(195 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 also focus on physical and chemical properties, not algorithmic performance.
No.
RELiZORB hydrolyzes fats in enteral formula outside of the body and does not directly interact with or treat the patient's body in a therapeutic manner. It aids in the digestion of formula before it enters the patient's digestive system.
No
The device is described as a "single-use, point-of-care digestive enzyme cartridge" that hydrolyzes fats in enteral formulas. Its function is to mimic the digestive process rather than to identify or determine the nature or cause of a disease or condition.
No
The device description clearly describes a physical cartridge with beads and filters, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- RELiZORB's Function: RELiZORB is a device that is connected in-line with an enteral feeding circuit. Its function is to hydrolyze fats within the enteral formula itself, before it enters the patient's body. It is not analyzing a sample taken from the patient.
- Intended Use: The intended use clearly states it is used "to hydrolyze fats in enteral formula." This is a process applied to the formula, not a diagnostic test performed on a patient sample.
Therefore, RELiZORB is a medical device used in the process of delivering nutrition, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RELiZORB™ is indicated for use with pediatric (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula.
Product codes (comma separated list FDA assigned to the subject device)
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. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipasebead 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 5 years and above) and adult
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 following test reports were included to demonstrate equivalence:
- Pouch seal/tensile/visual testing
- Primary pouch ship testing (ISTA 2A: Packaged-Products weighing 150 lb (68 kg) or less. Basic Requirements: atmospheric conditioning, compression, fixed displacement or random vibration and shock testing)
- Filter integrity performance
- Hydrolysis
- Flow rate
- Leak testing
All Non-Clinical test results show that the subject RELiZORB is equivalent to the predicate RELiZORB.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RELiZORB™ DEN150001, K161247, K163057
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 4, 2019
Alcresta Therapeutics, Inc. Nandini Murthy Regulatory Consultant to Alcresta One Newton Executive Park, Suite 100 Newton, MA 02462
K191379 Re:
Trade/Device Name: RELiZORB Regulation Number: 21 CFR 876.5985 Regulation Name: Enzyme packed cartridge Regulatory Class: II Product Code: PLQ Dated: November 6, 2019 Received: November 7, 2019
Dear Nandini Murthy:
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, Ph.D. Acting 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
K191379
Device Name
RELIZORB™
Indications for Use (Describe)
RELiZORB™ is indicated for use with pediatric (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
"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
3
Alcresta Therapeutics, Inc. RELiZORB 510(k) K191379
Section 5 – 510(k) Summary
510(k) SUMMARY
| Submitter Name: | Alcresta Therapeutics, Inc. |
|---|---|
| Submitter Address: | One Newton Executive Park, Suite 100 |
| Newton, MA 02462 | |
| 510(k) Submission Contact: | Nandini Murthy, Regulatory Consultant |
| Phone Number: | 781-710-5378 |
| Sponsor Contact Person: | Dr. Eric First, CMO |
| Phone Number: | (617) 838-8655 |
| Date Prepared: | 11/27/2019 |
| Device Trade Name: | RELiZORB™ |
| Device Classification: | Class II |
| Classification Name: | Enzyme packed cartridge |
| Subject device | |
| classification | 21 CFR 876.5985, Product code PLQ |
| Predicate Device: | RELiZORB™ DEN150001, K161247, K163057 |
| Predicate device | |
| classification | 21 CFR 876.5985, Product code 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 |
4
Alcresta Therapeutics, Inc. RELiZORB 510(k) K191379
Section 5 - 510(k) Summary
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. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipasebead 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.
Proposed Indications for Use: RELiZORB is indicated for use with pediatric (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula.
Predicate Indications for Use: RELiZORB is indicated for use with pediatric (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula.
