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 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) 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 RFLS is a prescription device meant only for use by trained professionals.

AI/ML Overview

Since the provided text is a 510(k) summary for a medical device (RFID Localization System), and not a study report for a diagnostic AI/ML device, much of the requested information regarding acceptance criteria for AI/ML performance, sample sizes for AI test/training sets, expert ground truth establishment, and MRMC studies is not directly applicable or present in this document.

The document discusses performance data related to the physical device's function, safety, and compatibility, rather than the performance of an AI model in a diagnostic context. The "RFID Localization System" is a marker-with-detector device, not an AI-powered diagnostic system.

However, I can extract the acceptance criteria and performance data as described for this physical device, along with other relevant information that is present.

Here's the closest possible interpretation of your request based on the provided text, focusing on the device validation rather than AI performance:

Device: RFID Localization System (RFLS)
Intended Use: Percutaneous placement in the breast to mark a lesion intended for surgical removal. Aids in non-imaging detection and localization of the implanted Tag for surgical removal.

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like the RFLS, "acceptance criteria" relate more to meeting design specifications and safety/performance standards. The document states that the RFLS met the applicable design and performance requirements. The "performance" is demonstrated by passing the various tests listed, affirming its functionality and safety.

Feature/Test Type	Acceptance Criteria (Implied: Met applicable design/performance requirements & standards)	Reported Device Performance
RFLS System Design Verification	Device meets product specifications defined in design requirement documentation.	"RFID Localization System verification testing was conducted to demonstrate that the RFID Localization System (RFLS) meets product specifications as defined in the design requirement documentation." "Testing was conducted to measure the effect of multiple tags on tag-to-probe distance readings." (Implied successful demonstration, as it supports substantial equivalence).
Tissue Marker Migration Eval	RFID Tag does not migrate due to MRI-induced forces or simple body movement beyond acceptable limits.	"A migration evaluation was performed to assess migration of the RFID Tag due to MRI-induced forces as well as simple migration resultant from body movement." "Migration has previously been established through evaluation for the RFID Localization System (K163667 and K181692)." (Implied successful demonstration, relying on previous clearances).
Usability Verification & Validation	Device design meets usability requirements.	"Usability testing was conducted to demonstrate that the RFID Localization System (RFLS) design meets Usability requirements." "Usability has previously been established through evaluation for the RFID Localization System (K181692 and K190932)." (Implied successful demonstration, relying on previous clearances).
Electrosurgery & MRI Compatibility	RFID Tag function is not adversely affected by electrosurgery. Device is safe and compatible in the MR environment.	"Testing was conducted to assess electromagnetic interference and RFID Tag functionality after direct exposure to electrical current from an electrosurgery instrument." "Electrosurgical compatibility has previously been established through testing for the RFID Localization System (K163667)." "Testing was conducted to evaluate the interaction (safety and compatibility) of the RFID Tag in the magnetic resonance (MR) environment." "MRI compatibility has previously been established through testing for the RFID Localization System (K163667 and K190932)." (Implied successful demonstration, relying on previous clearances).
Packaging Validation	Sterile components meet standards for packaging integrity and sterility.	"Package Qualification Testing for sterile components was completed in accordance with the following standards: ISO 11607-1, ASTM D4169-09, ASTM F1886/F1886M-16, ASTM F2096-11, ASTM F88/F88M-15, ASTM F1929-98 (2004)." "Ship testing was completed in accordance with ASTM D4149 and ISTA 2A." "Packaging qualification has previously been established through testing for the RFID Localization System (K163667)." "Shipping evaluations has previously been established through testing for the RFID Localization System (K190932)." (Implied successful demonstration, relying on previous clearances).
Sterilization Validation	Sterile components meet sterilization requirements.	"Sterilization Validation for the sterile components was completed in accordance with the following standards, as appropriate: AAMI ANSI ISO 11137-1, AAMI ANSI ISO 11137-2, AAMI ANSI ISO 10993-7." "Sterilization parameters have previously been validated through testing for the RFID Localization System (K163667, K181692 and K190932)." (Implied successful demonstration, relying on previous clearances).
Stability Testing	Device maintains performance and safety over its intended shelf-life.	"Shelf-life evaluations were conducted in accordance the Food & Drug Administrations; "Shelf Life of Medical Devices" and the ASTM Standard "F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"." "Device shelf-life has previously been established through testing for the RFID Localization System (K163667, K181692 and K190932)." (Implied successful demonstration, relying on previous clearances).
Biocompatibility	Patient-contacting materials are biocompatible per ISO 10993-1 for the expected contact category, type, and duration.	"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." "Biocompatibility has previously been established through biocompatibility testing for the RFID Localization System patient contacting materials (K190932 and DEN040007/K033440)." (Implied successful demonstration, relying on previous clearances).
Electrical Safety & EMC	Device meets electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2).	"Electrical safety and EMC safety testing was performed to, and passed, the following standards: IEC 60601-1, IEC 60601-1-2." (Explicitly states "passed the following standards").
Software V&V Testing	Software meets FDA guidance for medical device software and cybersecurity.	"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'." (Implies successful completion and adherence to guidance, relying on previous clearances K181692 and K190922).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set sample size" in the context of an AI/ML model. Instead, it refers to various engineering and biological validation tests. For many tests, it explicitly states that the performance was "previously established" through prior 510(k) clearances (e.g., K190932, K181692, K163667, DEN040007/K033440). This indicates that the current submission relies on historical test data and validations, with some additional testing (e.g., multiple tags, updated packaging/shipping in K190932, and the explicitly mentioned electrosurgery and MRI compatibility for K163667, and the current submission's specific software and electrical safety/EMC testing).

