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.

AI/ML Overview

This document describes the 510(k) premarket notification for several subcutaneous infusion sets. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly concerning a change in the sterilization facility and the adoption of a PFOA-free PTFE soft cannula.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Flow Test	Tubing Set: 40 ml/min at 1 bar pressure	Devices "passed all testing" (implied criteria met)
Leak Test	Luer-Lock: No Leaks at 3 bar pressure for 30 seconds	Devices "passed all testing" (implied criteria met)
	Pcap: No Leaks at 1.4 bar pressure for 30 seconds	Devices "passed all testing" (implied criteria met)
	Asante Hub: No Leaks at 0.56 bar pressure for 30 seconds	Devices "passed all testing" (implied criteria met)
Pull Tests	Soft Cannula to Cannula housing: 3 N, Dynamic Pull	Devices "passed all testing" (implied criteria met)
	Tubing to tubing Luer-lock: 15 N, Dynamic pull	Devices "passed all testing" (implied criteria met)
	Tubing to Needle Connector: 15 N, Dynamic pull	Devices "passed all testing" (implied criteria met)
	Cannula housing to Needle Connector: 15 N, Dynamic pull	Devices "passed all testing" (implied criteria met)
	Cannula housing to Adhesive: 15 N, Dynamic pull	Devices "passed all testing" (implied criteria met)
Bend Test	No leaks and no break at the tubing after 3000 bendings	Devices "passed all testing" (implied criteria met)
Biocompatibility (PFOA-Free PTFE)	Substantial equivalence to the previous PTFE material, per ISO 10993 for extraction and analysis	New material "found to substantially equivalent to the PTFE material"

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

The document explicitly states "The following verification testing was performed" but does not provide specific sample sizes for each test. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable in this context. The study is a series of engineering/performance verification tests for a medical device (infusion sets), not a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements (e.g., flow rate, leak detection, pull force, bend cycles) with clear pass/fail criteria, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or AI-assisted clinical decision support systems, which is not the nature of this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical device (infusion set), not an algorithm or AI system. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used:

The ground truth or reference standard for these tests are the established engineering specifications and physical properties of the materials and assembled device. For example:

Flow/Leak/Pull Tests: Engineering specifications for flow rates, pressure resistance, and tensile strength.
Bend Test: Durability and integrity requirements under mechanical stress.
Biocompatibility: Established ISO standards (ISO 10993) for material safety and equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to internal manufacturing process optimization and quality control, not data for an algorithm.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" for manufacturing and quality (if considered analogous) would be established through industry standards, regulatory requirements, and internal design specifications, often validated by extensive testing and risk analysis during the device development lifecycle.

Summary

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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 (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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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.

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.

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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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.

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: 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

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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

