Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

K162812 · Unomedical A/S · FPA · Nov 1, 2017 · General Hospital

Device Facts

• Record ID: K162812
• Device Name: Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Nov 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump. The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump. The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump. The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment. The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps. The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System. The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.

Device Story

Sterile, single-use subcutaneous infusion sets; consist of indwelling soft cannula assembly (PFOA-free PTFE cannula, adhesive fixation, injection port, click-lock connector) and infusion tubing set. Insertion facilitated by stainless-steel needle; needle withdrawn post-insertion. Tubing connects to external insulin/medication pumps via luer lock or proprietary connectors. Used in clinical or home environments by patients/caregivers. Provides continuous delivery of medication/insulin to subcutaneous tissue. Benefits include reliable, consistent drug delivery for chronic conditions like diabetes.

Clinical Evidence

Bench testing only. Testing included flow rate verification (40 ml/min), leak testing at various pressures (0.56-3 bar), dynamic pull tests (3N-15N) for component bonds, and bend testing (3000 cycles) to ensure structural integrity. Biocompatibility of the new PFOA-free PTFE material was evaluated per ISO 10993.

Technological Characteristics

Sterile, single-use subcutaneous infusion sets. Materials: PFOA-free PTFE soft cannula, silicone rubber septum, MABS/PVC connectors. Mechanical sensing/delivery via external pump. Connectivity: Luer lock or proprietary pump-specific connectors. Sterilization: Not specified (method unchanged).

Indications for Use

Indicated for subcutaneous infusion of insulin or medication via external infusion pumps in patients requiring such therapy, including home use by patients or caregivers.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Maersk Medical Pureline Comfort Subcutaneous Infusion Set (K972135)
• Abbott Comfort Subcutaneous Infusion Set (K051264)
• Asante Comfort Subcutaneous Infusion Set (K120872)
• Medtronic Silhouette Paradigm Infusion Set (K160648)

Reference Devices

• K032854

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.

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

November 1, 2017

Unomedical A/S % Lee Leichter President P/1 Biomedical 10882 Stonington Avenue Fort Myers, Florida 33913

Re: K162812

Trade/Device Name: Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set. Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set. Abbott Comfort Subcutaneous Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: August 31, 2017 Received: September 1, 2017

Dear Lee Leichter:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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

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,

Image /page/1/Picture/8 description: The image contains a signature that reads "Tina Kiang". The signature is written in a cursive style. There is also a scribble to the left of the name.

Tina Kiang, Ph.D. Acting 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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## Indications for Use

510(k) Number (if known) K162812

#### Device Name

Unomedical Comfort™ Subcutaneous Infusion Set Unomedical Comfort Short™ Subcutaneous Infusion Set Unomedical Neria Soft Subcutaneous Infusion Set

Indications for Use (Describe)

The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump.

The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CER 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CER 801 Subpart C) |

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## Indications for Use

510(k) Number (if known) K162812

#### Device Name

Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set Medtronic Silhouette Paradigm® Subcutaneous Infusion Set

#### Indications for Use (Describe)

The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump.

The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

### 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 [e-mail]

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## Indications for Use

### 510(k) Number (if known) K162812

#### Device Name

Roche Accu-Chek Tender™ Subcutaneous Infusion Set Asante Comfort™ Subcutaneous Infusion Set Abbott Comfort™ Subcutaneous Infusion Set

#### Indications for Use (Describe)

The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps.

The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System.

The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.

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.

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### *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."

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## "510(K) SUMMARY"

Submitted By/Contact Person: John M. Lindskog President Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4320 Leire, Denmark Telephone: + 45 46 42 78 10 (CET 0800-1700) Fax: + 45 46 42 78 65 E-mail: [e-mail]

Date Prepared: 27 August 2017

- 7.1 510(k) Number: K162812
- 7.2 Trade/Proprietary Name: Unomedical Comfort™ Subcutaneous Infusion set

Unomedical Comfort Short™ Subcutaneous Infusion Set Unomedical Neria Soft Subcutaneous Infusion Set Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set Medtronic Silhouette Paradigm® Subcutaneous Infusion Set Roche Accu-Chek Tender™ Subcutaneous Infusion Set Asante Comfort™ Subcutaneous Infusion Set Abbott Comfort™ Subcutaneous Infusion Set

- 7.3 Common/Usual Name Subcutaneous Infusion Set
- 7.4 Classification Name Intravascular Administration Set
- 7.5 Classification Class: II Panel: 80 Product Code: FPA Regulation: 21 CFR 880.5440

#### 7.6 Purpose of Submission

To accurately describe the currently marketed iterates of the Comfort Subcutaneous Infusion set line manufactured in multiple configurations, in multiple facilities and marketed under several brand names by several different companies.