Data Provenance: The document doesn't specify the country of origin for the underlying test data, but it refers to FDA-cleared predicate and reference devices, implying compliance with US regulatory standards. All validations appear to be retrospective or performed as part of device development and previous submissions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable. This is a physical medical device, not an AI/ML diagnostic algorithm requiring expert "ground truth" for interpretations of medical images or data. The "ground truth" for the device's performance would be established by objective measurements against engineering specifications and validated medical standards.

4. Adjudication Method for the Test Set:

Not applicable. This concept applies to human reader studies often used for AI/ML validation, not the direct performance testing of a physical medical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is for evaluating observer performance with or without AI assistance, which is not the subject of this 510(k). The device is a physical marker and localization system, not a diagnostic AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. This device is not an algorithm; it's a marker-with-detector system that a human surgeon uses. Its performance is inherent in its physical properties and functionality.

7. Type of Ground Truth Used:

The "ground truth" for this device's validation is based on:

Engineering specifications and design requirements.
Objective measurements (e.g., distance readings, physical stability, electrical safety parameters).
Compliance with established international and ASTM standards (e.g., ISO 11607-1, ASTM D4169-09, ISO 10993-1, IEC 60601-1).
Biocompatibility assessments of materials.
Validation of sterilization processes.

8. Sample Size for the Training Set:

Not applicable. This device does not use an AI/ML model that requires training data in the conventional sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no AI/ML training set. The "ground truth" for the device's design and manufacturing is established through scientific principles, engineering validated methods, and adherence to medical device regulatory standards and best practices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

May 6, 2020

Health Beacons, Inc. % Felicia Hosey Senior Principal Specialist R&Q Solutions 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K193189

Trade/Device Name: RFID Localization System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: April 4, 2020 Received: April 8, 2020

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 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

{1}------------------------------------------------

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 (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 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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193189

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)

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

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92 on May 5th, 2020.

I. Submitter

Submitter's Name:	Hologic, Inc.
Contact Person:	Dhaval SaraiyaPrincipal RA Specialist
Address:	250 Campus DriveMarlborough, MA 01752
Telephone:	(508) 263.8823
Email:	dhaval.saraiya@hologic.com

II. Application Correspondent

Contact's Name:	Regulatory and Quality Solutions, LLC
Contact Person:	Mrs. Felicia Hosey, RACSenior Principal 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

{4}------------------------------------------------

IV. Predicate Device

Health Beacons RFID Localization System
- K190932 (Health Beacons Inc.), FDA cleared on 09/13/2019 o

V. Reference Devices

JAMM Technologies Verichip Health Information Microtransponder And Pocket Reader ● DEN040007/K033440 (Digital Angel Corporation), FDA cleared on 10/12/2004 O
Cianna Medical SAVI Scout Reflector and SAVI Scout System
- K181007 (Cianna Medical, Inc.), FDA cleared on 08/02/2018 0

VI. Device Description

VII. Indications for Use

VIII. Comparison of Technological Characteristics with the Predicate Devices

The proposed RFID Localization System (RFLS) has identical indications for use, principles of operation, fundamental scientific technology and materials as the predicate device Health Beacons RFID Localization System. The only differences between the subject and predicate devices are minor software updates and revision of the instructions for use to clarify the use of multiple tags in on operative site.

