(302 days)
Not Found
No
The device description and performance studies focus on the physical properties and imaging visibility of a tissue marker and its delivery system. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is indicated for marking soft tissue for radiographic visibility, not for treating a disease or condition.
No
The device is a tissue marker, not a diagnostic device. Its purpose is to physically mark soft tissue for future radiographic imaging, rather than to analyze or interpret medical data for diagnostic purposes.
No
The device description clearly outlines physical components: a radiographic soft tissue marker made of chitosan and barium sulfate, and a delivery system consisting of a cannula, handle, push rod, plunger, and needle. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SchurSign Tissue Marker is a physical marker placed within soft tissue during surgical procedures. Its purpose is to be visible on various imaging modalities (x-ray, ultrasound, MRI) to help healthcare professionals locate a specific surgical site.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a physical object implanted in the body.
Therefore, the SchurSign Tissue Marker falls under the category of a medical device used for surgical marking and imaging guidance, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Under supervision of a healthcare professional
· The SchurSign Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes
NEU
Device Description
SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI).
The proposed SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location.
The proposed SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate.
The proposed SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker.
The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.
SchurSign is available in seven different sizes:
| Model | Diameter (mm) | Length (mm) |
|---|---|---|
| SchurSign 1.5-5 | 1.5 | 5 |
| SchurSign 1.5-8 | 1.5 | 8 |
| SchurSign 2.0-5 | 2.0 | 5 |
| SchurSign 2.0-8 | 2.0 | 8 |
| SchurSign 2.0-10 | 2.0 | 10 |
| SchurSign 2.5-10 | 2.5 | 10 |
| SchurSign 3.0-10 | 3.0 | 10 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, mammography, ultrasound, and Magnetic Resonance Imaging (MRI)
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under supervision of a healthcare professional (Rx)
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)
In vitro - Performance data were provided in support of the substantial equivalence determination. The characteristics of the SchurSign Tissue Marker were substantially equivalent to the predicate device. SchurSign is equivalent to Beacon in an ex vivo test of ultrasound imaging of chicken breast.
In vivo - A swine study was done where x-ray and ultrasound were used to localize SchurSign. Histopathology was also conducted. The animal study showed that the performance of SchurSign was equivalent to its predicate device.
Biocompatibility testing:
In vitro and in vivo tests were done in accordance with ISO standards:
- Cytotoxicity according to ISO 10993-5
- Acute systemic toxicity according to ISO 10993-11
- Sensitization according to ISO 10993-10
- Irritation according to the ISO 10993-23
- Subacute toxicity according to ISO 10993-11
- Implantation according to ISO 10993-6
- Pyrogenicity according to USP-NF 2021
- Genotoxicity according to ISO 10993-3
- Chemical characterization - according to ISO ISO 10993-18
Chronic toxicity and carcinogenicity endpoints were addressed through chemical characterization and toxicological risk assessment. It was concluded that neither the components nor potential leachables of SchurSign are of risk for the patient.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
January 23, 2024
SurgMark GmbH Christine König CEO Maria-Louisen-Straße 122 Hamburg, 22301 Germany
Re: K230836
Trade/Device Name: SchurSign Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: April 27, 2023 Received: December 12, 2023
Dear Christine König:
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
1
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).
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 medical devices and radiation-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.
2
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,
Tek N. Digitally signed by Lamichhane Tek N. Lamichhane -S
Date: 2024.01.23 -5 17:29:36 -05'00' Tek N. 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
3
Indications for Use
510(k) Number (if known) K230836
Device Name SchurSign Tissue Marker
Indications for Use (Describe) Under supervision of a healthcare professional
· The SchurSign Tissue 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 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Date Prepared: January 22, 2024
I. SUBMITTER
Submitter of 510(k):
SurgMark GmbH Maria-Louisen-Straße 122 D-22301 Hamburg Germany +49 177 4075795 / info@surgmark.com www.surgmark.com
Contact Person: Dr. Christine König Christine.koenig@surgmark.com
II. DEVICE
Name of Device: SchurSign Tissue Marker
Common or Usual Name: Implantable Clip
Classification Panel: General and Plastic Surgery
Classification of the device: Class II, 21 CFR 878.4300
Product Code: NEU
III PREDICATE DEVICE
Primary Predicate: Beacon (K130763) Manufactured by Scion Medical Technologies, LLC
IV DESCRIPTION
SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI).
The proposed SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location.
5
The proposed SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate.
The proposed SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker.
The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.
SchurSign is available in seven different sizes:
| Model | Diameter (mm) | Length (mm) |
|---|---|---|
| SchurSign 1.5-5 | 1.5 | 5 |
| SchurSign 1.5-8 | 1.5 | 8 |
| SchurSign 2.0-5 | 2.0 | 5 |
| SchurSign 2.0-8 | 2.0 | 8 |
| SchurSign 2.0-10 | 2.0 | 10 |
| SchurSign 2.5-10 | 2.5 | 10 |
| SchurSign 3.0-10 | 3.0 | 10 |
V. INDICATIONS FOR USE
Under supervision of a healthcare professional (Rx)
- SchurSign Tissue Marker is indicated for use to radiographically mark soft ● tissue during a surgical procedure or for future surgical procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
SchurSign has substantially equivalent indications to the Beacon Tissue Marker (K130763) in that they are indicated for use to mark soft tissue during a surgical procedure or for future surgical procedures.
SchurSign and Beacon are both made of polymeric material containing barium sulfate and have a cylindrical shape. Moreover, they are also sterilized by ethylene oxide.
