Relizorb

K161247 · Alcresta Therapeutics, Inc. · PLQ · Jun 30, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161247
• Device Name: Relizorb
• Applicant: Alcresta Therapeutics, Inc.
• Product Code: PLQ · Gastroenterology, Urology
• Decision Date: Jun 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5985
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

RELiZORB™ is indicated for use in adults to hydrolyze fats in enteral formula

Device Story

RELiZORB is a point-of-care, single-use, inline accessory for enteral feeding circuits. It consists of a cylindrical cartridge containing beads with covalently bound lipase (iLipase™). As enteral formula passes through the cartridge, the immobilized lipase hydrolyzes triglycerides into fatty acids and monoglycerides. This process mimics natural pancreatic lipase function, facilitating fat absorption and utilization in patients with pancreatic insufficiency. The device is used in clinical or home settings by patients or caregivers as part of standard enteral feeding setups. The healthcare provider monitors the patient's nutritional status; the device output is the hydrolyzed formula, which improves nutrient uptake and patient health outcomes.

Clinical Evidence

No new clinical data provided. Previous testing for the predicate device included tensile and mechanical strength, flow rate, enzymatic effect on macronutrients, impurities/degradants characterization, animal testing for hydrolysis effect, and human factors testing. Shelf life testing was completed and met acceptance criteria.

Technological Characteristics

Cylindrical hollow cartridge with inlet/outlet ports; contains beads with immobilized lipase (iLipase™) retained by filters. Standards: ISO 10993-1 (biocompatibility), EN 62366 (usability), EN ISO 14971 (risk management), ISTA 2A (packaging), AAMI/ANSI ID54 (connectors), ISO-14644 (cleanrooms). Mechanical/enzymatic principle; no energy source; single-use.

Indications for Use

Indicated for adults requiring hydrolysis of fats in enteral formula due to insufficient pancreatic lipase levels.

Regulatory Classification

Identification

An enzyme packed cartridge is an ex 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.

Special Controls

In combination with the general controls of the FD&C Act, the Enzyme Packed Cartridge is subject to the following special controls:

*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.

Predicate Devices

• RELiZORB™ (DEN150001)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2016

Alcresta Therapeutics, Inc. Nandini Murthy Regulatory Consultant to Alcresta One Newton Executive Park, Suite 102 Newton, MA 02462

Re: K161247

> Trade/Device Name: RELiZORB™ Regulation Number: 21 CFR §876.5985 Regulation Name: Enzyme Packed Cartridge Regulatory Class: II Product Code: PLO Dated: April 29, 2016 Received: May 3, 2016

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. 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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161247

Device Name RELiZORB™

Indications for Use (Describe)

RELiZORB™ is indicated for use in adults to hydrolyze fats in enteral formula

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) SUMMARY

| Submitter Name: | Alcresta Therapeutics, Inc. |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | One Newton Executive Park, Suite 100<br>Newton, MA 02462 |
| 510(k) Submission Contact: | Nandini Murthy, Regulatory Consultant |
| Phone Number: | 781-710-5378 |
| Sponsor Contact Person: | Robert Gallotto, President and COO |
| Phone Number: | 617-431-3600 |
| Date Prepared: | 30 June, 2016 |
| Device Trade Name: | RELiZORBTM |
| Device Common Name: | Enzyme Packed Cartridge |
| Subject device<br>classification | 21 CFR 876.5985, Product code PLQ |
| Predicate Device: | RELiZORBTM, DEN150001 |
| Predicate device<br>classification | 21 CFR 876.5985, Product code PLQ |
| Device Description: | The RELiZORB device is a point-of-care accessory designed to<br>fit in line with currently used enteral feeding circuits.<br>RELiZORB is designed to hydrolyze (break down) fats present<br>in enteral formulas from triglycerides into fatty acids and<br>monoglycerides to allow for their absorption and utilization by<br>the body. This breakdown of fats by the RELiZORB is intended<br>to mimic the function of the enzyme lipase in patients who do<br>not excrete sufficient levels of pancreatic lipase. RELiZORB is<br>comprised of a cylindrical, hollow cartridge with a single inlet<br>port and a single outlet port connection. Inside the cartridge,<br>there are small white beads. The digestive enzyme, lipase, is<br>covalently bound to the small white beads. The lipase-bead<br>complex, iLipaseTM (immobilized lipase), is retained within the<br>cartridge during use by filters on both ends of the cartridge. The<br>fat in enteral formulas is hydrolyzed as it comes in contact with<br>iLipase as the formula passes through the cartridge. |
| Indications for Use: | RELiZORB is indicated for use in adults to hydrolyze fats in<br>enteral formula. |

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## Rationale for Substantial Equivalence:

| Characteristics | Subject device: RELIZORB | Predicate device: RELIZORB<br>(DEN150001) |
|---------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Indications for<br>use | indicated for use in adults to<br>hydrolyze fats in enteral formula | indicated for use in adults to<br>hydrolyze fats in enteral formula |
| Device design | Cartridge with beads inside, with<br>lipase enzyme immobilized on<br>these beads | Cartridge with beads inside, with<br>lipase enzyme immobilized on<br>these beads |
| Principle of<br>Operation | Hydrolyze fats in enteral formula<br>as formula passes through the<br>cartridge | Hydrolyze fats in enteral formula<br>as formula passes through the<br>cartridge |
| How used | Accessory that fits inline as part<br>of enteral feeding circuit | Accessory that fits inline as part<br>of enteral feeding circuit |
| Conditions of<br>use | Single use | Single use |

## Table 1:Comparison of RELiZORB to the Predicate Device

| Performance Data: | Shelf life testing of RELIZORB was completed and met the acceptance criteria in the protocol. The shelf life test results support the proposed edit to the labeling with respect to product stability.<br><br>The RELIZORB device was previously tested to demonstrate that the device performs as intended under anticipated conditions of use, and safety, including:<br>Tensile and mechanical strength Flow rate Demonstration of enzymatic effect on macronutrients Impurities/degradants characterization Animal testing to demonstrate hydrolysis effect Human factors testing RELiZORB testing was done per design control requirements of 21 CFR Part 820. The Risk management file was reviewed and there was no significant change to the risk assessment as a result of the proposed minor change to the labeling.<br><br>Alcresta develops and manufactures RELIZORB in compliance with the Quality System regulations (21 CFR 820). |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Standards: | There were no standards that were applicable to the shelf life testing conducted. All prior testing with the predicate RELIZORB device (DEN150001) to the following standards are unaffected by the proposed labeling change. |

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- ISO 10993-1:2009/Cor 1:2010 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process · EN 62366:2008 Medical devices - Application of usability engineering
- to medical devices
- · EN ISO 14971:2012 Medical devices. Application of risk management.
- · ISTA 2A: Packaged-Products weighing 150 lb (68 kg) or Less. Basic Requirements: atmospheric conditioning, compression, fixed displacement or random vibration and shock testing.
- · AAMI/ANSI ID54: 1996/(R)2012: Enteral feeding set adapters and connectors
- · ISO-14644: Cleanrooms and associated controlled environments and associated controlled environments

#### Conclusion: The subject RELiZORB has the same indications for use as the predicate device. There have been no changes in warnings or instructions for use of the device. There are no changes to device design, technology or functionality. Therefore the subject RELiZORB is substantially equivalent to the predicate RELiZORB device.