Who is the manufacturer of RFID Localization System?

Health Beacons, Inc. filed the 510(k) submission for RFID Localization System (K193189).

What is the FDA product code for RFID Localization System?

NEU. It is classified under 21 CFR 878.4300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for RFID Localization System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RFID Localization System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RFID Localization System

K193189 · Health Beacons, Inc. · NEU · May 6, 2020 · General, Plastic Surgery

Device Facts

Record ID	K193189
Device Name	RFID Localization System
Applicant	Health Beacons, Inc.
Product Code	NEU · General, Plastic Surgery
Decision Date	May 6, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2

Intended 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.

Device Story

System consists of miniature RFID tag, hand-held reader, and surgical probe; used for breast lesion localization. Tag is percutaneously implanted in lesion using image guidance. During surgery, surgeon uses hand-held reader and probe to detect radiofrequency signals from tag; system provides visual and audible feedback to indicate distance to tag. Enables precise excision of target tissue. Used in clinical/surgical settings by trained professionals. System facilitates non-imaging detection of implanted markers, aiding surgical navigation and potentially improving excision accuracy.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including design verification, tissue marker migration evaluation, usability testing, electrosurgery/MRI compatibility, packaging validation, sterilization validation, and shelf-life stability testing. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

System uses radiofrequency wave technology. Components: RFID tag (Soda lime Bioglass, polypropylene), applicator (304 stainless steel, silicone coating), surgical probe (ABS, 304 stainless steel, TPU, silicone), reader (polycarbonate, polyester). Sterilization: Ethylene Oxide (tag/applicator), Gamma (probe). Connectivity: Hand-held reader/probe. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1, IEC 60601-1-2, ISO 11607-1, ASTM D4169-09, ASTM F1886/F1886M-16, ASTM F2096-11, ASTM F88/F88M-15, ASTM F1929-98, AAMI ANSI ISO 11137-1/2, ASTM F1980.

Indications for Use

Indicated for percutaneous placement in the breast to mark lesions (>30 days) intended for surgical removal in patients requiring localization for excision.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

Health Beacons RFID Localization System (K190932)

Reference Devices

JAMM Technologies Verichip Health Information Microtransponder And Pocket Reader (DEN040007/K033440)
Cianna Medical SAVI Scout Reflector and SAVI Scout System (K181007)

Related Devices

K190932 — RFID Localization System · Health Beacons, Inc. · Sep 13, 2019
K163667 — 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) · Health Beacons, Inc. · Apr 28, 2017
K181692 — 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) · Health Beacons, Inc. · Sep 25, 2018
K153044 — Sentimag System, Sentimark Magnetic Marker Systerm · Endomagnetics Ltd., · Mar 2, 2016
K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit · Sirius Medical Systems B.V. · Nov 9, 2023

Submission Summary (Full Text)

{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) 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) | ### 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 Saraiya Principal RA Specialist | | Address: | 250 Campus Drive Marlborough, 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, RAC Senior Principal Specialist | | Address: | 2790 Mosside Blvd #800 Monroeville, 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 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. #### VII. 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. #### 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 Device Health Beacons, Inc. RFID Localization System (RFLS) | Predicate Device Health 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 Comparison Proposed Device Health Beacons, Inc. RFID Localization System (RFLS) | Predicate Device Health Beacons RFID Localization System (K190932) | | Product Features | | | | Patient Contacting Materials | • Tag: Soda lime Bioglass, Kimble R6, Pro-fax PF-531 Polypropylene Homopolymer • Tag Applicator: 304 Stainless Steel with Dow Corning MDX4- 4159 Medical Grade Dispersion Silicone coating • Tag Applicator S: 304 Stainless Steel with Dow Corning MDX4- 4159 Medical Grade Dispersion 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 | -same- | | Sterilization Method (sterile, single-use components) | • 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 Design Verification | 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. Performance has previously been established through testing for the RFID Localization System (K181692 and K190932). Testing was conducted to measure the effect of multiple tags on tag-to- probe distance readings. | | Tissue Marker Migration Evaluation | 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). | | Usability Verification and Validation | 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). | | Electrosurgery and MRI Compatibility | 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). | | Packaging Validation | 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) Packaging qualification has previously been established through testing for the RFID Localization System (K163667). Ship testing was completed in accordance with ASTM D4149 and ISTA 2A | | Type | Description | | | Shipping evaluations has previously been established through testing for the RFID Localization System (K190932). | | Sterilization Validation | 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) | | Stability Testing | 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) | ### 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.