(334 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the syringes, with no mention of AI or ML capabilities.
No
The device is described as an enteral pump syringe used to deliver nutritional formula, not to treat or cure a disease or condition. It is a delivery mechanism for nutrition, not a therapeutic agent itself.
No
The device delivers nutritional formula and is not described as analyzing or interpreting data for diagnostic purposes.
No
The device description clearly states it consists of "disposable enteral feeding syringes" and describes physical components like plungers and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow." This is a direct therapeutic intervention on a patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as "disposable enteral feeding syringes" designed for administering nutritional formula. This aligns with a device used for direct patient care, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) for the purpose of providing information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health status. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for 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.
Product codes
PNR
Device Description
ENFit enteral pump syringes are designed to reduce the accidental risk of connection 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 be connected with enteral infusion pump. They have plungers, made of synthetic rubber which does not contain natural latex, in order to prevent any allergies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system
Indicated Patient Age Range
neonatal, pediatric and adult
Intended User / Care Setting
clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 TM and ENFit enteral pump syringes NUTRIFIT™ met the acceptance criteria defined in the product specification and performed comparably to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
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 Preparation | |
| 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 |
| ENFit enteral pump syringes NUTRIFITTM | |
| Common name of the device | ENFit enteral pump syringes |
| Classification Name and class | Enteral syringes with enteral specific connectors |
| Device Class: II | |
| Product Code: PNR | |
| Regulation Number 21 CFR 876.5980 | |
| Performance Standards | - ISO 803693-3:2016 Small-bore connectors for liquids and gases in |
| healthcare applications -- Part 3: Connectors for enteral applications |
- AAMI/ANSI/ISO 80369-1:2010 - Small-bore connectors for liquids and
gases in healthcare applications - Part 1: General requirements - AAMI/CN3:2014 (PS) Small Bore Connectors For Liquids And Gases In
Healthcare 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 and
gases in healthcare applications – Part 20: Common test methods - EP § 3.2.8
- ASTM D790- 15e2 Standard Test Methods for Flexural Properties of
Unreinforced and Reinforced Plastics and Electrical Insulating
Materials - EN 1615:2000 - Enteral Feeding Catheters And Enteral Giving Sets For
Single 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
4
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 |
| connection 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 be | |
| connected with enteral infusion pump. | |
| They have plungers, made of synthetic rubber which does not contain natural | |
| latex, in order to prevent any allergies. | |
| Indications for 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. | |
| Identification of Predicate Device | Proprietary Name: NeoMed, Inc |
| K143344 | |
| Classification Name: Gastrointestinal tube and accessories devices; 21 CFR | |
| 876.5980 | |
| K122373 | |
| Classification Name: Piston Syringe; 21 CFR 880.5560 | |
| Registered Establishment Name: NeoMed, Inc | |
| Registered Establishment Number: 3006520777 | |
| Owner/Operator: NeoMed, Inc. | |
| Owner/Operator Number: 10022926 | |
| Manufacturer 510 (k): K143344 | |
| Device Name: NeoConnectTM Enteral Syringes | |
| Manufacturer 510 (k): K122373 | |
| Device Name: NeoMed Oral / Enteral Syringe | |
| Applicant: NeoMed, Inc. | |
| 100 Londonderry Court | |
| Suite 112 | |
| Woodstock GA 30188 | |
| Common name of the | |
| predicate device for | |
| principles of operations | - K143344 |
| NeoConnect™ Enteral Syringes |
-
[K122373](https://510k.innolitics.com/search/K122373)
NeoMed Oral / Enteral Syringe |
| Classification Name of the
device | - K143344
Gastrointestinal tube and accessories devices
Device Class: II
Product Code: PIF
Regulation Number: 21 CFR 876.5980
-
[K122373](https://510k.innolitics.com/search/K122373)
Piston Syringe
Device Class: II
Product Code: FMF
Regulation Number: 21 CFR 880.5560 |
| Applicant name and
address: | NeoMed, Inc.
