(28 days)
Not Found
No
The device description focuses on mechanical components and fixed or manually adjustable flow rates, with no mention of AI or ML.
No.
The device is an infusion system used to deliver prescribed fluid medications, not to directly treat a disease or condition itself.
No
The device is described as an "Infusion System" and its intended use is for the "subcutaneous infusion of indicated fluids." It delivers medication, rather than diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a mechanical infusion pump, syringes, flow control infusion sets, and patient administration sets. It is not solely software.
Based on the provided text, the SCIg60 Infusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of indicated fluids (specifically, human plasma-derived immunoglobulin solutions) into a patient. This is a therapeutic delivery of medication, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a mechanical ambulatory infusion pump and associated components (syringes, flow controllers, infusion sets). These are all designed for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, the SCIg60 Infusion System falls under the category of a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SCIg60 Infusion System is intended for the subcutaneous infusion of indicated fluids in the home or hospital environment for adult or pediatric (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional.
The SCIg60 Infusion System is indicated for the subcutaneous infusion of:
- · Cuvitru Immune Globulin Infusion (Human) 20%, manufactured by Takeda.
- · Gammagard Liquid, Immune Globulin Infusion (Human) 10%, manufactured by Takeda,
- · Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring,
- · Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- · Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- · Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and
- Cutaquig Immune Globulin (Human), 16.5%, manufactured by Octapharma AG
The SCIg60 Infuser Pump is intended for single patient, multiple use only, while flow controller and patient administration sets are single-use only.
Product codes
PKP
Device Description
The EMED SClg60 Infusion System consists of the SClg60 Infuser (Pump), a 50 mL Luer lock syringe, a flow rate influset [fixed rate] flow control infusion set, VersaRate adjustable flow rate infusion set, or VersaRate Plus adjustable flow rate infusion set), and a commercially available subcutaneous (SUB-Q) infusion sets that utilize a standard Luer Lock style connector.
The SClg60 Infuser is a reusable mechanicambulatory infusion pump that does not require batteries or any electrical source. The SClg60 Infuser uses a spring as a source of energy to the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The SClg60 Infuser is provided with a carrying case and User Manual. The SCIg60 Infuser enclosure is made of synthetic polymer blend of glass reinforced polystyrene, the spring is made of stainless steel, and the spring enclosure is made of a blend of modified polyphenylene oxide and fibrous glass.
The Infuset flow control infusion set is an individually packaged, sterile, single-use device. It is assembled from standard Luer lock components and specified lengths of PVC microbore tubing. The tubing results in fixed flow rates when used with the SCIg60 Infuser, and include side-clamps for stopping and starting the SCIg60 Infusion System User Manual includes information to quide users in the selection of Infuset flow control infusion sets to achieve the desired infusion rates.
The VersaRate or VersaRate Plus adjustable flow rate individually packaged, sterile, single-use devices. It is assembled from standard Luer lock components, PVC microbore tubing and a dial made of polycarbonate, styrene-ethylene (VersaRate) or polycarbonate, polyoxymethylene (VersaRate Plus). They may be used with the SCIg60 Infuser to provide convenient control of the flow rate without having to select specific Infusion set. The barrel-shaped dial (VersaRate) or flat dial (VersaRate Plus) can be adjusted by turning a barrel or dial in order to set an appropriate flow rate of immune globulin solution or stop the fluid flow entirely. The SClg60 Infusion System User Manual includes information to guide users in the selection of Infuset, VersaRate Plus settings and SUB-Q infusion sets to achieve the desired infusion rates.
The following commercially available syringes not sold or distributed by EMED are compatible with SClg60 Infusion System: - BD 50 mL syringe (model no. 309653)
- Hizentra® 50 mL Prefilled Syringe (Model / Carton NDC# 44206-455-25)
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
adult or pediatric (2 years and older)
Intended User / Care Setting
home or hospital environment
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
The following testing was performed in support of this submission:
- Functional/Syringe Fitment Verification with the Hizentra 50 mL Prefilled Syringe,
- System Flow Rate Performance Verification with the Hizentra 50 mL Prefilled Syringe.
The non-clinical testing performed demonstrates that the EMED Technologies Corporation SCIg60 Infuser, Infuset flow control extension sets, VersaRate Plus flow controllers, used with SUB-Q patient administration sets, is substantially equivalent to the predicate device and provides infusion rates consistent with the FDA approved human plasma-derived immunoglobulin labeling, when used as directed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 16, 2024
EMED Technologies Corporation Olena Whalen QA/RA/CA Director 1262 Hawks Flight Court Suite 200 El Dorado Hills, California 95762
Re: K240148
Trade/Device Name: SCIg60 Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PKP Dated: January 18, 2024 Received: January 19, 2024
Dear Olena Whalen:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D. Assistant Director, Infusion Devices 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
3
Indications for Use
510(k) Number (if known) K240148
Device Name SCIg60 Infusion System
Indications for Use (Describe)
The SCIg60 Infusion System is intended for the subcutaneous infusion of indicated fluids in the home or hospital environment for adult or pediatric (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional.
The SCIg60 Infusion System is indicated for the subcutaneous infusion of:
- · Cuvitru Immune Globulin Infusion (Human) 20%, manufactured by Takeda.
