The Endomag Magseed Magnetic Marker is intended to be placed percutaneously in the breast to mark temporarily (< 30 days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimag® System) the Endomag Magseed Magnetic Marker is located and surgically removed with the target tissue.

The Endomag Sentimag® System is intended for the non-imaging detection and localization of the "Endomag Magseed Magnetic Marker" that has been implanted in a lumpectomy site intended for surgical removal.

Device Description

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 (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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Magseed Magnetic Marker System." It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device (K153044), particularly regarding a reduction in the length of the needle cannula used for delivery.

Based on the provided text, the document does not describe a study involving acceptance criteria and device performance in the context of human reader performance or algorithm-only performance for AI/ML devices. The submission is for a physical medical device (a tissue marker and its detection system), not an AI/ML algorithm.

Therefore, the requested information categories (#1-9) which are typical for AI/ML device studies, are largely not applicable to this document. The document describes a traditional medical device submission where equivalence is established through demonstrating that changes (like needle length) do not introduce new questions of safety or effectiveness, often relying on non-clinical testing and comparison to a predicate.

Here's the breakdown of why each point is not directly addressed by the provided text:

A table of acceptance criteria and the reported device performance: Not present. This document is not evaluating the performance of an AI/ML model against specific metrics like sensitivity, specificity, or AUC.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of an AI/ML evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic AI/ML algorithm is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device does not involve human readers interpreting images with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. The "ground truth" for this device would be its physical properties, sterility, safe implantation, and accurate detection, which are assessed through engineering tests and clinical use, not a labeled dataset.
The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The document describes a 510(k) submission for the Magseed Magnetic Marker System, which is a physical device used to mark lesions in the breast for surgical removal. The current submission is primarily to gain clearance for reduced needle cannula lengths (5cm, 7cm) compared to previously cleared lengths (12cm, 20cm).

The core of the submission relies on demonstrating that these shorter needles do not introduce new questions of safety or effectiveness because:

The implanted marker ("Magseed Magnetic Marker") remains identical to the predicate device component.
The detection system ("Sentimag System") remains identical to the predicate device.
There are no revisions in device materials or processes for the common design elements.
The product risk management file was reviewed, and no additional risks were identified for the shorter cannulas.

Therefore, the "study" proving the device meets acceptance criteria is implicitly the demonstration of substantial equivalence through technical comparisons and a risk assessment, rather than a clinical trial or AI/ML performance study as typically understood in the context of acceptance criteria tables.

Summary

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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)

Type of Use (Select one or both, as applicable)
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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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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SUBMITTER INFORMATION 1.1

Submitter's Name:	Endomagnetics Ltd.
Address:	The Jeffreys BuildingCowley RoadCambridgeCB4 0WSUnited Kingdom
Contact Person:	Andrew ShawcrossChief 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 DetectionSystem
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

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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.

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.

1.5 INTENDED USE

The Endomag Sentimag® System is intended for the non-imaging detection and

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localization of the "Endomag Magseed Magnetic Marker" that has been implanted in a lumpectomy site intended for surgical removal.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 1.6

The Magseed Magnetic Marker System utilizes non-imaging technologies that are comprised of a console that incorporates electronics and a simple user interface, plus a probe handpiece.

A location marker is placed percutaneously in situ at the clinical target site by a delivery system and then the detector handpiece is used for the intraoperative detection and localization of the implanted marker.

The handpiece is connected by a flexible cable to a console unit that provides the user with a visual indication of the presence and proximity of the marker.

DISCUSSION OF NON-CLINICAL TESTS SUBMITTED 1.7

No additional non-clinical testing was carried out over and above those discussed in K153044:

There is no revision in device materials or processes and the common ● design elements remain unchanged for the introduction of the shorter needle cannulas.
. The product risk management file was reviewed and no additional risks, revisions in wording or scoring were identified for the introduction of the shorter needle cannulas.

CONCLUSION 1.8

The Sentimag Magnetic Marker System has the same Intended Use as the predicate device. The different technological characteristics do not raise any new questions of safety or effectiveness. The test, verification and validation data presented in this submission demonstrate substantial equivalence of the Sentimag Magnetic Marker System.

Regulation Number and Section

§ 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.