ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

K161141 · Pentaferte Italia S.R.L. · PNR · Mar 22, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161141
• Device Name: ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
• Applicant: Pentaferte Italia S.R.L.
• Product Code: PNR · Gastroenterology, Urology
• Decision Date: Mar 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Disposable enteral feeding syringes (10ml, 20ml, 60ml) designed for delivery of nutritional formula to gastrointestinal system. Features female ENFit connector (AAMI/CN3:2014) to prevent accidental parenteral connection. Used in clinical or home settings by healthcare professionals or laypersons under clinician supervision. Compatible with enteral infusion pumps. Syringes consist of barrel, plunger, and synthetic rubber gasket (latex-free). Output is controlled delivery of enteral nutrition. Benefits include reduced risk of misconnection and safe administration of enteral formula.

Clinical Evidence

Bench testing only. Evaluated per ISO 7886-1/-2, AAMI/CN3:2014, EN 1615, ISO 80369-1/-3/-20. Testing included bioburden, sterility, EtO sterilization validation, EtO residuals (ISO 10993-7), biocompatibility (ISO 10993), and usability (AAMI/IEC 62366-1:2015). Results met all product specifications and demonstrated performance comparable to predicate devices.

Technological Characteristics

Materials: Polypropylene, ink/colorants, silicone oil (polydimethylsiloxane), latex-free synthetic rubber. Connector: Female ENFit (AAMI/CN3:2014). Sterilization: Ethylene Oxide (EO) to 10-6 SAL. Form factor: Disposable syringe (10ml, 20ml, 60ml). Standards: ISO 7886-1/-2, ISO 80369-3, ISO 10993, AAMI/CN3:2014.

Indications for Use

Indicated for neonatal, pediatric, and adult patients physically unable to eat or swallow, requiring delivery of nutritional formula to the gastrointestinal system via enteral infusion pump.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• NeoConnect™ Enteral Syringes (K143344)
• NeoMed Oral / Enteral Syringe (K122373)

Submission Summary (Full Text)

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely 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)

