Who is the manufacturer of UTC 3mL Medication Cartridge?

Gilero, LLC filed the 510(k) submission for UTC 3mL Medication Cartridge (K230718).

What is the FDA product code for UTC 3mL Medication Cartridge?

MRZ. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for UTC 3mL Medication Cartridge?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like UTC 3mL Medication Cartridge?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

UTC 3mL Medication Cartridge

K230718 · Gilero, LLC · MRZ · Jun 15, 2023 · General Hospital

Device Facts

Record ID	K230718
Device Name	UTC 3mL Medication Cartridge
Applicant	Gilero, LLC
Product Code	MRZ · General Hospital
Decision Date	Jun 15, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

Device Story

The UTC 3mL Medication Cartridge is a sterile, single-use syringe-like reservoir designed for use with the CADD-MS 3 Ambulatory Infusion Pump. The device is used by attaching a 22G x 0.5 in. needle to the male luer lock to extract medication from a vial. After filling, the needle and plunger are removed, and the cartridge is inserted into the infusion pump. The device is then connected to an infusion set for subcutaneous delivery. It is intended for use in hospital and outpatient settings by healthcare professionals or patients. The cartridge features 0.2mL graduation increments. It serves as a container for medication delivery, ensuring compatibility with the specified pump system.

Clinical Evidence

No clinical data. Bench testing only. Conformance demonstrated via ISO 7886-1 (manual syringes), ISO 7886-2 (power-driven pump syringes), ISO 594-1/2 (luer fittings), and USP <788> (particulate matter). Biocompatibility testing per ISO 10993-1 included cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity, subacute toxicity, and hemocompatibility. Sterilization validated via ethylene oxide (ISO 11135) with shelf-life validation per ASTM F1980-16.

Technological Characteristics

Polypropylene construction; 3mL volume; 1.898 x 0.550" barrel dimensions; 0.525 x 0.525" square thumb rest. Features male luer lock. Sterilized via ethylene oxide. Biocompatibility per ISO 10993-1. Designed for use with CADD-MS 3 Ambulatory Infusion Pump.

Indications for Use

Indicated for subcutaneous infusion of medication in adults using the CADD-MS 3 Ambulatory Infusion Pump in hospital and outpatient care environments.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

Smiths Medical MD, Inc. 3 ml Cartridge Reservoir (K051568)

Submission Summary (Full Text)

