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. 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 covalently bonded to the digestive enzyme, lipase. This 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 upon contact with iLipase as the formula passes through the cartridge.

AI/ML Overview

This document is a 510(k) summary for the RELiZORB® device, which is an enzyme-packed cartridge used to hydrolyze fats in enteral formula. It is a submission to the FDA seeking clearance for a modified version of an already cleared device.

The provided text focuses on demonstrating the substantial equivalence of the subject device (RELiZORB® K232784) to its predicate device (RELiZORB® K231156). It does not contain information about the acceptance criteria and study proving performance for an AI/Software as a Medical Device (SaMD).

Specifically, the document does not contain the following information typically found in acceptance criteria and study designs for AI/SaMD devices:

A table of acceptance criteria and reported device performance (for an AI/SaMD)
Sample sizes used for a test set (as would be used for an AI/SaMD model's performance evaluation)
Data provenance for a test set
Number of experts and qualifications for ground truth establishment
Adjudication method for a test set
MRMC comparative effectiveness study details
Standalone (algorithm-only) performance results
Type of ground truth used (e.g., pathology, outcomes data)
Sample size for the training set (for an AI/ML model)
How ground truth for the training set was established

Instead, the document details performance testing related to the physical and chemical characteristics of the RELiZORB® cartridge, which is a hardware medical device with an enzymatic function.

Here's a breakdown of the performance testing cited for this hardware device, which is different from "acceptance criteria" for an AI/SaMD:

Overview of Performance Testing for RELiZORB® (Hardware Device):

The performance testing listed is geared towards a physical device with a biological function (enzyme action). The "acceptance criteria" for this device would therefore relate to its physical integrity, chemical activity, and biocompatibility, rather than diagnostic accuracy or algorithmic performance.

1. Table of "Acceptance Criteria" (Inferred from Performance Testing) and Reported Device Performance:

The document lists categories of testing rather than specific numerical acceptance criteria or detailed results. However, we can infer some "acceptance criteria" that would be met by these tests:

Acceptance Criteria Category (Inferred)	Specific Tests Performed (from text)	Reported Device Performance (General Statement)
Biocompatibility	Biocompatibility testing (Sections 15, 19)	Device causes neither an adverse tissue response nor adverse performance.
Device Integrity/Durability	Internal and external appearance, Pouch integrity, Physical/Mechanical Testing (Filter tensile strength, Weld tensile strength, Filter integrity/bead retention), Ship testing	Demonstrated to withstand clinical forces, maintain integrity, and retain beads.
Enzymatic Function	Hydrolysis, Demonstration of enzymatic effect on intended macronutrient	Hydrolyzes fats in enteral formula from triglycerides into fatty acids and monoglycerides.
Enzyme Retention	Unconjugated protein, Amount of enzyme that exits the cartridge (Section 10)	Enzyme is retained within the cartridge during use by filters; amount exiting the cartridge is characterized.
Flow Dynamics	Flow rate and leakage testing, Validation that the device does not impede flow alarms on enteral feeding pumps (Sections 18 & 14)	Does not impede the flow of enteral formula or flow alarms on enteral feeding pumps.
Nutritional Impact	Validation that the device does not adversely impact the nutritional composition of enteral formula (Section 18)	Does not adversely impact the nutritional composition.
Shelf Life	Evaluation of product shelf life, Performance data to support shelf life by demonstrating package integrity and device functionality over the identified shelf life (Section 14)	Functionality and integrity maintained over identified shelf life.
Safety in Use	Human factors testing (Section 10), Preclinical Studies in porcine model	Risks characterized; safety and efficacy assessed, including impact on fat absorption and weaning from parenteral to enteral nutrition.
Labeling Requirements	Labeling (Section 13)	Labeling includes required summaries, instructions, warnings, and patient information.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical and chemical tests, typically specific numbers of units are tested according to standard protocols (e.g., n=3, n=5, n=10 per batch), but these specific numbers are not provided in the summary.
Data Provenance: The preclinical studies were conducted in a porcine model. The document does not specify the country of origin for the studies, nor whether they were retrospective or prospective, though preclinical animal studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not an AI/ML diagnostic device requiring human expert ground truth for interpretation of imaging or other complex data. The "ground truth" for this device's performance would be the scientific measurement of its physical properties and chemical activity (e.g., fat hydrolysis percentage).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for human interpretation or consensus in diagnostic studies, not for the performance testing of a physical medical device.

