(122 days)
The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (<30 days) mark a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue.
The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
The RFID Localization System (RFLS) 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, Reader, and Surgical Probe. 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.
The provided text details the 510(k) summary for the RFID Localization System (RFLS). While it outlines various performance tests conducted, it does not provide a specific table of acceptance criteria with corresponding reported device performance, nor does it detail a comparative effectiveness study involving human readers (MRMC). The information focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Based on the provided text, here's an attempt to answer the questions, highlighting what information is available and what is not:
Acceptance Criteria and Study for RFID Localization System (RFLS)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported performance for each criterion. It broadly states that "performance testing was conducted to evaluate and characterize the performance of the RFLS."
However, one specific performance metric is mentioned under "Localization Accuracy" in the comparison table:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Localization Accuracy | ±7 mm |
Other performance aspects mentioned (without specific numerical criteria or reported values):
- RFLS System Verification
- Reader/Probe Design Verification
- Localizer System and Component Accuracy, Repeatability Evaluation
- Test Media Evaluation
- Reader and Surgical Probe Operating Environment Evaluation
- Tissue Marker Migration Evaluation
- Usability Verification and Validation
- Electrosurgical tool compatibility
- EMC/Safety Testing
- Biocompatibility
- Magnetic Resonance Testing
- Packaging Validation
- Sterilization Validation
The document states that these tests "demonstrates the safety of the system for its intended use and confirms the performance of the system for use in intra-operative surgical guidance. Specifically, the performance testing demonstrates the safe use of the system to facilitate intra-operative guided surgical procedures by detecting the presence of the Tag by providing an audible tone which increases pitch and volume with decreased distance, a visible bar indicator, and a measurement readout."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the various performance tests (e.g., number of RFLS tags tested, number of measurement repetitions for accuracy, etc.).
It also does not detail the data provenance in terms of country of origin or whether the studies were retrospective or prospective. Given that this is a 510(k) summary for a medical device cleared by the FDA (USA), it's highly probable the testing was conducted in the USA, but this is not explicitly stated. The tests are described as "non-clinical testing," implying they were not conducted on human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or the establishment of ground truth by experts for the described performance tests. The tests appear to be primarily engineering and bench-top evaluations (e.g., accuracy, repeatability, EMC, sterilization validation) rather than studies requiring expert clinical judgment for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as expert involvement and clinical ground truth establishment are not described for the non-clinical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how human readers improve with AI vs. without AI assistance. The RFLS is a localization device, not an AI-assisted diagnostic tool that would typically involve comparative reader studies for diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The performance testing appears to be primarily focused on the standalone performance of the device's components and system operation (e.g., localization accuracy of ±7mm, detection of the tag, providing audible tone and visible indicators). The device's function is explicit: "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." This implies an "algorithm only" type of measurement in terms of its core function, but it's part of a human-guided surgical procedure.
7. The Type of Ground Truth Used
For "Localization Accuracy (±7 mm)," the ground truth would likely be established by a highly precise physical measurement system (e.g., an optical tracking system, a precisely calibrated measurement jig) during bench testing, rather than expert consensus, pathology, or outcomes data, as it's a direct physical measurement. For other tests like "Sterilization Validation" or "Biocompatibility," the ground truth would be adherence to established standards and test protocols.
8. The Sample Size for the Training Set
The document does not mention a training set. The RFLS is described as a marker-with-detector localization device, relying on RFID technology for detection and distance measurement. This does not suggest the use of machine learning or algorithms that require a distinct "training set" in the conventional sense (e.g., for image classification or prediction). The device's function appears to be based on direct physical principles of radiofrequency wave detection rather than learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set is not mentioned.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
Health Beacons, Inc. Ms. Nancy Confrey Chief Executive Officer 34 Walden Street, #753 Concord, Massachusetts 01742
Re: K163667
Trade/Device Name: RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System-Localizer Surgical Probe (5 Pack), RFID Localization System- Tag Applicator, RFIDd Localization System -tag Applicator (10 Pack) Regulation Number: 21 CFR 878.4300
Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PBY Dated: April 21, 2017 Received: April 24, 2017
Dear Ms. Confrey:
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. 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 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name RFID Localization System
Indications for Use (Describe)
The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (<30 days) mark 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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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
l. SUBMITTER
Health Beacons, Inc. 34 Walden Street #753 Concord, MA 01742 Phone: (978) 287-4635 Fax: (978) 246-6019 Establishment Registration No.: TBD
Contact Person: Nancy Confrey Chief Executive Officer Phone: (978) 287-4635 nconfrey@healthbeacons.com
Alternate Contact: Diana DeGregorio Lincé Consulting, LLC Regulatory Affairs Consultant (925) 980-8047 ddegregorio@linceconsulting.com
Date Prepared December 23, 2016
ll. DEVICE
Trade Name: RFID Localization System (RFLS) Common Name: Temporary Tissue Marker Classification Name: Implantable clip Classification: 21 CFR§ 878.4300 Product Code: PBY Class II Device Class:
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lll. PREDICATE
Cianna Medical, Inc. SAVI Scout Reflector and SAVI Scout System (K161507)
IV. DEVICE DESCRIPTION
The RFID Localization System (RFLS) 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, Reader, and Surgical Probe. 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.