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

SUBJECTDEVICE BRANDNAMES	UNOMEDICALCOMFORT	UNOMEDICALCOMFORT -SHORT	MEDTRONICSILHOUETTE®LUER LOCKINFUSION SET	ROCHEACCUCHECKTENDER	UNOMEDICALNERIA SOFT	MEDTRONICSILHOUETTE®PARADIGM®	ABBOTT COMFORT	ASANTECOMFORT
PREDICATE510(K) FILENUMBER	K972135	K972135	K972135	K972135	K972135	K160648	K051264*	K120872
PREDICATENAME	MAERSKMEDICALPURELINECOMFORTSUBCUTANEOUSINFUSION SET	MAERSKMEDICALPURELINECOMFORTSUBCUTANEOUSINFUSION SET	MAERSKMEDICALPURELINECOMFORTSUBCUTANEOUS INFUSION SET	MAERSKMEDICALPURELINECOMFORTSUBCUTANEOUS INFUSIONSET	MAERSKMEDICALPURELINECOMFORTSUBCUTANEOUS INFUSION SET	MEDTRONICSILHOUETTE®PARADIGM®	ABBOTT COMFORTSUBCUTANEOUSINFUSION SET	ASANTECOMFORTSUBCUTANEOUSINFUSION SET
CLEAREDINDICATIONSFOR USE	INFUSIONAND/ORINJECTION OFFLUIDS INTO THEBODY BELOWTHE SURFACEOF THE SKIN.	INFUSIONAND/ORINJECTION OFFLUIDS INTO THEBODY BELOWTHE SURFACEOF THE SKIN.	INFUSIONAND/ORINJECTION OFFLUIDS INTOTHE BODYBELOW THESURFACE OFTHE SKIN.	INFUSIONAND/ORINJECTION OFFLUIDS INTOTHE BODYBELOW THESURFACE OFTHE SKIN.	INFUSIONAND/ORINJECTION OFFLUIDS INTOTHE BODYBELOW THESURFACE OFTHE SKIN.	FOR USE WITHMEDTRONICPARADIGMINSULINSUBCUTANEOUSINFUSION PUMPSFORCONTINUOUSSUBCUTANEOUSINSULININFUSION BYPATIENTS ORCAREGIVERS INTHE HOMEENVIRONMENT.	INFUSION OFFLUIDS INTO THEBODY BELOW THESURFACE OF THESKIN WHENATTACHED TO AFLUID RESERVOIROF A COMPATIBLEABBOTT PUMP	SUBCUTANEOUSINFUSION OFMEDICATION,INCLUDINGINSULIN,ADMINISTEREDBY THE PEARL™EXTERNALINSULIN PUMPSYSTEM
PROPOSEDINDICATIONSFOR USE(K162812)	SUBCUTANEOUSINFUSION OFINSULINADMINISTEREDBY ANEXTERNAL PUMP	SUBCUTANEOUSINFUSION OFINSULINADMINISTEREDBY ANEXTERNAL PUMP	SUBCUTANEOUS INFUSION OFINSULIN FROMAN INFUSIONPUMP	SUBCUTANEOUS INFUSIONOF INSULINADMINISTEREDWITHMICRODOSAGE INSULINPUMPS.	SUBCUTANEOUS INFUSION OFMEDICATIONADMINISTEREDBY ANEXTERNALPUMP	NO CHANGE	NO CHANGE (IFCOMMERCIALIZED)	SUBCUTANEOUSINFUSION OFINSULINADMINISTEREDBY THE SNAP™INSULIN PUMPSYSTEM
DETAIL OFDIFFERENCES	SUBCUTANEOUSINFUSIONAND/ORINJECTION OFFLUIDS-INSULININTO THE BODY	SUBCUTANEOUSINFUSIONAND/ORINJECTION OFFLUIDS-INSULININTO THE BODY	SUBCUTANEOUS INFUSIONAND/ORINJECTION OFFLUIDS-INSULININTO THE BODY	SUBCUTANEOUS INFUSIONAND/ORINJECTION OFFLUIDSINSULIN INTO	SUBCUTANEOUS INFUSIONAND/ORINJECTION OFFLUIDSMEDICATION	NO CHANGE	NO CHANGE (IFCOMMERCIALIZED)	SUBCUTANEOUSINFUSION OFMEDICATION,INCLUDINGINSULIN,ADMINISTERED
	BELOW THESURFACE OFTHE SKINADMINISTEREDBY ANEXTERNALPUMP.	BELOW THESURFACE OFTHE SKINADMINISTEREDBY ANEXTERNALPUMP.	BELOW THESURFACE OFTHE SKIN-FROMAN INFUSIONPUMP.	THE BODYBELOW THESURFACE OFTHE SKINADMINISTEREDWITHMICRODOSAGE INSULINPUMPS.	INTO THE BODYBELOW THESURFACE OFTHE SKINADMINISTEREDBY ANEXTERNALPUMP.			BY THEPEARL™SNAP™EXTERNALINSULIN PUMPSYSTEM