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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,<br>I-64012 Campli (TE) - Italy |
| Summary Preparation<br>Date | 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 ENFitTM<br>ENFit enteral pump syringes NUTRIFITTM |
| Common name of the device | ENFit enteral pump syringes |
| Classification Name and class | Enteral syringes with enteral specific connectors<br>Device Class: II<br>Product Code: PNR<br>Regulation Number 21 CFR 876.5980 |
| Performance Standards | - ISO 803693-3:2016 Small-bore connectors for liquids and gases in<br>healthcare applications -- Part 3: Connectors for enteral applications<br>- AAMI/ANSI/ISO 80369-1:2010 - Small-bore connectors for liquids and<br>gases in healthcare applications - Part 1: General requirements<br>- AAMI/CN3:2014 (PS) Small Bore Connectors For Liquids And Gases In<br>Healthcare Applications Part 3: Connectors For Enteral Applications<br>- EN ISO 7886-1:1997: Sterile hypodermic syringes for single use.<br>Syringes for manual use<br>- EN ISO 7886-2:1997. Sterile hypodermic syringes for single use.<br>Syringes for use with power-driven syringe pumps<br>- ANSI/AAMI/ISO 80369-20:2015, Smallbore connectors for liquids and<br>gases in healthcare applications – Part 20: Common test methods<br>- EP § 3.2.8<br>- ASTM D790- 15e2 Standard Test Methods for Flexural Properties of<br>Unreinforced and Reinforced Plastics and Electrical Insulating<br>Materials<br>- EN 1615:2000 - Enteral Feeding Catheters And Enteral Giving Sets For<br>Single Use And Their Connectors Design And Testing<br>- 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. [phone] - Fax [phone] 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 of<br>connection to a parenteral system, as required by AAMI/CN3:2014 (PS),<br>allowing only enteral use.<br>In particular, these high volume syringes (sizes 10ml, 20 ml and 60ml) can be<br>connected with enteral infusion pump.<br>They have plungers, made of synthetic rubber which does not contain natural<br>latex, in order to prevent any allergies. |
| Indications for Use | ENFit enteral pump syringes PENTA ENFit TM and ENFit enteral pump syringes<br>NUTRIFIT TM deliver nutritional formula to the gastrointestinal system of a<br>patient who is physically unable to eat and swallow. ENFit enteral pump<br>syringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinical<br>or home care settings by users ranging from laypersons (under the supervision<br>of a clinician) to health care professionals, to administer nutritional formula.<br>In particular, these syringes can be connected with enteral infusion pump.<br>ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended<br>for neonatal, pediatric and adult use.<br>ENFit enteral pump syringes are single use devices. |
| Identification of Predicate Device | Proprietary Name: NeoMed, Inc<br>K143344<br>Classification Name: Gastrointestinal tube and accessories devices; 21 CFR<br>876.5980<br>K122373<br>Classification Name: Piston Syringe; 21 CFR 880.5560<br>Registered Establishment Name: NeoMed, Inc<br>Registered Establishment Number: 3006520777<br>Owner/Operator: NeoMed, Inc.<br>Owner/Operator Number: 10022926<br>Manufacturer 510 (k): K143344<br>Device Name: NeoConnectTM Enteral Syringes<br>Manufacturer 510 (k): K122373<br>Device Name: NeoMed Oral / Enteral Syringe<br>Applicant: NeoMed, Inc.<br>100 Londonderry Court<br>Suite 112<br>Woodstock GA 30188 |
| Common name of the<br>predicate device for<br>principles of operations | - K143344<br>NeoConnect™ Enteral Syringes<br>- K122373<br>NeoMed Oral / Enteral Syringe |
| Classification Name of the<br>device | - K143344<br>Gastrointestinal tube and accessories devices<br>Device Class: II<br>Product Code: PIF<br>Regulation Number: 21 CFR 876.5980<br>- K122373<br>Piston Syringe<br>Device Class: II<br>Product Code: FMF<br>Regulation Number: 21 CFR 880.5560 |
| Applicant name and<br>address: | NeoMed, Inc.<br>100 Londonderry Court<br>Suite 112<br>Woodstock, GA 30188 |
| Comparison of<br>Technological<br>Characteristics | In vitro bench testing was performed to support a determination of substantial<br>equivalence (refer to performance testing below) between ENFit enteral pump<br>syringes PENTA ENFit ™ , ENFit enteral pump syringes NUTRIFIT ™ , and<br>predicate devices.<br>The results of these tests provide reasonable assurance that the proposed<br>device has been designed and tested to assure conformance to the<br>requirements for its intended use and performs comparably to the existing<br>predicate 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:<br>NeoMed<br>NeoConnect™<br>Enteral Syringes<br>with ENFit<br>Connector<br>(K143344) | Predicate device:<br>NeoMed Oral /<br>Enteral Syringe<br>(K122373) | Subject Device<br>ENFit enteral pump<br>syringes PENTA<br>ENFit™, ENFit enteral<br>pump syringes<br>NUTRIFIT TM<br>(K161141) | Comparison<br>Description/<br>Justification for<br>the differences |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>description | An enteral syringe<br>consisting of a syringe<br>barrel with integral<br>tip (ENFit), plunger,<br>gasket,<br>barrel<br>lubricant and supplied<br>with a syringe tip cap. | An oral / enteral<br>syringe consisting of<br>a syringe barrel with<br>integral tip<br>(tapered), plunger,<br>gasket, barrel<br>lubricant and<br>supplied with a<br>syringe tip cap. | ENFit enteral pump<br>syringes consists of<br>disposable enteral feeding<br>syringes that deliver<br>nutritional formula to the<br>gastrointestinal system of<br>a patient who is physically<br>unable to eat and swallow.<br>ENFit enteral pump | No relevant<br>difference.<br>No reference to the<br>ENFit connector in<br>K122373 is due to<br>the absence of<br>specific standards<br>requirements at time<br>of that submission. |
