ENFit enteral pump syringes PENTA ENFit TM and ENFit enteral pump syringes NUTRIFIT TM deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.

ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended for neonatal, pediatric and adult use. ENFit enteral pump syringes are single use devices.

Device Description

ENFit enteral pump syringes consists of disposable enteral feeding syringes that deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes are designed so that, while administering enteral solutes and medication, any accidental risk of connection to a parenteral system is prevented, through the female ENFit connector for connection to an enteral access device, designed according to the AAMI/CN3:2014 (PS) Part 3 requirements, allowing only enteral use. They have plungers, made of synthetic rubber which does not contain natural latex, in order to prevent any allergies.

AI/ML Overview

The provided document for the PENTA ENFit™ and NUTRIFIT™ ENFit enteral pump syringes (K161141) outlines the acceptance criteria through compliance with various international standards and the study that proves the device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance standards, and for each, it implicitly states that the device met the acceptance criteria as demonstrated by in vitro bench testing. Specific numerical performance values are not provided in this summary.

Acceptance Criteria (Standard / Test)	Reported Device Performance
ISO 80369-3:2016 (Small-bore connectors for enteral applications)	Compliance stated through in vitro bench testing. Designed to reduce accidental connection to parenteral systems.
AAMI/ANSI/ISO 80369-1:2010 (General requirements for small-bore connectors)	Compliance stated through in vitro bench testing.
AAMI/CN3:2014 (PS) (Small-bore connectors for enteral applications)	Compliance stated through in vitro bench testing. Device designed according to AAMI/CN3:2014 (PS) Part 3 requirements for female ENFit connector.
EN ISO 7886-1:1997 (Manual hypodermic syringes)	Compliance stated through in vitro bench testing (specifically mentioned for pump compatibility).
EN ISO 7886-2:1997 (Hypodermic syringes for power-driven pumps)	Compliance stated through in vitro bench testing (specifically mentioned for pump compatibility).
ANSI/AAMI/ISO 80369-20:2015 (Common test methods for small-bore connectors)	Compliance stated through in vitro bench testing.
EP § 3.2.8 (European Pharmacopoeia standard)	Compliance stated through in vitro bench testing.
ASTM D790-15e2 (Flexural Properties of Plastics)	Compliance stated through in vitro bench testing.
EN 1615:2000 (Enteral Feeding Catheters and Giving Sets)	Compliance stated through in vitro bench testing.
AAMI ANSI ID54:1996/(R)2012 (Enteral Feeding Set Adapters And Connectors)	Compliance stated through in vitro bench testing.
Bioburden tests	Met acceptance criteria.
Sterility tests	Met acceptance criteria.
Validation of EtO Sterilization process	Met acceptance criteria.
Packaging evaluation	Met acceptance criteria.
Labeling evaluation	Met acceptance criteria.
EtO Residual (according to EN ISO 10993-7)	Met acceptance criteria.
Biocompatibility (according to ISO 10993 series)	Met acceptance criteria.
Usability tests (according to AAMI/IEC 62366-1:2015)	Met acceptance criteria.
Mechanical performance (e.g., integrity, leak resistance)	Implied through compliance with ISO 80369 series, typically covers these aspects. Device is "designed and tested to assure conformance to the requirements for its intended use."
Pump Compatibility (with enteral infusion pump)	Demonstrated by in vitro bench tests showing compliance with EN ISO 7886-1 and EN ISO 7886-2.
Dimensional compliance (ENFit connector)	Compliance to AAMI/CN3:2014 (PS) Part 3 Table B.2 Female Enteral Small-Bore Connector.

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

The document refers to "in vitro bench tests" and "performance evaluations" performed at the PENTAFERTE ITALIA S.r.l. site, Loc. Nocella SP 262, I-64012 Campli (TE) – Italy. This indicates the country of origin of the data is Italy.

The description "in vitro bench tests" implies a prospective test setup where specific tests are conducted under controlled laboratory conditions to evaluate the device against predefined standards.

The document does not specify the sample size used for the test sets in any of the performance evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the evaluation involved in vitro bench testing against published international standards for medical devices and not an expert-based clinical assessment of patient data. Therefore, there was no "ground truth" derived from expert consensus on a test set of cases in the traditional sense of diagnostic or clinical performance studies.

