(84 days)
K192659 Omnipod Insulin Management System and Omnipod DASH Insulin Management System
Not Found
No
The description focuses on standard insulin pump functionality, bolus calculations based on user input and pre-programmed settings, and communication protocols. There is no mention of AI or ML being used for decision-making, pattern recognition, or adaptive algorithms beyond basic calculations.
Yes
The device is intended for the "subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus," which directly qualifies it as a therapeutic device.
No
The "Intended Use" section explicitly states that "The glucose measurements should not be used for the diagnosis of or screening for diabetes." This indicates that while the device measures glucose, it is not intended for diagnostic purposes.
No
The device description clearly states that the system is comprised of two primary components: a disposable insulin infusion pump (Pod) and a wireless remote controller (PDM). Both of these are hardware components. While the PDM contains software for control and calculations, the system as a whole is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Mention of In Vitro Diagnostic: The "Intended Use / Indications for Use" section explicitly states that the Omnipod Insulin Management System is intended for the "quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger." The term "in vitro" directly indicates that a diagnostic test is being performed outside of the body.
- Glucose Measurement Component: The description of the Omnipod Insulin Management System clearly states that the PDM has an "integrated blood glucose meter" and uses "Abbott FreeStyle test strips" for the "quantitative measurement of blood glucose in fresh whole capillary blood." This component is performing a diagnostic test on a biological sample (blood).
- Purpose of Glucose Measurement: The glucose measurements are used for the "management of diabetes mellitus," which is a medical condition. While the measurements are not for initial diagnosis or screening, they are used to inform treatment decisions (insulin delivery), which is a key aspect of managing a disease.
While the primary function of the system is insulin delivery, the inclusion of a blood glucose meter for quantitative measurement of glucose in vitro makes it an IVD. The Omnipod DASH system, while not having an integrated meter, is interoperable with a compatible blood glucose meter, which would also be an IVD.
N/A
Intended Use / Indications for Use
The Omnipod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.
Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm, and palm. Abbott FreeStyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
Product codes (comma separated list FDA assigned to the subject device)
LZG, NBW, NDC
Device Description
The subject devices provide for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. They are each comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM). The PDMs incorporate a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading. programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.
Both systems are for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home setting by people with diabetes mellitus who require insulin on a daily basis.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Drug Stability and Compatibility 5.4.1
In-use stability and leachables testing was conducted with Lyumjev U100 insulin to verify and validate that the systems do not adversely affect the insulin.
Key Results: Performance testing demonstrates that the use of Lyumjev has no effect on safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K192659 Omnipod Insulin Management System and Omnipod DASH Insulin Management System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 13, 2021
Insulet Corporation Dennis Shay Regulatory Affairs Manager 100 Nagog Park Acton, MA 01720
Re: K211575
Trade/Device Name: Omnipod® Insulin Management System Omnipod DASH® Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG, NBW, NDC Dated: May 20, 2021 Received: May 21, 2021
Dear Dennis Shay:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211575
Device Name Omnipod Insulin Management System
Indications for Use (Describe)
The Omnipod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.
Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm, and palm. Abbott FreeStyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K211575
Device Name Omnipod DASH Insulin Management System
Indications for Use (Describe)
The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
5.0 510(K) SUMMARY
| Date prepared: | 11 August 2021 |
|---|---|
| Submitter Name: | Insulet Corporation |
| Submitter Address: | 100 Nagog Park |
| Acton, MA 01720 | |
| FDA Establishment | |
| Owner/Operator Number: | 9056196 |
| FDA Establishment Registration | |
| Number: | 3014585508 |
| Contact Information: | Dennis Shay, PhD |
| Regulatory Affairs Manager | |
| (978) 846-1247 (office) | |
| (978) 600-0120 (fax) | |
| Device Trade / Proprietary Name: | Omnipod® Insulin Management System |
| Omnipod DASH® Insulin Management | |
| System | |
| Device Common Name: | Pump, Infusion, Insulin |
| Regulation Description: | Infusion pump |
| Regulation Medical Specialty: | Clinical Chemistry |
| Review Panel: | Clinical Chemistry |
| Product Code: | LZG (Infusion Pump) |
| Subsequent: | |
| NBW (System, Test, Blood Glucose, Over the | |
| Counter) | |
| NDC (Calculator, Drug Dose) | |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 880.5725 |
| Device Class: | Class II |
| Device predicate: | K192659 Omnipod Insulin Management |
| System and Omnipod DASH Insulin | |
| Management System |
5
5.1 Purpose of Submission
Modification to legally marketed devices to add Lyumiev U100 to the labeling as an insulin that is compatible with the systems.
