The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring) with the BD 60 ml syringe (model no. 309653).

Device Description

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser, the Infuset™ flow control extension set and SUB-Q patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset™ flow control extension sets and SUB-Q patient administration sets are also manufactured by EMED Technologies (see K140133 and K140131).

The SCIg60 Infuser is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring).

The Infuset™ flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stopping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset™ flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates.

SCIg60 Infusion System should be used in accordance with its directions for use.

AI/ML Overview

Please find the requested information regarding the acceptance criteria and study details for the SCIg60 Infusion System below.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Conclusion
Infusion Accuracy	- Achieve specified flow rates using various SCIg60 Infuser, Infuset™ extension sets, and SUB-Q patient administration set combinations.- Account for the characteristics of Hizentra in flow rate accuracy.	Performance data demonstrated that the SCIg60 Infusion System provides infusion rates consistent with the FDA-approved Hizentra labeling when used as directed. The study included: - Infusion accuracy testing with SCIg60 Infusion System and Hizentra. - Infusion accuracy testing with combinations of SCIg60 Infuser, Infuset™ extension sets, and SUB-Q patient administration sets and Hizentra simulated test fluid. - Validation of simulated Hizentra test fluid.
Influence of Elevation	- Demonstrate consistent flow rates across varying elevations.	Influence of elevation on flow rate was tested. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance.
Residual Volume	- Minimize residual volume of Hizentra at the end of infusion.	Residual volume of Hizentra remaining at the end of infusion was measured. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance.
Reliability	- Maintain performance over the labeled shelf life (accelerated aging).	Reliability testing of SCIg60 Infuser devices that were aged (accelerated aging) to the labeled shelf life was conducted. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance.
Biocompatibility	- Be biocompatible for components in contact with the patient.	Biocompatibility data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards.
Sterility	- Ensure sterility of relevant components.	Sterility data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards.
Shelf Life	- Maintain integrity and function over the specified shelf life.	Shelf life data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards.
Human Factors	- Ensure safe and effective use by intended users.	Human factors testing was conducted to validate the SCIg60 Infusion System, implying that the device was found to be safe and effective for its intended users. The specific acceptance criteria are not detailed.
Hizentra Compatibility	- Demonstrate no adverse effects on Hizentra after infusion through the system regarding appearance, particulates, protein concentration, IgG fragments/polymers/aggregates, anti-complementary activity (ACA), density, and Fc-function.	Compatibility of Hizentra with the SCIg60 Infusion System was conducted. The characteristics of Hizentra (appearance, particulates, protein concentration, amount of IgG fragments, polymers or aggregates, anti-complementary activity (ACA), density, and Fc-function) were evaluated after being infused through the SCIg60 Infusion System and compared to a control. The document does not explicitly state quantitative acceptance criteria, but the overall conclusion of substantial equivalence suggests the device did not adversely affect Hizentra.
Safety Assurance	- Provide a safety assurance case as recommended by FDA guidance.	A safety assurance case for the SCIg60 Infusion System was provided, as recommended by the FDA guidance document, Infusion Pumps Total Product Life Cycle. This indicates that a comprehensive assessment of potential risks and their mitigation was performed to ensure the safety of the device. The explicit acceptance criteria for this case are not detailed.

Study Details:

Sample Size used for the test set and the data provenance:
The document does not specify the exact sample sizes for each performance test (e.g., number of infusers, sets, or Hizentra samples tested).
The data provenance is implied to be from laboratory testing conducted by EMED Technologies Corporation, likely within the United States. The data is retrospective in the sense that it was collected as part of the 510(k) submission process, not as a prospective clinical trial on human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given that the testing involves technical performance characteristics of an infusion pump, the "ground truth" would generally be established through calibrated laboratory measurements and validated test methods, rather than expert consensus on clinical findings. For the Hizentra compatibility testing, the "ground truth" would be the known properties of Hizentra before infusion and comparison to a control, likely measured by qualified laboratory personnel.
Adjudication method for the test set:
Not applicable. The testing primarily involves objective measurements of device performance characteristics (flow rate, residual volume, material properties, etc.) against pre-defined technical specifications. These types of tests do not typically require adjudication by multiple experts in the way clinical diagnostic studies might.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The SCIg60 Infusion System is an infusion pump, a mechanical device for drug delivery, not a diagnostic imaging device or an AI-powered system that assists human readers in interpreting medical data. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The SCIg60 Infusion System is a mechanical infusion pump. It does not contain algorithms for diagnostic interpretation or decision-making that would require a "standalone" algorithm performance study. Its performance is inherent in its mechanical design and function.
The type of ground truth used:
The ground truth for the performance testing was based on:
- Objective Laboratory Measurements: Calibrated instruments and established test methods to measure flow rates, residual volumes, and material properties.
- Predicate Device Performance: Comparison to the performance and characteristics of legally marketed predicate infusion systems.
- Hizentra Labeling and Properties: The known and approved properties of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid directly from the manufacturer and its FDA-approved labeling.
- FDA Guidance Documents: Compliance with recommendations from relevant FDA guidance, such as "Infusion Pumps Total Product Life Cycle," for the safety assurance case.
The sample size for the training set:
Not applicable. This device is a mechanical infusion pump and does not involve AI or machine learning algorithms that require a "training set" of data.
How the ground truth for the training set was established:
Not applicable, as no training set was used.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2015

EMED Technologies Corporation Mr. Peter Kollings Director Regulatory Affairs and Ouality Assurance 1264 Hawks Flight Court, Suite 200 El Dorado Hills, California 95762

Re: K142319

Trade/Device Name: SCIg60 Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: PKP Dated: April 13, 2015 Received: April 14, 2015

Dear Mr. Kollings:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
	Indications for Use
510(k) Number (if known)	K142319
Device Name	SCIg60 Infusion System
Indications for Use (Describe)	The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring) with the BD 60 ml syringe (model no. 309653).
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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FORM FDA 3881 (1/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740
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510(k) Summary

K142319

Summary Prepared: May 8, 2015

General Information

Classification Class II Trade Name SCIg60 Infusion System Common Name: Infusion Pump Classification Name and Reference: Pump, Infusion Regulation: 21 CFR §880.5725 Product Code: PKP (Hizentra Infusion System)

Submitter Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct El Dorado Hills, Ca Tel: 916.932.0071 Fax: 916.932.0074

Intended Use

The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liguid (manufactured by CSL Behring) with the BD 60 ml syringe (model no. 309653).

Comparison of Intended Use of Subject and Predicate devices

The SCIg60 Infusion System and the SUB-Q Tissue Infusion Set predicate are both intended for the subcutaneous infusion of medicines using an external syringe. The SCIg60 Infusion System is intended specifically for subcutaneous infusion of Hizentra from the BD 60 ml syringe, which is a narrower and more specific use than that of the predicate. This specific intended use falls within the more general intended use of the SUB-Q Tissue Infusion Set, and therefore does not alter the intended therapeutic effect of the SCIg60 Infusion System when used as labeled.

The intended use of the Infuset™ Flow Control Extension Set and Freedom 60 Syringe Infusion Pump System predicates are to administer fluids from specific 60 ml syringes to a patient's vascular system. The intended use of the SCIg60 Infusion System specifies the infusion of a single biological product from a specific syringe to the patient via a subcutaneous route of administration.

Specifying use of the SCIg60 Infusion System with Hizentra narrows the intended use to a single legally marketed biological product approved for subcutaneous infusion. The intended subcutaneous infusion route of administration is consistent with the indicated Hizentra package insert. Both the SCIg60 Infusion System and the predicates indicate for the BD 60 ml syringe (model no.

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309653), and both incorporate equivalent designs and rely upon the same principles of action to provide controlled flow of liquid medicines at flow rates and operating pressures appropriate for subcutaneous infusion therapy. The SCIg60 Infusion System design, labeling, and risk management activities effectively account for the specified liquid medicine, intended route of administration, and specified syringe.

Any differences between the intended use of the SCIg60 Infusion System and the Infuset™ Flow Control Extension Set and Freedom 60 Syringe Infusion Pump System do not alter the intended therapeutic effect of the SCIg60 Infusion System when used as labeled.