The only changes to the devices included in this submission that were not previously cleared were the change in sterilization facility and the change to a PFOA free silicone cannula, which was done under the U.S. Environmental Protection Agency PFOA Stewardship Program. These changes are supported by this submission.

- 7.7 Substantial Equivalence

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The Comfort™ subcutaneous infusion Sets are substantially equivalent to the Subcutaneous Infusion Sets cleared under the following 510(k)s: K972135 - Maersk Medical Pureline Comfort Subcutaneous Infusion Set K051264 - Abbott Comfort™ Subcutaneous Infusion Set K120872 – Asante Comfort™ Subcutaneous Infusion Set K160648 – Medtronic Silhouette® Paradigm Infusion Set

#### 7.8 Predicate Devices

The devices that serve as predicates for each of the subject devices is identified in Table 1.

#### 7.9 Device Description

The Comfort Subcutaneous Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. The current sets are designed to be used with commercially available infusion devices or are indicated for a specific pump where the set has a proprietary pump reservoir connection (e.g. Medtronic, Asante). Each has two basic components provided for each device. The first is a stand-alone subcutaneous indwelling Soft Cannula. This component of the set is provided as an integral assembly with a PFOA-Free PTFE soft cannula, adhesive backed fixation tape, an injection port and the female portion of a proprietary plastic "click-lock" connector. The assembly comes with a stainless-steel insertion needle. The insertion needle is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion needle comes to the user inserted through the injection port and the inner lumen of the soft cannula with the needle end protruding past the tip of the soft cannula. The male connector is locked to the female connector on the indwelling soft cannula. A needle protector is assembled over the soft cannula and the insertion needle. A separate male portion of the proprietary connector without the insertion needle is provided in the package. This component is used to attach to the female connector after the indwelling soft cannula has been inserted and the steel insertion needle has been withdrawn and protects the indwelling cannula when the infusion set is not attached. Each Soft cannula set comes individually packaged in its own blister pack sealed with paper lid stock.

The second component is the infusion tubing set. The infusion tubing set for all sets are comprised of a co-extruded tube with a stainless-steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. The proximal end of the current Comfort set terminates in either a standard luer lock connector or a proprietary connector compatible with the specified pump. The sets come individually packaged in blister packs sealed with paper lid stock.

#### 7.10 -Indication for Use

The Indications for use for each set is provided in Table 1.

#### 7.11 Intended Use

The intended use of these sets has not changed. These sets remain intended to be used for subcutaneous infusion of insulin or medication when connected to a compatible pump. The specific drug (insulin or medication) and the specific compatible pump differ depending on the intended use of each infusion set.

## 7.12 Technological Characteristics

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The technological characteristics of all the Comfort Subcutaneous infusion Sets (regardless of the branding) have not changed. The device's operating principle(s) or mechanism of action, configurations (models, lengths, etc.), performance specifications, and packaging have not changed. All changes in the materials of construction or design of any of the devices have already been submitted on at least one of the family of devices. All of these changes have been previously cleared except the change from of the PFTE Soft Cannula to a PFOA-Free PTFE Soft Cannula (due to mandatory material discontinuation by the suppliance with the U.S. Environmental Protection Agency PFOA Stewardship Program); which is cleared in this submission. This new material was extracted and analyzed per ISO 10993 and found to substantially equivalent to the PTFE material. This submission is to ensure that the information at the FDA on these devices is consistent with the latest configurations. Table 1 provides a comparison of the key characteristics of the devices.

