The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of insulin in one 24hour time period and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin. Specific basal rates are indicated for each model: V-Go 20 (20 Units/day or 0.83U/hr), V-Go 30 (30 Units/day or 1.25U/hr), and V-Go 40 (40 Units/day or 1.67U/hr).

Device Description

The Valeritas V-Go Disposable Insulin Delivery Device is a mechanical (no electronics), self-contained, sterile, patient fillable, single-use disposable insulin infusion device with an integrated stainless steel subcutaneous needle. It is designed for the subcutaneous infusion of insulin for the management of diabetes mellitus in persons requiring insulin. After filling the V-Go with insulin using the EZ Fill, the device is secured to the patient's skin over the infusion site with an adhesive backed foam pad. Once activated, the V-Go delivers a continuous infusion of insulin at a fixed rate. The device also allows the user to initiate bolus injections. Three device models (20, 30 and 40 Units/day) will be available. A window in the top of the pump allows the user to see into the reservoir to check the drug and to monitor the progress of the infusion.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Valeritas V-Go™ Insulin Delivery Device:

Disclaimer: This document describes a medical device, and the information presented here is based solely on the provided text. For full details and medical advice, always refer to the official documentation and consult with healthcare professionals.

The Valeritas V-Go™ Insulin Delivery Device is a mechanical, self-contained, sterile, patient-fillable, single-use disposable insulin infusion device for the management of diabetes mellitus. It provides continuous basal insulin infusion and on-demand bolus dosing.

The approval for this device (K103825) relies on substantial equivalence to a predicate device (K100504), implying that its performance characteristics are similar. The primary difference for this submission is the qualification of NovoLog for use in the device, in addition to Humalog.

1. Table of Acceptance Criteria and Reported Device Performance

Specification	Acceptance Criteria (Reported Performance)	Notes
Operational Specifications
Reservoir Volume (V-Go 20)	560 µL (56 IU of insulin)	Implicit acceptance criterion derived from reported performance. The document doesn't explicitly state the "acceptance criterion" as a separate value, but rather the device's specified performance.
Reservoir Volume (V-Go 30)	660 µL (66 IU of insulin)	Implicit acceptance criterion derived from reported performance.
Reservoir Volume (V-Go 40)	760 µL (76 IU of insulin)	Implicit acceptance criterion derived from reported performance.
Basal Rate (V-Go 20)	8.3 µL/hr (0.83 IU/hr is the stated intended use rate, 0.6 IU/hr is listed in the operational spec table. )	The document lists 0.83U/hr in the intended use and 0.6IU/hr in the operational specification table. For the purpose of acceptance, it would likely be one or the other, or a range around one of them. For this table, I've primarily used the 'Operational Specifications' table data as it's presented as a direct specification.
Basal Rate (V-Go 30)	12.5 µL/hr (1.25 IU/hr is the stated intended use rate, 1.2 IU/hr is listed in the operational spec table.)	Similar discrepancy as V-Go 20, using the operational spec table data.
Basal Rate (V-Go 40)	16.7 µL/hr (1.67 IU/hr is the stated intended use rate, 1.8 IU/hr is listed in the operational spec table.)	Similar discrepancy as V-Go 20, using the operational spec table data.
Bolus Increments	20 µL (2 IU) and 18 Actuations	Implicit acceptance criterion derived from reported performance.
Nominal Bolus Volume	360 µL (36 IU)	Implicit acceptance criterion derived from reported performance.
Basal Volume (24 Hours)	V-Go 20: 200 µL (20 IU)	Implicit acceptance criterion derived from reported performance.
	V-Go 30: 300 µL (30 IU)
	V-Go 40: 400 µL (40 IU)
Accuracy	+/- 10%	Explicit acceptance criterion. The document states "Accuracy: +/- 10%" for all models.
Environmental Specifications
Temperature	+5 to +37°C	Implicit acceptance criterion from reported performance per AAMI ID26, IPX8.
Humidity	20 - 90%	Implicit acceptance criterion from reported performance per AAMI ID26, IPX8.
Water Ingress Protection	IPX8 (submerged at 1 meter for 24 hours)	Implicit acceptance criterion from reported performance per AAMI ID26, IPX8.
Atmospheric Testing	0-10,000 feet	Implicit acceptance criterion from reported performance per AAMI ID26, IPX8.
Biocompatibility	Materials passed all testing per ISO 10993-1	Explicit acceptance criterion.
Drug Compatibility	Compatible with insulin for duration of use	Explicit acceptance criterion. Specifically, drug contact materials were tested and found compatible with insulin.
Sterilization	Sterilized to SAL of 10^-6 per ANSI/AAMI ST67:2003(R)2008	Explicit acceptance criterion.
Pyrogen Testing	Pyrogen free using USP <85> Bacterial Endotoxin Testing Gel Clot Method with acceptable maximum limit of 20EU/device	Explicit acceptance criterion.
Package Stability	Maintain sterility integrity for up to 36 months per AAMI/ISO 11607-1:2006	Explicit acceptance criterion.
Drug Stability	Humalog stable for up to 24 hours (refrigerated/room temp) + 24 hours wear in V-Go	Explicit acceptance criterion.
	NovoLog stable for up to 5 days (refrigerated) or 3 days (room temp) + 24 hours wear in V-Go	Explicit acceptance criterion. (This is the primary new claim of this 510(k) submission).
EZ Fill Stability	Acceptable for filling Humalog and NovoLog for up to 30 days use	Explicit acceptance criterion. (This acceptance criterion is for the accessory device).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., accuracy, environmental, biocompatibility, sterilization, package stability, drug stability). Instead, it refers to industry standards (e.g., AAMI ID26, ISO 10993-1, ANSI/AAMI ST67:2003(R)2008, USP <85>, AAMI/ISO 11607-1:2006) which typically include statistically appropriate sample size considerations within their methodologies.