Primary Predicate Device(s)

EMED Technologies Corporation K140131, SUB-0 Patient Administration Sets K140133, Infuset™ flow control extension sets

Repro-Med Systems, Inc. K933652, Freedom 60 Syringe Infusion Pump System with syringe set and tubing

Device Description

SCIg60 Infusion System should be used in accordance with its directions for use.

Technological Characteristics

The overall principle of action for the SCIg60 Infusion System and the Freedom 60 Infusion System are identical in that both consist of a constant pressure source acting upon a syringe filled with fluid. with the flow rate of that fluid being regulated by PVC tubing with fixed fluid path dimensions (i.e. tubing length and inner diameter). The flow control properties of the tubing follows the Poiseuille equation in that pressure, length of fluid path, diameter of fluid path, and viscosity of a fluid in a system directly influence resultant flow rates of that fluid.

The Infuset™ flow control extension sets are identical to K140133.

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The SUB-Q patient administration sets are identical to K140131.

Performance Testing

The following testing was a basis for substantial equivalence determination:

Infusion accuracy testing with SCIg60 Infusion System and Hizentra ●
Infusion accuracy testing with combinations of SCIg60 Infuser, Infuset™ extension sets, and . SUB-Q patient administration sets and Hizentra simulated test fluid.
Validation of simulated Hizentra test fluid.
Influence of elevation on flow rate.
. Residual volume of Hizentra remaining at the end of infusion.
Reliability testing of SCIg60 Infuser devices that were aged (accelerated aging) to the labeled ● shelf life.
. Biocompatibility, sterility, and shelf life data were incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (see K140131 and K140133).
A safety assurance case for the SCIg60 Infusion System was provided, as recommended by the FDA guidance document, Infusion Pumps Total Product Life Cycle.
. Human factors testing to validate the SCIg60 Infusion System.
. Compatibility of Hizentra with the SCIg60 Infusion System was conducted. The following characteristics were evaluated for Hizentra after being infused through the SCIg60 Infusion System in accordance with the device instructions for use, and were compared to a control:
- Appearance; O
- Particulates; O
- Protein concentration; o
- Amount of IgG fragments, polymers or aggregates; O
- Anti-complementary activity (ACA); O
- O Density; and,
- Fc-function o
The SCIg60 Infusion System includes directions for the selection of Infuset™ flow control . extension sets and SUB-Q patient administration sets in order to achieve desired infusion rates, in accordance with the following tables:

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SUB-QNeedleGauge	Number ofneedles	Total FlowRate(ml/hr)	Approx. PerSite FlowRate(ml/hr)	Infuset™ReorderNumber	SUB-Q Set
24	1	12	12	FP-0010008	SUB-109-G24
	4	39	10	FP-0010009	SUB-409-G24
27	2	25	13	FP-0010005	SUB-260
	4	47	12	FP-0010004	SUB-410

First Infusion of Hizentra – SUB-Q and Infuset™ Combinations

Standard Infusions – SUB-Q and Infuset™ Combinations

SUB-QNeedleGauge	Number ofneedles	Total FlowRate(ml/hr)	Approx. PerSite FlowRate(ml/hr)	Infuset™ReorderNumber	SUB-Q Set
	l	12	12	FP-0010008	SUB-109-G24
24		16	16	FP-0010007	SUB-109-G24
	2	26	13	FP-0010010	SUB-209-G24
		રેરિયાન સારત દેશના પાકની ખેતી કરવામાં આવે છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેર	18	FP-0010009	SUB-209-G24
	3	39	10	FP-0010009	SUB-309-G24
		રી	17	FP-0010005	SUB-309-G24
	ব	39	10	FP-0010009	SUB-409-G24
		52	13	FP-0010005	SUB-409-G24
27	1	14	14	FP-0010009	SUB-109-G27
		17	17	FP-0010004	SUB-109-G27
	2	25	13	FP-0010005	SUB-260
		30	16	FP-0010004	SUB-260
	3	43	14	FP-0010004	SUB-320
	4	47	12	FP-0010004	SUB-410

Summary of Substantial Equivalence

The performance data demonstrates that the EMED Technologies Corporation SCIg60 Infusion System is substantially equivalent to the predicate devices and provides infusion rates consistent with the FDA approved Hizentra labeling, when used as directed.

Regulation Number and Section

§ 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).