INSTRUCTIONFOR USECHANGES	NOSUBSTANTIVECHANGE -INSTRUCTIONSFOR USEPROVIDED INORIGINALSUBMISSIONHAVE BEENUPDATED ANDSTANDARDIZED(ALL AREPROVIDED INAPPENDIX II).	NOSUBSTANTIVECHANGE -INSTRUCTIONSFOR USEPROVIDED INORIGINALSUBMISSIONHAVE BEENUPDATED ANDSTANDARDIZED(ALL AREPROVIDED INAPPENDIX II).	NOSUBSTANTIVECHANGE -INSTRUCTIONSFOR USEPROVIDED INORIGINALSUBMISSIONHAVE BEENUPDATED ANDSTANDARDIZED(ALL AREPROVIDED INAPPENDIX II).	NOSUBSTANTIVECHANGE -INSTRUCTIONSFOR USEPROVIDED INORIGINALSUBMISSIONHAVE BEENUPDATED ANDSTANDARDIZED (ALL AREPROVIDED INAPPENDIX II).	NOSUBSTANTIVECHANGE -INSTRUCTIONSFOR USEPROVIDED INORIGINALSUBMISSIONHAVE BEENUPDATED ANDSTANDARDIZED(ALL AREPROVIDED INAPPENDIX II).	NO CHANGE	IFCOMMERCIALIZED,DRAFTINSTRUCTIONS FORUSE PROVIDED INORIGINALSUBMISSION WILLBE FINALIZED ANDSTANDARDIZED	NOSUBSTANTIVECHANGE -DRAFTINSTRUCTIONSFOR USEPROVIDED INORIGINALSUBMISSIONHAVE BEENFINALIZED ANDSTANDARDIZED(ALL AREPROVIDED INAPPENDIX II).
STERILIZATION/STERILIZATIONLOCATION/SUBCONTRACTORSCHANGES	CHANGE OFSTERILIZATIONSITE ONLY. NOCHANGE TOSTERILIZATIONMETHOD OR SAL.	CHANGE OFSTERILIZATIONSITE ONLY. NOCHANGE TOSTERILIZATIONMETHOD OR SAL.	CHANGE OFSTERILIZATIONSITE ONLY. NOCHANGE TOSTERILIZATIONMETHOD ORSAL.	CHANGE OFSTERILIZATIONSITE ONLY. NOCHANGE TOSTERILIZATIONMETHOD ORSAL.	CHANGE OFSTERILIZATIONSITE ONLY. NOCHANGE TOSTERILIZATIONMETHOD ORSAL.	CHANGE OFSTERILIZATIONSITE ONLY. NOCHANGE TOSTERILIZATIONMETHOD OR SAL.	IFCOMMERCIALIZED,STERILIZATIONSITE WILL BECHANGEDWITHOUT CHANGETO STERILIZATIONMETHOD OR SAL.	CHANGE OFSTERILIZATIONSITE ONLY. NOCHANGE TOSTERILIZATIONMETHOD OR SAL.
MATERIALS/COMPONENTSCHANGES	THE SOFTCANNULAMATERIAL WASMODIFIED TO APFOA FREEPTFE, (U.S.ENVIRONMENTAL PROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).	THE SOFTCANNULAMATERIAL WASMODIFIED TO APFOA FREEPTFE, (U.S.ENVIRONMENTALPROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).	THE SOFTCANNULAMATERIAL WASMODIFIED TO APFOA FREEPTFE,(U.S.ENVIRONMENTAL PROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).	THE SOFTCANNULAMATERIALWAS MODIFIEDTO A PFOAFREE PTFE,(U.S.ENVIRONMENTALPROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).	THE SOFTCANNULAMATERIAL WASMODIFIED TO APFOA FREEPTFE,(U.S.ENVIRONMENTAL PROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).	THE SOFTCANNULAMATERIAL WASMODIFIED TO APFOA FREEPTFE,(U.S.ENVIRONMENTALPROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).	IFCOMMERCIALIZED,THE SOFTCANNULAMATERIAL WILL BEMODIFIED TO APFOA FREE PTFE,(U.S.ENVIRONMENTALPROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).	THE SOFTCANNULAMATERIAL WASMODIFIED TO APFOA FREEPTFE,(U.S.ENVIRONMENTALPROTECTIONAGENCY PFOASTEWARDSHIPPROGRAM).
	THE SEPTUMWAS CHANGEDFROMTHERMOPLASTICELASTOMER(TPE) TOSILICONERUBBER. THISMATERIAL WASIDENTIFIED ANDCLEARED INSUBMISSIONK051264	THE SEPTUMWAS CHANGEDFROMTHERMOPLASTICELASTOMER(TPE) TOSILICONERUBBER. THISMATERIAL WASIDENTIFIED ANDCLEARED INSUBMISSIONK051264	THE SEPTUMWAS CHANGEDFROMTHERMOPLASTIC ELASTOMER(TPE) TOSILICONERUBBER. THISMATERIAL WASIDENTIFIED ANDCLEARED INSUBMISSIONK051264	THE SEPTUMWASCHANGEDFROMTHERMOPLASTIC ELASTOMER(TPE) TOSILICONERUBBER. THISMATERIALWASIDENTIFIEDAND CLEAREDIN SUBMISSIONK051264	THE SEPTUMWAS CHANGEDFROMTHERMOPLASTIC ELASTOMER(TPE) TOSILICONERUBBER. THISMATERIAL WASIDENTIFIED ANDCLEARED INSUBMISSIONK051264	THE SEPTUMWAS CHANGEDFROMTHERMOPLASTICELASTOMER(TPE) TOSILICONERUBBER. THISMATERIAL WASIDENTIFIED ANDCLEARED INSUBMISSIONK051264	NO CHANGE	NO CHANGE
