(92 days)
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.
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.
The provided FDA 510(k) summary for the UTC 3mL Medication Cartridge (K230718) does not describe an AI/ML-driven medical device, nor does it detail acceptance criteria related to algorithmic performance metrics (e.g., accuracy, sensitivity, specificity) for such a device. Instead, it concerns a physical medical device (a medication cartridge) and its substantial equivalence to a predicate device based on material, design, and performance testing for sterility, biocompatibility, and physical properties.
Therefore, many of the requested points regarding AI/ML device testing (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.
However, I can extract the performance data and acceptance criteria relevant to this specific device, as described in the 510(k) summary, and present them in a structured way that aligns with your request's format, even if the "performance" is mechanical/biological rather than algorithmic.
Here's the information based on the provided document, interpreting "acceptance criteria" and "device performance" in the context of a physical medical device clearance:
Device: UTC 3mL Medication Cartridge (K230718)
Type of Device: Infusion Pump Syringe (Accessory to an Infusion Pump)
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily demonstrated through conformance to recognized international standards and specific performance tests. The summary states that the tests "demonstrated to be in conformance with" or "met the USP acceptance criteria," indicating successful performance against these standards.
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit from Compliance) | Reported Device Performance |
|---|---|---|---|
| Performance Testing | ISO 7886-1:2017 | Conformance to "Syringes for manual use" | Demonstrated conformance. |
| ISO 7886-2:2020-04 | Conformance to "Syringes for use with power-driven syringe pumps" | Demonstrated conformance. | |
| ISO 594-1:1986 | Conformance to "Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements" | Demonstrated conformance. | |
| ISO 594-2:1998 | Conformance to "Conical fitting" | Demonstrated conformance. | |
| Biocompatibility | ISO 10993-1 series | Meets established biological safety parameters for "externally communicating, prolonged exposure device that indirectly contacts the blood path." | All required tests completed successfully (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Subacute Toxicity, Hemocompatibility). |
| Particulate Matter | USP <788> | Meets "Particulate Matter in Injection" acceptance criteria. | Met USP acceptance criteria. |
| Sterilization | ISO 113135:2014 | Validation via Overkill Approach (e.g., Half-Cycle method) and pyrogen test (Bacterial Endotoxin testing). | Sterilized with Ethylene Oxide as per standard, validation successful. |
| Packaging/Shelf-Life | ASTM D4169-16 | Packaging integrity after conditioning and simulated transportation deemed acceptable for product protection and sterility maintenance. | All packaging properties "deemed acceptable." |
| Sterile Barrier Packaging | ASTM 1929 | Conformance to Dye Penetration Test. | Performed, accepted. |
| ASTM F1886/F1886M-16 | Conformance to Visual Inspection Test. | Performed, accepted. | |
| ASTM F2069-11 | Conformance to Bubble Leak Test. | Performed, accepted. | |
| Shelf-Life | ASTM F1980-16 | Validation of 1-year shelf-life via accelerated aging. | 1-year shelf-life validated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each of the performance and biocompatibility tests. It only lists the standards followed. For medical device testing, sample sizes are typically defined by the specific test method within the referenced standards (e.g., ISO, ASTM, USP).
The data provenance is implied to be from laboratory testing conducted as part of the device development and regulatory submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the sense of clinical study data. These are bench/lab tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable here as the "ground truth" for this physical device is established by objective engineering and biological test standards (e.g., whether a Luer taper fits correctly, whether a material is cytotoxic, whether packaging maintains sterility) rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical data review, especially in imaging studies, where expert disagreement needs resolution. For physical device performance tests, the outcome is typically an objective pass/fail against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The UTC 3mL Medication Cartridge is a physical component, not an AI/ML algorithm used for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective engineering and biological test standards and measurements. This includes:
- Physical dimensions and tolerances (e.g., Luer taper).
- Material properties (e.g., polypropylene).
- Biological responses (e.g., cytotoxicity, irritation, hemocompatibility through ISO 10993 series).
- Sterility assurance (e.g., Bacterial Endotoxin testing, ethylene oxide validation).
- Particulate assessment (USP <788>).
- Packaging integrity and shelf-life stability.
8. The Sample Size for the Training Set
Not applicable, as 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, as there is no training set for this type of device.