The data provenance is not specified in terms of country of origin. The studies are described as non-clinical performance data which are typically conducted in a laboratory setting, not directly on human patients. The drug stability section implies testing in the V-Go device.

The study type is retrospective in the sense that the data presented are results of completed non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device's clearance is based on non-clinical performance data and substantial equivalence to a predicate device. There is no mention of "ground truth" derived from human expert consensus for a test set in the context of diagnostic interpretation, as this is a drug delivery device, not a diagnostic imaging or AI device.

4. Adjudication Method for the Test Set

Not applicable, as no human expert adjudication is mentioned or implied for the non-clinical performance testing.

5. 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. This is a drug delivery device and not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This device is a mechanical insulin delivery device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" implicitly refers to the established scientific and engineering standards and validated measurement methods used in laboratories to determine compliance with the specifications. For example:

Accuracy: Measured insulin delivery rates/volumes compared to a precise reference.
Environmental: Device function under defined temperature, humidity, pressure after exposure to specified conditions.
Biocompatibility: Results of standardized tests on materials (e.g., cytotoxicity, irritation, sensitization).
Sterilization: Results of sterilization cycle validation and biological indicator testing demonstrating a 10^-6 SAL.
Drug Stability: Analytical chemistry methods to assess insulin degradation/potency over time when exposed to the device materials and typical usage conditions.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI/machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's performance is demonstrated through various non-clinical performance studies designed according to established medical device standards. These include:

Operational Specifications Testing: This would involve testing the device's basal rate, bolus increments, reservoir volume, and overall volume delivery accuracy (stated as +/- 10%) under controlled laboratory conditions for all three models (V-Go 20, 30, 40).
Environmental Testing: The device was tested for its ability to perform within specified temperature, humidity, water ingress protection (IPX8), and atmospheric pressure ranges, following standards like AAMI ID26.
Biocompatibility Testing: Materials in contact with drug and skin were tested according to ISO 10993-1 to ensure safety.
Sterilization and Pyrogen Testing: The sterilization process was validated to achieve a Sterility Assurance Level (SAL) of 10^-6 using Ethylene Oxide, following ANSI/AAMI ST67:2003(R)2008. The device was also confirmed pyrogen-free per USP <85>.
Package Stability Testing: The packaging was validated to maintain sterility for up to 36 months, adhering to AAMI/ISO 11607-1:2006.
Drug Stability Testing: Crucially, Humalog and NovoLog insulin's stability was assessed within the V-Go device under various storage and wear conditions. This testing, especially for NovoLog, was a key component of this specific 510(k) submission. For NovoLog, it was shown to be stable for up to 5 days refrigerated or 3 days at room temperature, followed by 24 hours of wear. The EZ Fill accessory was also deemed acceptable for use with both insulins for up to 30 days.

