(169 days)
No
The summary describes a system using RFID technology for localization and does not mention any AI or ML components. The performance studies focus on traditional device testing like verification, migration, usability, and compatibility, not on AI/ML model performance.
No.
The device is intended for percutaneous placement to mark a lesion for surgical removal and aid in its localization, not to treat the lesion itself.
No
The device is a localization system used to mark and find breast lesions for surgical removal. It does not provide a diagnosis or interpretation of a patient's condition.
No
The device description explicitly states that the system is comprised of hardware components: a Tag, Tag Applicator/Tag Applicator S, LOCalizer Reader, and LOCalizer Surgical Probe. The performance studies also detail testing related to hardware aspects like migration, electrosurgical compatibility, MRI compatibility, packaging, sterilization, shelf-life, biocompatibility, and electromagnetic compatibility.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "percutaneous placement in the breast to mark... a lesion intended for surgical removal." It is used to physically locate a marker within the body for surgical guidance.
- Device Description: The description details a "marker-with-detector localization device" using RFID tags and a hand-held reader. This describes a system for physical localization within the body.
- Lack of In Vitro Activity: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease. This device does not perform any analysis on such specimens. It is used in vivo (within the body) to mark and locate tissue.
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
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound or radiography
Anatomical Site
Breast Tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals (Prescription Use)
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)
Performance Testing:
- 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." "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 K19092)."
- 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)."
Biocompatibility: "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."
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"
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.
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.
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) |
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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
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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.