The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

Device Description

The Medtronic Extended infusion set manufactured by Unomedical a/s is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication administered by an external pump.

The insertion needle and soft cannula of the Medtronic Extended infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevent needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use.

The Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, and how ground truth was established) are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a clinical evaluation.

Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a table format within the provided document. Instead, the document states that "The Medtronic Extended infusion set meets all the requirements for overall design, sterilization, biocompatibility, and usability confirming that the design output meets the design inputs and specifications for the device." The "Reported Device Performance" is derived from the "Clinical Evaluation" section.

Acceptance Criteria Category	Device Performance (Medtronic Extended Infusion Set)
Overall Design	Meets internal, national, and international standards.
Sterilization	Meets internal, national, and international standards (e.g., ISO 11135, ISO 11737).
Biocompatibility	Meets internal, national, and international standards (e.g., ISO 10993-1).
Usability	Meets internal, national, and international standards (e.g., IEC 62366-1).
Functional Performance (e.g., Leak/Tightness, Flow, Tensile Strength, Serter Functionality)	Meets internal requirements and is substantially equivalent to predicate based on bench testing.
Packaging and Transportation	Meets internal requirements.
Drug and Device Compatibility	Meets internal requirements.
Dimensional Accuracy	Meets internal requirements.
Pyrogen/Endotoxin	Meets internal requirements.
Shelf Life	Demonstrated for 2 years (reduced from 3 years for predicate).
Clinical Safety and Effectiveness	Safe and effective for full 7 days of use; no device-related serious adverse events.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test set sample size: For the clinical evaluation, 291 subjects were enrolled for the clinical study.
Data provenance: The clinical study was conducted in the US and was a prospective study (implied by "clinical study has been conducted").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a non-AI/ML device, "ground truth" and expert involvement in establishing it as typically understood in AI/ML validation is not directly applicable. The clinical study results establish the device's safety and effectiveness.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically relevant for human review of AI/ML outputs, which is not the primary focus here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating AI assistance to human readers, which is not relevant for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical medical device (infusion set), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical evaluation, the "ground truth" is implied by clinical outcomes data related to safety (e.g., adverse events) and effectiveness of the infusion set over the 7-day wear time.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device requiring a training set. The clinical evaluation used 291 subjects for its primary testing.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/ML device requiring a training set.

Summary

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July 16, 2021

Unomedical A/S Lone Vestergaard Jepsen Regulatory Affairs Specialist Aaholmvei 1-3 Osted, Lejre 4320 Denmark

Re: K210544

Trade/Device Name: Medtronic Extended infusion set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 5, 2021 Received: May 10, 2021

Dear Lone Vestergaard Jepsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210544

Device Name Medtronic Extended infusion set

Indications for Use (Describe)

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. 510(k) Summary

Device Name:

Medtronic Extended infusion set

5.1 Submission Sponsor

Unomedical a/s Aaholmvej 1-3, Osted DK-4320 Lejre, Denmark Primary contact: Lone Sylvest Vestergaard Jepsen Title: Regulatory Affairs Specialist

Secondary contact: Mette Busk Henningsen Title: Regulatory Affairs Specialist

5.2 Date Prepared

July 13, 2021

5.3 Device Identification

Trade/Proprietary Name:	Medtronic Extended infusion set
Common/Usual Name:	Set, Administration, Intravascular
Classification Name:	Intravascular administration set
Regulation Number:	880.5440
Product Code:	FPA, Intravascular administration set
Device Class:	Class II
Classification Panel:	General Hospital

5.4 Legally Marketed Predicate Device(s)

Table 5.1: Legally Marketed Predicate Device.

Device Name	510(k)No.	ProductCode	ClassificationRegulation	Sponsor
MiniMed™ Mio™ Advance Infusion Set	K173879	FPA	880.5440	Unomedical

5.5 Indication for Use Statement

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

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5.6 Device Description

The Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.