5.2 Device Description
The subject devices provide for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. They are each comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM). The PDMs incorporate a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading. programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.
Both systems are for prescription use only.
6
5.2.1 Indications for Use
5.2.1.1 Omnipod Insulin Management System
The Omnipod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
The glucose measurements should not be used for the diagnosis or screening for diabetes. The PDM glucose meter is intended for single patient use and should not be shared.
Abbott FreeStyle® test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
5.2.1.2 Omnipod DASH Insulin Management System
The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
The subject devices have the same intended use and indications for use as their predicates.
5.3 Summary of Technological Characteristics Compared to Predicate Device
The subject devices are identical to the predicate devices cleared in K192659. There have been no modifications to the materials, design, sterilization method, software, or manufacturing processes. The only difference is adding Lyumjev™ U100 insulin to the labeling as an insulin that has been tested and found safe to use with both systems.
5.4 Performance Data
The following performance testing data were provided in support of the substantial equivalence determination.
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Drug Stability and Compatibility 5.4.1
In-use stability and leachables testing was conducted with Lyumjev U100 insulin to verify and validate that the systems do not adversely affect the insulin.
ર.ર Safety Assurance Case
A safety assurance case for the labeling change to add Lyumjev was provided for each system as recommended in the FDA Guidance: Infusion Pumps Total Product Life Cycle.
The stated goal of the Omnipod Insulin Management System safety assurance case is:
The Omnipod Insulin Management System with blood glucose monitor and dose calculator is acceptably safe for the infusion of U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis.
The stated goal of the Omnipod DASH Insulin Management System safety assurance case is:
The Omnipod DASH Insulin Management System with dose calculator is acceptably safe for the infusion of U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis.
Additions to the safety assurance cases from the predicate devices' cases include the use of the device with Lyumjev U100.
5.5.1 Risk Management
Risk Management was completed in accordance with ISO 14971:2007- Medical Devices-Application of Risk Management to Medical Devices. Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the devices are safe for use.
5.5.2 Standards Compliance
The Omnipod Insulin Management System and the Omnipod DASH Insulin Management System comply with the following standards as documented in the predicate devices (K192659) and in the applicable test reports provided in this 510(k) submission.
- ISO 10993-1 (2018)- 4th Edition Biological Evaluation of Medical Devices- Part 1: . Evaluation and Testing within a Risk Management Process
- ISO 14971 Second Edition (2007) Medical Devices- Application of Risk Management . to Medical Devices
8
Summary of Substantial Equivalence to the Predicate 5.6
The devices described in this 510(k) are equivalent to those cleared in K192659. The equivalence is based upon the fact that the subject and predicate devices have the same principals of operation, technological characteristics and, indications for use. The only difference between the subject and predicate devices is the addition of Lyumjev U100 to the labeling as an insulin that is compatible with the systems. The following tables below illustrate the equivalence of the subject devices to their predicate.
9
| Element
Of
Comparison | Subject Device:
Omnipod Insulin
Management System | Predicate Device:
Omnipod Insulin
Management System
(K192659) | Discussion |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for subcutaneous
delivery of insulin at set
and variable rates for the
management of diabetes
mellitus in persons
requiring insulin and for
the quantitative
measurement of glucose
in fresh whole capillary
blood (in vitro).
The glucose measurements
should not be used for the
diagnosis of or screening
for diabetes. The PDM
glucose meter is intended
for single-patient use and
should not be shared.
