(156 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on RFID technology for localization, not AI/ML for image analysis or decision support.
No
The device is described as a marker-with-detector localization device with the intended use of marking and locating a lesion for surgical removal. It does not treat or cure any condition.
No
The device is described as a "marker-with-detector localization device" used for percutaneous placement in the breast to mark a lesion for surgical removal and guide the surgeon during excision. Its purpose is to localize a lesion, not to diagnose it.
No
The device description explicitly lists multiple hardware components: Tag, Tag Applicator, Tag Applicator S, LOCalizer Reader, and LOCalizer Surgical Probe. The performance studies also include hardware-specific testing like magnetic field emission and mechanical force testing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Tag is placed in the breast tissue and the system is used to locate and surgically remove it from the body. It is not used to analyze a sample taken from the body.
- The device is used for localization and guidance during surgery. Its function is to help the surgeon find and remove a specific lesion within the breast, not to diagnose a condition based on analyzing a biological sample.
The device is a surgical localization system, not an IVD.
N/A
Intended Use / Indications for Use
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The Tag, Tag Applicator, Tag Applicator S, LOCalizer Reader, and LOCalizer Surgical Probe are components of the Health Beacons RFID Localization System (RFLS). The proposed device is a marker-with-detector localization device that employs miniature RFID tags as markers and a handheld reader that can measure distance to the Tag. The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.
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
Not Found
Intended User / Care Setting
Prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.
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)
The following performance testing was provided to support the substantial equivalence determination.
- Magnetic field emission testing per IEC 60601-1-2:2014
- Delivery testing
- Deployment Force testing .
- Needle Penetration Force testing .
- Usability testing
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2019
Health Beacons, Inc. % Ms. Carol Vierling Sr. Principal Advisor R&Q Solutions 2790 Mosside Blvd, Suite 800 Monroeville, Pennsylvania 15146
Re: K190932
Trade/Device Name: RFID Localization System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: May 3, 2019 Received: August 13, 2019
Dear Carol Vierling:
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 and Part 809); medical device reporting (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) K190932
Device Name RFID Localization System (RFLS)
Indications for Use (Describe)
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
| 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
This 510(k) Summary is provided per the requirements of section 21 CFR 807.92 on April 8, 2019.
I. Submitter
| Submitter's Name: | Health Beacons, Inc. |
|---|---|
| Contact Person: | Ms. Nancy Confrey |
| Chief Executive Officer | |
| Address: | 34 Walden St., #753 |
| Concord, MA 01742 | |
| Telephone: | (978) 287-4635 |
| Fax: | (978) 246-6019 |
| Email: | nconfrey@healthbeacons.com |
II. Application Correspondent
| Contact's Name: | Regulatory and Quality Solutions, LLC |
|---|---|
| Contact Person: | Ms. Carol Vierling, RAC (Consultant) |
| Senior Principal Advisor | |
| Address: | 2790 Mosside Blvd #800 |
| Monroeville, PA 15146 | |
| Telephone: | 877-652-0830 |
| Email: | cvierling@rqteam.com |
III. Device
| Trade Name: | RFID Localization System (RFLS) |
|---|---|
| Common Name: | Marker, Radiographic, Implantable |
| Classification Name: | Implantable clip. |
| Product Classification: | Class II, §878.4300, Product Code NEU |
Health Beacons, Inc.
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IV. Predicate Device
- . Health Beacons RFID Localization System - 5cm Tag Applicator, 7cm Tag Applicator, 10 Cm Tag Applicator, 5 Cm Tag Applicator (10 Pack), 7cm Tag Applicator (10 Pack), 10cm Tag Applicator (10 Pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 Pack)
- K181692 (Health Beacons Inc.), FDA cleared on September 25th, 2018 O
V. Device Description
The Tag, Tag Applicator, Tag Applicator S, LOCalizer Reader, and LOCalizer Surgical Probe are components of the Health Beacons RFID Localization System (RFLS). The proposed device is a marker-with-detector localization device that employs miniature RFID tags as markers and a handheld reader that can measure distance to the Tag. The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.
