Magseed Magnetic Marker System

K163541 · Endomagnetics Ltd., · PBY · Jan 13, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163541
• Device Name: Magseed Magnetic Marker System
• Applicant: Endomagnetics Ltd.,
• Product Code: PBY · General, Plastic Surgery
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

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 Story

System comprises sterile, single-use magnetic marker (seed) and 18-gauge needle delivery system; Sentimag base unit; hand-held probe. Marker placed percutaneously in breast using ultrasound/radiography guidance. During surgery, probe emits alternating magnetic field; detects magnetic response of implanted seed. Base unit converts signal into visual/audible feedback for surgeon. Used in operating room by trained physicians to locate target excision sites. Enables precise localization of non-palpable lesions; facilitates surgical removal. Submission specifically introduces shorter needle cannula lengths (5cm and 7cm) compared to predicate.

Clinical Evidence

No clinical data presented. Bench testing only; reliance on previously cleared data from K153044 for core device function and materials.

Technological Characteristics

System includes console with electronics, user interface, and probe handpiece. Marker is soft magnetic seed. Delivery via 18-gauge needle cannula (5cm or 7cm lengths). Sensing principle: magnetic field detection. Connectivity: handpiece connected to console via flexible cable. Single-use, sterile.

Indications for Use

Indicated for patients requiring temporary (< 30 days) marking of a breast lumpectomy site for surgical removal. Used by physicians for non-palpable lesion localization.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Sentimag System, Sentimark Magnetic Marker System (K153044)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 (< 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.

| 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)

# 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<br>Cowley Road<br>Cambridge<br>CB4 0WS<br>United Kingdom |
| Contact Person: | Andrew Shawcross<br>Chief Operations Officer |
| Tel: | [phone] |
| Email: | [e-mail] |
| 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<br>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 (< 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

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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.