(287 days)
No
The summary describes a passive magnetic marker and a system for detecting it. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on magnetic detection, not algorithmic interpretation of complex data.
No.
The device is indicated for marking soft tissue for surgical targeting, not for treating a disease or condition.
No
Neither the "Intended Use / Indications for Use" nor the "Device Description" sections mention any diagnostic purpose for the device. Its primary use is to mark soft tissue for surgical removal, and the Sentimag system aids in localization, not diagnosis.
No
The device description clearly states it is a physical marker composed of a nitinol structure with a magnetic core, delivered via a needle system. It is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures." This describes a device used in vivo (within the body) for marking and localization during surgery.
- Device Description: The description details a physical marker placed into tissue and located using imaging or a magnetic detection system. This is a surgical aid, not a device that analyzes biological samples in vitro.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis on biological samples.
The device is clearly intended for use within the body to facilitate surgical procedures.
N/A
Intended Use / Indications for Use
The Endomag Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes
NEU
Device Description
The Endomag Magseed Pro Magnetic Marker is intended for use as a soft 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 Pro Magnetic Marker is a sterile, single use device composed of a selfexpanding four-sided tetrahedral nitinol structure, with side lengths of 6.3 mm with a magnetic core. The device is not inherently magnetic. It is capable of being magnetized and located by Endomagnetics' Sentimag Gen 2 or Gen 3 devices. The Magseed Pro Magnetic Marker comes preloaded in a 17-gauge needle delivery system.
The Magseed Pro Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site intended for surgical removal. The Magseed Pro Magnetic Marker is subsequently localized by using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimage Systems, Sentimag Gen 3 K222832 or Sentimag Gen 2 K153044). The marker can be detected up to 45 mm from the Sentimage 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.
Additionally, Magseed Pro can be used in combination with Sentimag Gen 3 in Measure mode. When used in this modality, the distance between the location of Magseed Pro and the tip of the Sentimag Gen 3 probe can be measured. This distance is graphically displayed on the LCD screen of Sentimag Gen 3 in this mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, radiography
Anatomical Site
soft tissue, breast/soft tissue lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedure, future surgical procedures
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)
Performance testing was conducted to evaluate and characterize the performance of the Magseed Pro Magnetic Marker when used with Sentimag (Gen 2 and Gen 3) Systems. This included:
- Dimensional verification
- Robustness testing
- Insertion, deployment and withdrawal force testing
- MRI Compatibility
- Biocompatibility testing per ISO 10993-1
- Corrosion testing
- Simulated use testing .
Clinical performance testing was conducted in 60 patients to evaluate and characterize the performance of the Magseed Pro Magnetic Marker with Sentimag Gen 3 System in patients with breast cancer.
Clinical testing included:
- Efficacy To provide evidence that the Magseed Pro marker can be successfully placed and retrieved- The primary end points are retrieval rates of Magseed Pro marker with the target reqion excised in specimen for breast/soft tissue lesions.
- Safety Endpoints-
- Rate of device related Adverse Events (AE's or SAE's)
- Presence of unexpected histological tissue responses
No device-related adverse events or unexpected tissue reactions were observed in any of the patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
June 28, 2024
Endomagnetics Ltd Mehryar Behizad Regulatory Director 330 Cambridge Science Park, Milton Road Cambridge, Cambridgeshire CB4 0WS United Kingdom
Re: K232865
Trade/Device Name: Magseed Pro Magnetic Marker System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: May 30, 2024 Received: May 31, 2024
Dear Mehryar Behizad:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Date: 2024.06.28 12:10:06 -04'00' Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232865
Device Name Magseed Pro Magnetic Marker System
Indications for Use (Describe)
The Endomag Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY-K232865
SUBMITTER INFORMATION
| Submitter's Name: | Endomagnetics Ltd. |
|---|---|
| Address: | 330 Cambridge Science Park, |
| Milton Road Cambridge CB4 0WN United Kingdom | |
| Contact Person: | Dr. Mehryar Behizad |
| Regulatory Director | |
| Tel: | +44 1223 652540 |
| Email: | mbehizad@endomag.com |
| Date summary prepared: | 26th June 2024 |
DEVICE INFORMATION
| Trade name: |
|---|
| Common name: |
| Classification name: |
| Regulation: |
| Device Classification: |
| Product Code: |
Magseed Pro Magnetic Marker System Tissue Marker, Marker Delivery System Marker, Radiographic, Implantable 21 CFR 878.4300 Class II NEU
PREDICATE DEVICES
- Primary Predicate K173587 Magseed Magnetic Marker
- Secondary Predicate K073095 Tumark Professional tissue marker
DESCRIPTION OF DEVICE
The Endomag Magseed Pro Magnetic Marker is intended for use as a soft 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 Pro Magnetic Marker is a sterile, single use device composed of a selfexpanding four-sided tetrahedral nitinol structure, with side lengths of 6.3 mm with a magnetic core. The device is not inherently magnetic. It is capable of being magnetized and located by Endomagnetics' Sentimag Gen 2 or Gen 3 devices. The Magseed Pro Magnetic Marker comes preloaded in a 17-gauge needle delivery system.
