· The SchurSign Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

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

AI/ML Overview

The provided text describes the SchurSign Tissue Marker and its comparison to a predicate device, Beacon Tissue Marker, to demonstrate substantial equivalence for FDA clearance. However, the document focuses on biocompatibility testing, imaging visibility (in vitro and in vivo), and overall device equivalence rather than the performance of an AI/algorithm-based diagnostic device.

Therefore, many of the requested points regarding AI/algorithm performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, types of ground truth for AI) are not applicable or not present in this document because the SchurSign Tissue Marker is a physical medical device, not an AI software.

Below is a summary of the information that is available in the document, framed as closely as possible to your request.

Acceptance Criteria and Study for SchurSign Tissue Marker

The document describes the acceptance criteria and studies conducted to demonstrate the substantial equivalence of the SchurSign Tissue Marker to its predicate device, the Beacon Tissue Marker (K130763). This is primarily focused on physical and biocompatibility performance, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the biocompatibility tests according to ISO standards and a demonstration of equivalent imaging visibility to the predicate. The "reported device performance" section focuses on the results of these tests and the conclusion of substantial equivalence.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility
Cytotoxicity	No cytotoxic potential to L-929 mouse fibroblast cells.	Test article extract showed no cytotoxic potential.
Acute Systemic Toxicity	No mortality or evidence of systemic toxicity from extracts in mice.	No mortality or evidence of systemic toxicity.
Sensitization	No delayed sensitization in guinea pig.	Not considered a sensitizer.
Irritation/Intracutaneous	Difference between test extract mean score and control blank mean score = 0.0.	Met requirements; difference was 0.0.
Subacute Toxicity	No evidence of systemic toxicity 4 weeks post-implantation in rat.	No evidence of systemic toxicity.
Implantation	Macroscopic reaction not significant compared to negative control; microscopic reaction not significant compared to negative control.	Macroscopic reaction not significant; microscopic reaction moderate.
Pyrogenicity	Non-pyrogenic according to US Pharmacopoeia.	Judged as non-pyrogenic.
Genotoxicity	Non-mutagenic in bacterial reverse mutation study.	Considered to be non-mutagenic.
Chemical Characterization	Neither components nor potential leachables pose a risk.	Concluded no risk to patient.
Imaging Visibility	Equivalent visibility to predicate device on X-ray, mammography, ultrasound, and MRI.
In Vitro (Ultrasound)	Equivalent to Beacon in ex vivo ultrasound imaging of chicken breast.	Equivalent to Beacon.
In Vivo (X-ray, Ultrasound, Histopathology)	Demonstrates localization and biological response equivalent to predicate.	Performance equivalent to predicate device; histopathology conducted.
Substantial Equivalence	Same intended use and similar characteristics/functional properties as predicate; any differences do not raise new safety/performance questions.	Concluded to be substantially equivalent in design and function to Beacon.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for each biocompatibility test or imaging study. The studies refer to "mice," "guinea pig," "rat," and "swine" without specific numbers for each group. For the in vitro imaging, it mentions "chicken breast."
Data Provenance: The studies were conducted as part of the regulatory submission, implying they were performed by or for the manufacturer. The location (country of origin) of these tests is not specified, but the manufacturer is based in Germany. The studies are prospective in nature, designed specifically for this regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This device is a physical tissue marker, not an AI/algorithmic diagnostic device requiring expert interpretation for ground truth establishment. Biocompatibility results are typically determined by laboratory assays and pathologist evaluation of tissue samples, not a consensus of clinical experts in the manner described for AI. The swine study involved histopathology, which would be interpreted by pathologists, but details on the number or qualifications are not provided.

4. Adjudication Method for the Test Set

Not Applicable. No expert adjudication method (like 2+1, 3+1) is mentioned as it's not relevant for the type of device and studies conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is specifically for evaluating the effectiveness of AI or diagnostic systems with human readers. The SchurSign Tissue Marker is a passive marker device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. The device is not an algorithm.