#### 7.13 -Performance Data

The following verification testing was performed:

- 7.8.1 Flow test:
7.8.1.1 Tubing Set - 40 ml/min at 1 bar pressure

- 7.8.2 Leak test:
- 7.8.2.1 Luer-Lock - No Leaks at 3 bar pressure for 30 seconds
- 7.8.2.2 Pcap - No Leaks at 1.4 bar pressure for 30 seconds
- Asante Hub No Leaks at 0.56 bar pressure for 30 seconds 7.8.2.3

## 7.8.3 Pull tests:

- Soft Cannula to Cannula housing: 3 N, Dynamic Pull 7.8.3.1
- 7.8.3.2 Tubing to tubing Luer-lock: 15 N, Dynamic pull
- Tubing to Needle Connector: 15 N. Dynamic pull 7.8.3.3
- Cannula housing to Needle Connector: 15 N, Dynamic pull 7.8.3.4
- 7.8.3.5 Cannula housing to Adhesive: 15 N, Dynamic pull

## 7.8.4 Bend test:

- No leaks and no break at the tubing after 3000 bendings 7.8.4.1
#### 7.14 Conclusion

Unomedical A/S confirmed that the devices passed all testing and concluded that the Subject Devices are substantially equivalent to the predicate devices currently legally marketed in the USA.