| | | | syringes are designed so<br>that, while administering<br>enteral solutes and<br>medication, any accidental<br>risk of connection to a<br>parenteral system is<br>prevented, through the<br>female ENFit connector for<br>connection to an enteral<br>access device, designed<br>according to the<br>AAMI/CN3:2014 (PS) Part<br>3 requirements, allowing<br>only enteral use. | |
| Indication for<br>Use | The device<br>is<br>indicated for use as a<br>dispenser,<br>a<br>measuring device and<br>a fluid transfer device.<br>It is used to deliver<br>fluids into the body<br>via extension sets and<br>feeding tubes in<br>neonatal and small<br>pediatric patients. | The device is<br>indicated for use as a<br>dispenser, a<br>measuring device<br>and an oral fluid<br>transfer device. It is<br>used to inject fluids<br>into the body via<br>extension sets and<br>feeding tubes in<br>neonatal and small<br>pediatric patients. | ENFit enteral pump<br>syringes PENTA ENFit ™<br>and ENFit enteral pump<br>syringes NUTRIFIT ™<br>deliver nutritional formula<br>to the gastrointestinal<br>system of a patient who is<br>physically unable to eat<br>and swallow. ENFit enteral<br>pump syringes (PENTA<br>ENFit ™ and NUTRIFIT ™)<br>are intended to be used in<br>clinical or home care<br>settings by users ranging<br>from laypersons (under<br>the supervision of a<br>clinician) to health care<br>professionals, to<br>administer nutritional<br>formula. In particular,<br>these syringes can be<br>connected with enteral<br>infusion pump.<br>ENFit enteral pump<br>syringes (PENTA ENFit ™<br>and NUTRIFIT ™) are<br>intended for neonatal,<br>pediatric and adult use.<br>ENFit enteral pump<br>syringes are single use<br>devices. | Indication for use is<br>equivalent, even if<br>the target population<br>of the subject device<br>is wider.<br>Based on the<br>consideration that<br>the target population<br>of the predicates<br>(neonatal and small<br>pediatric patients) is<br>considered worst<br>case if compared<br>with the target<br>population of the<br>subject device<br>(intended for<br>patients of all age<br>groups), the<br>indication for use of<br>the subject device is<br>considered<br>substantially<br>equivalent to those<br>of the predicates.<br>Additional<br>statements on<br>Directions for use<br>and warning<br>according to FDA<br>Guidance "Safety<br>Considerations to<br>Mitigate the Risks of |
| | | | Misconnections with<br>Small-bore<br>Connectors Intended<br>for Enteral<br>Applications".<br><br>No relevant<br>difference. | |
| Model available | 0.5ml to 100ml sizes | 0.5ml to 100ml sizes | 10ml, 20 ml, 60 ml | No relevant<br>difference,<br>Pentaferte Italia<br>devices are in the<br>range of predicate<br>volume sizes. |
| Pump<br>compatibility | Not specified, but in<br>510(k) summary is<br>stated that the device<br>is equivalent to the<br>predicate device<br>(K122373, see related<br>column). | Pump compatibility<br>is demonstrated by<br>the statement in the<br>510(k) summary<br>(K122373) "the<br>devices meet the<br>applicable<br>requirements of ISO<br>7886-1 and ISO<br>7886-2, Sterile<br>hypodermic syringes<br>for single use – part<br>2: syringes for use<br>with power driven<br>syringe pump". | Pump compatibility is<br>demonstrated by the in<br>vitro bench tests on ENFit<br>enteral pump syringes,<br>which show the<br>compliance with the<br>applicable requirements of<br>the ISO 7886-1 and ISO<br>7886-2, (see also Chapter<br>17 and related<br>documents). | No difference, pump<br>compatibility is<br>demonstrated by the<br>statement in the<br>510(k) summary<br>(K122373) "the<br>devices meet the<br>applicable<br>requirements of ISO<br>7886-1 and ISO 7886-<br>2, Sterile hypodermic<br>syringes for single<br>use - part 2: syringes<br>for use with power<br>driven syringe pump"<br>and in vitro bench<br>tests on the subject<br>devices, which show<br>the compliance with<br>the applicable<br>requirements of the<br>ISO 7886-1 and ISO<br>7886-2, (see also<br>Chapter 17 and<br>related documents) |
| Connection type | ENFit<br>(Dimensional<br>compliance<br>to<br>AAMI/CN3:2014 (PS)<br>Part 3 Table B.2<br>Female Enteral Small-<br>Bore Connector). | Tapered | ENFit<br>(Dimensional compliance<br>to AAMI/CN3:2014 (PS)<br>Part 3 Table B.2 Female<br>Enteral Small-Bore<br>Connector). | No difference,<br>presence of ENFit<br>connector is<br>according to<br>AAMI/CN3:2014 (PS)<br>Part 3.<br>No reference to the<br>ENFit connector in |
| | | | | K122373 is due to<br>the absence of<br>specific standards<br>requirements at time<br>of that submission. |
| Biocompatibility<br>requirements | The devices satisfy<br>the applicable<br>Biocompatibility<br>requirements<br>according to ISO<br>10993. | The devices satisfy<br>the applicable<br>Biocompatibility<br>requirements<br>according to ISO<br>10993. | ENFit enteral pump<br>syringes satisfy the<br>applicable Biocompatibility<br>requirements according to<br>ISO 10993. | No difference |
| Materials | Polypropylene<br>Ink / Colorants<br>Polydimethylsiloxane<br>Silicone | Polypropylene<br>Ink / Colorants<br>Polydimethylsiloxane<br>Silicone | Polypropylene<br>Ink / Colorants<br>Silicone oil<br>(Polydimethylsiloxane)<br>Latex Free, nontoxic<br>synthetic rubber | No relevant<br>differences |
| Description of<br>the sterilization<br>method | Ethylene Oxide (EO),<br>10-6 SAL | Ethylene Oxide (EO),<br>10-6 SAL | Ethylene Oxide (EO),<br>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 [phone] - Fax [phone]

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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 [phone] - Fax [phone]

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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 [phone] - Fax [phone]

{8}------------------------------------------------

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

Sede Legale e Stabilimento Località Nocella S.P. 262 - 64012 CAMPLI (TE) - Italy Uffici Commerciali e Amministrazione: Via Modera, 119 - 44122 FERRARA-Tel. [phone] - Fax [phone] 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/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

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