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K Number
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
Manufacturer
UNOMEDICAL A/S
Date Cleared
2017-11-01

(391 days)

Product Code
FPA
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

K972135, K160648, K051264*, K120872

Not Found

No
The document describes a mechanical infusion set and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

No.
The device is an infusion set, which is used to deliver medication, but it is not a therapeutic device itself as it does not directly treat a disease or condition.

No

The devices described are infusion sets, which are used to deliver medication subcutaneously. They do not perform any diagnostic function such as identifying a disease or medical condition.

No

The device description clearly outlines physical components like cannulas, tubing, connectors, and needles, indicating it is a hardware medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the devices are for "subcutaneous infusion of insulin" or "subcutaneous infusion of medication" administered by an external pump. This involves delivering substances into the body, not analyzing samples from the body.
  • Device Description: The description details components like cannulas, tubing, connectors, and needles, all designed for delivering fluids subcutaneously. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases

The device is a delivery system for medication, which falls under a different regulatory category than IVDs.

N/A

Intended Use / Indications for 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.

Product codes

FPA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subcutaneous

Indicated Patient Age Range

Not Found

Intended User / Care Setting

patients or caregivers in the home environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
    • 7.8.2.3 Asante Hub No Leaks at 0.56 bar pressure for 30 seconds
  • 7.8.3 Pull tests:
    • 7.8.3.1 Soft Cannula to Cannula housing: 3 N, Dynamic Pull
    • 7.8.3.2 Tubing to tubing Luer-lock: 15 N, Dynamic pull
    • 7.8.3.3 Tubing to Needle Connector: 15 N. Dynamic pull
    • 7.8.3.4 Cannula housing to Needle Connector: 15 N, Dynamic pull
    • 7.8.3.5 Cannula housing to Adhesive: 15 N, Dynamic pull
  • 7.8.4 Bend test:
    • 7.8.4.1 No leaks and no break at the tubing after 3000 bendings

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K972135, K160648, K051264*, K120872

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.

0

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.

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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)
☑ Prescription Use (Part 21 CER 801 Subpart D)☐ Over-The-Counter Use (21 CER 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) 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)
☑ 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

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.

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."

5

"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: John.Lindskog@convatec.com

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

6

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

7

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.

8

TABLE 1

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

9

10

11

*The Abbott Set was cleared but has not been commercialized