Both SchurSign and Beacon have the same delivery system, which is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue
6
during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
The following table compares the SchurSign device to the predicate device with respect to intended use, material characteristics, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Parameter | Device | Primary Predicate
Device | Equivalence |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade name | SchurSign Tissue
Marker | Beacon Tissue
Marker | - |
| Company Name | SurgMark GmbH | Scion Medical
Technologies, LLC | - |
| 510(k) # | K230836 | K130763 | - |
| Product Code | NEU | NEU | Same |
| Indications For
Use | The SchurSign
Tissue Marker is
indicated for use to
radiographically
mark soft tissue
during a surgical
procedure or for
future surgical
procedures. | The Beacon Tissue
Marker is indicated
for use to
radiographically
mark soft tissue
during a surgical
procedure or for
future surgical
procedures. | Same |
| Type of
polymeric
material | Chitosan | Oxford Performance
Materials (OPM)
OXPEKK-IG200 | Different |
| Physical form | Cylinder | Cylinder | Same |
| Dimensions of
tissue marker | Length: 5-10 mm,
Diameter: 1.5-3.0
mm | Length: 5 mm,
Diameter: 1.5 mm | Different |
| Is the marker for
single use? | Yes | Yes | Same |
| X-ray contrast
agent
incorporated in
the marker | Barium Sulfate | Barium Sulfate | Same |
| Sterilization
Method | EO | EO | Same |
| Imaging modality | X-ray,
mammography,
ultrasound, and
Magnetic
Resonance Imaging | X-ray,
mammography,
ultrasound, and
Magnetic
Resonance Imaging | Same |
| Type of delivery
system | Distal delivery
needle tip, rigid | Distal delivery
needle tip, rigid | Same |
DEVICE COMPARISON CHART
7
| shaft and sterile. | shaft and sterile. | ||
|---|---|---|---|
| Dimensions of | |||
| canula | Length: 12 cm | ||
| Diameter: 14 - 10 | |||
| gauge | Length: 12 cm | ||
| Diameter: 14 gauge | Different | ||
| Components of | |||
| the delivery | |||
| system | Cannula with a | ||
| handle, a push rod | |||
| with a plunger, and | |||
| an end cap | Cannula with a | ||
| handle, a push rod | |||
| with a plunger, and | |||
| an end cap | Same | ||
| Material of | |||
| canula | Stainless steel | Stainless steel | Same |
| Is the tissue | |||
| marker already | |||
| preloaded in the | |||
| delivery system? | Yes | Yes | Same |
| Are the tissue | |||
| marker and the | |||
| delivery system | |||
| sterilized | |||
| together? | Yes | Yes | Same |
The only difference between SchurSign and Beacon is the polymeric composition of the tissue marker and that SchurSign comes in different sizes. To prove that SchurSign is as safe and efficacious as its predicate device, a series of tests were done as shown below.
VII. PERFORMANCE DATA
In vitro - Performance data were provided in support of the substantial equivalence determination. The characteristics of the SchurSign Tissue Marker were substantially equivalent to the predicate device. SchurSign is equivalent to Beacon in an ex vivo test of ultrasound imaging of chicken breast.
In vivo - A swine study was done where x-ray and ultrasound were used to localize SchurSign. Histopathology was also conducted. The animal study showed that the performance of SchurSign was equivalent to its predicate device.
Biocompatibility testing
In vitro and in vivo tests:
To demonstrate that SchurSign is biocompatible, the following tests were done in accordance with ISO standards:
-
- Cytotoxicity according to ISO 10993-5
-
- Acute systemic toxicity according to ISO 10993-11
-
- Sensitization according to ISO 10993-10
-
- Irritation according to the ISO 10993-23
8
-
- Subacute toxicity according to ISO 10993-11
-
- Implantation according to ISO 10993-6
-
- Pyrogenicity according to USP-NF 2021
-
- Genotoxicity according to ISO 10993-3
- Chemical characterization - according to ISO ISO 10993-18
Chronic toxicity and carcinogenicity endpoints were addressed through chemical characterization and toxicological risk assessment. It was concluded that neither the components nor potential leachables of SchurSign are of risk for the patient.
| Test | Result |
|---|---|
| Cytotoxicity | The test article extract showed no cytotoxic potential |
| to L-929 mouse fibroblast cells. | |
| Acute systemic toxicity | There was no mortality or evidence of systemic |
| toxicity from the extracts injected into mice. | |
| Sensitization | The topical application of the SC and SO extracts |
| did not induce delayed sensitization in the guinea | |
| pig. The test article was not considered a sensitizer. | |
| Irritation/Intracutaneous | |
| reactivity | The test article met the requirements of the test |
| since the difference between each test extract | |
| overall mean score and corresponding control blank | |
| overall mean score was 0.0 for the SC and SO test | |
| extracts. | |
| Subacute toxicity | There was no evidence of systemic toxicity from the |
| test article 4 weeks following subcutaneous | |
| implantation in the rat. | |
| Implantation | The macroscopic reaction was not significant as |
| compared to the negative control article. | |
| Microscopically, the test article caused a moderate | |
| reaction as compared to the negative control article. | |
| Pyrogenicity | The test article met the requirements of the US |
| Pharmacopoeia and was judged as non-pyrogenic. | |
| Genotoxicity | The SC and DMSO test article extracts were |
| considered to be non-mutagenic in the bacterial | |
| reverse mutation study. |
VIII. CONCLUSIONS
The SchurSign Tissue Marker to be distributed by SurgMark GmbH is substantially equivalent in design and function to Beacon Tissue Marker (K130763) manufactured by Scion Medical Technologies, LLC. The subject device has the same intended use and similar characteristics and functional properties as the predicate device. Moreover, documentation supplied in this submission demonstrates that any differences in their technological characteristics or materials do not raise any new questions of safety or performance, and that the non-clinical data for the device supports the safety of the device.