(128 days)
Not Found
No
The device description details a mechanical and enzymatic process for fat hydrolysis, with no mention of AI or ML technologies. The performance study relies on retrospective registry data analysis, not AI/ML model training or evaluation.
Yes
The device is intended to hydrolyze fats in enteral formula, mimicking the function of the digestive enzyme lipase, to aid in absorption and utilization by the body in patients who do not excrete sufficient levels of the enzyme. This directly addresses a physiological insufficiency, making it a therapeutic device.
No
RELiZORB® is designed to break down fats in enteral formulas, mimicking the function of the digestive enzyme lipase. Its purpose is to aid in nutrient absorption by pre-digesting fats, not to diagnose a medical condition.
No
The device description clearly outlines a physical cartridge with beads and filters, indicating it is a hardware device, not software-only.
Based on the provided information, no, 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 direct action on the formula itself, outside of the body, to prepare it for digestion. It is not intended to diagnose a condition, monitor a physiological state, or screen for diseases by analyzing a sample from the human body.
- Device Description: The description clearly states that the device "connects in-line with existing enteral feeding circuits" and "hydrolyzes (digests) fats contained in enteral formulas." This is a process applied to the food source, not a diagnostic test performed on a biological sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about the patient's health status.
- Mechanism of Action: The device's mechanism is enzymatic hydrolysis of fats in the formula, mimicking a digestive process. This is a therapeutic or preparatory action, not a diagnostic one.
In summary, RELiZORB® is a device that modifies enteral formula before it enters the body to aid in digestion. This function falls outside the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
RELiZORB® is indicated for use with pediatric (ages 2 years and above) and adult patients to hydrolyze fats in enteral formula.
Product codes
PLQ
Device Description
RELiZORB® is a single-use, point-of-care digestive enzyme cartridge that connects in-line with existing enteral feeding circuits. RELiZORB® is designed to hydrolyze (digest) fats contained in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This hydrolysis of fats by RELiZORB® is intended to mimic the function of the digestive enzyme lipase in patients who do not excrete sufficient levels of the lipase enzyme. RELiZORB® is comprised of a clear cylindrical, plastic cartridge with a single inlet connection port and a single outlet connection port. Inside the cartridge, there are small white beads that the digestive enzyme, lipase, is covalently bound to. 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 as 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 (ages 2 years and above) and adult
Intended User / Care Setting
point-of-care
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 a change in the indications for use is presented in a retrospective registry study performed by Alcresta that evaluated multiple data outputs in Electronic Medical Records (EMRs) for patients between ages 2 year and 5 years to whom RELiZORB® had been prescribed to them by the This Real World Data supports the Real World Evidence that use in this use population is both safe and effective. This study and the related data analysis and conclusions have been performed in accordance with the 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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August 30, 2023
Alcresta Therapeutics, Inc. % Matthew King Senior Director of Regulatory Affairs 130 Turner Street. Building 3. Suite 200 Waltham, Massachusetts 02453
Re: K231156
Trade/Device Name: Enzyme Packed Cartridge - RELiZORB® Regulation Number: 21 CFR 876.5985 Regulation Name: Enzyme Packed Cartridge Regulatory Class: Class II Product Code: PLQ Dated: July 28, 2023 Received: July 31, 2023
Dear Matthew King:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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).
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. 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
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Indications for Use
510(k) Number (if known) K231156
Device Name RELiZORB®
Indications for Use (Describe)
RELiZORB® is indicated for use with pediatric (ages 2 years and above) and adult patients to hydrolyze fats in enteral formula.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY (K231156)
1. General Information
| Submitter Name | Alcresta Therapeutics, Inc. |
|---|---|
| Submitter Address | 130 Turner Street |
| Building 3, Suite 200 | |
| Waltham, MA 02453 | |
| FDA Establishment Owner Operator Number | 10050687 |
| FDA Establishment Registration Number/FEI | 3009596666 |
| Contact Person | Matthew King |
| Senior Director of Regulatory Affairs | |
| Alcresta Therapeutics | |
| Contact Information | Email: mking@alcresta.com |
| Phone: 603-459-9755 | |
| Submission Type | Traditional 510(k) |
| Date Prepared | 04/20/2023 |
2. Subject Device
| Device Trade/Proprietary Name | RELIZORB® |
|---|---|
| Device Common / Regulation 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 | K191379 |
| Device Common / Regulation Name | Enzyme Packed Cartridge |
| Regulation Number | 21 CFR 876.5985 |
| Product Code | PLQ |
| Device Classification | II |
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4. Device Description
RELiZORB® is a single-use, point-of-care digestive enzyme cartridge that connects in-line with existing enteral feeding circuits. RELiZORB® is designed to hydrolyze (digest) fats contained in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This hydrolysis of fats by RELiZORB® is intended to mimic the function of the digestive enzyme lipase in patients who do not excrete sufficient levels of the lipase enzyme. RELiZORB® is comprised of a clear cylindrical, plastic cartridge with a single inlet connection port and a single outlet connection port. Inside the cartridge, there are small white beads that the digestive enzyme, lipase, is covalently bound to. 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 as it comes in contact with iLipase as the formula passes through the cartridge.
