GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 16, 2026 GT Metabolic Solutions, Inc. Lisa Griffin Vincent Chief Regulatory, Quality, Clinical Officer 5450 Quam Avenue N.E. Suite 100 St. Michael, Minnesota 55376 Re: K261467 Trade/Device Name: GT Metabolic MagDI System (MAG-04, DS-01 and MAG-05, DS-01) Regulation Number: 21 CFR 878.4816 Regulation Name: Magnetic Compression Anastomosis System Regulatory Class: Class II Product Code: SAH Dated: May 2, 2026 Received: May 4, 2026 Dear Lisa Griffin Vincent: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253102 - Lisa Griffin Vincent Page 2 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, you 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production {2} K253102 - Lisa Griffin Vincent Page 3 (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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 Programs U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center - WO66-G609 10903 New Hampshire Avenue {3} K253102 - Lisa Griffin Vincent Page 4 Silver Spring, MD 20993-0002 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-and-track-medical-device-premarket-submissions-online-cdrh-portal. Sincerely, # TEK N. LAMICHHANE -S 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 {4} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K261467 Device Name GT Metabolic MagDI™ System (MAG-04, DS-01 and MAG-05, DS-01) Indications for Use (Describe) The GT Metabolic Magnet System (60mm, 70mm) is intended for use in the creation of side-to-side gastroileostomy or gastrojejunostomy 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 GT Metabolic MagDI System is intended for use in adult patients > 21 years. 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) **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."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {5} # 510(k) Summary # (K261467) # Submitter GT Metabolic Solutions, Inc. 5450 Quam Ave NE, Suite 100 St. Michael, MN 55376 U.S.A. Contact Person: Lisa Griffin Vincent, PhD, MA Date Prepared: September 16, 2026 # Name of Device Proprietary/Trade Name: GT Metabolic Magnet System Device Common Name: Magnet System Model Numbers: MAG-04, DS-01 and MAG-05, DS-01 Product Code Name: Magnetic compression anastomosis system Product Code: SAH Regulation Number: 21 CFR 878.4816 Review Panel: General and Plastic Surgery Device Classification: Class II # Predicate Device Proprietary/Trade Name: GT Metabolic MagDI™ System Device Common Name: Magnet System Model Numbers: MAG-01, DS-01 and MAG-02, DS-01 Submission Number: K242086, K243359, K253102 Product Code Name: Magnetic compression anastomosis system Product Code: SAH Regulation Number: 21 CFR 878.4816 Review Panel: General and Plastic Surgery Device Classification: Class II Page 1 of 3 {6} # Device Description The set of two (2) Magnets of the same size (either a set of 60mm (MAG-04) or 70mm (MAG-05)) is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis. After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device detaches, together with the necrosed tissue that was compressed by the Magnets. The device is expected to naturally expel in less than 30 days but may be longer in some patients.. # Intended Use / Indications for Use The GT Metabolic Magnet System (60mm, 70mm) is intended for use in the creation of side-to-side gastroileostomy or gastrojejunostomy 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 GT Metabolic Magnet System is intended for use in adults > 21 years. # Technological Characteristics The subject device, the GT Metabolic Magnet System, does not change the fundamental magnetic compression anastomosis technology employed in the predicate device and has the same intended use with different indications for use. The subject device indications for use includes use of the device for side-to-side gastroileostomy or gastrojejunostomy, as opposed to the predicate devices whose indications for use include side-to-side duodeno-ileal anastomosis. The device length the subject Magnets (60mm and 70mm) are longer than the predicate Magnets (40mm and 50mm) to support the gastric tissue application. The subject and predicate GT Metabolic Magnet System devices provide surgeons with the option to choose length of Magnet based on medical judgement according to individual patient morphology, clinical characteristics, tissue application, and underlying clinical procedure. # Performance Testing # Preclinical Testing - Biocompatibility testing demonstrated the device is biocompatible according to ISO 10993-1. - Magnet field strength testing characterized the distances from the magnets are safe for patients and users with ferromagnetic implants, devices, or objects. - The Magnets maintain adequate separation forces over the use life. - The Magnets connect and disconnect