Abbott FreeStyle test strips
are used with the built-in
FreeStyle meter for the
quantitative measurement
of blood glucose in fresh
whole capillary blood from
the finger, upper arm and
palm. Abbott Freestyle
Control Solutions are used
to verify that the meter and
test strips are working
together properly and that
the test is performed
correctly. | Intended for subcutaneous
delivery of insulin at set
and variable rates for the
management of diabetes
mellitus in persons
requiring insulin and for
the quantitative
measurement of glucose in
fresh whole capillary
blood (in vitro).
The glucose measurements
should not be used for the
diagnosis of or screening for
diabetes. The PDM glucose
meter is intended for single-
patient use and should not
be shared.
Abbott FreeStyle test strips
are used with the built-in
FreeStyle meter for the
quantitative measurement of
blood glucose in fresh
whole capillary blood from
the finger, upper arm and
palm. Abbott Freestyle
Control Solutions are used
to verify that the meter and
test strips are working
together properly and that
the test is performed
correctly. | Same |
| Specific
Drug/Biologic
Use | U-100 Insulin.
System has been tested
with NovoLog, Humalog,
Apidra, Admelog, Fiasp,
and Lyumjev | U-100 Insulin.
System has been tested
with NovoLog, Humalog,
Apidra, Admelog, and
Fiasp | Lyumjev U100 is a
Fast-acting Insulin
Lispro-aabc.
Performance testing
demonstrates that the
use of Lyumjev has
no effect on safety |
| Prescription
Status | Prescription Device | Prescription Device | Same |
| Components
and
Accessories | Pump (Pod), hand-held
controller (PDM) with
integrated Freestyle blood
glucose meter. Accessories
include batteries, test
strips, lancets, control
solution, prep pads and
carry pouch. | Pump (Pod), hand-held
controller (PDM) with
integrated Freestyle blood
glucose meter. Accessories
include batteries, test
strips, lancets, control
solution, prep pads and
carry pouch. | Same |
| Infusion
pump | Pod, fill syringe, fill needle | Pod, fill syringe, fill needle | Same |
| Pumping
Mechanism | Step Drive Mechanism is
activated by
microprocessor; turns
leadscrew; presses on
syringe style reservoir. | Step Drive Mechanism is
activated by
microprocessor; turns
leadscrew; presses on
syringe style reservoir. | Same |
| Administrativ
e
Sets And | Integrated reservoir and
patient activated cannula
insertion system. | Integrated reservoir and
patient activated cannula
insertion system. | Same |
| Non-Fluid
Pathway
Materials | Pod Housing:
Polycarbonate
Adhesive: Biocompatible
Medical Grade Acrylic
Adhesive with a Non-
woven Polyester Backing | Pod Housing:
Polycarbonate
Adhesive: Biocompatible
Medical Grade Acrylic
Adhesive with a Non-
woven Polyester Backing | Same |
| | | | |
| Fluid Pathway
Materials | Perfluorocopolymer (FEP) | Perfluorocopolymer (FEP) | Same |
| | Silicone Lubricants | Silicone Lubricants | |
| | Stainless Steel | Stainless Steel | |
| | Silicone Rubber | Silicone Rubber | |
| | Polypropylene | Polypropylene | |
| | Polyvinylchloride (PVC)
Cyclic Olefin Copolymer | Polyvinylchloride (PVC)
Cyclic Olefin Copolymer | |
| | Polypropylene & EPDM
Rubber (non-latex) | Polypropylene & EPDM
Rubber (non-latex) | |
| | Polyisoprene | Polyisoprene | |
| | Flow Rates
and
Profiles | Basal: 0.05 -30 units/hour
in 0.05 unit increments. | |
| Bolus: 0.05 - 30 units in
0.05 unit increments.
7 Basal Profiles | | Bolus: 0.05 - 30 units in
0.05 unit increments.
7 Basal Profiles | |
| Maximum
Bolus
Flow Rate | 1.5 units per minute | 1.5 units per minute | Same |
| Delivery
Accuracy | Basal: ± 5% at rates ≥ 0.05
U/hr
Bolus: ± 5% for all set
values ≥ 1.0 unit, ± 0.05
unit for set values