The Magseed Pro Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site intended for surgical removal. The Magseed Pro Magnetic Marker is subsequently localized by using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimage Systems, Sentimag Gen 3 K222832 or Sentimag Gen 2 K153044). The marker can be detected up to 45 mm from the Sentimage 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.
4
Additionally, Magseed Pro can be used in combination with Sentimag Gen 3 in Measure mode. When used in this modality, the distance between the location of Magseed Pro and the tip of the Sentimag Gen 3 probe can be measured. This distance is graphically displayed on the LCD screen of Sentimag Gen 3 in this mode.
INTENDED USE/INDICATIONS FOR USE
The Endomag Magseed Pro Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
As with the primary predicate K173587. Magseed Pro is a soft tissue marker placed percutaneously 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. Both the Magseed Pro Magnetic Marker and primary predicate are detected using the Sentimag detection system. The localisation system used in the primary predicate and the current device both work based on magnetic susceptometry.
In common with the secondary predicate, K073095, the tissue contacting part of the implanted Magseed Pro marker consists of Nitinol. Also in common with this predicate, Magseed Pro is self-expanding after deployment and can be implanted for more than 30 days.
In Counts Mode, the Sentimag Gen 3 system can detect any Endomag magnetic marker including the Magseed marker (predicate) and the Magseed Pro marker. This mode is the same as the predicate device which can detect a Magseed Marker from up to 30mm. The Sentimag Gen3 system additionally has Measure Mode which measures the distance from its probe tip to the Magseed Pro marker, providing a millimetre distance on the screen. The probe can detect this marker to a depth of up to 45 mm within soft tissue and provide a millimeter measurement up to 40mm.
Like both predicates, Magseed Pro can be detected by radiographic imaging modalities. The devices are delivered by conventional needle delivery systems of similar gauge (17G, Magseed Pro; 18G Magseed).
SUMMARY OF SAFETY AND PERFORMANCE TESTS SUBMITTED
Performance testing was conducted to evaluate and characterize the performance of the Magseed Pro Magnetic Marker when used with Sentimag (Gen 2 and Gen 3) Systems. This included:
- Dimensional verification ●
- Robustness testing
- Insertion, deployment and withdrawal force testing ●
- . MRI Compatibility
- . Biocompatibility testing per ISO 10993-1
- . Corrosion testing
- Simulated use testing .
SUMMARY OF CLINICAL TESTS SUBMITTED
Clinical performance testing was conducted in 60 patients to evaluate and characterize the performance of the Magseed Pro Magnetic Marker with Sentimag Gen 3 System in patients with breast cancer.
5
Clinical testing included:
- Efficacy To provide evidence that the Magseed Pro marker can be successfully . placed and retrieved- The primary end points are retrieval rates of Magseed Pro marker with the target reqion excised in specimen for breast/soft tissue lesions.
- . Safety Endpoints-
- Rate of device related Adverse Events (AE's or SAE's) o
- Presence of unexpected histological tissue responses o
No device-related adverse events or unexpected tissue reactions were observed in any of the patients.
CONCLUSION
The Magseed Pro device has the same intended use and indication and similar technological characteristics to its predicates. The performance and safety testing conducted demonstrate that the Magseed Pro device is substantially equivalent to the predicate devices, Magseed (K173587) and Tumark Professional U (K073095), with equivalent safety and performance.
The Magseed Pro Magnetic Marker has the same Intended Use as the predicate devices. The different technological characteristics do not raise any new questions of safety or effectiveness. Therefore, the Magseed Pro Magnetic Marker System can be found to be substantially equivalent to the primary predicate device, Magseed K173587.