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

This information is not applicable for in vitro bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess cases, and a discrepancy resolution process is needed to establish a consensus ground truth.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This document describes the premarket notification for an ENTERAL PUMP SYRINGE, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

This information is not applicable as this submission is for a physical medical device (enteral pump syringes), not an algorithm or AI system.

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

As indicated in point 3, the concept of "ground truth" as it applies to clinical or diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not applicable here. The performance of the device was assessed against predefined technical and safety specifications outlined in international and national standards (e.g., ISO, AAMI, EN, ASTM, EP). Compliance with these standards serves as the "truth" for device functionality and safety.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical medical device. The concept of a "training set" typically applies to machine learning or AI models, which are not involved in this device's evaluation.

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

This information is not applicable as there is no "training set" for this physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.

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

March 22, 2017

Pentaferte Italia S.r.l. Rosa Di Gioia Regulatory Affairs Manager Loc. Nocella S.P. 262 I-64012 Campli (TE) Italy

Re: K161141 Trade/Device Name: ENFit enteral pump syringes PENTA ENFit™ ENFit enteral pump syringes NUTRIFIT™ Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: January 9, 2017 Received: February 1, 2017

Dear Rosa Di Gioia:

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.

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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 yours,

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161141

Device Name

ENFit enteral pump syringes PENTA ENFit TM ENFit enteral pump syringes NUTRIFIT TM

Indications for Use (Describe)

ENFit enteral pump syringes PENTA ENFit EM and ENFit enteral pump syringes NUTRIFIT TM deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.

ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended for neonatal, pediatric and adult use. ENFit enteral pump syringes are single use devices.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/0 description: The image shows the logo for Pentaferte Italia SRL. The logo features a red cross-like symbol with a black number 5 next to it. To the right of this symbol is the word "pentaferte" in black, with the word "ITALIA" in red and "SRL" in black below it. There is also a red oval containing the letters "PF".

510(K) SUMMARY, AS REQUIRED BY 21 CFR 807.92

Submitter's Name	Pentaferte Italia s.r.l.
Address	Loc. Nocella SP 262,I-64012 Campli (TE) - Italy
Summary PreparationDate	January 09th, 2017
Contact Person	Dr. Rosa Di Gioia, Regulatory Affairs Manager
Telephone Number	+39.0861.560201
Fax Number	+39.0861.560200
Name of the Device	ENFit enteral pump syringes PENTA ENFitTMENFit enteral pump syringes NUTRIFITTM
Common name of the device	ENFit enteral pump syringes
Classification Name and class	Enteral syringes with enteral specific connectorsDevice Class: IIProduct Code: PNRRegulation Number 21 CFR 876.5980
Performance Standards	- ISO 803693-3:2016 Small-bore connectors for liquids and gases inhealthcare applications -- Part 3: Connectors for enteral applications- AAMI/ANSI/ISO 80369-1:2010 - Small-bore connectors for liquids andgases in healthcare applications - Part 1: General requirements- AAMI/CN3:2014 (PS) Small Bore Connectors For Liquids And Gases InHealthcare Applications Part 3: Connectors For Enteral Applications- EN ISO 7886-1:1997: Sterile hypodermic syringes for single use.Syringes for manual use- EN ISO 7886-2:1997. Sterile hypodermic syringes for single use.Syringes for use with power-driven syringe pumps- ANSI/AAMI/ISO 80369-20:2015, Smallbore connectors for liquids andgases in healthcare applications – Part 20: Common test methods- EP § 3.2.8- ASTM D790- 15e2 Standard Test Methods for Flexural Properties ofUnreinforced and Reinforced Plastics and Electrical InsulatingMaterials- EN 1615:2000 - Enteral Feeding Catheters And Enteral Giving Sets ForSingle Use And Their Connectors Design And Testing- AAMI ANSI ID54:1996/(R)2012 Enteral Feeding Set Adapters And

Sede Legale e Stabilimento Località Nocella S.P. 262 - 64012 CAMPLI (TE) - Italy Uffici Commerciali e Amministrazione: Via Modera, 119 - 44122 FERRARA-Tel. +39 0532 778811 - Fax +39 0532 778812 R.E.A : TE-159 867 - P.IVA e Codice Fiscale : IT 01866900671 - Capitale Sociale € 20.000,00 Versati € 20.000,00

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Image /page/4/Picture/0 description: The image contains a logo for Pentaferte Italia SRL. The logo features a red cross and the number 5 in black on the left side. To the right of this is the word "pentaferte" in black, with the word "ITALIA" in red and "SRL" in smaller letters below it. There is also a red oval containing the letters "PF" on the right side of the logo.

