(283 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a medication cartridge, with no mention of AI or ML.
No.
The device is a medication cartridge used with an infusion pump to deliver medication; it does not directly provide therapeutic benefits itself.
No
Explanation: The device is a medication cartridge designed for subcutaneous infusion of medication. Its purpose is to deliver medication, not to diagnose a condition.
No
The device description clearly details a physical, sterile, single-use medication cartridge with a barrel, plunger, and Luer lock fitting, intended for use with a physical infusion pump. The performance studies also focus on physical characteristics and interactions with the pump hardware.
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 to deliver substances into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe-like cartridge designed to hold and deliver medication via an infusion pump. It's a reservoir and delivery mechanism.
- 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 examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for drug delivery.
N/A
Intended Use / Indications for Use
The RG 3ml Medication Cartridge is designed for use in hospitals 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 RG 3ml Medication Cartridge is a sterile, single-use, non-pyrogenic, 3.0 ml piston syringe intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The CADD-MS®3 Ambulatory Infusion Pump requires use of a 3 ml medication cartridge and an infusion set. The RG 3ml Medication Cartridge consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. The male Luer lock fitting of the cartridge is connected to the female Luer fitting of an infusion set. The reservoir is placed in the CADD-MS®3 Ambulatory Infusion Pump to achieve its intended use. The RG 3ml Medication Cartridge is available with a 0.7mm (22G) x 12.5mm (1/2in.) needle and cap. The needle is attached to the end of the RG 3ml Medication Cartridge and operates as a syringe to withdraw medication from a vial.
After the medication is filled in the RG 3ml Medication Cartridge, the plunger stopper is removed to allow the RG 3ml Medication Cartridge to fit inside the Smiths CADD-MS®3 Infusion Pump. A cartridge cap from the Smiths CADD-MS®3 Infusion Pump secures the RG 3ml Medication Cartridge into place. An infusion set is then attached to the luer lock fitting of the RG 3ml Medication 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
adults
Intended User / Care Setting
hospitals 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)
Non-Clinical Performance Testing:
Biocompatibility testing per ISO 10993-1:2009 and the Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process. Tests performed include Cytotoxicity (ISO 10993-5:2009), Dermal Sensitization (ISO 10993-10:2010), Intracutaneous Irritation Test (ISO 10993-10 :2010), Acute Systemic Toxicity (ISO 10993-11 :2017), Subacute Toxicity (ISO 10993-11 :2017), Pyrogenicity (ISO 10993-11 :2017), and Hemolysis (Direct Contact and Indirect Contact) (ISO 10993-4:2017).
Shelf life of 2 years supported by sterility, packaging, and performance testing.
Sterilization validation using Ethylene Oxide per FDA recognized standard ISO 11135: 2014, achieving a sterility assurance level (SAL) of 10-6.
Packaging testing per FDA recognized standards: ASTM F2096 (Bubble Test), ASTM F1929 (Dye Penetration Test), ASTM F1886 (Visual Inspection), STM D4169 (Simulated Shipping), and ISO 11607-2 (General Packaging Standard). Seal strength testing was also conducted.
Performance testing using Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump:
- ISO 7886-2:2020 (Flow rate testing using the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump)
- Occlusion Alarm Testing
- Cartridge Loading and Detection Testing
- Cartridge Volume Alarm Testing
Key results: Results showed that the RG 3ml Medication Cartridge when used with the CADD-MS®3 Ambulatory Infusion Pump passed all testing required in ISO 7886-2 and flow rate testing within pump specifications, supporting substantial equivalence to the predicate device.
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 26, 2021
Chengdu Shifeng Medical Technology Co., Ltd. % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K201634
Trade/Device Name: RG 3ml Medication Cartridge Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ Dated: February 23, 2021 Received: February 23, 2021
Dear Maureen O'Connell:
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 and Part 809); 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,
For CAPT Alan Stevens Acting 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) K201634
Device Name RG 3ml Medication Cartridge
Indications for Use (Describe)
The RG 3ml Medication Cartridge is designed for use in hospitals and outpatient care environments with the CADD-MS3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K201634 510(k) SUMMARY
Chengdu Shifeng Medical Technology Co., Ltd. RG 3ml Medication Cartridge
510(k) Owner
Chengdu Shifeng Medical Technology Co., Ltd. No 31, Yinyuan Road Jinhua Town Xinjin County Chengdu, Sichuan, China
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 Phone: 978-207-1245
Date Prepared: March 26, 2021
Subject Device
| Trade Name: | RG 3ml Medication Cartridge |
|---|---|
| Common or Usual Name: | Infusion Pump Syringe |
| Classification Name: | Pump, Infusion |
| Device Classification: | 21 CFR 880.5725 |
| Class | II |
| Product Code: | MRZ |
| Classification Panel: | General Hospital |
Predicate Device
| Trade Name: | Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump |
|---|---|
| 510(k) Reference: | K051568 |
| Common or Usual Name: | Infusion Pump Syringe |
| Classification Name: | Pump, Infusion |
| Device Classification: | 21 CFR 880.5725 |
| Class | II |
| Product Code: | FRN |
| Classification Panel: | General Hospital |
Device Description
The RG 3ml Medication Cartridge is a sterile, single-use, non-pyrogenic, 3.0 ml piston syringe intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The CADD-MS®3 Ambulatory Infusion Pump requires use of a 3 ml medication cartridge and an infusion set. The RG 3ml Medication Cartridge consists of a hollow barrel, movable plunger with
4
O-rings for sealing and a male Luer lock fitting at the distal end. The male Luer lock fitting of the cartridge is connected to the female Luer fitting of an infusion set. The reservoir is placed in the CADD-MS®3 Ambulatory Infusion Pump to achieve its intended use. The RG 3ml Medication Cartridge is available with a 0.7mm (22G) x 12.5mm (1/2in.) needle and cap. The needle is attached to the end of the RG 3ml Medication Cartridge and operates as a syringe to withdraw medication from a vial.