{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. June 15, 2023 Gilero, LLC Jessica Czamanski Regulatory Consultant 635 Davis Drive Ste 100 Morrisville, North Carolina 27560 Re: K230718 Trade/Device Name: UTC 3mL Medication Cartridge Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRZ Dated: March 14, 2023 Received: March 15, 2023 Dear Jessica Czamanski: 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, Image /page/1/Picture/5 description: The image shows the name "Jake K. Lindstrom -S" in large, bold font. Above this name is the text "Digitally signed by Jake K. Lindstrom -S". Below the name is the date "Date: 2023.06.15" and the time "14:35:28 -04'00'". Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230718 Device Name UTC 3mL Medication Cartridge Indications for Use (Describe) The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults. 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) | #### 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." {3}------------------------------------------------ # K230718- 510(k) SUMMARY #### Submitter l. | Submitter's Name: | Gilero LLC | |-------------------|--------------------------------------------------------------------------| | Contact Person: | James Fentress Director, Research, Development, and Regulatory Policy | | Address: | 635 Davis Dr. Ste 100 Morrisville, NC 27560 USA | | Telephone: | +35 387-943-5990 | | Email: | jfentress@gilero.com | | Date Preparation: | June 15, 2023 | # II. Application Correspondent | Contact's Name: | Gilero, LLC | |-----------------|---------------------------------------------------| | Contact Person: | Jessica Czamanski Regulatory Consultant | | Address: | 635 Davis Dr. Ste 100 Morrisville, NC 27560 | | Telephone: | (754) 422-9101 | | Email: | jczamanski@gilero.com | # III. Subject Device | Trade Name: | UTC 3mL Medication Cartridge | |----------------------|------------------------------| | Common Name: | Infusion Pump Syringe | | Classification Name: | Accessories, Pump, Infusion | {4}------------------------------------------------ | Product Classification: | Class II | Product Features | Subject United Therapeutics Corporation's UTC 3mL Medication Cartridge | Predicate Smiths Medical MD, Inc.'s Smiths Medical MD, Inc 3ml cartridge reservoir (K051568) | Substantial Equivalence Determination | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Number: | 21 CFR §880.5725 | Classification | Class II | Class II | -same- | | Product Code: | MRZ | Product Code | MRZ | FRN | Different The predicate was cleared within the pump submission, hence the different product code. A recently cleared cartridge, cleared independent from the pump, has been cleared under product code MRZ. | | IV. Predicate Device | | Regulation Number | 21 CFR §880.5725 | 21 CFR §880.5725 | -same-- | | Device Name: | Smiths Medical MD, Inc. 3 ml Cartridge Reservoir | Device Classification Name | Infusion Pump | Infusion Pump | -same- | | Indications for Use | The UTC 3 mL Medication Cartridge is intended for use in professional healthcare and outpatient settings with the CADD- MS 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults. | The Smiths Medical MD, Inc. 3-ml Cartridge Reservoir is designed for use with the CADD- MS™ 3 for delivering medication. | Different The subject device's indications for use, limit use to adult patients, specify environment of use, and limit use to subcutaneous infusion only. These differences limit the use and thus, do not raise new questions for safety or effectiveness. Therefore, the | | | 510(k) Number: K051568 ## V. Device Description The UTC 3 mL Cartridge (UTC Cartridge) is a is a sterile, single-use cartridge intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The UTC Cartridge is for use in hospitals and outpatient care environments. The UTC 3 mL Medication Cartridge consists of 3 primary components: a 3mL cartridge that looks like a small syringe, 22G x 0.5 in. needle, and protective cap. The distal end of the device has a male luer lock used to attach the needle and withdraw medication from a vial. Once filled, the plunger is removed, needle is discarded, and protective cap is place on the luer until the cartridge is inserted into the CADD-MS 3 Infusion Pump and secured into place with the infusion pump's lid. The protective cap can then be discarded and the male luer can then be attached to the female luer of an infusion set. ## VI. Indications for Use The UTC 3 mL Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults. #### VII. Comparison of Technological Characteristics with the Predicate Devices The subject and predicate devices have the same intended use. Both are cartridges comprised of the same components, designed to be used with the CADD-MS™ 3 Infusion Pump. The predicate device's barrel, plunger, and plunger rod are made from a polypropylene resin that has been discontinued. The subject device components will also be made from polypropylene, supplied by a different supplier. Furthermore, the {5}------------------------------------------------ indication for use of the predicate device lacks specificity around patient population and environment of use. The subject device's indications include environment of use, patient population, and limit the use of the device to subcutaneous infusion only. Table 5-1 provides a comparison