Connectors
DESCRIPTION of the device:	ENFit enteral pump syringes are designed to reduce the accidental risk ofconnection to a parenteral system, as required by AAMI/CN3:2014 (PS),allowing only enteral use.In particular, these high volume syringes (sizes 10ml, 20 ml and 60ml) can beconnected with enteral infusion pump.They have plungers, made of synthetic rubber which does not contain naturallatex, in order to prevent any allergies.
Indications for Use	ENFit enteral pump syringes PENTA ENFit TM and ENFit enteral pump syringesNUTRIFIT TM deliver nutritional formula to the gastrointestinal system of apatient who is physically unable to eat and swallow. ENFit enteral pumpsyringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinicalor home care settings by users ranging from laypersons (under the supervisionof a clinician) to health care professionals, to administer nutritional formula.In particular, these syringes can be connected with enteral infusion pump.ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intendedfor neonatal, pediatric and adult use.ENFit enteral pump syringes are single use devices.
Identification of Predicate Device	Proprietary Name: NeoMed, IncK143344Classification Name: Gastrointestinal tube and accessories devices; 21 CFR876.5980K122373Classification Name: Piston Syringe; 21 CFR 880.5560Registered Establishment Name: NeoMed, IncRegistered Establishment Number: 3006520777Owner/Operator: NeoMed, Inc.Owner/Operator Number: 10022926Manufacturer 510 (k): K143344Device Name: NeoConnectTM Enteral SyringesManufacturer 510 (k): K122373Device Name: NeoMed Oral / Enteral SyringeApplicant: NeoMed, Inc.100 Londonderry CourtSuite 112Woodstock GA 30188
Common name of thepredicate device forprinciples of operations	- K143344NeoConnect™ Enteral Syringes- K122373NeoMed Oral / Enteral Syringe
Classification Name of thedevice	- K143344Gastrointestinal tube and accessories devicesDevice Class: IIProduct Code: PIFRegulation Number: 21 CFR 876.5980- K122373Piston SyringeDevice Class: IIProduct Code: FMFRegulation Number: 21 CFR 880.5560
Applicant name andaddress:	NeoMed, Inc.100 Londonderry CourtSuite 112Woodstock, GA 30188
Comparison ofTechnologicalCharacteristics	In vitro bench testing was performed to support a determination of substantialequivalence (refer to performance testing below) between ENFit enteral pumpsyringes PENTA ENFit ™ , ENFit enteral pump syringes NUTRIFIT ™ , andpredicate devices.The results of these tests provide reasonable assurance that the proposeddevice has been designed and tested to assure conformance to therequirements for its intended use and performs comparably to the existingpredicate devices.

Pentaferte Italia s.r.| unipersonale

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Image /page/5/Picture/0 description: The image contains a logo for Pentaferte Italia SRL. The logo features a red cross and the number 5 on the left side. To the right of this is the company name "pentaferte" in black, with "ITALIA SRL" in red below it. There is also a red oval with the letters "PF" inside it.

