(28 days)
No
The summary describes a magnetic marker and a system for its detection, focusing on physical components and their function. There is no mention of AI, ML, or any computational analysis of data that would suggest the use of such technologies. The detection is based on a magnetic field and signal conversion, not algorithmic learning or pattern recognition.
No.
The device is intended to mark a site for surgical removal and aid in its localization, which are diagnostic/localization functions rather than therapeutic.
No
The device is intended to mark a lumpectomy site and aid in its surgical removal, not to diagnose a condition. The "diagnosis and treatment of breast lesions" mentioned refers to the user's expertise, not the device's function.
No
The device description explicitly details physical components including a magnetic marker, a needle delivery system, and a hand-held Sentimag probe and base unit.
Based on the provided text, 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 Endomag Magseed Magnetic Marker and Sentimag System are used to physically mark and locate a site within the breast for surgical removal. They do not analyze biological samples or provide diagnostic information based on the composition of those samples.
- Intended Use: The intended use clearly states that the marker is placed "percutaneously in the breast to mark temporarily... a lumpectomy site intended for surgical removal." The Sentimag System is for "non-imaging detection and localization" of the marker. This is a procedural aid, not a diagnostic test.
The device is a surgical marker and localization system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Endomag Magseed Magnetic Marker is intended to be placed percutaneously in the breast to mark 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2017
Endomagnetics, Ltd Dr. Andrew Shawcross Chief Operations Officer The Jeffreys Building Cowley Road Cambridge CB4 OWS UK
Re: K163541
Trade/Device Name: Magseed Magnetic Marker System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PBY Dated: December 13, 2016 Received: December 16, 2016
Dear Dr. Shawcross:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
K163541 510(k) Number (if known)
Endomag Magseed Magnetic Marker Device Name
Indications for Use (Describe)
The Endomag Magseed Magnetic Marker is intended to be placed percutaneously in the breast to mark temporarily ( Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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SUBMITTER INFORMATION 1.1
| Submitter's Name: | Endomagnetics Ltd. |
|---|---|
| Address: | The Jeffreys Building |
| Cowley Road | |
| Cambridge | |
| CB4 0WS | |
| United Kingdom | |
| Contact Person: | Andrew Shawcross |
| Chief Operations Officer | |
| Tel: | +44 1223 652540 |
| Email: | ashawcross@endomag.com |
| Date summary prepared: | 13 December 2016 |
DEVICE INFORMATION 1.2
| Trade name: | Magseed Magnetic Marker and Sentimag System |
|---|---|
| Common name: | Tissue Marker, Marker Delivery System and Detection |
| System | |
| Classification name: | Temporary Tissue Marker |
| Regulation: | 21 CFR 878.4300 |
| Device Classification: | Class II |
| Product Code: | PBY |
PREDICATE DEVICE 1.3
Sentimag System, Sentimark Magnetic Marker System (K153044).
DESCRIPTION OF DEVICE 1.4
The Magseed Magnetic Marker is identical to the Sentimark Magentic marker described in K153044. Only the trade name has changed. The Magseed Magnetic Marker is supplied to end users as a pre-packaged sterile, single-use delivery system. The system comprises an individual soft magnetic marker
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(magnetic seed) and a 18-gauge needle delivery system that is used to deliver the seed to the intended deployment location. This product is designed as a single use device that is supplied sterile in an individual sealed tyvek pouch.
This Premarket Submission is solely concerned with a reduction in the length of the 18-gauge needle cannula that is used to introduce the Magseed Magnetic Marker. K153044 describes two device configurations, where:
- REF: SM18-1-12 has a length of 12cm ●
- REF: SM18-1-20 has a length of 20cm ●
This submission solely considers a reduction in the needle canulla to a minimum length of 5cm.
- REF: SM18-1-05 has a length of 5cm .
- REF: SM18-1-07 has a length of 7cm .
There is no revision to the implanted marker.
The Sentimag Detector remains identical to that described in K153044
The Sentimag System is intended for the non-imaging detection and localization of the Magseed Magnetic Marker that has been implanted in a lumpectomy site intended for surgical removal.
The Sentimag System and Magseed Magnetic Marker System are designed for use in an operating room environment by suitably trained physicians who are experienced in diagnosis and treatment of breast lesions.
The Sentimag System aids the surgeon to detect surgically invasively magnetic marker material that has been placed for the purpose of detecting a non-palpable lesion, and to locate target excision sites.
Prior to a lumpectomy procedure, the Magseed Magnetic Marker is placed percutaneously into the breast, using imaging quidance such as ultrasound or radiography, to temporarily mark a site intended for surgical removal. During a surqical procedure, the hand-held Sentimag probe emits an alternating maqnetic field that detects the magnetic response of the Magseed magnetic marker, this signal is converted by the base unit into a visual and audible response that is similar in use to the predicate device.
1.5 INTENDED USE
The Endomag Magseed Magnetic Marker is intended to be placed percutaneously in the breast to mark temporarily (