(90 days)
Not Found
No
The device description focuses on a mechanical and enzymatic process for fat hydrolysis, with no mention of AI or ML technologies. The performance studies are based on retrospective observational data and postmarket surveillance, not on the training or testing of an AI/ML model.
Yes
The device is intended to hydrolyze fats in enteral formula, mimicking the function of pancreatic lipase, to allow for their absorption and utilization by the body, which directly impacts the patient's physiological function and health.
No
Explanation: The device description states RELiZORB "functions to hydrolyze (break down) fats present in enteral formulas" and is "intended to mimic the function of the enzyme pancreatic lipase." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly outlines a physical cartridge containing beads with an immobilized enzyme, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hydrolyze fats in enteral formula." This is a therapeutic action, directly affecting the composition of the food being delivered to the patient.
- Device Description: The device functions to "hydrolyze (break down) fats present in enteral formulas." This is a physical or chemical process applied to the formula before it enters the body.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in a biological sample, or provide information for diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. RELiZORB does not perform this function. It acts on the enteral formula itself.
N/A
Intended Use / Indications for Use
RELiZORB is indicated for use in pediatric (ages 1 year and above) and adults patients to hydrolyze fats in enteral formula.
Product codes
PLQ
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 enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This 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 acrylic 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 enteral formulas is hydrolyzed when it comes in contact with iLipase as the formula passes through the cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric patients (ages 1 year and above) and adult patients
Intended User / Care Setting
Not Found
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)
The evidence supporting this change in the Indications for Use is presented in a retrospective observational study and an evaluation of postmarket safety surveillance of RELiZORB that demonstrate device safety and effectiveness for the patient population of 1 year of age and greater. The retrospective study was performed by Alcresta and evaluated multiple data outputs in Medical Records for patients initiating RELiZORB use between ages 1 and
§ 876.5985 Enzyme packed cartridge.
(a)
Identification. An enzyme packed cartridge is anex vivo prescription device that is used in enzymatic hydrolysis of macronutrients into their essential nutrient forms at the time of delivery. The device consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. The device fits in line with enteral feeding systems.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2)
In vivo testing must be performed and must demonstrate that the device causes neither an adverse tissue response nor adverse performance.(3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
(i) Mechanical testing to demonstrate that the device can withstand clinical forces;
(ii) Flow rate and leakage testing to demonstrate that the device does not impede the flow of enteral formula;
(iii) Demonstration of enzymatic effect on intended macronutrient;
(iv) The amount of enzyme that exits the cartridge must be characterized;
(v) Validation that the device does not adversely impact the nutritional composition of enteral formula; and
(vi) Validation that the device does not impede flow alarms on enteral feeding pumps.
(4) Human factors testing must be performed to characterize use error risks.
(5) Performance data must support shelf life by demonstrating package integrity and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) A detailed summary of
in vivo testing pertinent to use of the device, including device-related adverse events;(ii) A detailed summary of compatible formulas that is supported by non-clinical testing, including the expected enzymatic conversion as a percentage;
(iii) Detailed instructions on how to place the device into an enteral feeding circuit;
(iv) A warning regarding the possibility for misconnections; and
(v) Expiration date or shelf life.
(7) Patient labeling must be provided and must include:
(i) Relevant warnings, precautions, adverse effects, and complications;
(ii) A description of the device and how it operates;
(iii) Instructions on how to correctly use the device; and
(iv) The benefits and risks associated with the use of the device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2025
Alcresta Therapeutics, Inc. Rookmin Persaud Associate Director Regulatory Affairs 130 Turner Street Building 3. Suite 200 Waltham, Massachusetts 02453
Re: K243284
Trade/Device Name: RELiZORB Regulation Number: 21 CFR 876.5985 Regulation Name: Enzyme Packed Cartridge Regulatory Class: Class II Product Code: PLQ Dated: October 17, 2024 Received: October 17, 2024
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.
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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.
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-device-advicecomprehensive-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-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-regulatory
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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
Indications for Use
Submission Number (if known)
K243284
Device Name
RELiZORB (100300/ 100301)
Indications for Use (Describe)
RELiZORB is indicated for use in pediatric (ages 1 year and above) and adults patients to hydrolyze fats in enteral formula.
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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Image /page/4/Picture/1 description: The image shows the logo for Alcresta Therapeutics. The logo consists of a blue and gray geometric shape above the company name. The company name is written in blue, with the word "ALCRESTA" in a larger font than the word "THERAPEUTICS".
510(k) SUMMARY (21 CFR 807.92)
1. General Information
| Submitter Name | Daniel Orlando |
|---|---|
| Submitter Address | Alcresta Therapeutics |
| 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 | |
| Contact Information | Email: rpersaud@alcresta.com |
| Phone: 732-829-7620 | |
| Submission Type | Traditional 510(k) |
| Date Prepared | October 17th, 2024 |
2. Subject Device
| Device Trade/Proprietary Name | RELIZORB® |
|---|---|
| Device Common Name | Enzyme Packed Cartridge |
| Regulation Number | 21 CFR 876.5985 |
| 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 | K232784 |
| Device Common Name | Enzyme Packed Cartridge |
| Regulation Number | 21 CFR 876.5985 |
| Product Code | PLQ |
| Device Classification | II |
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 enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by
5
Image /page/5/Picture/1 description: The image shows the logo for Alcresta Therapeutics. The logo features a blue and gray geometric shape above the company name. The company name is written in a blue serif font, with the word "ALCRESTA" in a larger font size than the word "THERAPEUTICS" which is written below it.
the body. This 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 acrylic 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 enteral formulas is hydrolyzed when it comes in contact with iLipase as the formula passes through the cartridge.
5. Indications for Use
RELiZORB® is indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula.
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 K232784. Two minor updates to labeling have been implemented since the clearance of K232784 supported by test data included in reports provided in this submission: (1) the shelf-life of the device was extended to 24 months from 12 months, and (2) manual bolus enteral feeding by syringe gravity (cleared under K232784) instructions have been added to the Instructions For Use (IFU). As these changes have been implemented, Alcresta is including them to provide FDA with an update on changes to the device since the clearance of K232784. 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 K232784.
The subject of this premarket notification is an update to the Indications for Use of RELiZORB that provides the minimum age for use to 1 year old patients, currently set at 2 years old and greater. The evidence supporting this change in the Indications for Use is presented in a retrospective observational study and an evaluation of postmarket safety surveillance of RELiZORB that demonstrate device safety and effectiveness for the patient population of 1 year of age and greater. The retrospective study was performed by Alcresta and evaluated multiple data outputs in Medical Records for patients initiating RELiZORB use between ages 1 and