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.

Device Description

The Tag, Tag Applicator, 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 hand-held reader that can measure distance to 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.

AI/ML Overview

This document is a 510(k) Summary for the RFID Localization System (RFLS). It describes a medical device and provides information on its performance data, but it does not contain the results of a clinical study with acceptance criteria and a detailed comparison against it. The document primarily focuses on technical performance testing and equivalence to predicate devices, rather than a clinical effectiveness study measuring human reader improvement or standalone algorithm performance against a clinical ground truth.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document lists "Performance Testing" categories, but it does not provide specific acceptance criteria or quantitative performance results for clinical endpoints. Instead, it states that tests were performed to demonstrate that the RFLS "met the applicable design and performance requirements."

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in terms of clinical performance or specific thresholds for accuracy, sensitivity, specificity, etc.)	- RFLS System Verification performed.- Reader/Probe Design Verification performed.- Localizer System and Component Accuracy, Repeatability Evaluation performed.- Test Media Evaluation performed.- Reader and Surgical Probe Operating Environment Evaluation performed.- Tissue Marker Migration Evaluation performed.- Usability Verification and Validation performed.- Electrosurgical tool compatibility performed.- Packaging Validation performed.- Sterilization Validation performed.
Biocompatibility requirements per ISO 10993-1	Met requirements; previously established for reference device (K163667) using identical patient-contacting materials.
Electrical Safety and EMC per IEC 60601-1 and IEC 60601-1-2	Passed testing for both standards.
Software Verification and Validation testing per FDA Guidances	Conducted and documentation provided.

2. Sample size used for the test set and the data provenance: Not mentioned. The performance data refers to device-level technical testing rather than a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this document does not describe a study involving expert-established ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This document does not describe an MRMC study or AI assistance. The device is a localization system, not an AI diagnostic tool for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" performance. The device is a "marker-with-detector localization device" used by trained professionals. The performance tests mentioned are for the physical device system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this document does not describe a study involving clinical ground truth. The "ground truth" for the device's technical performance would be engineering specifications and measurements.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the conventional sense.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

Device Name: RFID Localization System (RFLS)
Intended Use: Percutaneous placement of a Tag in the breast to mark a lesion for surgical removal. The RFLS (hand-held reader and surgical probe) assists in non-imaging detection and localization of the Tag.
Predicate Device: Cianna Medical SAVI Scout Reflector and SAVI Scout System (K171767)
Comparison: The RFLS has the "same indications for use, principles of operation and similar fundamental scientific technology and materials" as the predicate.
Performance Data Types: System verification, design verification, accuracy/repeatability, test media evaluation, operating environment, tissue marker migration, usability, electrosurgical tool compatibility, packaging, sterilization, biocompatibility, electrical safety, and software V&V.
Biocompatibility: Established based on an identical reference device (K163667) and adherence to ISO 10993-1.
Electrical Safety & EMC: Passed IEC 60601-1 and IEC 60601-1-2 standards.
Software V&V: Conducted per FDA guidances.

The document concludes that the RFLS is substantially equivalent to its predicate device based on these performance and technical characteristic comparisons.

Summary

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2018

Health Beacons, Inc. % Felicia Hosey Principal Specialist Regulatory and Ouality Solutions, LLC. 2790 Mosside Boulevard, Suite 800 Monroeville, Pennsylvania 15146

Re: K181692

Trade/Device Name: 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) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: June 21, 2018 Received: June 27, 2018

Dear Ms. Hosey:

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

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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 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 mediation-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,

David Krause -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) K181692

Device Name RFID Localization System (RFLS)

Indications for Use (Describe)

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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RFID Localization System (RFLS)

510(k) SUMMARY

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92 on June 21, 2018.

I. Submitter

Submitter's Name:	Health Beacons, Inc.
Contact Person:	Ms. Nancy ConfreyChief Executive Officer
Address:	34 Walden St., #753Concord, 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:	Mrs. Felicia Hosey, RACPrincipal Specialist
Address:	2790 Mosside Blvd #800Monroeville, PA 15146
Telephone:	(877) 652-0830 ext. 161
Email:	fhosey@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

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IV. Predicate Device

Cianna Medical SAVI Scout Reflector and SAVI Scout System . O K171767 (Cianna Medical, Inc.), FDA cleared on 10/31/2017

V. Reference Devices

Health Beacons RFID Localization System Localizer Reader, RFID Localization System -● LOCalizer Surgical Probe, RFID Localization System - LOCalizer Surgical Probe (5 Pack), RFID Localization System - Tag Applicator, RFID Localization System - Tag Applicator (10 Pack)
- o K163667 (Health Beacons Inc.), FDA cleared on 04/28/2017
JAMM Technologies Verichip Health Information Microtransponder And Pocket Reader DEN040007/K033440 (Digital Angel Corporation), FDA cleared on 10/12/2004 O

VI. Device Description

VII. Indications for Use

Comparison of Technological Characteristics with the Predicate Devices VIII.