VI. Indications for Use
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
There have been no changes to the indication for use.
| Product Features | Modified Device
Health Beacons, Inc. RFID
Localization System | Predicate Device
Health Beacons RFID Localization
System (K181692) |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Device Description | The proposed RFID Localization System
is a marker-with-detector localization
device that employs miniature RFID tags
as markers and a hand-held reader that
can measure distance to the tag. The
RFLS is comprised of a Tag, Tag
Applicator, Tag Applicator S, LOCalizer
Reader (Reader), and LOCalizer
Surgical Probe (Surgical Probe). The
Tag, when used in conjunction with the
Reader and Surgical Probe, can be used
as a guide for the surgeon to refer to in
the excision of tissue. The RFID tag
emits no radiation, the Reader provides
an accurate distance measurement to the
tag, and the RFID Tag can be placed at a
convenient time before surgery without
migration prior to removal. | Same except that there is only one Tag
Applicator |
| Product Features | Modified Device
Health Beacons, Inc. RFID
Localization System | Predicate Device
Health Beacons RFID Localization
System (K181692) |
| Intended Use | The Tag of the RFLS is intended for
percutaneous placement in the breast to
mark a lesion intended for surgical
removal. | -same- |
| Indications for Use | The Tag of the RFLS is intended for
percutaneous placement in the breast to
mark (>30 days) a lesion intended for
surgical removal. Using image guidance
(such as ultrasound or radiography) or
aided by non-imaging guidance (RFLS),
the RFID Tag is located and surgically
removed with the target tissue. The
RFLS is intended only for the non-
imaging detection and localization of the
Tag that has been implanted in a lesion
intended for surgical removal. | -same- |
| Classification | Class II | -same- |
| Product Code | NEU | -same- |
| Regulation Number | §878.4300 | -same- |
| Regulation Name | Marker, Radiographic, Implantable | -same- |
| Anatomical Locations | Breast Tissue | -same- |
| Breast Tissue
Penetration /Delivery
Device | Needle Implanter | -same- |
| Visibility | X-ray, Ultrasound and MRI (artifact
only) | -same- |
| Primary Device
Components | RFID Tag pre-loaded in Tag Applicator,
Reader and Surgical Probe | -same- |
| Principle of Operation | Radiofrequency wave technology to
detect tissue marker | -same- |
| Indicators | Visual and Audible | -same- |
| Implant Delivery
Device Size/Working
Length | • 12 Gauge/5cm
• 12 Gauge/7cm
• 12 Gauge/10cm | -same- |
| Implant Delivery
Device Needle
Marking | 1 cm marker increments | -same- |
| Tag Applicator Tip
Geometry | 22° bevel | 28° bevel |
| Tag Implant
Dimensions | Approximately 0.08" (2.29mm) diameter
x 0.43" (10.8mm) long | Approximately 0.09" (2.26 mm)
diameter x 0.37" (9.52 mm) long |
| Product Features | Modified Device
Health Beacons, Inc. RFID
Localization System | Predicate Device
Health Beacons RFID Localization
System (K181692) |
| Patient Contacting
Materials | • Tag: Soda lime Bioglass, Kimble R6,
Biobond™, (a.k.a. Pro-fax PF-531)
Polypropylene Homopolymer
• Tag Applicator: 304 Stainless Steel
with silicone coating
• Tag Applicator S: 304 Stainless Steel
with silicone coating
• Surgical Probe: Acrylonitrile
Butadiene Styrene (ABS), Sabic
Cycolac HMG94-8H7D195, 304
Stainless Steel, Thermoplastic
polyurethane (TPU) IROGRANR A75
E 5040, white, Silicone Elastomer
• Reader: Polycarbonate, LTL Color
Compounds Colorfast PC200,
Polyester, Flexcon Compucal Excel
10442 Label Stock | • Tag: -same-
• Tag Applicator: 304 Stainless Steel
• Surgical Probe: -same-
• Reader: -same- |
| Sterilization Method
(sterile, single-use
components) | • Tag Applicator and RFID Tag:
Ethylene Oxide
• Surgical Probe: Gamma | -same- |
| Tissue Marker
Locator | Reusable, non-sterile Console | -same- |
VII. Comparison of Technological Characteristics with the Predicate Device
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VIII. Design Control Activities
A risk analysis was performed to identify new risks based on the device modification. Risks are mitigated as far as possible. All verification and validation activities identified as necessary were performed by designated individuals and results demonstrate that predetermined acceptance criteria were met. The manufacturing facility fulfills design procedure requirements.
The following performance testing was provided to support the substantial equivalence determination.
- Magnetic field emission testing per IEC 60601-1-2:2014
- . Delivery testing
- Deployment Force testing .
- Needle Penetration Force testing .
- . Usability testing
IX. Conclusion
The proposed RFID Localization System (RFLS) has the same indications for use, principles of operation and fundamental scientific technology as the predicate device, Health Beacons RFID Localization System. The proposed changes do not raise any new questions regarding safety and effectiveness of the RFLS. Therefore, the information provided in this submission supports the RFLS being as safe and effective as the predicate device for its intended use and demonstrates that the device is substantially equivalent to its predicate.
Health Beacons, Inc.