(88 days)
The Endomag Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
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.
Based on the provided text, the device in question is the Endomag Magseed® Magnetic Marker, which is a tissue marker. The document is a 510(k) summary for its premarket notification.
It's important to note that this document does not describe a study proving the device meets specific acceptance criteria related to an AI/algorithm's performance. Instead, it details the non-clinical testing done to demonstrate the substantial equivalence of the Magseed Magnetic Marker to predicate devices for its intended use as a radiographic tissue marker.
Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance, effect size) are not applicable to this specific device submission as described in the provided text.
The information primarily focuses on the device's physical properties, biocompatibility, and performance in simulated use, not an AI or algorithmic diagnostic performance.
Here's a breakdown of the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria for a diagnostic performance study as would be seen for an AI/algorithm. Instead, it states that "Testing was conducted to evaluate and characterize the safety and performance of the Magseed Magnetic Marker." The acceptance here is based on demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria Category (Inferred from 510(k) submission) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Safety: | |
| Biological Evaluation (Biocompatibility) | Met standards (implied by substantial equivalence determination) |
| Performance: | |
| Visibility under ultrasound and radiographic imaging | Visible (as stated in description of device) |
| Ability to mark soft tissue | Functions as a tissue marker (indicated use) |
| Detectability by Sentimag® System (up to 3cm) | Detectable (stated, aided by non-imaging guidance) |
| Surgical Removeability with target tissue | Removable with target tissue (stated) |
| No new questions of safety or effectiveness associated with material, dimensions, and surface finish differences from predicate | Evaluation determined no new questions of safety or effectiveness. |
| Substantial Equivalence to Predicate Devices: K070436, K153044, K163541 | Demonstrated (conclusion of 510(k)) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of a "test set" for a diagnostic performance study. The document refers to "Pre-clinical testing included: Biological Evaluation, Simulated Use." The specific number of samples or instances tested for these evaluations is not mentioned.
- Data Provenance: Not specified (e.g., country, retrospective/prospective). This type of detail is typically for clinical performance studies, which are not the focus of this 510(k) for a tissue marker.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This information pertains to studies establishing ground truth for diagnostic AI/algorithms. This device is a passive tissue marker, not an AI/algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This refers to methods for resolving discrepancies in expert labeling for AI ground truth.
5. 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 is not an AI for diagnostic interpretation, nor does it assist human readers in that capacity.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be established by engineering tests, material standards, and biological compatibility standards. For example, in biological evaluation, the "ground truth" is compliance with ISO standards for biocompatibility. For "simulated use," the "ground truth" is successful physical performance under conditions mimicking clinical use. There is no "ground truth" in the sense of a medical diagnosis.
8. The sample size for the training set:
- Not Applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set.
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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 (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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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.
§ 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.