7. The Type of Ground Truth Used

Biocompatibility: Ground truth is based on established biological and chemical assay readouts (e.g., cell viability in cytotoxicity, observed reactions in sensitization tests, macroscopic/microscopic findings in implantation) as per ISO and USP standards.
Imaging Visibility: Ground truth is the physical presence and visibility of the marker in anatomical models (ex vivo chicken breast) and living tissue (in vivo swine), confirmed by direct observation on imaging modalities (X-ray, ultrasound) and potentially post-mortem examination or histopathology.
Histopathology: Ground truth is established by pathological examination of tissue samples from the swine study.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set exists for this device.

Summary

{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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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

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.

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 PredicateDevice	Equivalence
Trade name	SchurSign TissueMarker	Beacon TissueMarker	-
Company Name	SurgMark GmbH	Scion MedicalTechnologies, LLC	-
510(k) #	K230836	K130763	-
Product Code	NEU	NEU	Same
Indications ForUse	The SchurSignTissue Marker isindicated for use toradiographicallymark soft tissueduring a surgicalprocedure or forfuture surgicalprocedures.	The Beacon TissueMarker is indicatedfor use toradiographicallymark soft tissueduring a surgicalprocedure or forfuture surgicalprocedures.	Same
Type ofpolymericmaterial	Chitosan	Oxford PerformanceMaterials (OPM)OXPEKK-IG200	Different
Physical form	Cylinder	Cylinder	Same
Dimensions oftissue marker	Length: 5-10 mm,Diameter: 1.5-3.0mm	Length: 5 mm,Diameter: 1.5 mm	Different
Is the marker forsingle use?	Yes	Yes	Same
X-ray contrastagentincorporated inthe marker	Barium Sulfate	Barium Sulfate	Same
SterilizationMethod	EO	EO	Same
Imaging modality	X-ray,mammography,ultrasound, andMagneticResonance Imaging	X-ray,mammography,ultrasound, andMagneticResonance Imaging	Same
Type of deliverysystem	Distal deliveryneedle tip, rigid	Distal deliveryneedle tip, rigid	Same

DEVICE COMPARISON CHART

{7}------------------------------------------------

	shaft and sterile.	shaft and sterile.
Dimensions ofcanula	Length: 12 cmDiameter: 14 - 10gauge	Length: 12 cmDiameter: 14 gauge	Different
Components ofthe deliverysystem	Cannula with ahandle, a push rodwith a plunger, andan end cap	Cannula with ahandle, a push rodwith a plunger, andan end cap	Same
Material ofcanula	Stainless steel	Stainless steel	Same
Is the tissuemarker alreadypreloaded in thedelivery system?	Yes	Yes	Same
Are the tissuemarker and thedelivery systemsterilizedtogether?	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:

1. Cytotoxicity according to ISO 10993-5
1. Acute systemic toxicity according to ISO 10993-11
1. Sensitization according to ISO 10993-10
1. Irritation according to the ISO 10993-23

{8}------------------------------------------------

1. Subacute toxicity according to ISO 10993-11
1. Implantation according to ISO 10993-6
1. Pyrogenicity according to USP-NF 2021
1. 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 potentialto L-929 mouse fibroblast cells.
Acute systemic toxicity	There was no mortality or evidence of systemictoxicity from the extracts injected into mice.
Sensitization	The topical application of the SC and SO extractsdid not induce delayed sensitization in the guineapig. The test article was not considered a sensitizer.
Irritation/Intracutaneousreactivity	The test article met the requirements of the testsince the difference between each test extractoverall mean score and corresponding control blankoverall mean score was 0.0 for the SC and SO testextracts.
Subacute toxicity	There was no evidence of systemic toxicity from thetest article 4 weeks following subcutaneousimplantation in the rat.
Implantation	The macroscopic reaction was not significant ascompared to the negative control article.Microscopically, the test article caused a moderatereaction as compared to the negative control article.
Pyrogenicity	The test article met the requirements of the USPharmacopoeia and was judged as non-pyrogenic.
Genotoxicity	The SC and DMSO test article extracts wereconsidered to be non-mutagenic in the bacterialreverse 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.

Regulation Number and Section

§ 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.