5.7 Substantial Equivalence

The following table compares the Medtronic Extended infusion set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The proposed device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Unomedical a/s	Unomedical a/s	Device Comparison
Trade Name	MiniMed™ Mio™ AdvanceInfusion Sets(predicate device)	Medtronic Extended infusionset(proposed device)	N/A
510(k)Number	K173879	K210544	N/A
Product Code	FPA	FPA	Same
RegulationNumber	880.5440	880.5440	Same
RegulationName	Intravascular AdministrationSet	Intravascular AdministrationSet	Same
Indicationsfor Use	The MiniMed™ Mio™Advance Infusion Set isindicated for subcutaneousinfusion of medicationadministered by an externalpump.	The Medtronic Extendedinfusion set is indicated for thesubcutaneous infusion ofmedication from an externalpump.The infusion set is indicated forsingle use	Same"The infusion set isindicated for singleuse" has beenmoved from"Warnings" sectionfor clarification.
Mechanism ofAction	The MiniMed™ Mio™Advance Infusion Set is aninfusion administration set,connecting to areservoir/infusion pump andinserted in the subcutaneoustissue of a user.	The Medtronic Extendedinfusion set is an infusionadministration set, connectingto a reservoir/infusion pumpand inserted in thesubcutaneous tissue of a user.	Same
Manufacturer	Unomedical a/s	Unomedical a/s	Device Comparison
Trade Name	MiniMed™ Mio™ AdvanceInfusion Sets(predicate device)	Medtronic Extended infusionset(proposed device)	N/A
TechnologyOverview	Serter:• Subcutaneous insertion ofsoft cannula by introducerneedle situated inside softcannula at a 90° insertionangle.• insertion of soft cannula: 2user steps for insertion:remove protective cap forbase and press release button• The Base Set in MiniMed™ Mio™Advance infusion set ismade of two components, theFluid Part and the Base Part• The MiniMed™ Mio™Advance infusion set isdelivered ready to use in apre-loaded insertion devicewith automatic needleretraction. This mechanismallows the needle to be hiddenfrom the user and/or caregiverbefore and after insertion.	Serter:• Subcutaneous insertion ofsoft cannula by introducerneedle situated inside softcannula at a 90° insertionangle.• insertion of soft cannula: 2user steps for insertion:remove protective cap for baseand press release button• The Base Set in MedtronicExtended infusion set is madeof two components, the FluidPart and the Base Part• The Medtronic Extendedinfusion set is delivered readyto use in a pre-loadedinsertion device with automaticneedle retraction. Thismechanism allows the needleto be hidden from the userand/or caregiver before andafter insertion.	Serter:Visually identical,with identical modeof operation.The design of theMedtronic Extendedinfusion set isdetailed in section 11of this 510K.
	Administration Set:The administration setattaches to the reservoir bymeans of a "tubing connector",and subcutaneously into theuser through an indwellingcannula made ofpolytetrafluoroethylene(PTFE).The tubing is made of twolayers: the inner layer ispolyethylene; the outer ispolyurethane.The indwelling cannula isintroduced into thesubcutaneous tissue by aremovable 27-gaugeintroducer needle (catheter)made of AISI 304 stainlesssteel.	Administration Set:The administration setattaches to the reservoir bymeans of a "tubing connector",and subcutaneously into theuser through an indwellingcannula made ofpolytetrafluoroethylene(PTFE).The tubing connector and theadhesive patch are updated tofacilitate an extended weartime. The tubing is made ofthree layers: the inner layer ispolypropylene; the middle layeris polyethylene and the outer ispolyurethane.The indwelling cannula isintroduced into thesubcutaneous tissue by aremovable 27-gaugeintroducer needle (catheter)made of AISI 304 stainlesssteel.	Administration Set:Same technology
Manufacturer	Unomedical a/s	Unomedical a/s	Device Comparison