Rationale for Substantial Equivalence:
Table 1- Similarities between Subject device to FDA-Cleared RELiZORB:
| Characteristics | Subject device RELIZORB | FDA-cleared RELIZORB
DEN150001, K161247, K163057 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | RELiZORB is indicated for use in pediatric patients (ages 5 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 bead
ENFit compatible | 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 |
5
Section 5 – 510(k) Summary
| Characteristics | Subject device RELIZORB | FDA-cleared RELIZORB
DEN150001, K161247, K163057 |
|-------------------|-------------------------|-----------------------------------------------------|
| Conditions of use | Single use | Single use |
Table 2 - Minor Differences between Subject device to FDA-Cleared RELiZORB:
| Characteristics | Subject device RELIZORB | FDA-cleared RELIZORB
DEN150001, K161247,
K163057 |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Flow Rate | 10-120 mL/hour single cartridge
48-120 mL/hour tandem
configuration | 24-120 mL/hour single cartridge |
| | | |
| | | |
| Cartridge
instructions
for use
(optional
tandem) | 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) | Single cartridge configuration
(limit of 2 cartridges a day; 1
cartridge for up to 500 mL) |
| | | |
| | | |
| | | |
| | | |
| Optional
Pause time
during use | 15 minutes (up to 1 hour) | 15 minutes |
| | | |
| | | |
| Primary pouch | 5.24" x 5.50" | 8.00" x 4.48" |
| Manufacturing
process | Weld process parameter update,
with minor changes to cartridge to
improve yield (no change to
method for attaching components) | Welded interface in cartridge |
| | | |
| | | |
| | | |
| Filters | Inlet and Outlet filter
configuration & inspection
instructions updated. No change to
materials, functional
specifications, placement,
manufacturing method of filter | Includes Inlet and Outlet filters |
| | | |
| | | |
| | | |
| | | |
| | | |
| iLipase beads | Small change in median range for
bead size, density characteristics.
No change in placement | iLipase beads in cartridge |
| | | |
| | | |
6
Alcresta Therapeutics, Inc. RELiZORB 510(k) K191379
Section 5 - 510(k) Summary
| Performance data: | The following test reports were included to demonstrate equivalence: |
|---|---|
| Pouch seal/tensile/visual testing | |
| Primary pouch ship testing (ISTA 2A: Packaged-Products weighing 150 lb | |
| (68 kg) or less. Basic Requirements: atmospheric conditioning, | |
| compression, fixed displacement or random vibration and shock testing) | |
| Filter integrity performance | |
| Hydrolysis | |
| Flow rate | |
| Leak testing | |
| Standards: | All prior testing with the predicate RELIZORB device (DEN150001, |
| K161247, K161247/A001) to the following standards are unaffected. | |
| • EN 62366:2008 Medical devices - Application of usability engineering | |
| to medical devices. | |
| • EN ISO 14971:2012 – Medical devices. Application of risk | |
| management. | |
| • ISO-14644: Cleanrooms and associated controlled environments and | |
| associated controlled environments. | |
| • ISO / FDIS 80369-3 First Edition 2016-04-25, Small-Bore Connectors | |
| For Liquids And Gases In Healthcare Applications - Part 3: Connectors | |
| For Enteral Applications |
Substantial Equivalence rationale:
The Indications for Use is identical to the predicate. There are no changes to target population or intended use.
Indications for Use:
RELiZORB is indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula
Technology & Design:
The materials of construction, size, instructions for use (including connection instructions, limit of 2 cartridges/day, use of 1 cartridge/500 mL of enteral formula) between the subject and predicate devices are equivalent. Minor differences noted in Table 2 above do not raise new
7
Alcresta Therapeutics, Inc. RELiZORB 510(k) K191379
Section 5 – 510(k) Summary
questions of safety and effectiveness. Where changes required verification or validation testing, such testing was conducted to confirm equivalence.
Test Results:
All Non-Clinical test results show that the subject RELiZORB is equivalent to the predicate RELiZORB.
Substantial Equivalence Conclusion:
The subject RELiZORB is equivalent to the predicate RELiZORB.