RELiZORB (100300/100301)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 17, 2025 Alcresta Therapeutics, Inc Rookmin Persaud Associate Director, Regulatory Affairs 130 Turner Street Building 3, Suite 200 Waltham, Massachusetts 02453 Re: K250499 Trade/Device Name: RELiZORB (100300/100301) Regulation Number: 21 CFR 876.5985 Regulation Name: Enzyme Packed Cartridge Regulatory Class: Class II Product Code: PLQ Dated: February 20, 2025 Received: February 20, 2025 Dear Rookmin Persaud: 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250499 - Rookmin Persaud Page 2 (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 (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 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 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. {2} K250499 - Rookmin Persaud Page 3 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). Sincerely, Anthony Lee -S Anthony C. Lee Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} 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. Submission Number (if known) K250499 Device Name RELiZORB (100300/100301) Indications for Use (Describe) RELiZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding. 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." {4} K250499 Page 1 of 4 ALCRESTA THERAPEUTICS # 510(k) SUMMARY (21 CFR 807.92) ## 1. General Information | Submitter Name | Daniel Orlando | | --- | --- | | Submitter Address | Alcresta Therapeutics, Inc. 130 Turner Street Building 3, Suite 200 Waltham, MA 02453 Phone: 847-830-6205 | | FDA Establishment Owner Operator Number | 10050687 | | FDA Establishment Registration Number/FEI | 3009596666 | | Contact Person | Rookmin Persaud Associate Director Regulatory Affairs Alcresta Therapeutics, Inc. | | Contact Information | Email: rpersaud@alcresta.com Phone: 732-829-7620 | | Submission Type | Traditional 510(k) | | Date Prepared | February 20th, 2025 | ## 2. Subject Device | 510(k) Number | K250499 | | --- | --- | | Device Trade/Proprietary Name | RELiZORB (100300/100301) | | Device Common Name | Enzyme Packed Cartridge | | Regulation Number | 21 CFR 876.5985 | | Regulation Name | Enzyme Packed Cartridge | | Product Code | PLQ | | Device Classification | II | | Review Panel | Gastroenterology/Urology | | Premarket Review | Renal, Gastrointestinal, Obesity and Transplant Devices (DHTA3A) | ## 3. Predicate Device | Device Trade/Proprietary Name | RELiZORB® | | --- | --- | | 510(k) Number | K243284 | | Device Common Name | Enzyme Packed Cartridge | | Regulation Number | 21 CFR 876.5985 | | Product Code | PLQ | | Device Classification | II | RELiZORB Traditional 510(k) Confidential {5} K250499 Page 2 of 4 ALCRESTA THERAPEUTICS ## 4. Device Description RELiZORB® is a point-of-care device designed to fit in-line with currently used enteral feeding circuits. RELiZORB functions to hydrolyze (break down) fats present in formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. Formulas are liquid food products that are specially formulated and designed to increase the amount of various food elements and nutrients that will maintain proper physiological function of the body. The breakdown of fats by RELiZORB is intended to mimic the function of the enzyme pancreatic lipase. RELiZORB is comprised of a cylindrical, hollow cartridge with a single inlet port and a single outlet port connection. Inside the cartridge, there are small white beads. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipase-bead complex, iLipase® (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in formulas is hydrolyzed when it encounters iLipase as the formula passes through the cartridge. ## 5. Indications for Use RELiZORB® is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding. ## 6. Performance Data, Special Controls The technological characteristics, design, material composition, principle of operation and all other features of RELiZORB have not changed in any manner since the clearance of Predicate Device K243284 on 15 January 2025. There is no effect on the special controls applied to this product per 21 CFR 876.5985 or any of the standards to which the product was demonstrated to be in conformity with as determined in K243284. The subject of this premarket notification is an update to the indications for use of RELiZORB to include neonates and infants with proposed conditions of use of up to 6 cartridges per day for infant, pediatric and adult patients (>6 months of age) and up to 2 cartridges per day for neonates and infants (≤6 months of age). RELiZORB is currently indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula. In accordance with FDA Guidance for Industry and Food and Drug Administration Staff: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (August 31, 2017), a retrospective observational study and the related data analysis, have been designed and conducted to support the safety and effectiveness of RELiZORB for neonates and infants. The retrospective study was performed by Alcresta and evaluated RELiZORB Traditional 510(k) Confidential {6} K250499 Page 3 of 4 ALCRESTA THERAPEUTICS multiple data outputs in Medical Records for patients initiating RELiZORB use between ages <1 year, during the time period of 16 January 2020 to 31 October 2024. Patients, <1 year, received formula (infant/enteral formula) administered through RELiZORB at more than 60 centers across the US. The Real World Data (RWD) supports the Real World Evidence (RWE) that RELiZORB use in the <1 year population is safe and effective. In addition, RELiZORB functional performance was evaluated and found to be compatible with commercially available infant formulas. Post Market Surveillance data was collected during the same time period as the collection of RWD, 16 January 2020 to 31 October 2024. Review and evaluation of the Post Market Surveillance data showed no newly identified complaints associated with RELiZORB use in the <1 year population as compared to the >1 year population. # 7. Substantial Equivalence The subject RELiZORB is substantially equivalent to the predicate RELiZORB (K243284). The following table illustrates the identical nature of the subject and predicate devices. Table 1. Subject and Predicate Devices Comparison | Characteristics | Subject device RELiZORB | Predicate device RELiZORB (K243284) | | --- | --- | --- | | Indications for Use | RELiZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding. | RELiZORB is indicated for use in pediatric (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula. | | Conditions of use | Up to 6 cartridges per day for infant, pediatric and adult patients (>6 months of age) and up to 2 cartridges per day for neonates and infants (≤6 months of age). | Up to 6 cartridges per day | | Device design | Cartridge housing is filled with immobilized lipase Single use, non-sterile ENFit Compatible | Cartridge housing is filled with immobilized lipase Single use, non-sterile ENFit compatible | | Principle of Operation | Hydrolyze fats in formula as it passes through the cartridge | Hydrolyze fats in formula as it passes through the cartridge | | How used | Cartridge that fits inline as part of enteral feeding circuit in single or tandem configuration | Cartridge that fits inline as part of enteral feeding circuit in single or tandem configuration | RELiZORB Traditional 510(k) Confidential {7} K250499 Page 4 of 4 ALCRESTA THERAPEUTICS | Characteristics | Subject device RELiZORB | Predicate device RELiZORB (K243284) | | --- | --- | --- | | Enteral feeding mode | Enteral pump; manual bolus by enteral syringe, (syringe push or gravity) | Enteral pump; manual bolus by enteral syringe, (syringe push or gravity) | | Hydrolysis information | Fat hydrolysis for compatible formulas listed in labeling. | Fat hydrolysis for compatible formulas listed in labeling. | | Storage Conditions | 2°C to 27°C (36°F to 80°F) | 2°C to 27°C (36°F to 80°F) | | Shelf Life | 24 months | 24 months | ## 8. Conclusion for Substantial Equivalence Based on the information provided in this premarket notification to support the update to the indications for use and the demonstration of Substantial Equivalence between the subject and predicate devices, RELiZORB is shown to raise no new questions of safety and effectiveness and is substantially equivalent to RELiZORB cleared in K243284. RELiZORB Traditional 510(k) Confidential