The GI Windows FLEX SFM System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows FLEX SFM is intended for use in adult patients > 21 years.

Device Description

The FLEX SFM device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The systems are comprised of magnet devices and include delivery systems. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally (within 3-6 weeks).

AI/ML Overview

Here is an analysis of the acceptance criteria and study information for the FLEX SFM device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document mostly outlines performance tests undertaken rather than explicitly stating pre-defined numerical acceptance criteria for each test and then reporting precise numerical results against those. However, some clinical performance metrics are provided and can be inferred as acceptance criteria for successful anastomosis creation.

Acceptance Criteria (Inferred from Predicate & Clinical Outcomes)	Reported Device Performance (FLEX SFM)
Biocompatibility (per ISO 10993)	Passed all specified ISO 10993 tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subchronic Toxicity/Implantation, Genotoxicity, Chemical Characterization).
Sterilization Validation (SAL of 1 x 10^-6)	Validated to an SAL of 1 x 10^-6 per ISO 11137-1.
Transportation Validation	Performed per ASTM D 4169: 2022. (Result: Met requirements, implied by clearance).
Packaging Validation	Performed. (Result: Met requirements, implied by clearance).
Shelf-life Testing	Performed. (Result: Met requirements, implied by clearance).
Device Performance (magnetic clamping force, pressure & tensile strength, magnetic interference, corrosion resistance)	Performed, design meets functional and performance requirements. (Results: Met requirements, implied by clearance).
Clinical placement of device with ≥90% alignment of magnets (from predicate)	N=70 (100%) successful placement with alignment.
Creation of a patent anastomosis confirmed radiologically (from predicate)	N=70 (100%) successful creation of a patent anastomosis.
Safety: Low incidence of serious adverse events (SAEs) and resolution without sequelae. No anastomotic bleeding, leakage, or deaths.	Most adverse events were low grade (Clavien-Dindo Classification I-II). SAEs resolved without sequelae. No cases of anastomotic bleeding, leakage, and no deaths.
Effectiveness: Creation of durable small bowel to small bowel anastomosis (from animal study)	Performed as well as or better than control devices (60mm linear staple and sutures) with respect to tissue burst pressure and histological architecture.
Device Expulsion: Magnets pass naturally or with minimal non-surgical intervention.	For all subjects, the device passed as a pair of connected magnets naturally or with minimal non-surgical intervention.

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

Test Set (Clinical Study): N=70 patients.
Data Provenance: Clinical studies were conducted in Argentina, Canada, Spain, and the United States. This indicates a prospective, multi-country clinical study.
Test Set (GLP Animal Studies): Porcine model. The exact number of animals is not specified, but it was a "chronic swine anastomosis model" comparing FLEX SFM to controls (60mm linear staple and sutures).

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

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical test set. It mentions "patent anastomosis confirmed radiologically," implying radiologists were involved, but details on their number or experience are absent. For the animal study, histological evaluation and tissue burst pressure tests would typically be assessed by pathologists, but their specific qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for the clinical or animal study data. Outcomes like "successful placement with alignment" and "patent anastomosis confirmed radiologically" imply assessments were made, but the process for resolving disagreements or establishing a definitive ground truth by multiple experts is not detailed.

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

No, the FLEX SFM is a physical magnetic compression anastomosis system, not an AI software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

This question is not applicable as the device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

Clinical Study: Inferred ground truth includes:
- Radiological Confirmation: For patent anastomoses.
- Clinical Observation: For magnet alignment, expulsion, and occurrence/severity of adverse events.
- Surgical Observation/Reporting: For successful placement.
GLP Animal Studies:
- Histology: For architecture of healed tissue.
- Mechanical Testing: Tissue burst pressure.
- Direct Observation: For usability, safety, and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable as the FLEX SFM device is a physical medical device and does not involve AI/machine learning models that require a "training set."

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

This question is not applicable as the FLEX SFM device is a physical medical device and does not involve AI/machine learning models that require a "training set."

Summary

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January 29, 2025

GI Windows Inc. Yverre Bobay VP of Regulatory 380 University Ave. Westwood, Massachusetts 02090

Re: K243213

Trade/Device Name: Self-Forming Magnet (FLEX SFM) Regulation Number: 21 CFR 878.4816 Regulation Name: Magnetic Compression Anastomosis System Regulatory Class: Class II Product Code: SAH Dated: October 2, 2024 Received: October 3, 2024

Dear Yverre Bobay:

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 (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, and the July 2, 2024 De Novo classification order for this type of device. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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Per the July 2, 2024 De Novo classification order for this device type, you must demonstrate that the device performs as intended under anticipated conditions of use in the intended patient population. The special control requirements set forth in that order include initiation, enrollment, completion, and reporting requirements associated with any required postmarket surveillance. Within 30 days of receipt of this letter, vou must submit a complete study protocol for a postmarket surveillance study consistent with the special control requirements. FDA expects to work with you to approve your study protocol within 60 days of this letter. Your submission should be clearly labeled as a "Postmarket Study Protocol" and submitted to the Agency as specified below. Please reference the 510(k) number above to facilitate processing. If there are multiple protocols being finalized after clearance of this 510(k) submission, please submit each protocol as a separate submission, identified by their unique study name(s).

