(88 days)
No
The summary describes a passive magnetic marker and a system for detecting it, with no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is used to mark soft tissue for surgical procedures, not to treat a disease or condition.
No
The device is a tissue marker used to radiographically mark soft tissue for surgical targeting, not to diagnose a disease or condition. Its purpose is to facilitate localization of a target area for surgical removal.
No
The device description clearly describes a physical implantable marker (Magseed Magnetic Marker) and a system for detecting it (Endomag Sentimag® System), which are hardware components.
Based on the provided information, the Endomag Magseed® Magnetic Marker is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The Magseed marker is placed within the soft tissue of the patient.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. While the Magseed marker aids in surgical procedures, its primary function is physical marking and localization, not providing diagnostic information from a biological sample.
- The intended use clearly states it's for radiographically marking soft tissue during or for future surgical procedures. This is a surgical aid, not a diagnostic test performed on a sample outside the body.
The device description and intended use align with a surgical marker or implantable device, not an IVD.
N/A
Intended Use / Indications for Use
The Endomag Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, radiography
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was conducted to evaluate and characterize the safety and performance of the Magseed Magnetic Marker. Pre-clinical testing included:
- Biological Evaluation .
- Simulated Use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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: | +44 1223 652540 |
| Email: | ashawcross@endomag.com |
| 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
-
- 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.