5. Indications for Use
RELiZORB® is indicated for use with pediatric (ages 2 years and above) and adult patients to hydrolyze fats in enteral formula
6. Performance Data
The technological characteristics, design, materials composition, principal of operation and all other features of RELiZORB® have not changed in any manner since the clearance of K191379. Updates to the device that have taken place since the clearance of K191379 are included in this submission for the benefit of the Agency reviewers. 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 K191379.
The evidence supporting a change in the indications for use is presented in a retrospective registry study performed by Alcresta that evaluated multiple data outputs in Electronic Medical Records (EMRs) for patients between ages 2 year and 5 years to whom RELiZORB® had been prescribed to them by the This Real World Data supports the Real World Evidence that use in this use population is both safe and effective. This study and the related data analysis and conclusions have been performed in accordance with the 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).
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7. Substantial Equivalence:
The subject device is identical to the predicate device in every manner with the exception of the indications for use, which have been extended to include 2 year olds and up, where the predicate indications for use include 5 year olds and up. There have been minor updates to RELiZORB® since its last clearance for which descriptions and documentation are included in this submission to bring the current state of the device to the full attention of the Agency. The following table illustrates the identical nature of the subject and predicate devices.
| Characteristics | Subject device RELIZORB | Predicate RELIZORB (K191379) | |
|---|---|---|---|
| Indications for use | RELIZORB® is indicated for use | ||
| in pediatric patients (ages 2 years | |||
| and above) and adult patients to | |||
| hydrolyze fats in enteral formula | RELIZORB® is indicated for use in | ||
| pediatric patients (ages 5 years and | |||
| above) and adult patients to hydrolyze | |||
| fats in enteral formula | |||
| Device design | Cartridge with iLipase inside: | ||
| lipase enzyme immobilized on | |||
| polyacrylate beads | Cartridge with iLipase inside: lipase | ||
| enzyme immobilized on polyacrylate | |||
| beads | |||
| ENFit compatible | |||
| Principle of | |||
| Operation | Hydrolyze fats in enteral formula | ||
| as formula passes through the | |||
| cartridge | Hydrolyze fats in enteral formula as | ||
| formula passes through the cartridge | |||
| How used | Accessory that fits inline as part | ||
| of enteral feeding circuit | Accessory that fits inline as part of | ||
| enteral feeding circuit | |||
| Conditions of use | Single use | ||
| Flow Rate | 10-120 mL/hour single cartridge | 10-120 mL/hour single cartridge | |
| 24-120 mL/hour tandem | |||
| configuration | 24-120 mL/hour tandem configuration | ||
| Cartridge | |||
| configuration in | |||
| Enteral feeding | |||
| set | Tandem and Single cartridge | ||
| configuration (limit of 2 | |||
| cartridges a day; Single cartridge | |||
| for up to 500 mL; Tandem | |||
| cartridge for up to 1000 mL) | Tandem and Single cartridge | ||
| configuration (limit of 2 cartridges a | |||
| day; Single cartridge for up to 500 | |||
| mL; Tandem cartridge for up to 1000 | |||
| mL) | |||
| Hydrolysis | |||
| information | Hydrolysis rates for compatible | ||
| enteral formulas in labeling | Hydrolysis rates for compatible | ||
| enteral formulas labeling |
Table 7.1: Subject Device to Predicate Device Comparison
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8. Conclusion
Based on the information provided in this premarket notification to support the update to the indications for use and the demonstration that there are no differences between the subject and predicate device, RELiZORB is shown to raise no new questions of safety and is substantially equivalent to the RELiZORB cleared in K191379.