(122 days)
Not Found
No
The description focuses on RFID technology for localization and does not mention any AI/ML components or algorithms. The performance studies also do not indicate the use of AI/ML.
No
The device is described as a localization system used to mark and locate lesions for surgical removal, not to treat a condition.
No
This device is used for localizing a lesion for surgical removal, not for diagnosing a condition. It guides the surgeon to the target tissue rather than identifying or characterizing a disease.
No
The device description explicitly lists hardware components (Tag, Tag Applicator, Reader, and Surgical Probe) and the performance studies include hardware-specific testing (e.g., Reader/Probe Design Verification, EMC/Safety Testing, Biocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The RFLS is a localization device used during surgery to help a surgeon find and remove a previously placed marker (the Tag) within the breast tissue. It is a tool for guiding a surgical procedure, not for analyzing a sample in vitro to diagnose or monitor a condition.
- Intended Use: The intended use clearly states it's for "percutaneous placement in the breast to temporarily (
N/A
Intended Use / Indications for Use
The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (
§ 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/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
1
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 ( | |
| | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 (