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# TABLE 1

| SUBJECT<br>DEVICE BRAND<br>NAMES | UNOMEDICAL<br>COMFORT | UNOMEDICAL<br>COMFORT -<br>SHORT | MEDTRONIC<br>SILHOUETTE®<br>LUER LOCK<br>INFUSION SET | ROCHE<br>ACCUCHECK<br>TENDER | UNOMEDICAL<br>NERIA SOFT | MEDTRONIC<br>SILHOUETTE®<br>PARADIGM® | ABBOTT COMFORT | ASANTE<br>COMFORT |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREDICATE<br>510(K) FILE<br>NUMBER | K972135 | K972135 | K972135 | K972135 | K972135 | K160648 | K051264* | K120872 |
| PREDICATE<br>NAME | MAERSK<br>MEDICAL<br>PURELINE<br>COMFORT<br>SUBCUTANEOUS<br>INFUSION SET | MAERSK<br>MEDICAL<br>PURELINE<br>COMFORT<br>SUBCUTANEOUS<br>INFUSION SET | MAERSK<br>MEDICAL<br>PURELINE<br>COMFORT<br>SUBCUTANEOU<br>S INFUSION SET | MAERSK<br>MEDICAL<br>PURELINE<br>COMFORT<br>SUBCUTANEO<br>US INFUSION<br>SET | MAERSK<br>MEDICAL<br>PURELINE<br>COMFORT<br>SUBCUTANEOU<br>S INFUSION SET | MEDTRONIC<br>SILHOUETTE®<br>PARADIGM® | ABBOTT COMFORT<br>SUBCUTANEOUS<br>INFUSION SET | ASANTE<br>COMFORT<br>SUBCUTANEOUS<br>INFUSION SET |
| CLEARED<br>INDICATIONS<br>FOR USE | INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS INTO THE<br>BODY BELOW<br>THE SURFACE<br>OF THE SKIN. | INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS INTO THE<br>BODY BELOW<br>THE SURFACE<br>OF THE SKIN. | INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS INTO<br>THE BODY<br>BELOW THE<br>SURFACE OF<br>THE SKIN. | INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS INTO<br>THE BODY<br>BELOW THE<br>SURFACE OF<br>THE SKIN. | INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS INTO<br>THE BODY<br>BELOW THE<br>SURFACE OF<br>THE SKIN. | FOR USE WITH<br>MEDTRONIC<br>PARADIGM<br>INSULIN<br>SUBCUTANEOUS<br>INFUSION PUMPS<br>FOR<br>CONTINUOUS<br>SUBCUTANEOUS<br>INSULIN<br>INFUSION BY<br>PATIENTS OR<br>CAREGIVERS IN<br>THE HOME<br>ENVIRONMENT. | INFUSION OF<br>FLUIDS INTO THE<br>BODY BELOW THE<br>SURFACE OF THE<br>SKIN WHEN<br>ATTACHED TO A<br>FLUID RESERVOIR<br>OF A COMPATIBLE<br>ABBOTT PUMP | SUBCUTANEOUS<br>INFUSION OF<br>MEDICATION,<br>INCLUDING<br>INSULIN,<br>ADMINISTERED<br>BY THE PEARL™<br>EXTERNAL<br>INSULIN PUMP<br>SYSTEM |
| PROPOSED<br>INDICATIONS<br>FOR USE<br>(K162812) | SUBCUTANEOUS<br>INFUSION OF<br>INSULIN<br>ADMINISTERED<br>BY AN<br>EXTERNAL PUMP | SUBCUTANEOUS<br>INFUSION OF<br>INSULIN<br>ADMINISTERED<br>BY AN<br>EXTERNAL PUMP | SUBCUTANEOU<br>S INFUSION OF<br>INSULIN FROM<br>AN INFUSION<br>PUMP | SUBCUTANEO<br>US INFUSION<br>OF INSULIN<br>ADMINISTERED<br>WITH<br>MICRODOSAG<br>E INSULIN<br>PUMPS. | SUBCUTANEOU<br>S INFUSION OF<br>MEDICATION<br>ADMINISTERED<br>BY AN<br>EXTERNAL<br>PUMP | NO CHANGE | NO CHANGE (IF<br>COMMERCIALIZED) | SUBCUTANEOUS<br>INFUSION OF<br>INSULIN<br>ADMINISTERED<br>BY THE SNAP™<br>INSULIN PUMP<br>SYSTEM |