of the subject and predicate devices. Table 5-1: General Technological Characteristics Comparison {6}------------------------------------------------ | Table 5-1: General Technological Characteristics Comparison | | | | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Product Features | Subject United Therapeutics Corporation's UTC 3mL Medication Cartridge | Predicate Smiths Medical MD, Inc.'s Smiths Medical MD, Inc 3ml cartridge reservoir (K051568) | Substantial Equivalence Determination | | | | | substantially equivalent to its predicate. | | Materials | Polypropylene | Polypropylene | -same | | Environment of Use | Hospital and Outpatient | Hospital and Outpatient | -same- | | Mechanism of Action | The cartridge is used by first filling it with medication and then inserting the pre- filled cartridge to the CADD-MS 3 Infusion Pump. The user will attach the needle to the luer of the device, extract medication from a vile, remove the needle and plunger, insert into the Infusion Pump and then attach to the female luer of an administration set for subcutaneous infusion. | The cartridge is used by first filling it with medication and then inserting the pre-filled cartridge to the CADD- MS 3 Infusion Pump. The user will attach the needle to the luer of the device, extract medication from a vile, remove the needle and plunger, insert into the Infusion Pump and then attach to the female luer of an administration set for subcutaneous infusion. | -same- | | Pump Compatibility | With CADD-MS® 3 Ambulatory Infusion Pump | With CADD-MS® 3 Ambulatory Infusion Pump | -same- | | Sterility Status | Sterile, via ethylene oxide | Sterile, via ethylene oxide | -same- | | Volume | 3mL | 3mL | -same- | | Biocompatibility | per ISO 10993-1 | per ISO 10993-1 | -same- | | Use Type | Prescription Use | Prescription Use | -same- | | Barrel Dimensions | 1.898 x 0.550" (L x OD) | 1.898 x 0.550" (L x OD) | -same- | | Thumb Rest Dimensions | 0.525 x 0.525" Square | 0.525 x 0.525" Square | -same- | | Product Features | Subject | Predicate | Substantial Equivalence Determination | | Graduations | United Therapeutics Corporation's UTC 3mL Medication Cartridge | Smiths Medical MD, Inc.'s Smiths Medical MD, Inc 3ml cartridge reservoir (K051568) | -same- | | | 0.2mL increments with differentiating graduations at 1, 2, and 3 mL | 0.2mL increments with differentiating graduations at 1, 2, and 3 ml | | {7}------------------------------------------------ #### VIII. Performance Data The following performance data was considered in support of the substantial equivalence determination. The following tests were performed to demonstrate that the proposed UTC Cartridge met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards. #### a. Performance Testing The sterile, single use UTC 3ml Medication Cartribed in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards: - ISO 7886-1:2017 Sterile hypodermic syringes for single-use Part 1: . Syringes for manual use - ISO 7886-2:2020-04 Sterile hypodermic syringes for single-use Part 2: ● Syringes for use with power-driven syringe pumps - ISO 594-1:1986 Conical fitting with 6% (Luer) taper for syringed, needles and certain other medical equipment - Part 1: General requirements - ISO 594-2:1998 Conical fitting ● ## b. Biocompatibility Biocompatibility testing was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," September 4, 2020, as recognized by FDA. The proposed UTC Cartridge is considered an externally communicating, prolonged exposure device that indirectly contacts the blood path. Therefore, the following tests were completed: {8}------------------------------------------------ - Cytotoxicity ● - Irritation - Sensitization - Acute Systemic Toxicity ● - Pyrogenicity ● - SubacuteToxicity ● - Hemocompatibility . Particulate testing was conducted in accordance with USP<788>Particulate Matter in Injection and met the USP acceptance criteria. ## c. Sterilization The UTC 3mL Medication Cartridge is sterilized with Ethylene Oxide using ISO 113135:2014, validation method by Overkill Approach (e.g., Half-Cycle method) and pyrogen test method using Bacterial Endotoxin testing. - Packaging integrity testing after environment conditioning and simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance. - Sterile Barrier Packaging Testing performed on the proposed device: ● - Dye Penetration Test ASTM 1929 о - Visual Inspection Test ASTM F1886/F1886M-16 o - Bubble Leak Test ASTM F2069-11 o - Shelf-Life of 1 year is validated using FDA recognized standard . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. ## IX. Conclusion The proposed UTC 3mL Medication Cartridge has the same intended use, mechanism of operation and fundamental technology, and similar materials compared to the predicate device, Smiths Medical MD, Inc. 3 ml Cartridge Reservoir (K051568). Any differences in the materials do not raise any new questions or concerns of safety and effectiveness. The information provided in this submission demonstrates that the subject device is substantially equivalent to its predicate.

UTC 3mL Medication Cartridge

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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UTC 3mL Medication Cartridge

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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