(92 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, material properties, and sterilization of a medication cartridge, with no mention of AI or ML capabilities.
No
The device is a sterile, single-use medication cartridge intended for use with an infusion pump to deliver medication, not to directly treat or prevent a disease or condition itself.
No
The device is a medication cartridge used for the subcutaneous infusion of medication, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (cartridge, needle, cap) and the performance studies focus on physical properties and testing (ISO standards for syringes, biocompatibility, sterilization, packaging). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous infusion of medication in adults" using an infusion pump. This describes a device used for delivering substances into the body, not for examining specimens from the body to obtain diagnostic information.
- Device Description: The description details a cartridge that functions like a syringe for holding and delivering medication. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and material properties of the cartridge (syringe standards, luer fittings, biocompatibility, sterilization, packaging), which are relevant to a device used for drug delivery, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MRZ
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.
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
adults
Intended User / Care Setting
hospital and outpatient care environments
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 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:
- Cytotoxicity ●
- Irritation
- Sensitization
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- SubacuteToxicity ●
- Hemocompatibility .
Particulate testing was conducted in accordance with USPParticulate 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.
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.
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
§ 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).
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) |
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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 USPParticulate 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.