| DETAIL OF<br>DIFFERENCES | SUBCUTANEOUS<br>INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS-INSULIN<br>INTO THE BODY | SUBCUTANEOUS<br>INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS-INSULIN<br>INTO THE BODY | SUBCUTANEOU<br>S INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS-INSULIN<br>INTO THE BODY | SUBCUTANEO<br>US INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS<br>INSULIN INTO | SUBCUTANEOU<br>S INFUSION<br>AND/OR<br>INJECTION OF<br>FLUIDS<br>MEDICATION | NO CHANGE | NO CHANGE (IF<br>COMMERCIALIZED) | SUBCUTANEOUS<br>INFUSION OF<br>MEDICATION,<br>INCLUDING<br>INSULIN,<br>ADMINISTERED |
| | BELOW THE<br>SURFACE OF<br>THE SKIN<br>ADMINISTERED<br>BY AN<br>EXTERNAL<br>PUMP. | BELOW THE<br>SURFACE OF<br>THE SKIN<br>ADMINISTERED<br>BY AN<br>EXTERNAL<br>PUMP. | BELOW THE<br>SURFACE OF<br>THE SKIN-FROM<br>AN INFUSION<br>PUMP. | THE BODY<br>BELOW THE<br>SURFACE OF<br>THE SKIN<br>ADMINISTERED<br>WITH<br>MICRODOSAG<br>E INSULIN<br>PUMPS. | INTO THE BODY<br>BELOW THE<br>SURFACE OF<br>THE SKIN<br>ADMINISTERED<br>BY AN<br>EXTERNAL<br>PUMP. | | | BY THE<br>PEARL™SNAP™<br>EXTERNAL<br>INSULIN PUMP<br>SYSTEM |
| INSTRUCTION<br>FOR USE<br>CHANGES | NO<br>SUBSTANTIVE<br>CHANGE -<br>INSTRUCTIONS<br>FOR USE<br>PROVIDED IN<br>ORIGINAL<br>SUBMISSION<br>HAVE BEEN<br>UPDATED AND<br>STANDARDIZED<br>(ALL ARE<br>PROVIDED IN<br>APPENDIX II). | NO<br>SUBSTANTIVE<br>CHANGE -<br>INSTRUCTIONS<br>FOR USE<br>PROVIDED IN<br>ORIGINAL<br>SUBMISSION<br>HAVE BEEN<br>UPDATED AND<br>STANDARDIZED<br>(ALL ARE<br>PROVIDED IN<br>APPENDIX II). | NO<br>SUBSTANTIVE<br>CHANGE -<br>INSTRUCTIONS<br>FOR USE<br>PROVIDED IN<br>ORIGINAL<br>SUBMISSION<br>HAVE BEEN<br>UPDATED AND<br>STANDARDIZED<br>(ALL ARE<br>PROVIDED IN<br>APPENDIX II). | NO<br>SUBSTANTIVE<br>CHANGE -<br>INSTRUCTIONS<br>FOR USE<br>PROVIDED IN<br>ORIGINAL<br>SUBMISSION<br>HAVE BEEN<br>UPDATED AND<br>STANDARDIZE<br>D (ALL ARE<br>PROVIDED IN<br>APPENDIX II). | NO<br>SUBSTANTIVE<br>CHANGE -<br>INSTRUCTIONS<br>FOR USE<br>PROVIDED IN<br>ORIGINAL<br>SUBMISSION<br>HAVE BEEN<br>UPDATED AND<br>STANDARDIZED<br>(ALL ARE<br>PROVIDED IN<br>APPENDIX II). | NO CHANGE | IF<br>COMMERCIALIZED,<br>DRAFT<br>INSTRUCTIONS FOR<br>USE PROVIDED IN<br>ORIGINAL<br>SUBMISSION WILL<br>BE FINALIZED AND<br>STANDARDIZED | NO<br>SUBSTANTIVE<br>CHANGE -<br>DRAFT<br>INSTRUCTIONS<br>FOR USE<br>PROVIDED IN<br>ORIGINAL<br>SUBMISSION<br>HAVE BEEN<br>FINALIZED AND<br>STANDARDIZED<br>(ALL ARE<br>PROVIDED IN<br>APPENDIX II). |
| STERILIZATION/<br>STERILIZATION<br>LOCATION/<br>SUBCONTRACT<br>ORS<br>CHANGES | CHANGE OF<br>STERILIZATION<br>SITE ONLY. NO<br>CHANGE TO<br>STERILIZATION<br>METHOD OR SAL. | CHANGE OF<br>STERILIZATION<br>SITE ONLY. NO<br>CHANGE TO<br>STERILIZATION<br>METHOD OR SAL. | CHANGE OF<br>STERILIZATION<br>SITE ONLY. NO<br>CHANGE TO<br>STERILIZATION<br>METHOD OR<br>SAL. | CHANGE OF<br>STERILIZATION<br>SITE ONLY. NO<br>CHANGE TO<br>STERILIZATION<br>METHOD OR<br>SAL. | CHANGE OF<br>STERILIZATION<br>SITE ONLY. NO<br>CHANGE TO<br>STERILIZATION<br>METHOD OR<br>SAL. | CHANGE OF<br>STERILIZATION<br>SITE ONLY. NO<br>CHANGE TO<br>STERILIZATION<br>METHOD OR SAL. | IF<br>COMMERCIALIZED,<br>STERILIZATION<br>SITE WILL BE<br>CHANGED<br>WITHOUT CHANGE<br>TO STERILIZATION<br>METHOD OR SAL. | CHANGE OF<br>STERILIZATION<br>SITE ONLY. NO<br>CHANGE TO<br>STERILIZATION<br>METHOD OR SAL. |