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

{5}------------------------------------------------

Table 7-1: General Technological Characteristics Comparison
Product Features	Proposed DeviceHealth Beacons, Inc.RFID Localization System(RFLS)	Predicate DeviceHealth Beacons RFID Localization System(K190932)
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-
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-
	Table 7-1: General Technological Characteristics ComparisonProposed DeviceHealth Beacons, Inc.RFID Localization System(RFLS)	Predicate DeviceHealth Beacons RFID Localization System(K190932)
Product Features
Patient ContactingMaterials	• Tag: Soda lime Bioglass, KimbleR6, Pro-fax PF-531Polypropylene Homopolymer• Tag Applicator: 304 StainlessSteel with Dow Corning MDX4-4159 Medical Grade DispersionSilicone coating• Tag Applicator S: 304 StainlessSteel with Dow Corning MDX4-4159 Medical Grade DispersionSilicone coating• Surgical Probe: AcrylonitrileButadiene Styrene (ABS), SabicCycolac HMG94-8H7D195, 304Stainless Steel, Thermoplasticpolyurethane (TPU) IROGRANRA75 E 5040, white, SiliconeElastomer• Reader: Polycarbonate, LTLColor Compounds ColorfastPC200, Polyester, FlexconCompucal Excel 10442 LabelStock	-same-
SterilizationMethod(sterile, single-usecomponents)	• Tag Applicator and RFID Tag:Ethylene Oxide• Surgical Probe: Gamma	-same-

Table 7-1: General Technological Characteristics Comparison

{6}------------------------------------------------

mola

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.

{7}------------------------------------------------

Table 7-2: Performance Testing
Type	Description
RFLS System DesignVerification	RFID Localization System verification testing was conducted todemonstrate that the RFID Localization System (RFLS) meets productspecifications as defined in the design requirement documentation.Performance has previously been established through testing for theRFID Localization System (K181692 and K190932).Testing was conducted to measure the effect of multiple tags on tag-to-probe distance readings.
Tissue MarkerMigration Evaluation	A migration evaluation was performed to assess migration of the RFIDTag due to MRI-induced forces as well as simple migration resultantfrom body movement.Migration has previously been established through evaluation for theRFID Localization System (K163667 and K181692).
Usability Verificationand Validation	Usability testing was conducted to demonstrate that the RFIDLocalization System (RFLS) design meets Usability requirements.Usability has previously been established through evaluation for theRFID Localization System (K181692 and K190932).
Electrosurgery andMRI Compatibility	Testing was conducted to assess electromagnetic interference and RFIDTag functionality after direct exposure to electrical current from anelectrosurgery instrument.Electrosurgical compatibility has previously been established throughtesting for the RFID Localization System (K163667).Testing was conducted to evaluate the interaction (safety andcompatibility) of the RFID Tag in the magnetic resonance (MR)environment.MRI compatibility has previously been established through testing forthe RFID Localization System (K163667 and K190932).
Packaging Validation	Package Qualification Testing for sterile components was completed inaccordance with the following standards:• ISO 11607-1• ASTM D4169-09• ASTM F1886/F1886M-16• ASTM F2096-11• ASTM F88/F88M-15• ASTM F1929-98 (2004)Packaging qualification has previously been established through testingfor the RFID Localization System (K163667).Ship testing was completed in accordance with ASTM D4149 and ISTA2A
Type	Description
	Shipping evaluations has previously been established through testing forthe RFID Localization System (K190932).
SterilizationValidation	Sterilization Validation for the sterile components was completed inaccordance with the following standards, as appropriate:AAMI ANSI ISO 11137-1 AAMI ANSI ISO 11137-2 AAMI ANSI ISO 10993-7 Sterilization parameters have previously been validated through testingfor the RFID Localization System (K163667, K181692 and K190932)
Stability Testing	Shelf-life evaluations were conducted in accordance the Food & DrugAdministrations; "Shelf Life of Medical Devices" and the ASTMStandard "F1980, Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices".Device shelf-life has previously been established through testing for theRFID Localization System (K163667, K181692 and K190932)

Table 7-2: Performance Testing

{8}------------------------------------------------

Table 7-2: Performance Testing

Biocompatibility

The proposed RFID Localization System (RFLS) has identical patient contacting materials, expected contact category, type and duration as the Predicate Device. Health Beacons RFID Localization System (K190932) and Reference Device, JAMM Technologies Verichip Health Information Microtransponder And Pocket Reader, (DEN040007/K033440). 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 09/13/2019 (K190932).

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 (K190932 and DEN040007/K033440).

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 (K190932). 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

{9}------------------------------------------------

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". Reference K181692 and K190932

X. Conclusion

The proposed RFID Localization System (RFLS) has identical indications for use, principles of operation, fundamental scientific technology, and materials as the predicate device Health Beacons RFID Localization System. Information provided in this submission supports the continued 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.