The conclusion is that the "Results of performance testing demonstrated substantial equivalence of the V-Go Disposable Insulin Delivery System to the predicate 510(k) device." This implies that the device successfully met all the non-clinical performance acceptance criteria through these tests. No clinical performance data was deemed required for this specific submission to validate the intended uses and user needs, with design validation completed through human factors simulated use and clinical evaluation testing (though specifics of these are not detailed in the provided text).

Summary

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K103825 800 Turnpike Road
Shrewsbury, MA 01545

Phone

— --- ---

FEB 2 3 2011

510(k) Summary

Owner's Name:	Valeritas, Inc.750 Route 202 South, Suite 100Bridgewater, NJ 08807
Company Contact:	Scott HuieVice President, Regulatory Affairs and Product ComplianceValeritas, Inc.800 Boston TurnpikeShrewsbury, MA 01545(508) 845-1177 X222shuie@valeritas.com
Date Summary Prepared:	9 February 2011
Trade Name:	Valeritas V-Go™ Insulin Delivery Device
Common Name:	Disposable Insulin Delivery Device
Classification Name:	Pump, Infusion, Insulin/Set, Administration, Intravascular
Classification regulation:	Class II: 21 CFR 880.5725Panel: 80, LZG External Insulin Infusion PumpFPA Intravascular Administration Set
Substantial Equivalence:	The Valeritas V-Go Disposable Insulin Delivery Device issubstantially equivalent to the Valeritas V-Go Disposable InsulinDelivery Device K100504, cleared by this Center on December 1,2010
Device Description:	The Valeritas V-Go Disposable Insulin Delivery Device is amechanical (no electronics), self-contained, sterile, patient fillable,single-use disposable insulin infusion device with an integratedstainless steel subcutaneous needle.
	It is designed for the subcutaneous infusion of insulin for themanagement of diabetes mellitus in persons requiring insulin.After filling the V-Go with insulin using the EZ Fill, the device issecured to the patient's skin over the infusion site with an adhesivebacked foam pad, which is attached to the back of the pump. Onceactivated, the V-Go delivers a continuous infusion of insulin at a

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fixed rate. The device also allows the user to initiate bolus injections to supplement their daily basal insulin requirements. Three device models (20, 30 and 40 Units/day) will be available to address the different basal and bolus requirements of each patient. A window in the top of the pump allows the user to see into the reservoir to check the drug and to monitor the progress of the infusion.

Intended Use:

V-Go 20:

The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24hour time period (0.83U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin

V-Go 30:

The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24hour time period (1.25U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin

V-Go 40:

The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24hour time period (1.67U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin

Technological Characteristics:

The V-Go has two delivery mechanisms, one for basal infusion and one for bolus delivery. Both operate by providing force against a plunger, which is inserted into a cylindrical reservoir filled with high viscosity fluid. This force is directly translated against the rear of the delivery piston at the rear of the insulin reservoir.

The Basal Hydraulic Pump operates by applying a constant force by means of a compressed spring. The spring pushes against a disk inserted internally at the rear of the cylindrical fluid filled basal reservoir, forcing the fluid through a restrictive orifice. This displacement translates into displacement of the medicinal delivery

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piston, providing a continuous basal infusion. The basal delivery rate can be varied by the substitution of a different orifice into the device during assembly.

The Bolus Hydraulic Pump operates by applying a force by means of a manually depressed actuator (Bolus Button). Manual actuation allows the displacement of a disk inserted internally at the rear of the cylindrical fluid-filled bolus reservoir in pre-set increments that will displace the volume of fluid and the medicinal delivery piston. The manual actuation requires two steps. First, the user must press the Bolus Release Button. Displacement of the Bolus Release allows the Bolus Button to "pop-out" so that it protrudes slightly from the end of the pump. The user then depresses the Bolus Button, which displaces the Bolus Piston and delivers a pre-set bolus increment. This process is repeated until the desired volume has been delivered or the labeled number of actuations are used up. The Bolus Release Button extends from the pump and locks preventing further use as there are no additional bolus actuations remaining.

Substantial Equivalence:

The Valeritas V-Go Insulin Delivery Device is substantially equivalent to the predicate device, the Valeritas V-Go Insulin Delivery Device cleared by this center on 1 December 2010 (K100504). The Valeritas V-Go device has the same intended use and performance characteristics. The primary difference qualifies the use of NovoLog in the device in addition to Humalog.