| MATERIALS/<br>COMPONENTS<br>CHANGES | THE SOFT<br>CANNULA<br>MATERIAL WAS<br>MODIFIED TO A<br>PFOA FREE<br>PTFE, (U.S.<br>ENVIRONMENTA<br>L PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). | THE SOFT<br>CANNULA<br>MATERIAL WAS<br>MODIFIED TO A<br>PFOA FREE<br>PTFE, (U.S.<br>ENVIRONMENTAL<br>PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). | THE SOFT<br>CANNULA<br>MATERIAL WAS<br>MODIFIED TO A<br>PFOA FREE<br>PTFE,<br>(U.S.<br>ENVIRONMENTA<br>L PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). | THE SOFT<br>CANNULA<br>MATERIAL<br>WAS MODIFIED<br>TO A PFOA<br>FREE PTFE,<br>(U.S.<br>ENVIRONMENT<br>AL<br>PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). | THE SOFT<br>CANNULA<br>MATERIAL WAS<br>MODIFIED TO A<br>PFOA FREE<br>PTFE,<br>(U.S.<br>ENVIRONMENTA<br>L PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). | THE SOFT<br>CANNULA<br>MATERIAL WAS<br>MODIFIED TO A<br>PFOA FREE<br>PTFE,<br>(U.S.<br>ENVIRONMENTAL<br>PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). | IF<br>COMMERCIALIZED,<br>THE SOFT<br>CANNULA<br>MATERIAL WILL BE<br>MODIFIED TO A<br>PFOA FREE PTFE,<br>(U.S.<br>ENVIRONMENTAL<br>PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). | THE SOFT<br>CANNULA<br>MATERIAL WAS<br>MODIFIED TO A<br>PFOA FREE<br>PTFE,<br>(U.S.<br>ENVIRONMENTAL<br>PROTECTION<br>AGENCY PFOA<br>STEWARDSHIP<br>PROGRAM). |
| | THE SEPTUM<br>WAS CHANGED<br>FROM<br>THERMOPLASTIC<br>ELASTOMER<br>(TPE) TO<br>SILICONE<br>RUBBER. THIS<br>MATERIAL WAS<br>IDENTIFIED AND<br>CLEARED IN<br>SUBMISSION<br>K051264 | THE SEPTUM<br>WAS CHANGED<br>FROM<br>THERMOPLASTIC<br>ELASTOMER<br>(TPE) TO<br>SILICONE<br>RUBBER. THIS<br>MATERIAL WAS<br>IDENTIFIED AND<br>CLEARED IN<br>SUBMISSION<br>K051264 | THE SEPTUM<br>WAS CHANGED<br>FROM<br>THERMOPLASTI<br>C ELASTOMER<br>(TPE) TO<br>SILICONE<br>RUBBER. THIS<br>MATERIAL WAS<br>IDENTIFIED AND<br>CLEARED IN<br>SUBMISSION<br>K051264 | THE SEPTUM<br>WAS<br>CHANGED<br>FROM<br>THERMOPLAST<br>IC ELASTOMER<br>(TPE) TO<br>SILICONE<br>RUBBER. THIS<br>MATERIAL<br>WAS<br>IDENTIFIED<br>AND CLEARED<br>IN SUBMISSION<br>K051264 | THE SEPTUM<br>WAS CHANGED<br>FROM<br>THERMOPLASTI<br>C ELASTOMER<br>(TPE) TO<br>SILICONE<br>RUBBER. THIS<br>MATERIAL WAS<br>IDENTIFIED AND<br>CLEARED IN<br>SUBMISSION<br>K051264 | THE SEPTUM<br>WAS CHANGED<br>FROM<br>THERMOPLASTIC<br>ELASTOMER<br>(TPE) TO<br>SILICONE<br>RUBBER. THIS<br>MATERIAL WAS<br>IDENTIFIED AND<br>CLEARED IN<br>SUBMISSION<br>K051264 | NO CHANGE | NO CHANGE |
| | THE LUER LOCK<br>CONNECTOR<br>CHANGED FROM<br>PVC (POLYVINYL<br>CHLORIDE) TO<br>MABS<br>(METHYLMETHA<br>CRYLATE<br>ACRYLONITRILE<br>BUTADIENE<br>STYRENE).<br>THIS MATERIAL<br>WAS IDENTIFIED<br>AND CLEARED IN<br>SUBMISSION<br>K032854 | THE LUER LOCK<br>CONNECTOR<br>CHANGED FROM<br>PVC (POLYVINYL<br>CHLORIDE) TO<br>MABS<br>(METHYLMETHAC<br>RYLATE<br>ACRYLONITRILE<br>BUTADIENE<br>STYRENE).<br>THIS MATERIAL<br>WAS IDENTIFIED<br>AND CLEARED IN<br>SUBMISSION<br>K032854 | THE LUER LOCK<br>CONNECTOR<br>CHANGED<br>FROM PVC<br>(POLYVINYL<br>CHLORIDE) TO<br>MABS<br>(METHYLMETHA<br>CRYLATE<br>ACRYLONITRILE<br>BUTADIENE<br>STYRENE).