Magseed Magnetic Marker Systtem

K173587 · Endomagnetics Ltd., · NEU · Feb 16, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173587
• Device Name: Magseed Magnetic Marker Systtem
• Applicant: Endomagnetics Ltd.,
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Feb 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Endomag Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Device Story

Magseed Magnetic Marker is an implantable tissue marker placed percutaneously into soft tissue using ultrasound or radiographic guidance. It marks sites intended for surgical removal. The marker is localized post-placement using imaging guidance or the Endomag Sentimag System (non-imaging magnetic guidance). The Sentimag probe detects the marker up to 3cm away; tissue compression may be used to enhance detection. The marker is surgically removed along with the target tissue. Used in clinical settings by surgeons to facilitate precise excision of marked tissue, potentially improving surgical outcomes by ensuring accurate site identification.

Clinical Evidence

Bench testing only. Pre-clinical evaluation included biological safety testing and simulated use testing to characterize performance.

Technological Characteristics

Implantable tissue marker. Visible under ultrasound and radiographic imaging. Detectable via magnetic sensing (Sentimag system). Differences from predicates include specific marker material, dimensions, and surface finish.

Indications for Use

Indicated for radiographic marking of soft tissue during or prior to surgical procedures. Applicable to patients requiring tissue site localization for surgical removal.

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

• BiomarC Gold Tissue Marker (K070436)
• Sentimag System, Sentimark (Magseed) Magnetic Marker System (K153044 & K163541)

Submission Summary (Full Text)

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

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

February 16, 2018

Endomagnetics Ltd. % Dr. Andrew Shawcross Chief Operations Officer The Jeffreys Building, Cowley Road Cambridge. CB4 OWS United Kingdom

Re: K173587

Trade/Device Name: Magseed Magnetic Marker Regulation Number: 21 CFR § 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: Dated: November 15, 2017 Received: November 20, 2017

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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## Indications for Use

510(k) Number (if known) K173587

Device Name Endomag Magseed® Magnetic Marker

Indications for Use (Describe)

The Endomag Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

| 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)

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# 5 510(K) SUMMARY

#### SUBMITTER INFORMATION 5.1

| Submitter's Name: | Endomagnetics Ltd. |
|------------------------|--------------------------|
| Address: | The Jeffreys Building |
| | Cowley Road |
| | Cambridge |
| | CB4 0WS |
| | United Kingdom |
| Contact Person: | Andrew Shawcross |
| | Chief Operations Officer |
| Tel: | [phone] |
| Email: | [e-mail] |
| Date summary prepared: | 15 November 2017 |

#### 5.2 DEVICE INFORMATION

| Trade name: | Magseed Magnetic Marker |
|------------------------|-------------------------|
| Common name: | Tissue Marker |
| Classification name: | Implantable Clip |
| Regulation: | 21 CFR 878.4300 |
| Device Classification: | Class II |
| Product Code: | NEU |

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#### 5.3 PREDICATE DEVICES

- 1. Carbon Medical Technolgies, Inc. BiomarC Gold Tissue Marker (K070436).
- Sentimag System, Sentimark (Magseed) Magnetic Marker System (K153044 & 2. K163541)

#### DESCRIPTION OF DEVICE 5.4

The Endomaq Maqseed® Magnetic Marker is intended for use as a tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Magseed Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site that is for example intended for surgical removal. The Magseed Magnetic Marker is subsequently localized by using imaging quidance (such as ultrasound or radiography) or aided by non-imaging quidance (Endomag Sentimag® System, K153044 and K163541). The marker can be detected up to 3cm from the Sentimag® probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue.

#### 5.5 INTENDED USE

The Endomaq Maqseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

#### 5.6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Endomagnetics has performed a comparison of the technological characteristics of the Magseed Magnetic Marker with those of the predicate device. Three differences in the technological characteristics (marker material, dimensions and surface finish) have been identified. Evaluation of the differences has determined that there are no new questions of safety or effectiveness.

#### 5.7 DISCUSSION OF NON-CLINICAL TESTS SUBMITTED

Testing was conducted to evaluate and characterize the safety and performance of the Magseed Magnetic Marker. Pre-clinical testing included:

- Biological Evaluation .
- Simulated Use

#### CONCLUSION 5.8

The Magseed Magnetic Marker 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 data presented in this submission demonstrate substantial equivalence of the Magseed Magnetic Marker with the predicate device.