From the date of study protocol approval, you must meet the following timelines:

First subject enrolled within 6 months ●
20% of subjects enrolled within 12 months .
50% of subjects enrolled within 18 months ●
100% of subjects enrolled within 24 months ●

In addition, you must submit separate periodic reports on the progress of the study as follows:

. Postmarket surveillance progress reports every six (6) months until subject enrollment has been completed, and annually thereafter, from the date of the protocol approval letter, unless otherwise specified by FDA.
. If any enrollment milestones are not met, you must begin submitting enrollment status reports every three (3) months in addition to your periodic postmarket study progress reports, until enrollment has been completed, or FDA notifies you otherwise.
. Submit the final postmarket study report three (3) months from study completion (i.e., last subject's last follow-up date).

Each postmarket surveillance report should be submitted to the Agency as specified below, identified as a "Postmarket Surveillance Report" in accordance with how the study is identified above, and bearing the applicable 510(k) reference number.

Be advised that failure to comply with any special control requirement, including the initiation, enrollment, completion, and reporting per the postmarket surveillance data requirements outlined above, may result in the adulteration and misbranding of your device.

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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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. 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).

All required documents should be submitted, unless otherwise specified, to the address below and should reference the above 510(k) number to facilitate processing.

Postmarket Mandated Studies Program U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

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Alternatively, documents can be submitted electronically through the CDRH Portal. For more information on the CDRH Portal, please visit https://www.fda.gov/medical-devices/industry-medical-devices/send-andtrack-medical-device-premarket-submissions-online-cdrh-portal.

Sincerely,

Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Date: 2025.01.29 17:27:27 -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

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Indications for Use

510(k) Number (if known) K243213

Device Name FLEX SFM

Indications for Use (Describe)

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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510(K) Summary

(K243213)

Contact Details:

Applicant Name: GI Windows, Inc. Applicant Address: 381 University Ave., Westwood, MA 02090 Applicant Contact Telephone: 617 669 6181 Applicant Contact: Ms. Yverre Bobay Applicant Contact Email: Yverre.bobay@giwindows.com

Device Name:

Device Trade Name: FLEX SFM Common Name: Self-Forming Magnet Classification Name: Magnetic Compression Anastomosis System Regulation Number: 878.4816 Product Codes: SAH

Legally Marketed Predicate: Mag DI (DEN240013) - Product Code: SAH

Device Description Summary

Intended Use/Indications for Use:

Indications for Use Comparison:

There is no change to Indications for Use in comparison to the predicate device.

Technological Comparison

The FLEX SFM and predicate device system have the same technological characteristics (principal of operation, magnetic core technology and anatomical target placement location and packaging) as the predicate device as shown in Table 1.

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Table 1: FLEX SFM Comparison with Predicate
Characteristics	FLEX SFM	MagDI
	K243213	DEN240013
Core Technology	Magnetic compression	Same
SFM Electroplating /Coatings	Nickel, Copper, Nickel, Gold,Parylene	Substantially equivalent asproposed and predicate devicesare made of biocompatiblematerials and coatingsappropriate for transientimplantation in thegastrointestinal system
Magnet ImplantDimensions	In the octagonal shape, the outerdiameter is 0.98" (25 mm) X innerdiameter is 0.71"(18 mm) X 0.12" (3mm) thickness	0.75"(19.1mm) length x 0.25"(6.4mm) width x 0.13" (3.2mm)thickness
Overall length Flat-to-Flat Dimension	25.8 mm	19.1 mm length is substantiallyequivalent in creating anadequately sized duodenal-ilealanastomosis for enteral flow
Magnet placement:target location	Minimally invasive deliveryinstruments are used to positionthe magnets to the targetanastomosis locations in theduodenum and ileum and connectthe two Magnets.	Same
Mechanism of Action	The clamping pressure provided bythe magnets is sufficient to causetissue hypoxia to occur in themicroenvironment during healingof the anastomotic site¹. Necrosisof the trapped tissue then occursaround and between theassemblies. As the surroundingtissue heals and the magnetassemblies fall away, the desiredanastomosis is formed.	The device provides a methodfor the creation of a round(oval/circular) compressionanastomosis. After a period ofapproximately 7-21 days, acompression-induced necrosisof the tissue between theMagnets occurs and the wholedevice, together with thenecrosed tissue that wascompressed by the Magnets,
Table 1: FLEX SFM Comparison with Predicate
Characteristics	FLEX SFM	MagDI
	K243213	DEN240013
	magnets naturally pass through theintestinal tract.	detaches, and is naturallyexpelled with the stool.2
Clinical AnastomosisFormation:
-Clinical placement ofthe device with ≥90%alignment of magnets	- N=70 (100%)	- N=49 (100%)2
-Creation of a patentanastomosisconfirmedradiologically	- N=70 (100%)	-N=49 (100%)2
Single Use - Sterile	Self-Forming Magnet (SFM)Anastomosis Device (Magnet Awith Endoscopic Delivery Device)and Self-Forming Magnet (SFM)Anastomosis Device (Magnet Bwith Laparoscopic Delivery Device)are provided sterile and are singleuse devices	Substantially equivalent asproposed and predicate devicesare packaged as sterile devicesintended for single use.

