RFID Localization System

K190932 · Health Beacons, Inc. · NEU · Sep 13, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190932
• Device Name: RFID Localization System
• Applicant: Health Beacons, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Sep 13, 2019
• 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

RFID Localization System (RFLS) marks breast lesions for surgical excision; consists of miniature RFID tag, tag applicator, handheld reader, and surgical probe. Tag implanted percutaneously under image guidance; remains in tissue >30 days. During surgery, surgeon uses handheld reader/probe to detect RFID tag via radiofrequency waves; reader provides distance measurement to tag. System provides visual and audible indicators to guide surgeon to lesion location. Enables precise tissue removal; reduces need for wire localization. Used in clinical settings by breast surgeons and radiologists.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including magnetic field emission testing (IEC 60601-1-2:2014), delivery testing, deployment force testing, needle penetration force testing, and usability testing.

Technological Characteristics

System uses radiofrequency wave technology. Tag materials: Soda lime Bioglass, Kimble R6, Biobond (Polypropylene Homopolymer). Applicator: 304 Stainless Steel with silicone coating. Surgical Probe: ABS, 304 Stainless Steel, TPU, Silicone Elastomer. Reader: Polycarbonate, Polyester. Tag dimensions: 2.29mm x 10.8mm. Delivery via 12-gauge needle. Sterilization: Ethylene Oxide (Tag/Applicator), Gamma (Surgical Probe).

Indications for Use

Indicated for patients requiring percutaneous placement of a marker in the breast to identify a lesion for surgical removal. The marker remains in place for >30 days. Used by breast surgeons and diagnostic radiologists.

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 (K181692)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span style="padding-right: 10px;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> <span style="padding-right: 10px;"> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |

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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<br>Chief Executive Officer |
| Address: | 34 Walden St., #753<br>Concord, MA 01742 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

## II. Application Correspondent

| Contact's Name: | Regulatory and Quality Solutions, LLC |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Ms. Carol Vierling, RAC (Consultant)<br>Senior Principal Advisor |
| Address: | 2790 Mosside Blvd #800<br>Monroeville, PA 15146 |
| Telephone: | 877-652-0830 |
| Email: | [e-mail] |

## 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<br>Health Beacons, Inc. RFID<br>Localization System | Predicate Device<br>Health Beacons RFID Localization<br>System (K181692) |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Device Description | The proposed RFID Localization System<br>is a marker-with-detector localization<br>device that employs miniature RFID tags<br>as markers and a hand-held reader that<br>can measure distance to the tag. The<br>RFLS is comprised of a Tag, Tag<br>Applicator, Tag Applicator S, LOCalizer<br>Reader (Reader), and LOCalizer<br>Surgical Probe (Surgical Probe). The<br>Tag, when used in conjunction with the<br>Reader and Surgical Probe, can be used<br>as a guide for the surgeon to refer to in<br>the excision of tissue. The RFID tag<br>emits no radiation, the Reader provides<br>an accurate distance measurement to the<br>tag, and the RFID Tag can be placed at a<br>convenient time before surgery without<br>migration prior to removal. | Same except that there is only one Tag<br>Applicator |
| Product Features | Modified Device<br>Health Beacons, Inc. RFID<br>Localization System | Predicate Device<br>Health Beacons RFID Localization<br>System (K181692) |
| Intended Use | The Tag of the RFLS is intended for<br>percutaneous placement in the breast to<br>mark a lesion intended for surgical<br>removal. | -same- |
| Indications for Use | The Tag of the RFLS is intended for<br>percutaneous placement in the breast to<br>mark (>30 days) a lesion intended for<br>surgical removal. Using image guidance<br>(such as ultrasound or radiography) or<br>aided by non-imaging guidance (RFLS),<br>the RFID Tag is located and surgically<br>removed with the target tissue. The<br>RFLS is intended only for the non-<br>imaging detection and localization of the<br>Tag that has been implanted in a lesion<br>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<br>Penetration /Delivery<br>Device | Needle Implanter | -same- |
| Visibility | X-ray, Ultrasound and MRI (artifact<br>only) | -same- |
| Primary Device<br>Components | RFID Tag pre-loaded in Tag Applicator,<br>Reader and Surgical Probe | -same- |
| Principle of Operation | Radiofrequency wave technology to<br>detect tissue marker | -same- |
| Indicators | Visual and Audible | -same- |
| Implant Delivery<br>Device Size/Working<br>Length | • 12 Gauge/5cm<br>• 12 Gauge/7cm<br>• 12 Gauge/10cm | -same- |
| Implant Delivery<br>Device Needle<br>Marking | 1 cm marker increments | -same- |
| Tag Applicator Tip<br>Geometry | 22° bevel | 28° bevel |
| Tag Implant<br>Dimensions | Approximately 0.08" (2.29mm) diameter<br>x 0.43" (10.8mm) long | Approximately 0.09" (2.26 mm)<br>diameter x 0.37" (9.52 mm) long |
| Product Features | Modified Device<br>Health Beacons, Inc. RFID<br>Localization System | Predicate Device<br>Health Beacons RFID Localization<br>System (K181692) |
| Patient Contacting<br>Materials | • Tag: Soda lime Bioglass, Kimble R6,<br>Biobond™, (a.k.a. Pro-fax PF-531)<br>Polypropylene Homopolymer<br>• Tag Applicator: 304 Stainless Steel<br>with silicone coating<br>• Tag Applicator S: 304 Stainless Steel<br>with silicone coating<br>• Surgical Probe: Acrylonitrile<br>Butadiene Styrene (ABS), Sabic<br>Cycolac HMG94-8H7D195, 304<br>Stainless Steel, Thermoplastic<br>polyurethane (TPU) IROGRANR A75<br>E 5040, white, Silicone Elastomer<br>• Reader: Polycarbonate, LTL Color<br>Compounds Colorfast PC200,<br>Polyester, Flexcon Compucal Excel<br>10442 Label Stock | • Tag: -same-<br>• Tag Applicator: 304 Stainless Steel<br>• Surgical Probe: -same-<br>• Reader: -same- |
| Sterilization Method<br>(sterile, single-use<br>components) | • Tag Applicator and RFID Tag:<br>Ethylene Oxide<br>• Surgical Probe: Gamma | -same- |
| Tissue Marker<br>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.