The Endomag Sentimark® 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 nonimaging guidance (Endomag Sentimag® System) the Endomag Sentimark® 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 Sentimark® Magnetic Marker" that has been implanted in a lumpectomy site intended for surgical removal.

Device Description

The Sentimag System is intended for the non-imaging detection and localization of the Sentimark Magnetic Marker that has been implanted in a lumpectomy site intended for surqical removal. The Sentimag System and Sentimark 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 Sentimark 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 surgical procedure, the hand-held Sentimaq probe emits an alternating magnetic field that detects the magnetic response of the Sentimark 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

The provided document is a 510(k) premarket notification for the Sentimag System and Sentimark Magnetic Marker System, which means it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense for an AI/ML device.

Therefore, the requested information regarding "acceptance criteria" for device performance, given the context of an AI/ML device study, and "the study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic performance, is not directly available or applicable in this document. The document describes non-clinical performance testing for a medical device that uses magnetic detection, not an AI/ML algorithm.

However, I can extract information regarding the non-clinical tests performed to demonstrate substantial equivalence to the predicate device.

Information Extracted from the Document:

The document describes non-clinical performance tests to evaluate and characterize the Sentimag System and Sentimark Magnetic Marker System. These tests are conducted to demonstrate substantial equivalence to the predicate device, not to establish AI/ML diagnostic performance against predefined acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance: Not applicable/provided in the context of an AI/ML device study. The document lists "Pre-clinical testing included:" followed by bullet points. These are tests for the physical device, not an AI/ML algorithm's performance metrics like sensitivity, specificity, or AUC against clinical ground truth.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance	Demonstrated through:
	- Dimensional Verification
	- Insertion, Deployment and Withdrawal Force
	- MRI Compatibility
	- Simulated Use
Biocompatibility	Demonstrated through:
	- 28-Day GLP Implantation Trial

Sample size used for the test set and the data provenance: Not applicable. The tests performed are pre-clinical (e.g., dimensional verification, force testing, MRI compatibility, simulated use, and a GLP implantation trial), not on a clinical test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic AI/ML algorithms (e.g., expert consensus on clinical images) is not relevant for the described pre-clinical device performance tests.
Adjudication method 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: No. This is not an AI/ML device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a medical device for magnetic detection, not an AI algorithm.
The type of ground truth used: For the "28-Day GLP Implantation Trial," the ground truth would likely be histological analysis and observation of the implanted device in animal models to assess biocompatibility and lack of adverse reactions. For other tests like "Dimensional Verification," the ground truth would be engineering specifications and measurements. This is a hardware device, not an AI/ML algorithm.
The sample size for the training set: Not applicable. There is no AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary from the Document regarding Device Performance:

The Sentimag System and Sentimark Magnetic Marker System underwent various non-clinical tests to demonstrate their performance and safety, ultimately supporting the claim of substantial equivalence to the predicate device (Cianna Medical Tissue Marker and Delivery System K120804). The tests included:

Dimensional Verification
Insertion, Deployment, and Withdrawal Force
MRI Compatibility
Simulated Use
A 28-Day GLP Implantation Trial

The submitter concludes that "The detailed technological characteristics of the two systems have been identified and compared. The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness." and "The test, verification and validation data presented in this submission demonstrate substantial equivalence of the Sentimag Magnetic Marker System."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2016

Endomagnetics Ltd Dr. Andrew Shawcross Chief Operations Officer The Jeffreys Building, Cowley Road Cambridge, UK CB4 0WS

Re: K153044

Trade/Device Name: Sentimag System, Sentimark Magnetic Marker System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PBY Dated: January 29, 2016 Received: February 1, 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

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device-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/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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4. INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Endomag Sentimark® Magnetic Marker

Indications for Use:

Prescription Use __ V

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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5 510(K) SUMMARY

5.1 SUBMITTER INFORMATION

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:	2nd March 2016

5.2 DEVICE INFORMATION

Trade name:	Sentimark Magnetic Marker and Sentimag System
Common name:	Tissue Marker, Marker Delivery System and DetectionSystem
Classification name:	Implantable Clip
Regulation:	21 CFR 878.4300
Device Classification:	Class II
Product Code:	PBY

5.3 PREDICATE DEVICE

Cianna Medical Tissue Marker and Delivery System (K120804).

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DESCRIPTION OF DEVICE 5.4

The Sentimag System is intended for the non-imaging detection and localization of the Sentimark Magnetic Marker that has been implanted in a lumpectomy site intended for surqical removal.

The Sentimag System and Sentimark 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 Sentimark 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 surgical procedure, the hand-held Sentimaq probe emits an alternating magnetic field that detects the magnetic response of the Sentimark 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.

INTENDED USE 5.5

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

5.6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The K120804 predicate uses imaging technology to locate the device. This can be a handheld Ultrasound transducer. The Sentimark Magnetic Marker System utilizes nonimaging technologies that are comprised of a console that incorporates electronics and a simple user interface, plus a probe handpiece.

In both cases, a location marker is placed percutaneously in situ at the clinical target site by a delivery system. Both devices then employ the handpiece for the intraoperative detection and localization of the implanted marker.

In both systems 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.

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The detailed technological characteristics of the two systems have been identified and compared. The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness.

DISCUSSION OF NON-CLINICAL TESTS SUBMITTED 5.7

Performance testing was conducted to evaluate and characterize the performance of the Sentimag System and Sentimark Magnetic Marker System. Pre-clinical testing included:

. Dimensional Verification
. Insertion, Deployment and Withdrawal Force
MRI Compatibility
. Simulated Use
28-Day GLP Implantation Trial

5.8 CONCLUSION

Endomagnetics believes that the Cianna Medical Tissue Marker and Delivery System (K120804) is the closest predicate device because it has the same intended use and very similar technological characteristics.

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.