Non-Clinical Performance Data:

Physical Specifications

Maximum Dimensions: Weight: Cannula: Pump Mechanism: Interfaces:

84 mm x 47 mm x 13 mm 20 - 50 grams Stainless Steel' J' shaped needle (J-needle) Spring and Manual Hydraulic Displacement Mechanical Buttons

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Operational Specifications

Operational Specifications
Pump Model	V-Go 20	V-Go 30	V-Go 40
Reservoir volume	560 µL(56 IU of insulin)	660 µL(66 IU of insulin)	760 µL(76 IU of insulin)
Basal Rate	8.3 µL/hr(0.6 IU/hr)	12.5 µL/hr(1.2 IU/hr)	16.7 µL/hr(1.8 IU/hr)
Bolus Increments	20 µL (2 IU)18 Actuations	20 µL (2 IU)18 Actuations	20 µL (2 IU)18 Actuations
Nominal BolusVolume	360 µL (36 IU)	360 µL (36 IU)	360 µL (36 IU)
Basal Volume(24 Hours)	200 µL (20 IU)	300 µL (30 IU)	400 µL (40 IU)
Accuracy	+/- 10%	+/- 10%	+/- 10%

Environmental Specifications - Per AAMI ID26, IPX8.

Temperature:	+5 to +37°C
Humidity:	20 - 90%
Water Ingress Protection:	IPX8 (submerged at 1 meter for 24 hours)
Atmospheric Testing:	0-10,000 feet

Biocompatibility - Per ISO 10993-1

Drug and skin contact materials passed all testing per ISO 10993-1. Drug Contact materials were tested and found to be compatible with insulin for the duration of use. Please see the package insert for specific insulin information.

Sterilization and Package Stability

The V-Go and EZ Fill are sterilized using Ethylene Oxide to a Sterility Assurance Level (SAL) of 10 " per ANSI/AAMI ST67:2003(R)2008, Sterilization of Health Care Products - Requirements for products labeled "Sterile".

The V-Go and EZ Fill have been tested as pyrogen free using USP <85> Bacterial Endotoxin Testing Gel Clot Method with an acceptable maximum limit of 20EU/device.

Packaging consists of a thermoformed plastic tray with a Tyvek heat sealable lidstock. Packaging validation demonstrated that the packaging can maintain sterility integrity for up to 36 months per AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems.

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Drug Stability

Humalog has been tested in the V-Go and has been demonstrated to be stable for up to 24 hours storage refrigerated or at room temperature followed by 24 hours wear. NovoLog has been demonstrated to be stable for up to 5 days at refrigerated storage or 3 days at room temperature storage followed by 24 hours wear. The EZ Fill has been demonstrated to be acceptable for filling Humalog and NovoLogfor up to 30 days use.

Clinical Performance Data:

No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use and clinical evaluation testing.

Conclusion:

Results of performance testing demonstrated substantial equivalence of the V-Go Disposable Insulin Delivery System to the predicate 510(k) device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

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

Mr. Scott Huie Vice President, Regulatory Affairs and Product Compliance Valeritas, Incorporated 800 Boston Turnpike Shrewbury, Massachusetts 01545

FEB 2 3 2011

Re: K103825

Trade/Device Name: V-Go™ 20 Disposable Insulin Delivery Device, V-Go™ 40 Disposable Insulin Delivery Device & V-Go™ 30 Disposable Insulin Delivery Device Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, FPA Dated: December 29, 2010 Received: December 30, 2010

Dear Mr. Huie:

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. and the contract of the states of the states of the subscription . . . . . . . .

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Page 2- Mr. Huie

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. Indications for Use Statement

510(k) Number (if known):

Device Name:

V-GoTM 20 Disposable Insulin Delivery Device

Indications For Use:

The V-Go 20 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24hour time period (0.83U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of AneSthesithogy, Son.
Infection Control, Dental Devicesse 1 of 510(k) Number:

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Indications for Use Statement

510(k) Number (if known):

Device Name:

V-GoTM 30 Disposable Insulin Delivery Device

Indications For Use:

The V-Go 30 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24hour time period (1.25U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

2/23/14

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

Page 2 of _ 3_________________________________________________________________________________________________________________________________________________________________

510(k) Number: K103825

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Indications for Use Statement

510(k) Number (if known):

Device Name:

V-GoTM 40 Disposable Insulin Delivery Device

Indications For Use:

The V-Go 40 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24hour time period (1.67U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2/23/16

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 3 of 3

510(k) Number: K103825

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).