1 Wang et al., Magnamosis improves the healing of gastrojejunal anastomosis; Nature (2024) 14:20367

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Summary of Performance Data

The determination of substantial equivalence is based on an assessment of non-clinical performance data. To verify that the device design meets the functional and performance requirements, the FLEX SFM underwent the following performance testing. The tests were performed on the subject device using the same method as the predicate device, and acceptance criteria.

Transportation Validation and Shipping test / ASTM D 4169: 2022
Biocompatibility tests / ISO 10993 standards. All patient-contacting components of FLEX SFM . system passed per ISO 10993-1. Biocompatibility testing included:
- Cytotoxicity MEM Elution (ISO 10993-5) O
- O Sensitization (ISO 10993-10)
- Intracutaneous Irritation (ISO 10993-10) O
- Acute Systemic Toxicity (10993-11) O
- Material-Mediated Pyrogenicity (10993-11) O

2 DEN240013 - Mag DI Decision Summary

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o Subchronic Toxicity / Implantation (10993-11 and 10993-6)
Genotoxicity Ames Assay / Mouse Lymphoma Assay (ISO 10993-3) O
о Chemical Characterization (ISO 10993-18)
E-Beam Radiation Sterilization Validation to an SAL of 1 x 10-6 / ISO 11137-1:2006 +A1:2013 and EN ISO 11137-1:2015
Porcine Survival Studies
Simulated Use Cadaver testing
Packaging Validation
. Shelf-life testing
Device performance tests on magnet clamping force, pressure and tensile strength, magnetic interference and corrosion resistance.

GLP Animal Studies

GLP animal studies were conducted to evaluate the FLEX SFM device for use in the small bowel in comparison to a 60mm linear staple and sutures as controls in a porcine model.

In all evaluations, the FLEX SFM device and the anastomoses created using the GI Windows suite of products performed as well as or better than the control devices and anastomoses when evaluating tissue burst pressure and histological architecture of the healed tissue. The FLEX SFM self-forming magnets met all the usability, safety and effectiveness acceptance criteria predefined in the protocols. There were no device failures reported with the magnets. Compared to a common and accepted control anastomosis devices and procedures, the GI Windows device is safe, effective and capable of creating a durable small bowel to small bowel anastomosis in a chronic swine anastomosis model.

Clinical

Clinical testing was conducted in patients using the FLEX SFM Device to create side duodenalileal anastomoses in a total of 70 patients, including studies in Argentina, Canada, Spain and the United States. The Magnets were sequentially delivered endoscopically and laparoscopically using the Delivery Systems. The Magnets were successfully placed in all cases with alignment, and for all subjects, the device passed as a pair of connected Magnets naturally or with minimal non-surgical intervention. Most adverse events were of low grade, Clavien-Dindo Classification I-II and those that met the criteria as a serious adverse event (SAE), were resolved without sequelae. There were no cases of anastomotic bleeding, leakage and no deaths. The FLEX SFM System performed safely and as intended to create patent anastomoses with a profile as least as the predicate compression anastomosis device (Mag DI System, DEN240013).

Postmarket Surveillance

In summary, the premarket data demonstrates several probable benefits and risks when used in the creation of duodeno-ileal anastomoses. The risks of the FLEX SFM System and clinical study limitations are mitigated by the special controls and labeling. Outstanding uncertainty regarding the generalizability of effectiveness of device use in the target U.S. patient population will be addressed by postmarket data collection associated with special controls requirements. GI Windows will meet defined enrollment milestones following device clearance and will submit periodic postmarket surveillance progress reports until enrollment is complete, followed by annual updates.

Conclusion

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Based on the nonclinical and clinical tests completed, the FLEX SFM device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Mag DI (DEN240013). The subject device, GI Windows FLEX SFM System has demonstrated to be substantially equivalent to the predicate device, Mag DI (DEN240013) based on the same intended use and Indications for Use, technological characteristics and performance testing.

Regulation Number and Section

N/A