V. INDICATIONS FOR USE
The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (<30 days) mark a lesion intended for surgical removal. Using image quidance (such as ultrasound or radiography) or aided by non-imaging quidance (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.
VI. COMPARISON CHARACTERISTICS THE OF TECHNOLOGICAL WITH PREDICATE DEVICE
The RFLS has similar features as compared to the predicate device as shown in the following table:
| Manufacturer | Cianna Medical, Inc. | Health Beacons, Inc. |
|---|---|---|
| Device Name | SAVI Scout Reflector and SAVIScout System | RFID Localization System (RFLS) |
| 510(k) Number | K161507 | TBD |
| AnatomicalLocations | Breast Tissue | Same |
| Primary DeviceComponents | Electromagnetic wave reflectivedevice (Reflector) pre-loaded inDelivery System, Handpiece, andConsole | RFID Tag pre-loaded in TagApplicator, Reader, and SurgicalProbe |
| Breast TissuePenetration /Delivery Device | Needle Implanter | Same |
| Visibility | X-ray, Ultrasound | Same |
| Principles ofOperation | electromagnetic wave technology todetect the tissue marker | radiofrequency wave technology todetect tissue marker |
| LocalizationAccuracy | Unknown | ±7 mm |
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| Manufacturer | Cianna Medical, Inc. | Health Beacons, Inc. |
|---|---|---|
| Device Name | SAVI Scout Reflector and SAVIScout System | RFID Localization System (RFLS) |
| 510(k) Number | K161507 | TBD |
| Indicators | Visual and Audible | Same |
| ImplantDelivery DeviceSize/WorkingLength | 16 Ga/130mm | 12 Ga/100mm |
| ImplantDelivery DeviceNeedle Marking | 1 cm marker increments | Same |
| ImplantDimensions | Approximately0.05" (1.27 mm) x 0.49" (12.4 mm)long | Approximately0.09" (2.3 mm) diameter x 0.37"(10.6 mm) long |
| Patient ContactMaterials | Reflector: 3922 Loctite, Nitinol•SE508, light oxideDelivery System: 304 Stainless•SteelHandpiece: Acrylonitrile butadiene•styrene, Polyester film, Loctite4011, NPO (COG) K20 (Dielectricmaterial)• Console: N/A (no patient contact) | Tag: Soda lime bioglass,polypropylene homopolymer• Tag Applicator: 304 StainlessSteel• Surgical Probe: Acrylonitrilebutadiene styrene, 304 Stainless•Steel, TPU, Silicone ElastomerReader: Polycarbonate, Polyester•film (label) |
| SterilizationMethod | Single-use, sterilized components:• Implanter and reflector (EthyleneOxide)• Handpiece (Ethylene Oxide) | Single-use, sterilized components:• Tag Applicator and RFID Tag(Ethylene Oxide)• Surgical Probe (Gamma) |
| Tissue MarkerLocator | Reusable, non-sterile Console | Reusable, non-sterile Reader |
| Conformanceto Standards | ISO 10993IEC 60601-1IEC 60601-1-2ASTM F2119-07 | ISO 10993IEC 60601-1 (3rd edition)IEC 60601-1-2 (4th edition)FCC 47 CFR Part 15 subpart CASTM F2119-07 (2013) |
The technological characteristics and principals of operation of the RFLS is substantially equivalent to the named predicate device. The primary difference between the two systems is the Savi Scout device uses electromagnetic wave technology to detect the tissue marker, while the subject device tissue marker is located using RFID technology (radiofrequency wave). However, this minor difference in technology does not raise new or different questions of safety and effectiveness. The performance testing included in the 510k demonstrates the safety of the system for its intended use and confirms the performance of the system for use in intra-operative surgical guidance. Specifically, the performance testing demonstrates the safe use of the system to facilitate intra-operative guided surgical procedures by detecting the presence of the Tag by providing an audible tone which
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increases pitch and volume with decreased distance, a visible bar indicator, and a measurement readout.
VII. PERFORMANCE DATA
Performance testing was conducted to evaluate and characterize the performance of the RFLS. The following performance testing was conducted on the RFLS to support a determination of substantial equivalence to the predicate device.
- RFLS System Verification ●
- Reader/Probe Design Verification
- Localizer System and Component Accuracy, Repeatability Evaluation ●
- . Test Media Evaluation
- Reader and Surgical Probe Operating Environment Evaluation ●
- Tissue Marker Migration Evaluation
- Usability Verification and Validation ●
- Electrosurgical tool compatibility
- EMC/Safety Testing
- Biocompatibility ●
- Magnetic Resonance Testing ●
- Packaging Validation ●
- Sterilization Validation
VIII. CONCLUSIONS
The RFLS has been carefully compared to the legally marketed predicate device with respect to intended use/indications for use, technological characteristics, anatomical sites, performance, safety characteristics, and labeling. In addition, non-clinical testing was conducted to verify and validate the performance of the device and ensure the RFLS functions as intended and meets design specifications. The comparison and non-clinical performance testing results demonstrate that the device is substantially equivalent to the predicate device for its intended use.
§ 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.