SCIg60 Infuser, Infuset

• K Number: K142319
• Device Name: SCIg60 Infuser, Infuset
• Manufacturer: EMED TECHNOLOGIES CORPORATION
• Date Cleared: 2015-05-14 ( 267 days)
• Product Code: PKP
• Regulation Number: 880.5725

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% 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.

Predicate Devices

K140131, K140133, K933652

Reference Devices

K140133,K140131

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a "reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source" and uses a spring for pressure. There is no mention of any computational or learning capabilities.

Therapeutic

Yes
The device is intended for the subcutaneous infusion of a therapeutic drug (Hizentra, Immune Globulin Subcutaneous), which directly contributes to a therapeutic effect in the patient.

Diagnostic

No

Explanation: The device described is an "Infusion System" designed for the subcutaneous infusion of a specific medication (Hizentra). Its function is to deliver medication, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the SCIg60 Infuser is a "reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source" and uses a spring as a source of pressure. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, the SCIg60 Infusion System is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use is for the "subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid". This describes a device used to administer a medication directly into a patient's body.
• Device Description: The description details a mechanical infusion pump and associated tubing and sets used for delivering fluid.
• Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SCIg60 Infusion System does not perform any such analysis of biological specimens. It is a drug delivery device.

Therefore, the SCIg60 Infusion System is a medical device for drug administration, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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% Liquid (manufactured by CSL Behring) with the BD 60 ml syringe (model no. 309653).

Product codes

PKP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subcutaneous

Indicated Patient Age Range

Not Found

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 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;
  • Particulates;
  • Protein concentration;
  • Amount of IgG fragments, polymers or aggregates;
  • Anti-complementary activity (ACA);
  • Density; and,
  • Fc-function
• 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:
  • First Infusion of Hizentra – SUB-Q and Infuset™ Combinations table for Needle Gauge 24 (1 and 4 needles) and 27 (2 and 4 needles) with Total Flow Rate, Approx. Per Site Flow Rate, Infuset™ Reorder Number and SUB-Q Set.
  • Standard Infusions – SUB-Q and Infuset™ Combinations table for Needle Gauge 24 (1, 2, 3, 4 needles) and 27 (1, 2, 3, 4 needles) with Total Flow Rate, Approx. Per Site Flow Rate, Infuset™ Reorder Number and SUB-Q Set.

Key Metrics

Not Found

Predicate Device(s)

K140131, K140133, K933652

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style.

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 [phone] or [phone] 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 [phone] or [phone] 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 SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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) |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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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: [phone] Fax: [phone]

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

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.

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-Q
Needle
Gauge | Number of
needles | Total Flow
Rate
(ml/hr) | Approx. Per
Site Flow
Rate
(ml/hr) | Infuset™
Reorder
Number | 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-Q
Needle
Gauge | Number of
needles | Total Flow
Rate
(ml/hr) | Approx. Per
Site Flow
Rate
(ml/hr) | Infuset™
Reorder
Number | 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.