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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
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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
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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) |
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K230718- 510(k) SUMMARY
Submitter l.
| Submitter's Name: | Gilero LLC |
|---|---|
| Contact Person: | James FentressDirector, Research, Development, and Regulatory Policy |
| Address: | 635 Davis Dr.Ste 100Morrisville, 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 CzamanskiRegulatory Consultant |
| Address: | 635 Davis Dr.Ste 100Morrisville, 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 |
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| Product Classification: | Class II | ProductFeatures | SubjectUnited TherapeuticsCorporation'sUTC 3mL MedicationCartridge | PredicateSmiths Medical MD,Inc.'sSmiths Medical MD,Inc 3ml cartridgereservoir(K051568) | SubstantialEquivalenceDetermination |
|---|---|---|---|---|---|
| Regulation Number: | 21 CFR §880.5725 | Classification | Class II | Class II | -same- |
| Product Code: | MRZ | Product Code | MRZ | FRN | DifferentThe predicate wascleared within thepump submission,hence the differentproduct code. Arecently clearedcartridge, clearedindependent fromthe pump, hasbeen cleared underproduct code MRZ. |
| IV. Predicate Device | RegulationNumber | 21 CFR §880.5725 | 21 CFR §880.5725 | -same-- | |
| Device Name: | Smiths Medical MD, Inc. 3 ml Cartridge Reservoir | DeviceClassificationName | Infusion Pump | Infusion Pump | -same- |
| Indications forUse | The UTC 3 mL MedicationCartridge is intended foruse in professionalhealthcare and outpatientsettings with the CADD-MS 3 Ambulatory InfusionPump for subcutaneousinfusion of medication inadults. | The Smiths Medical MD,Inc. 3-ml CartridgeReservoir is designed foruse with the CADD-MS™ 3 for deliveringmedication. | DifferentThe subjectdevice's indicationsfor use, limit use toadult patients,specifyenvironment of use,and limit use tosubcutaneousinfusion only.These differenceslimit the use andthus, do not raisenew questions forsafety oreffectiveness.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
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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
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| Table 5-1: General Technological Characteristics Comparison | |||
|---|---|---|---|
| ProductFeatures | SubjectUnited TherapeuticsCorporation'sUTC 3mL MedicationCartridge | PredicateSmiths Medical MD,Inc.'sSmiths Medical MD,Inc 3ml cartridgereservoir(K051568) | SubstantialEquivalenceDetermination |
| substantiallyequivalent to itspredicate. | |||
| Materials | Polypropylene | Polypropylene | -same |
| Environment ofUse | Hospital and Outpatient | Hospital and Outpatient | -same- |
| Mechanism ofAction | The cartridge is used byfirst filling it with medicationand then inserting the pre-filled cartridge to theCADD-MS 3 InfusionPump. The user will attachthe needle to the luer of thedevice, extract medicationfrom a vile, remove theneedle and plunger, insertinto the Infusion Pump andthen attach to the femaleluer of an administrationset for subcutaneousinfusion. | The cartridge is used byfirst filling it withmedication and theninserting the pre-filledcartridge to the CADD-MS 3 Infusion Pump.The user will attach theneedle to the luer of thedevice, extractmedication from a vile,remove the needle andplunger, insert into theInfusion Pump and thenattach to the female luerof an administration setfor subcutaneousinfusion. | -same- |
| PumpCompatibility | With CADD-MS® 3Ambulatory Infusion Pump | With CADD-MS® 3Ambulatory InfusionPump | -same- |
| Sterility Status | Sterile, via ethylene oxide | Sterile, via ethyleneoxide | -same- |
| Volume | 3mL | 3mL | -same- |
| Biocompatibility | per ISO 10993-1 | per ISO 10993-1 | -same- |
| Use Type | Prescription Use | Prescription Use | -same- |
| BarrelDimensions | 1.898 x 0.550" (L x OD) | 1.898 x 0.550" (L x OD) | -same- |
| Thumb RestDimensions | 0.525 x 0.525" Square | 0.525 x 0.525" Square | -same- |
| ProductFeatures | Subject | Predicate | SubstantialEquivalenceDetermination |
| Graduations | United TherapeuticsCorporation'sUTC 3mL MedicationCartridge | Smiths Medical MD,Inc.'sSmiths Medical MD,Inc 3ml cartridgereservoir(K051568) | -same- |
| 0.2mL increments withdifferentiating graduationsat 1, 2, and 3 mL | 0.2mL increments withdifferentiatinggraduations at 1, 2, and3 ml |
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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:
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- 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.
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).