The following table (Table 7-1) provides an overview of general technological characteristics in comparison to the predicate device.

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Table 7-1: General Technological Characteristics Comparison
Product Features	Proposed DeviceHealth Beacons, Inc.RFID Localization System(RFLS)	Predicate DeviceCianna Medical SAVI ScoutReflector and SAVI Scout System(K171767)
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.	The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.
Classification	Class II	-same-
Product Code	NEU	-same-
RegulationNumber	§878.4300	-same-
Regulation Name	Marker, Radiographic, Implantable	-same-
AnatomicalLocations	Breast Tissue	-same-
Breast TissuePenetration/Delivery Device	Needle Implanter	-same-
Visibility	X-ray, Ultrasound andMRI (artifact only)	X-ray, Ultrasound and MRI
Primary DeviceComponents	RFID Tag pre-loaded in TagApplicator, Reader, and SurgicalProbe	Electromagnetic wave reflectivedevice (Reflector) pre-loaded inDelivery System, Handpiece, andConsole
Principle ofOperation	Radiofrequency wave technology todetect tissue marker	Electromagnetic wave technologytodetect the tissue marker
Indicators	Visual and Audible	-same-
Implant DeliveryDeviceSize/WorkingLength	• 12 Gauge/5cm• 12 Gauge/7cm• 12 Gauge/10cm	• 16 Gauge/13cm
Table 7-1: General Technological Characteristics Comparison
	Proposed Device	Predicate Device
	Health Beacons, Inc.	Cianna Medical SAVI Scout
	RFID Localization System	Reflector and SAVI Scout System
Product Features	(RFLS)	(K171767)
Implant DeliveryDevice NeedleMarking	1 cm marker increments	-same-
ImplantDimensions	Approximately 0.09" (2.3 mm) diameter x 0.37" (10.6 mm) long	Approximately 0.05" (1.27 mm) x0.49"(12.4 mm) long
Patient ContactingMaterials	• Tag: Soda lime bioglass, polypropylene homopolymer• Tag Applicator: 304 Stainless Steel• Surgical Probe: Acrylonitrile butadiene styrene, 304 Stainless Steel, TPU, Silicone Elastomer• Reader: Polycarbonate, Polyester Film (label)	• Reflector: 3922 Loctite, Nitinol SE508, light oxide• Delivery System: 304 Stainless Steel• Handpiece: Acrylonitrile butadiene styrene, Polyester film, Loctite 4011, NPO (COG) K20 (Dielectric material)• Console: N/A (no patient contact)
SterilizationMethod(sterile, single-usecomponents)	• Tag Applicator and RFID Tag:Ethylene Oxide• Surgical Probe: Gamma	• Delivery System and Reflector:Ethylene Oxide• Handpiece: Ethylene Oxide

Table 7-1: Ge al Technological Ch cteristics Co .

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Table 7-1• C

IX. Performance Data

The following performance data was considered in support of the substantial equivalence determination.

Performance Testing

The following tests were performed to demonstrate that the proposed RFID Localization System (RFLS) met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.

RFLS System Verification ●
Reader/Probe Design Verification
Localizer System and Component Accuracy, Repeatability Evaluation
Test Media Evaluation
Reader and Surgical Probe Operating Environment Evaluation
Tissue Marker Migration Evaluation
Usability Verification and Validation
Electrosurgical tool compatibility ●
Packaging Validation ●
Sterilization Validation

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Biocompatibility

A biocompatibility evaluation was completed for the proposed RFID Localization System (RFLS), which has identical patient contacting materials as the Reference Device, Health Beacons RFID Localization System (K163667). There have been no changes to the Health Beacons RFID Localization System patient contacting materials or manufacturing process since the device was originally cleared on 04/28/2017 (K163667).

Testing completed met the requirements of the respective test methods per the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as appropriate for the expected contact category, type and duration. Therefore, biocompatibility has previously been established through biocompatibility testing for the RFID Localization System patient contacting materials (K163667).

Electrical Safety and Electromagnetic Compatibility (EMC)

An electromagnetic compatibility evaluation was completed for the proposed RFID Localization System (RFLS), which has the same technological characteristics as the Reference Device, Health Beacons RFID Localization System (K163667). Electrical safety and EMC safety testing was performed to, and passed, the following standards:

IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic compatibility -Requirements and tests

Software Verification and Validation Testing

Software verification and validation testing for the proposed RFID Localization System (RFLS) was conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

X. Conclusion

The proposed RFID Localization System (RFLS) has the same indications for use, principles of operation and similar fundamental scientific technology and materials as the predicate device, Cianna Medical SAVI Scout Reflector and SAVI Scout System. The differences in fundamental scientific technology, principles of operation and materials do not raise new safety and effectiveness questions as compared to a legally marketed predicate device. Therefore, the information provided in this submission supports safety and effectiveness of the proposed device for its intended use and demonstrates that the device is substantially equivalent to its predicate.

Regulation Number and Section

§ 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.