- · Gammagard Liquid, Immune Globulin Infusion (Human) 10%, manufactured by Takeda,
- · Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring,
- · Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- · Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- · Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and
- Cutaquig Immune Globulin (Human), 16.5%, manufactured by Octapharma AG
The SCIg60 Infuser Pump is intended for single patient, multiple use only, while flow controller and patient administration sets are single-use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) Summary | Prepared on: 2024-01-18 | |
|---|---|---|
| -- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | EMED Technologies Corporation | |
| Applicant Address | 1262 Hawks Flight Court Suite 200 EL Dorado Hills CA 95762 United States | |
| Applicant Contact Telephone | 916-932-0071 | |
| Applicant Contact | Mrs. Olena Whalen | |
| Applicant Contact Email | owhalen@emedtc.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | SCIg60 Infusion System (FP-0010002) | |
| Common Name | Infusion pump | |
| Classification Name | Immunoglobulin G (Igg) Infusion System | |
| Regulation Number | 880.5725 | |
| Product Code(s) | PKP |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K222087 | SCIg60 Infusion System | PKP |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
|---|---|---|
| ---------------------------- | -- | --------------------- |
The EMED SClg60 Infusion System consists of the SClg60 Infuser (Pump), a 50 mL Luer lock syringe, a flow rate influset [fixed rate] flow control infusion set, VersaRate adjustable flow rate infusion set, or VersaRate Plus adjustable flow rate infusion set), and a commercially available subcutaneous (SUB-Q) infusion sets that utilize a standard Luer Lock style connector.
The SClg60 Infuser is a reusable mechanicambulatory infusion pump that does not require batteries or any electrical source. The SClg60 Infuser uses a spring as a source of energy to the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The SClg60 Infuser is provided with a carrying case and User Manual. The SCIg60 Infuser enclosure is made of synthetic polymer blend of glass reinforced polystyrene, the spring is made of stainless steel, and the spring enclosure is made of a blend of modified polyphenylene oxide and fibrous glass.
The Infuset flow control infusion set is an individually packaged, sterile, single-use device. It is assembled from standard Luer lock components and specified lengths of PVC microbore tubing. The tubing results in fixed flow rates when used with the SCIg60 Infuser, and include side-clamps for stopping and starting the SCIg60 Infusion System User Manual includes information to quide users in the selection of Infuset flow control infusion sets to achieve the desired infusion rates.
The VersaRate or VersaRate Plus adjustable flow rate individually packaged, sterile, single-use devices. It is assembled from standard Luer lock components, PVC microbore tubing and a dial made of polycarbonate, styrene-ethylene (VersaRate) or polycarbonate, polyoxymethylene (VersaRate Plus). They may be used with the SCIg60 Infuser to provide convenient control of the flow rate without having to select specific Infusion set. The barrel-shaped dial (VersaRate) or flat dial (VersaRate Plus) can be adjusted by turning a barrel or dial in order to set an appropriate flow rate of immune globulin solution or stop the fluid flow entirely. The SClg60 Infusion System User Manual includes information to guide users in the selection of Infuset, VersaRate Plus
5
settings and SUB-Q infusion sets to achieve the desired infusion rates.
The following commercially available syringes not sold or distributed by EMED are compatible with SClg60 Infusion System: - BD 50 mL syringe (model no. 309653)
- Hizentra® 50 mL Prefilled Syringe (Model / Carton NDC# 44206-455-25)
Intended Use/Indications for Use
The SClg60 Infusion System is intended for the subcutaneous infusion of indicated fluids in the home or hospital environment for adult or pediatric patients (2 years and older) that reguire subcutaneous infusion of fluid medication prescribed by a healthcare professional.
The SCIg60 Infusion System is indicated for the subcutaneous infusion of:
- · Cuvitru Immune Globulin Infusion (Human) 20%, manufactured by Takeda,
- · Gammagard Liguid, Immune Globulin Infusion (Human) 10%, manufactured by Takeda,
- · Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring,
- · Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- · Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and
- · Cutaquiq Immune Globulin (Human), 16.5%, manufactured by Octapharma AG
The SClg60 Infuser Pump is intended for single patient, multiple use only, while flow controller and patient administration sets are single-use only.
Indications for Use Comparison
The proposed indications for use for the subject device are identical to that of the predicate. The system is intended for the subcutaneous infusion of indicated immunoglobulin. The Hizentra 50 mL Prefilled Syringe was added as one of the syringes compatible with SClg60 Infusion System. No new biologics have been added to the indications for use. Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring is already indicated for use with SCIg60 Infusion System. The change does not constitute a new intended use/indications for use. Syringes compatible with the system are listed in the subject device's for Use in the list of compatible syringes.
Additionally, while the intended population did not change and the SCIg60 Infuser remains for single use, while flow controller and patient administration sets are single-use only – these details are now specified in the indications for use statement.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
The subject device has the same technological characteristics as the predicate device. No design changes were made to the SCIg60 Infuser or any of the infusion sets in order to be compatible with the Hizentra 50 mL Prefilled Syringe. Since Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring is already indicated for use with SCIg60 Infusion System, adding the Hizentra 50 mL Prefilled Syringe as compatible with the system does not raise new questions of safety and effectiveness in terms of drug-device compatibility. The syringe fitment and flow rate accuracy against Hizentra prescribing information has been verified during bench testing to confirm that safety and effectiveness were not impacted when used in the same manner as the predicate device. The physical or geometrical differences between the syringe models are negligible hence there is no difference between the two syringe models in terms of the SCIg60 Infusion System usability.
Non-Clinical and/or Clinical Tests Summary & Conclusions
Clinical testing is not applicable for this submission.
The following testing was performed in support of this submission:
- Functional/Syringe Fitment Verification with the Hizentra 50 mL Prefilled Syringe,
- System Flow Rate Performance Verification with the Hizentra 50 mL Prefilled Syringe.
The non-clinical testing performed demonstrates that the EMED Technologies Corporation SCIg60 Infuser, Infuset flow control extension sets, VersaRate Plus flow controllers, used with SUB-Q patient administration sets, is substantially equivalent to the predicate device and provides infusion rates consistent with the FDA approved human plasma-derived immunoglobulin labeling, when used as directed.