After the medication is filled in the RG 3ml Medication Cartridge, the plunger stopper is removed to allow the RG 3ml Medication Cartridge to fit inside the Smiths CADD-MS®3 Infusion Pump. A cartridge cap from the Smiths CADD-MS®3 Infusion Pump secures the RG 3ml Medication Cartridge into place. An infusion set is then attached to the luer lock fitting of the RG 3ml Medication Cartridge.
Indications for Use
The RG 3ml Medication Cartridge is designed for use in hospitals and outpatient care environments with the CADD-MS®3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.
Comparison of Technological Characteristics with the Predicate Device
Table 1 provides a tabular presentation of the RG 3ml Medication Cartridge compared with the predicate device. Both the subject device and the 3 ml cartridge component of the predicate device are intended for use in delivering medication utilizing the CADD-MS®3 Ambulatory Infusion Pump. The table below also assess the differences to demonstrate that there no new or different questions of safety and effectiveness between the subject and predicate device.
| RG 3ml Medication Cartridge Substantial Equivalence | |||
|---|---|---|---|
| Characteristic | RG 3ml Medication | ||
| Cartridge | Smiths Medical MD, | ||
| Inc. CADD-MS®3 | |||
| Ambulatory Infusion | |||
| Pump, 3 mL | |||
| Cartridge Reservoir | Discussion of | ||
| Differences | |||
| 510(k) Number | K201634 | K051568 | N/A |
| Product Code | MRZ | FRN | Both are within |
| Infusion pump | |||
| regulation : 21 CFR | |||
| 880.5725, which | |||
| supports substantial | |||
| equivalence | |||
| Indications for Use | The RG 3ml Medication | ||
| Cartridge is designed | |||
| for use in hospitals and | |||
| outpatient care | |||
| environments with the | |||
| CADD-MS®3 | |||
| Ambulatory Infusion | |||
| Pump for subcutaneous | The Smiths Medical | ||
| Inc. 3 ml Cartridge | |||
| Reservoir Indications | |||
| for use are: | |||
| The Smiths Medical | |||
| MD, Inc. 3-ml | |||
| Cartridge Reservoir is | |||
| designed for use with | The predicate device | ||
| includes both a pump | |||
| and cartridge. The | |||
| subject device | |||
| indications are | |||
| compared to the | |||
| cartridge indications | |||
| for use and support |
| Table 1 |
|---|
| RG 3ml Medication Cartridge Substantial Equivalence |
5
| | infusion of medication
in adults. | the CADD-MS 3 for
delivering medication. | substantial
equivalence |
|------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------|
| Use Type | Prescription Use | Prescription Use | Same |
| Cartridge Use | With CADD-MS ® 3
Ambulatory Infusion
Pump | With CADD-MS 3
Ambulatory Infusion
Pump | Same |
| Volume | 3 ml | 3 ml | Same |
| Sterility Status | Sterile, single use | Sterile, single use | Same |
| Biocompatibility | Yes per ISO 10993-1 | Yes per ISO 10993-1 | Same |
Non-Clinical Performance Testing
The following non-clinical/performance testing was used to support substantial equivalence:
The materials used for the RG 3ml Medication Cartridge comply with biocompatibility requirements outlined in ISO 10993-1:2009 and the Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process and are considered to be biocompatible.
The following biocompatibility testing was performed:
| Test | Standard |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 |
| Dermal Sensitization | ISO 10993-10:2010 |
| Intracutaneous Irritation Test | ISO 10993-10 :2010 |
| Acute Systemic Toxicity | ISO 10993-11 :2017 |
| Subacute Toxicity | ISO 10993-11 :2017 |
| Pyrogenicity | ISO 10993-11 :2017 |
| Hemolysis (Direct Contact | |
| and Indirect Contact) | ISO 10993-4:2017 |
The device has a 2-year shelf life. This was supported by sterility, packaging, and performance testing.
Ethylene Oxide is used to sterilize the device and validation was provided per FDA recognized standard ISO 11135: 2014 - Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. A sterility assurance level (SAL) was validated to 10-6.
Packaging testing was also conducted via the following FDA recognized standards: ASTM F2096 (Bubble Test), ASTM F1929 (Dye Penetration Test), ASTM F1886 (Visual Inspection), STM D4169 (Simulated Shipping), and ISO 11607-2 (General Packaging Standard). In addition, seal strength testing was conducted on the packaging.
The following performance testing was conducted using Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump:
6
- . ISO 7886-2:2020 (Flow rate testing using the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump)
- . Occlusion Alarm Testing
- Cartridge Loading and Detection Testing ●
- Cartridge Volume Alarm Testing ●
In order to establish compatibility with the CADD-MS 3 Ambulatory Infusion Pump and demonstrate adequate performance within the pump specifications as compared to the Smiths Medical CADD-MS 3 Cartridge Reservoir, flow rate accuracy testing was conducted using the RG 3 mL Medication Cartridge and the CADD-MS 3 Ambulatory Infusion Pump. Results showed that the RG 3ml Medication Cartridge when used with the CADD-MS®3 Ambulatory Infusion Pump passed all testing required in ISO 7886-2 and flow rate testing within pump specifications, supporting substantial equivalence to the predicate device.
Conclusion
Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing and risk management activities. The RG 3ml Medication Cartridge is Substantially Equivalent (SE) to the Smiths Medical MD. Inc. CADD-MS®3 Ambulatory Infusion Pump, 3 mL Cartridge Reservoir, cleared under K051568.