Trade Name	MiniMed ™™ Mio™™ AdvanceInfusion Sets(predicate device)	Medtronic Extended infusionset(proposed device)	N/A
AnatomicalLocation	Standard recommended sitesfor subcutaneous infusion ofmedication i.e. subcutaneoussites are selected based onthe presence of adequateadipose tissue. The choice ofinsertion site depends ontreatment and patient specificfactors as recommended byHCP. Preference is given tosites that do not affect thepatient's mobility, the insertionsite has to be free of skinirritation and inflammationsuch as redness, scar tissueand bleeding.Site selection: the abdomen, ina roughly semicircular areaaround and below theumbilicus is preferred as anapplication site. Otherinsertion sites include theupper leg, upper buttocks,hips, upper arms and lowerback and occasionally thechest when other sites haveedema.The area to place the infusionset is particularly important inpatients with many years ofuse, since the overuse of skinsites has an influence onabsorption variability.	Standard recommended sitesfor subcutaneous infusion ofmedication i.e. subcutaneoussites are selected based on thepresence of adequate adiposetissue. The choice of insertionsite depends on treatment andpatient specific factors asrecommended by HCP.Preference is given to sitesthat do not affect the patient'smobility, the insertion site hasto be free of skin irritation andinflammation such as redness,scar tissue and bleeding.Site selection: the abdomen, ina roughly semicircular areaaround and below theumbilicus is preferred as anapplication site. Other insertionsites include the upper leg,upper buttocks, hips, upperarms and lower back andoccasionally the chest whenother sites have edema.The area to place the infusionset is particularly important inpatients with many years ofuse, since the overuse of skinsites has an influence onabsorption variability.	Same
Material	Materials include:Polypropylene,polyoxymethylene, stainlesssteel, polytetraflouroethylene,nonwovenpolyester/polyacrylate,polyethylene, silicone, MethylMethacrylate AcrylonitrileButadieneStyrene (MABS), Terlux 2802HD, transp., medical gradepaper, polycarbonate	Materials include:Polypropylene,polyoxymethylene, stainlesssteel, polytetraflouroethylene,nonwovenpolyester/polyacrylate,polyethylene, silicone, MethylMethacrylate AcrylonitrileButadieneStyrene (MABS), Terlux 2802HD, transp., medical gradepaper, polycarbonate,polyvinylalcohol	Essentially identical,with the notableaddition ofpolyvinylalcohol.Appropriatebiocompatibilitytesting has beenconducted on theproposed device.
Sterile	Yes - EO – SAL 10-6	Yes - EO - SAL 10-6	Same
Single-Use	Yes	Yes	Same
Shelf Life	3 years	2 years	Shelf life reduced
Complieswith ISO10993-1	Yes	Yes	Same
Manufacturer	Unomedical a/s	Unomedical a/s	Device Comparison
Trade Name	MiniMed™ Mio™ AdvanceInfusion Sets	Medtronic Extended infusionset	N/A
	(predicate device)	(proposed device)
Soft CannulaLength	6 and 9 mm	6 and 9 mm	Same
Tubing:IDOD	0.385 mm,1.50 mm	0.406 mm,1.52 mm	Change due toadded middle layer intubing. Substantiallyequivalent based onbench testing.
Soft CannulaOD	0.68 mm	0.68 mm	Same
Needle Gauge	27 gauge	27 gauge	Same
TubingLength	46, 60 and 110 cm	46, 60, 80 and 110 cm	Same tubing lengthrange. Addedintermediate size.
Angle ofInsertion	90 degrees, perpendicular	90 degrees, perpendicular	Same
InsertionMethod	Pre-loaded insertion devicewith automatic needleretraction. Theinsertion needle and softcannula are hidden from theuser before, during and afterinsertion of the soft cannula.	Pre-loaded insertion devicewith automatic needleretraction. Theinsertion needle and softcannula are hidden from theuser before, during and afterinsertion of the soft cannula.	Same
Time of Use	Up to 72 hours (3 days)	Up to 168 hours (7 days)	Recommendedmaximum wear timeextended. The claimis supported by theclinical performancetesting (see section20).