	THE LUER LOCKCONNECTORCHANGED FROMPVC (POLYVINYLCHLORIDE) TOMABS(METHYLMETHACRYLATEACRYLONITRILEBUTADIENESTYRENE).THIS MATERIALWAS IDENTIFIEDAND CLEARED INSUBMISSIONK032854	THE LUER LOCKCONNECTORCHANGED FROMPVC (POLYVINYLCHLORIDE) TOMABS(METHYLMETHACRYLATEACRYLONITRILEBUTADIENESTYRENE).THIS MATERIALWAS IDENTIFIEDAND CLEARED INSUBMISSIONK032854	THE LUER LOCKCONNECTORCHANGEDFROM PVC(POLYVINYLCHLORIDE) TOMABS(METHYLMETHACRYLATEACRYLONITRILEBUTADIENESTYRENE).THIS MATERIALWAS IDENTIFIEDAND CLEAREDIN SUBMISSIONK032854	THE LUERLOCKCONNECTORCHANGEDFROM PVC(POLYVINYLCHLORIDE) TOMABS(METHYLMETHACRYLATEACRYLONITRILE BUTADIENESTYRENE).THISMATERIALWASIDENTIFIEDAND CLEAREDIN SUBMISSIONK032854	THE LUER LOCKCONNECTORCHANGEDFROM PVC(POLYVINYLCHLORIDE) TOMABS(METHYLMETHACRYLATEACRYLONITRILEBUTADIENESTYRENE).THIS MATERIALWAS IDENTIFIEDAND CLEAREDIN SUBMISSIONK032854	NO CHANGE	NO CHANGE	NO CHANGE
SPECIFCATION/TEST METHODSCHANGES	A BENDING TESTHAS BEENINTRODUCED TOVERIFYROBUSTESS OFTUBING BONDSWHENSUBJECTED TOSTRESSES SEENDURING USE.	A BENDING TESTHAS BEENINTRODUCED TOVERIFYROBUSTESS OFTUBING BONDSWHENSUBJECTED TOSTRESSES SEENDURING USE.	A BENDINGTEST HAS BEENINTRODUCEDTO VERIFYROBUSTESS OFTUBING BONDSWHENSUBJECTED TOSTRESSESSEEN DURINGUSE.	A BENDINGTEST HASBEENINTRODUCEDTO VERIFYROBUSTESSOF TUBINGBONDS WHENSUBJECTEDTO STRESSESSEEN DURINGUSE.	A BENDINGTEST HAS BEENINTRODUCEDTO VERIFYROBUSTESS OFTUBING BONDSWHENSUBJECTED TOSTRESSESSEEN DURINGUSE.	A BENDING TESTHAS BEENINTRODUCED TOVERIFYROBUSTESS OFTUBING BONDSWHENSUBJECTED TOSTRESSES SEENDURING USE.	IFCOMMERCIALIZED,A BENDING TESTWILL BEINTRODUCED TOVERIFYROBUSTESS OFTUBING BONDSWHEN SUBJECTEDTO STRESSESSEEN DURING USE.	A BENDING TESTHAS BEENINTRODUCED TOVERIFYROBUSTESS OFTUBING BONDSWHENSUBJECTED TOSTRESSES SEENDURING USE.
A TENSION TESTHAS BEENINTRODCUEDAFTER PRE-CONDITIONINGOF TESTSAMPLESIMMERSED IN37°C WATER FOR18-24 HRS.	A TENSION TESTHAS BEENINTRODCUEDAFTER PRE-CONDITIONINGOF TESTSAMPLESIMMERSED IN37°C WATER FOR18-24 HRS.	A TENSIONTEST HAS BEENINTRODCUEDAFTER PRE-CONDITIONINGOF TESTSAMPLESIMMERSED IN37°C WATERFOR 18-24 HRS.	A TENSIONTEST HASBEENINTRODCUEDAFTER PRE-CONDITIONINGOF TESTSAMPLESIMMERSED IN37°C WATERFOR 18-24 HRS.	A TENSIONTEST HAS BEENINTRODCUEDAFTER PRE-CONDITIONINGOF TESTSAMPLESIMMERSED IN37°C WATERFOR 18-24 HRS.	A TENSION TESTHAS BEENINTRODCUEDAFTER PRE-CONDITIONINGOF TESTSAMPLESIMMERSED IN37°C WATER FOR18-24 HRS.	IFCOMMERCIALIZED,A TENSION TESTWILL BEINTRODCUEDAFTER PRE-CONDITIONING OFTEST SAMPLESIMMERSED IN 37°CWATER FOR 18-24HRS.	A TENSION TESTHAS BEENINTRODCUEDAFTER PRE-CONDITIONINGOF TESTSAMPLESIMMERSED IN37°C WATER FOR18-24 HRS.

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*The Abbott Set was cleared but has not been commercialized

Regulation Number and Section

§ 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.