	Predicate device:NeoMedNeoConnect™Enteral Syringeswith ENFitConnector(K143344)	Predicate device:NeoMed Oral /Enteral Syringe(K122373)	Subject DeviceENFit enteral pumpsyringes PENTAENFit™, ENFit enteralpump syringesNUTRIFIT TM(K161141)	ComparisonDescription/Justification forthe differences
Devicedescription	An enteral syringeconsisting of a syringebarrel with integraltip (ENFit), plunger,gasket,barrellubricant and suppliedwith a syringe tip cap.	An oral / enteralsyringe consisting ofa syringe barrel withintegral tip(tapered), plunger,gasket, barrellubricant andsupplied with asyringe tip cap.	ENFit enteral pumpsyringes consists ofdisposable enteral feedingsyringes that delivernutritional formula to thegastrointestinal system ofa patient who is physicallyunable to eat and swallow.ENFit enteral pump	No relevantdifference.No reference to theENFit connector inK122373 is due tothe absence ofspecific standardsrequirements at timeof that submission.
			syringes are designed sothat, while administeringenteral solutes andmedication, any accidentalrisk of connection to aparenteral system isprevented, through thefemale ENFit connector forconnection to an enteralaccess device, designedaccording to theAAMI/CN3:2014 (PS) Part3 requirements, allowingonly enteral use.
Indication forUse	The deviceisindicated for use as adispenser,ameasuring device anda fluid transfer device.It is used to deliverfluids into the bodyvia extension sets andfeeding tubes inneonatal and smallpediatric patients.	The device isindicated for use as adispenser, ameasuring deviceand an oral fluidtransfer device. It isused to inject fluidsinto the body viaextension sets andfeeding tubes inneonatal and smallpediatric patients.	ENFit enteral pumpsyringes PENTA ENFit ™and ENFit enteral pumpsyringes NUTRIFIT ™deliver nutritional formulato the gastrointestinalsystem of a patient who isphysically unable to eatand swallow. ENFit enteralpump syringes (PENTAENFit ™ and NUTRIFIT ™)are intended to be used inclinical or home caresettings by users rangingfrom laypersons (underthe supervision of aclinician) to health careprofessionals, toadminister nutritionalformula. In particular,these syringes can beconnected with enteralinfusion pump.ENFit enteral pumpsyringes (PENTA ENFit ™and NUTRIFIT ™) areintended for neonatal,pediatric and adult use.ENFit enteral pumpsyringes are single usedevices.	Indication for use isequivalent, even ifthe target populationof the subject deviceis wider.Based on theconsideration thatthe target populationof the predicates(neonatal and smallpediatric patients) isconsidered worstcase if comparedwith the targetpopulation of thesubject device(intended forpatients of all agegroups), theindication for use ofthe subject device isconsideredsubstantiallyequivalent to thoseof the predicates.Additionalstatements onDirections for useand warningaccording to FDAGuidance "SafetyConsiderations toMitigate the Risks of
			Misconnections withSmall-boreConnectors Intendedfor EnteralApplications".No relevantdifference.
Model available	0.5ml to 100ml sizes	0.5ml to 100ml sizes	10ml, 20 ml, 60 ml	No relevantdifference,Pentaferte Italiadevices are in therange of predicatevolume sizes.
Pumpcompatibility	Not specified, but in510(k) summary isstated that the deviceis equivalent to thepredicate device(K122373, see relatedcolumn).	Pump compatibilityis demonstrated bythe statement in the510(k) summary(K122373) "thedevices meet theapplicablerequirements of ISO7886-1 and ISO7886-2, Sterilehypodermic syringesfor single use – part2: syringes for usewith power drivensyringe pump".	Pump compatibility isdemonstrated by the invitro bench tests on ENFitenteral pump syringes,which show thecompliance with theapplicable requirements ofthe ISO 7886-1 and ISO7886-2, (see also Chapter17 and relateddocuments).	No difference, pumpcompatibility isdemonstrated by thestatement in the510(k) summary(K122373) "thedevices meet theapplicablerequirements of ISO7886-1 and ISO 7886-2, Sterile hypodermicsyringes for singleuse - part 2: syringesfor use with powerdriven syringe pump"and in vitro benchtests on the subjectdevices, which showthe compliance withthe applicablerequirements of theISO 7886-1 and ISO7886-2, (see alsoChapter 17 andrelated documents)
Connection type	ENFit(DimensionalcompliancetoAAMI/CN3:2014 (PS)Part 3 Table B.2Female Enteral Small-Bore Connector).	Tapered	ENFit(Dimensional complianceto AAMI/CN3:2014 (PS)Part 3 Table B.2 FemaleEnteral Small-BoreConnector).	No difference,presence of ENFitconnector isaccording toAAMI/CN3:2014 (PS)Part 3.No reference to theENFit connector in
				K122373 is due tothe absence ofspecific standardsrequirements at timeof that submission.
Biocompatibilityrequirements	The devices satisfythe applicableBiocompatibilityrequirementsaccording to ISO10993.	The devices satisfythe applicableBiocompatibilityrequirementsaccording to ISO10993.	ENFit enteral pumpsyringes satisfy theapplicable Biocompatibilityrequirements according toISO 10993.	No difference
Materials	PolypropyleneInk / ColorantsPolydimethylsiloxaneSilicone	PolypropyleneInk / ColorantsPolydimethylsiloxaneSilicone	PolypropyleneInk / ColorantsSilicone oil(Polydimethylsiloxane)Latex Free, nontoxicsynthetic rubber	No relevantdifferences
Description ofthe sterilizationmethod	Ethylene Oxide (EO),10-6 SAL	Ethylene Oxide (EO),10-6 SAL	Ethylene Oxide (EO),10-6 SAL	No difference