Table 5.2: Comparison of Characteristics.

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5.8 Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Medtronic Extended infusion set and in showing substantial equivalence to the predicate device, Unomedical completed a number of non-clinical performance tests. The Medtronic Extended infusion set meets all the requirements for overall design, sterilization, biocompatibility, and usability confirming that the design output meets the design inputs and specifications for the device.

The Medtronic Extended infusion set has met the requirements for testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

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Testing:

1. Functional tests
- Leak/Tightness o
- o Flow (Occlusion)
- Tensile tests of introducer needle hub, tubing connections, soft cannula from o Fluid Part assembly, adhesive tape from base, connector from base, connector needle from connector
- O Strength tests of Fluid Part assembly from base assembly, base assembly from cylinder, serter activation force (intended and unintended), disassembly of cylinder from cover
- Serter functionality tests O
1. Packaging tests:
- Dynamic and Visual Peel Test O
- Print on Packaging and labelling o
1. Transportation Tests:
- Transportation tests general o
1. Compatibility Tests:
- Drug and Device Compatibility O
1. Dimensional Tests:
- Distance soft cannula to set o
- Distance of introducer needle bevel to soft cannula O
- Length of tubes O
Biocompatibility Testing in accordance with ISO 10993-1 6.
1. EO/ECH residuals Testing
Pyrogen/Endotoxin Testing 8.
Shelf life Testing 9.
1. Sterilization Testing
1. Usability Testing

5.9 Clinical Evaluation

A clinical study has been conducted in the US. A total of 291 subjects were enrolled at 15 investigational centers.

The results of the clinical study demonstrated that the use of the Medtronic Extended infusion set was safe and effective for the full 7 days. There were no device-related serious adverse events.

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5.10 Standards Used

ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residual

ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11737-1:2018, Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products

ISO 11737-2:2019, Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the definition, validation, and maintenance of a sterilization process

ASTM F1980-16: 2016, Standard Guide for Accelerated Aging Sterile Barrier Systems for Medical Devices

EN 556-1:2001 & EN556-1/AC:2006, "Sterilization of medical devices – Requirements for medical devices to be designated "Sterile"- Part 1: Requirements for terminally sterilized medical devices"

EN ISO 11138-1: 2017, "Sterilization of heath care products – Biological indicators – Part 1: General Requirements"

EN ISO 11138-2: 2017, "Sterilization of heath care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes"

ISO 11607-1:2019, Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems

ISO 11607-2:2019, Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for forming, sealing and assembly processes

ISO 15223-1:2016, Medical devices – Symbols to be used with medical devices labeling, and information to be supplied - Part 1: General requirements

EN ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing

ISO 10993-3:2014, Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity and Reproductive Toxicity

ISO 10993-4:2017, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood

ISO 10993-5:2009, Biological Evaluation of Medical Devices – Part 5: Tests for in-vitro Cytotoxicity

ISO 10993-6:2016, Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects after Implantation

EN ISO 10993-7:2008 & EN ISO 10993-7/AC:2009, Biological Evaluation of Medical Devices – Part 7: Ethylene oxide sterilization residuals

ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

EN ISO 10993-11:2017, Biological Evaluation of Medical Devices – Part 11: Tests for systemic toxicity

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ISO 10993-12:2012, Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials

ISO 10993-17:2002, Biological Evaluation of Medical Devices – Part 17: Establishment of Allowable Limits for Leachable Substances

EN ISO 10993-18:2009, Biological Evaluation of Medical Devices – Part 18: Chemical characterization of materials

EN ISO 8536-8:2015 Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed

ISO 8536-9:2015 Infusion Equipment for Medical Use – Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment

ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems

IEC 62366-1:2015/AC, "Medical devices – Part 1: Application of usability engineering to medical devices"

ISO 14971:2019, Medical devices – Application of risk management to medical devices.

5.11 Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The Medtronic Extended infusion set, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

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.