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. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this device, the "ground truth" for its performance is established through standard laboratory testing for:
- Chemical Analysis: Measuring the hydrolysis of fats (e.g., quantifying fatty acids and monoglycerides produced).
- Physical Measurements: Tensile strength, flow rates, bead retention, appearance.
- Biological Testing: Biocompatibility tests (e.g., cytotoxicity, sensitization), and in vivo animal studies (porcine model) to assess safety and efficacy (fat absorption, impact on parenteral nutrition weaning).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable.

In summary: The provided text details the regulatory clearance process for a physical medical device (enzyme-packed cartridge), not an AI/Software as a Medical Device (SaMD). Therefore, the criteria and study types described in the prompt (which are typical for AI/SaMD) are not present in this document. The "performance data" here refers to standard engineering, chemical, and biological testing of a hardware product.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

December 21, 2023

Alcresta Therapeutics, Inc. Matthew King Senior Director Regulatory Affairs 130 Turner Street, Building 3, Suite 200 Waltham, Massachusetts 02453

Re: K232784

Trade/Device Name: RELiZORB® Regulation Number: 21 CFR 876.5985 Regulation Name: Enzyme Packed Cartridge Regulatory Class: Class II Product Code: PLQ Dated: November 17, 2023 Received: November 20, 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 (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.

{1}------------------------------------------------

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 (OS) 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.

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.

{2}------------------------------------------------

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,

Sivakami Venkatachalam -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 Ouality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known)

K232784

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)

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}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Alcresta Therapeutics. The logo features a stylized triangular shape at the top, with the left side in blue and the right side in gray. Below the shape is the word "ALCRESTA" in a large, blue sans-serif font. Underneath "ALCRESTA" is the word "THERAPEUTICS" in a smaller, gray sans-serif font.

510(k) SUMMARY (21 CFR 807.92)

1. General Information

Submitter Name	Alcresta Therapeutics, Inc.
Submitter Address	130 Turner StreetBuilding 3, Suite 200Waltham, MA 02453
FDA Establishment Owner Operator Number	10050687
FDA Establishment Registration Number/FEI	3009596666
Contact Person	Matthew KingSenior Director of Regulatory AffairsAlcresta Therapeutics
Contact Information	Email: mking@alcresta.comPhone: 603-459-9755
Submission Type	Traditional 510(k)
Date Prepared	September 8, 2023

2. Subject Device

Device Trade/Proprietary Name	RELiZORB®
510(k) Number	K232784
Device Common Name	Enzyme Packed Cartridge
Regulation Number	21 CFR 876.5985
Regulation Name	Enzyme Packed Cartridge
Product Code	PLQ
Device Classification	II

3. Predicate Device

Device Trade/Proprietary Name	RELiZORB®
510(k) Number	K231156
Device Common Name	Enzyme Packed Cartridge
Regulation Number	21 CFR 876.5985
Product Code	PLQ
Device Classification	II

{5}------------------------------------------------

Image /page/5/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 name "ALCRESTA" is in a large, light blue font, and the word "THERAPEUTICS" is in a smaller, gray font below it.

4. Device Description

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. Summary of Technological Characteristics Compared to Predicate Device

The subject and predicate device have the exact same indications for use. Both devices are designed as cartridges containing lipase enzyme immobilized on polymethacrylate beads. The cartridges of the subject and predicate device are constructed of injection molded polycarbonate, with differences including new inlet and outlet filter material and design, and updates to the shape and color of the outlet fitting. The active component of the subject device, iLipase 4, consists of a Generally Accepted as Safe (GRAS) lipase preparation immobilized on a polymethacrylate bead which is under review by the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA) under Food Contact Notification (FCN) 2295 with an anticipated clearance date of October 26, 2023. The predicate iLipase uses the same bead composition and lipase enzyme cleared under FCN 1498 by CFSAN on January 20, 2015. The polymethacrylate beads used in the subject device have a larger mean diameter than the predicate device to support expanded formula compatibility. Both the subject and the predicate device use standard ENFit connectors per ISO 80369-3 for specific connection to ENFit compatible supplies for enteral feeding. The subject device was designed for connection to enteral syringes for manual bolus feeding in addition to enteral pump sets.