Pentaferte Italia s.r.| unipersonale

Sede Legale e Stabilimento Località Nocella S.P. 262 - 64012 CAMPLI (TE) - Italy

Uffici Commerciali e Amministrazione: Via Modera, 118 - 44122 FERRARA – Tel +39 0532 77881 - Fax +39 052 778812

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Image /page/6/Picture/0 description: The image is a logo for Pentaferte Italia SRL. The logo features a red cross and the number 5 in black on the left side. To the right of that is the word "pentaferte" in black, with the word "ITALIA" in red below it, and the letters "SRL" in smaller red font to the right of that. There is also a red oval surrounding the letters "PF" on the right side of the logo.

Pentaferte Italia s.r.| unipersonale

Sede Legale e Stabilimento Località Nocella S.P. 262 - 64012 CAMPLI (TE) - Italy Uffici Commerciali e Amministrazione: Via Modera, 118 - 44122 FERRARA – Tel +39 0532 77881 - Fax +39 052 778812

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Image /page/7/Picture/0 description: The image contains a logo for Pentaferte Italia SRL. The logo features a red cross and the number 5 in black on the left side. To the right of this is the word "pentaferte" in black, with the words "ITALIA SRL" in red below. There is also a red circle with the letters "PF" inside.

Pentaferte Italia s.r.| unipersonale

Sede Legale e Stabilimento Località Nocella S.P. 262 - 64012 CAMPLI (TE) - Italy

Uffici Commerciali e Amministrazione: Via Modera, 118 - 44122 FERRARA – Tel +39 0532 77881 - Fax +39 052 778812

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Image /page/8/Picture/0 description: The image contains the logo for Pentaferte Italia SRL. The logo features a red cross with the number 5 in black next to it. The words "Pentaferte" are written in black, with "Italia SRL" in red below it. There is also a red oval with the letters "PF" inside.

Performance Testing In vitro bench tests were carried out, according to the requirements of FDAs (non-clinical) document Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s and applicable standards. The following areas have been tested and/or evaluated: Performance test according to ISO 7886-1/-2, AAMI/CN3:2014 (PS), EN -1615 and ISO FDIS 80369/3, ISO 80369-1/-20 -Bioburden tests, Sterility tests, --Validation of the EtO Sterilization process, at the PENTAFERTE ITALIA S.r.l. site, Loc. Nocella SP 262, I-64012 Campli (TE) – Italy, -Packaging evaluation, -Labelling evaluation, -EtO Residual, according to EN ISO 10993-7, Biocompatibility, according to ISO 10993 series requirements. -Usability tests according to AAMI/IEC 62366-1:2015. -Results from these performance evaluations demonstrated that the ENFit enteral pump syringes PENTA ENFit ™ and ENFit enteral pump syringes NUTRIFIT™ met the acceptance criteria defined in the product specification and performed comparably to the predicate device. ENFit enteral pump syringes PENTA ENFit ™ and ENFit enteral pump syringes SUBSTANTIAL EQUIVALENCE: NUTRIFIT ™ are equivalent to the predicate device in terms of intended use, indications for use and medical technique. ENFit enteral pump syringes (PENTA ENFit ™ and NUTRIFIT ™) deliver

Pentaferte Italia s.r.| unipersonale

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Image /page/9/Picture/0 description: The image shows the logo for Pentaferte Italia SRL. The logo features a red plus sign with the number 5 in black next to it. To the right of the plus sign and number is the word "pentaferte" in black, with the word "ITALIA" in red below it and the letters "SRL" in smaller font to the right. There is also a red oval with the letters "PF" inside it.

nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. They are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.

ENFit enteral pump syringes (PENTA ENFit ™ and NUTRIFIT ™), are intended for neonatal, pediatric and adult use.

ENFit enteral (PENTA ENFit ™ and NUTRIFIT ™) pump syringes are single use devices.

Based on the safety and performance testing, technological characteristics and the indications for use for the device, proposed ENFit enteral pump syringes PENTA ENFit ™ and ENFit enteral pump syringes NUTRIFIT ™ have been demonstrated to be appropriate for the intended use and considered substantially equivalent to the, NeoConnect™ Enteral Syringes and NeoMed Oral / Enteral Syringe (K143344, K122373).

Table 1 -Summary Table

Pentaferte Italia s.r.| unipersonale

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.