<br>THIS MATERIAL<br>WAS IDENTIFIED<br>AND CLEARED<br>IN SUBMISSION<br>K032854 | THE LUER<br>LOCK<br>CONNECTOR<br>CHANGED<br>FROM PVC<br>(POLYVINYL<br>CHLORIDE) TO<br>MABS<br>(METHYLMETH<br>ACRYLATE<br>ACRYLONITRIL<br>E BUTADIENE<br>STYRENE).<br>THIS<br>MATERIAL<br>WAS<br>IDENTIFIED<br>AND CLEARED<br>IN SUBMISSION<br>K032854 | THE LUER LOCK<br>CONNECTOR<br>CHANGED<br>FROM PVC<br>(POLYVINYL<br>CHLORIDE) TO<br>MABS<br>(METHYLMETHA<br>CRYLATE<br>ACRYLONITRILE<br>BUTADIENE<br>STYRENE).<br>THIS MATERIAL<br>WAS IDENTIFIED<br>AND CLEARED<br>IN SUBMISSION<br>K032854 | NO CHANGE | NO CHANGE | NO CHANGE |
| SPECIFCATION/<br>TEST METHODS<br>CHANGES | A BENDING TEST<br>HAS BEEN<br>INTRODUCED TO<br>VERIFY<br>ROBUSTESS OF<br>TUBING BONDS<br>WHEN<br>SUBJECTED TO<br>STRESSES SEEN<br>DURING USE. | A BENDING TEST<br>HAS BEEN<br>INTRODUCED TO<br>VERIFY<br>ROBUSTESS OF<br>TUBING BONDS<br>WHEN<br>SUBJECTED TO<br>STRESSES SEEN<br>DURING USE. | A BENDING<br>TEST HAS BEEN<br>INTRODUCED<br>TO VERIFY<br>ROBUSTESS OF<br>TUBING BONDS<br>WHEN<br>SUBJECTED TO<br>STRESSES<br>SEEN DURING<br>USE. | A BENDING<br>TEST HAS<br>BEEN<br>INTRODUCED<br>TO VERIFY<br>ROBUSTESS<br>OF TUBING<br>BONDS WHEN<br>SUBJECTED<br>TO STRESSES<br>SEEN DURING<br>USE. | A BENDING<br>TEST HAS BEEN<br>INTRODUCED<br>TO VERIFY<br>ROBUSTESS OF<br>TUBING BONDS<br>WHEN<br>SUBJECTED TO<br>STRESSES<br>SEEN DURING<br>USE. | A BENDING TEST<br>HAS BEEN<br>INTRODUCED TO<br>VERIFY<br>ROBUSTESS OF<br>TUBING BONDS<br>WHEN<br>SUBJECTED TO<br>STRESSES SEEN<br>DURING USE. | IF<br>COMMERCIALIZED,<br>A BENDING TEST<br>WILL BE<br>INTRODUCED TO<br>VERIFY<br>ROBUSTESS OF<br>TUBING BONDS<br>WHEN SUBJECTED<br>TO STRESSES<br>SEEN DURING USE. | A BENDING TEST<br>HAS BEEN<br>INTRODUCED TO<br>VERIFY<br>ROBUSTESS OF<br>TUBING BONDS<br>WHEN<br>SUBJECTED TO<br>STRESSES SEEN<br>DURING USE. |
| A TENSION TEST<br>HAS BEEN<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING<br>OF TEST<br>SAMPLES<br>IMMERSED IN<br>37°C WATER FOR<br>18-24 HRS. | A TENSION TEST<br>HAS BEEN<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING<br>OF TEST<br>SAMPLES<br>IMMERSED IN<br>37°C WATER FOR<br>18-24 HRS. | A TENSION<br>TEST HAS BEEN<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING<br>OF TEST<br>SAMPLES<br>IMMERSED IN<br>37°C WATER<br>FOR 18-24 HRS. | A TENSION<br>TEST HAS<br>BEEN<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING<br>OF TEST<br>SAMPLES<br>IMMERSED IN<br>37°C WATER<br>FOR 18-24 HRS. | A TENSION<br>TEST HAS BEEN<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING<br>OF TEST<br>SAMPLES<br>IMMERSED IN<br>37°C WATER<br>FOR 18-24 HRS. | A TENSION TEST<br>HAS BEEN<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING<br>OF TEST<br>SAMPLES<br>IMMERSED IN<br>37°C WATER FOR<br>18-24 HRS. | IF<br>COMMERCIALIZED,<br>A TENSION TEST<br>WILL BE<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING OF<br>TEST SAMPLES<br>IMMERSED IN 37°C<br>WATER FOR 18-24<br>HRS. | A TENSION TEST<br>HAS BEEN<br>INTRODCUED<br>AFTER PRE-<br>CONDITIONING<br>OF TEST<br>SAMPLES<br>IMMERSED IN<br>37°C WATER FOR<br>18-24 HRS. | |

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*The Abbott Set was cleared but has not been commercialized