7. Performance Data, Special Controls, and Standards Compliance

{6}------------------------------------------------

Image /page/6/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 a serif font, with the word "ALCRESTA" in blue and the word "THERAPEUTICS" in gray.

Performance Testing

Performance testing to support the substantial equivalence of the subject device to the predicate device in this submission include:

Evaluation of product shelf life ●
Internal and external appearance ●
o Pouch integrity
Hydrolysis ●
Unconjugated protein
Microbial testing ●
Physical/Mechanical Testing, including. o
- O Filter tensile strength
- Weld tensile strength O
- o Filter integrity/bead retention
Ship testing .
Biocompatibility ●

Preclinical Studies

Two preclinical studies were executed with the subject device in a porcine model of short bowel syndrome as assessments of safety and efficacy as well as functional performance. The first study investigated the impact of RELiZORB use during enteral feeding on fat absorption. The second study focused on the effect of bolus enteral feeding 6X per day with RELiZORB on weaning from parenteral to enteral nutrition.

Special Controls

RELiZORB is subject to special controls detailed under 21 CFR 876.5985. Each is addressed throughout this submission (summarized here):

Special Controls	Location in Submission
(1)The patient contacting components of the device must bedemonstrated to be biocompatible.	Section 15
(2)In vivo testing must be performed and must demonstratethat the device causes neither an adverse tissue responsenor adverse performance.	Section 19
(3) Non-clinical testing must demonstrate that the deviceperforms as intended under anticipated conditions of use.The following performance characteristics must bedemonstrated:
Special Controls	Location in Submission
(i) Mechanical testing to demonstrate that the device can withstand clinical forces	Section 18
(ii) Flow rate and leakage testing to demonstrate that the device does not impede the flow of enteral formula	Section 18
(iii) Demonstration of enzymatic effect on intended macronutrient	Section 18
(iv) The amount of enzyme that exits the cartridge must be characterized	Section 10
(v) Validation that the device does not adversely impact the nutritional composition of enteral formula	Section 18
(vi) Validation that the device does not impede flow alarms on enteral feeding pumps.	Section 18 & 14
(4)Human factors testing must be performed to characterize user error risks.	Section 10
(5)Performance data must support the shelf life by demonstrating package integrity and device functionality over the identified shelf life.	Section 14
(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;	Section 13
(ii) A detailed summary of compatible formulas that is supported by non-clinical testing, including the expected enzymatic conversion as a percentage;	Section 13
(iii) Detailed instructions on how to place the device into an enteral feeding circuit;	Section 13
(iv) A warning regarding the possibility for misconnections; and	Section 13
(v) Expiration date or shelf life.	Section 13
(7) Patient labeling must be provided and must include:
(i) Relevant warnings, precautions, adverse effects, and complications;	Section 13
(ii) A description of the device and how it operates;	Section 13
(iii) Instructions on how to correctly use the device; and	Section 13
(iv) The benefits and risks associated with the use of the device.	Section 13

{7}------------------------------------------------

Image /page/7/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 a sans-serif font, with "ALCRESTA" in a larger, blue font and "THERAPEUTICS" in a smaller, gray font.

Compliance with Standards

RELiZORB has been designed in accordance with the following standards:

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Alcresta Therapeutics. The logo features a stylized blue and gray shape above the word "ALCRESTA" in large, blue, sans-serif font. Below that, the word "THERAPEUTICS" is written in a smaller, sans-serif font, also in blue. The edition date of 2018-08 is at the bottom.