to the Delivery System over the use life. - Patient-contacting materials conform to ISO 10993-1 and FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" issued September 8, 2023. - The Magnet System demonstrates a SAL of 10⁻⁶, a continued sterility through the labeled shelf life of the device, and conforms to ISO 11137-1, ISO 11137-2, and ISO 11137-3. # Animal Testing - Animal testing in a porcine animal model was conducted over 6 weeks for the subject GT Metabolic Magnet System (60mm and 70mm Magnets) with a comparison to sutures enterotomies and gastrotomies as a proxy for the conventional hand-sutured technique. The GT Metabolic Magnet System successfully induced gastro-jejunostomy when placed by gastrotomy and enterostomy. Four animals experienced post-operative vomiting, two of which required temporary gastric tube placement for acute gastric distention which resolved without further sequelae in one animal and required euthanasia due to progression of clinical signs in another study animal at Day 4 post-procedure. At the 6-week necropsy, the Magnets had naturally expelled in 5 of 7 completed animals while 2 animals retained the devices in the colon, attributed to the length and anatomy of the porcine lower gastrointestinal tract. The GT Metabolic Magnets were well tolerated clinically and associated with good healing response when evaluated microscopically, characterized by low-levels of inflammation, ideal mucosal apposition, and minimal smooth muscle loss at 6-weeks post- Page 2 of 3 {7} operatively. In contrast, closure of enterotomy and gastrotomy sites with sutures was associated with higher degrees of inflammation and tissue damage. The animal data support that the subject GT Metabolic Magnet System performs as intended under anticipated conditions of use and demonstrate the ability of the device to create an anastomosis as supported by histology of the anastomosis site. ## Clinical Testing - Clinical testing was conducted in adult obese patients with type 2 diabetes mellitus or weight regain following previous sleeve gastrectomy or endoscopic sleeve gastroplasty using the GT Metabolic Magnet System (60mm or 70mm Magnets) for creation of a side-to-side gastroileostomy or gastrojejunostomy in an underlying gastrointestinal diversion procedure. The Magnets were sequentially delivered orogastrically either by swallow (first, distal Magnet only) or endoscopically using the Delivery System. Magnets were successfully placed in all cases with alignment and creation of patent anastomoses (100%). Two subjects following patent anastomosis creation, required minimally invasive retrieval of the Magnets at study Day 168 and 92 without clinical issues. 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. No cases of internal hernia or bowel obstruction at the mesentery were reported. There were no cases of anastomotic bleeding, infection, or obstruction and no deaths. There was one SAE related to an anastomosis tear leading to a leak and peritonitis that was associated with tension at the anastomosis site. The tear was laparoscopically sutured and peritonitis addressed; the Magnets were left in place, expelled naturally, and created a wide anastomosis that remained patent through one-year follow up. Two additional procedural SAEs involving iatrogenic tissue tears occurred during laparoscopic manipulation and were resolved with suturing. On subject received a laparoscopic reversal of the anastomosis at Day 143 due to serious gastrointestinal intolerance of the diversion procedure. The subject GT Metabolic Magnet System (60mm and 70mm Magnets) performed safely and as intended to create patent side-to-side gastroileostomy or gastrojejunostomy with a profile as least as safe as the predicate magnetic compression anastomosis devices (GT Metabolic MagDI System (also called Magnet System), 40mm and 50mm Magnets, K242086, K243359). - The subject GT Metabolic Magnet System devices (60mm (MAG-04) or 70mm (MAG-05)) will be subject to a postmarket surveillance study to address the generalizability of the device's safety and effectiveness for side-to-side gastroileostomy or gastrojejunostomy in U.S. patients, representative of the U.S. intended use population who are treated with the GT Metabolic Magnet System. Labeling conforms to 21 CFR 801 and ISO 15223. ## Substantial Equivalence Conclusion The proposed subject device, GT Metabolic Magnet System (MAG-04 (60mm), DS-01) and (MAG-05 (70mm), DS-01)), has demonstrated to be substantially equivalent to the predicate GT Metabolic Magnet System devices (MagDI Systems; K242086, K243359, K253102) based on the same intended use, same primary mechanism of action (magnetic compression anastomosis), same or similar technological characteristics, and performance testing for its indications for use. Page 3 of 3