View Point" are stacked on top of the word "MEDICAL". The words are in a sans-serif font and are blue. To the left of the word "MEDICAL" is a stylized image of a circle with lines coming out of it.
- Applicator: Component made of plastic and stainless steel that pushes the marker into ● the tissue.
- Marker: 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 Lung Biopsy Site Marker is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K041331 | Lung Biopsy Site Marker / Biopsy Sciences, LLC | ✓ |
| K071937 | BonAlive granules and plates / Vivoxid, Ltd. | (Reference Device) |
| K110925 | NovaBone MacroPor-Si+ – Bioactive Synthetic Bone | |
| Graft | (Reference Device) |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for SignalMark Lung Biopsy Site Marker.
Patient-contacting material was subjected to biocompatibility testing in compliance to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
The following performance testing was completed in order to demonstrate equivalence to the predicate device:
- . Performance testing (Bench)
- Visual Inspection of the Applicator о
- Applicator Deployment Test O
- Applicator Dimensional Inspection O
- Applicator Stroke Length Test O
- Applicator Compression Test O
- Applicator Tensile Test O
- Visual Inspection of the Marker Pad O
- Marker Pad Diameter O
- Marker Pad Length O
- Marker Pad Hydration O
- Marker Pad Ultrasound Visual Test O
- Wipe test with 70% IPA O
- Packaged Contents Verification O
- Performance testing (Animal) ●
- Biodistribution in rodents o
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Image /page/5/Picture/0 description: The image shows the logo for ViewPoint Medical. The words "View Point" are in a large, blue, sans-serif font. Below that, the word "MEDICAL" is in a smaller, blue, sans-serif font. To the left of the word "MEDICAL" is a blue graphic with a yellow circle.
510(k) Summary
- Safety and efficacy in porcine o
- Biologic response in porcine O
EQUIVALENCE TO PREDICATE DEVICE
The SignalMark Lung Biopsy Site Marker is substantially equivalent to the predicate device based on the information summarized here:
The subject device uses similar or identical materials as the devices cleared in K041331, K071937, and K110925. The subject device has the same intended use, intended population, and use environments as the predicate device cleared in K041331. The subject device has similar technological characteristics to the device cleared in K041331. Unlike the predicate device, the SignalMark Lung Biopsy Site Marker uses silicon dioxide microspheres and USP grade porcine gelatin-based hydrogel in the marker. These technological characteristics have undergone bench and animal testing to ensure the device is substantially equivalent to the predicate.
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 device. The similar technological characteristics and performance characteristics for the proposed SignalMark Lung Biopsy Site Marker device are assessed to be substantially equivalent to the predicate device.