ISO 10993-1:2018, 5th Edition 2018-08 0 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO 10993-3:2014, 3rd Edition 2014-10-01 0 Biological evaluation of medical devices- Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
o ISO 10993-5: 2009, 3rd Edition 2009-06-01 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
ISO 10993-6: 2016, 3rd Edition 2016-12-01 . Biological evaluation of medical devices- Part 6: Tests for local effects after implantation
. ISO 10993-10: 2021, 4th Edition 2021-11 Biological evaluation of medical devices- Part 10: Tests for skin sensitization
ISO 10993-11: 2017 Third edition 2017-09 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ISO 10993-12: 2021, 5th Edition 2021-01 ● Biological evaluation of medical devices- Part 12: Sample preparation and reference materials
ISO 10993-13: 2010, 2nd Edition 2010-06-15 0 Biological evaluation of medical devices- Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-17: 2002, 1st Edition 2002-12-01 0 Biological evaluation of medical devices- Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18: 2020. 2nd Edition 2020-01 /Amend 1 2022-05 ● Biological evaluation of medical devices- Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]
ISO 10993-23: 2021, 1st Edition 2021-01 0 Biological evaluation of medical devices- Part 23: Tests for irritation
. ISO/TR 10993-33 First Edition 2015-03-01 Biological evaluation of medical devices- Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
ISO 80369-1: Second Edition 2018-11

{9}------------------------------------------------

Image /page/9/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 a blue serif font for "ALCRESTA" and a gray sans-serif font for "THERAPEUTICS".

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General Requirements

ISO 80369-3 First Edition 2016-07-01 ● Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (including AMMENDMENT 1 (2019)
ISO 80369- 20: 2015 First Edition 2015-05-15 ● Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common Test Methods
ISO 20695 First Edition 2020-03 Enteral feeding systems- Design and testing
ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less

8. Substantial Equivalence:

The subject is nearly identical to the predicate device. The subject and predicate have identical indications for use and differ only in the modifications made from the predicate to the subject to optimize performance to support expanded formula compatibility, allow for bolus feeding, and the use of 6 cartridges per day where the predicate is limited to 2 per day. The following table illustrates the substantial equivalence of the subject to the predicate.

Description	Subject device: RELIZORB	Predicate device: RELIZORB
	(Internal project code- ALC-078)	(K231156)
Indications for use	RELiZORB® is indicated for use inpediatric patients (ages 2 years andabove) and adult patients tohydrolyze fats in enteral formula.	RELiZORB is indicated for use inpediatric patients (ages 2 years andabove) and adult patients tohydrolyze fats in enteral formula.
Device design	Cartridge with iLipase 4 inside:lipase enzyme immobilized onpolymethacrylate beadsENFit compatible	Cartridge with iLipase inside: lipaseenzyme immobilized onpolymethacrylate beadsENFit compatible
Principle ofOperation	Hydrolyze fats in enteral formula asformula passes through the cartridge	Hydrolyze fats in enteral formula asformula passes through the cartridge

{10}------------------------------------------------

Image /page/10/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 a sans-serif font, with the word "ALCRESTA" in blue and the word "THERAPEUTICS" in gray.

T H E R A P E U T I C S
Description	Subject device: RELIZORB(Internal project code- ALC-078)	Predicate device: RELIZORB(K231156)
How used	Cartridge that fits inline as part ofenteral feeding circuit in single ortandem configuration	Cartridge that fits inline as part ofenteral feeding circuit in single ortandem configuration
Conditions of use	Single use- up to 6 cartridges perday (supported by FCN 2295).	Single use- up to 2 cartridges perday (supported by FCN 1498)
Enteral feeding mode	Enteral pump; enteral syringe,(syringe push or gravity)	Enteral pump
Storage Conditions	2°C to 27°C (36°F to 80°F)	2°C to 27°C (36°F to 80°F)

9. Conclusion

Based on the information provided in this premarket notification to support modifications to the currently marketed RELiZORB to optimize performance to support expanded formula compatibility there are no significant differences between the subject and predicate device. The subject RELiZORB is shown to raise no new questions of safety and efficacy and is substantially equivalent to the RELiZORB cleared as K231156.

Regulation Number and Section

§ 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.