100 Londonderry Court
Suite 112
Woodstock, GA 30188 |
| Comparison of
Technological
Characteristics | In vitro bench testing was performed to support a determination of substantial
equivalence (refer to performance testing below) between ENFit enteral pump
syringes PENTA ENFit ™ , ENFit enteral pump syringes NUTRIFIT ™ , and
predicate devices.
The results of these tests provide reasonable assurance that the proposed
device has been designed and tested to assure conformance to the
requirements for its intended use and performs comparably to the existing
predicate devices. |
Pentaferte Italia s.r.| unipersonale
5
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:
NeoMed
NeoConnect™
Enteral Syringes
with ENFit
Connector
(K143344) | Predicate device:
NeoMed Oral /
Enteral Syringe
(K122373) | Subject Device
ENFit enteral pump
syringes PENTA
ENFit™, ENFit enteral
pump syringes
NUTRIFIT TM
(K161141) | Comparison
Description/
Justification for
the differences |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | An enteral syringe
consisting of a syringe
barrel with integral
tip (ENFit), plunger,
gasket,
barrel
lubricant and supplied
with a syringe tip cap. | An oral / enteral
syringe consisting of
a syringe barrel with
integral tip
(tapered), plunger,
gasket, barrel
lubricant and
supplied with a
syringe tip cap. | 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 | No relevant
difference.
No reference to the
ENFit connector in
K122373 is due to
the absence of
specific standards
requirements at time
of that submission. |
| | | | 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. | |
| Indication for
Use | The device
is
indicated for use as a
dispenser,
a
measuring device and
a fluid transfer device.
It is used to deliver
fluids into the body
via extension sets and
feeding tubes in
neonatal and small
pediatric patients. | The device is
indicated for use as a
dispenser, a
measuring device
and an oral fluid
transfer device. It is
used to inject fluids
into the body via
extension sets and
feeding tubes in
neonatal and small
pediatric patients. | ENFit enteral pump
syringes PENTA ENFit ™
and ENFit enteral pump
syringes NUTRIFIT ™
deliver nutritional formula
to the gastrointestinal
system of a patient who is
physically unable to eat
and swallow. ENFit enteral
pump syringes (PENTA
ENFit ™ and NUTRIFIT ™)
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 pump
syringes are single use
devices. | Indication for use is
equivalent, even if
the target population
of the subject device
is wider.
Based on the
consideration that
the target population
of the predicates
(neonatal and small
pediatric patients) is
considered worst
case if compared
with the target
population of the
subject device
(intended for
patients of all age
groups), the
indication for use of
the subject device is
considered
substantially
equivalent to those
of the predicates.
Additional
statements on
Directions for use
and warning
according to FDA
Guidance "Safety
Considerations to
Mitigate the Risks of |
| | | | Misconnections with
Small-bore
Connectors Intended
for Enteral
Applications".
No relevant
difference. | |
| Model available | 0.5ml to 100ml sizes | 0.5ml to 100ml sizes | 10ml, 20 ml, 60 ml | No relevant
difference,
Pentaferte Italia
devices are in the
range of predicate
volume sizes. |
| Pump
compatibility | Not specified, but in
510(k) summary is
stated that the device
is equivalent to the
predicate device
(K122373, see related
column). | Pump compatibility
is demonstrated by
the statement in the
510(k) summary
(K122373) "the
devices meet the
applicable
requirements of ISO
7886-1 and ISO
7886-2, Sterile
hypodermic syringes
for single use – part
2: syringes for use
with power driven
syringe pump". | Pump compatibility is
demonstrated by the in
vitro bench tests on ENFit
enteral pump syringes,
which show the
compliance with the
applicable requirements of
the ISO 7886-1 and ISO
7886-2, (see also Chapter
17 and related
documents). | No difference, pump
compatibility is
demonstrated by the
statement in the
510(k) summary
(K122373) "the
devices meet the
applicable
requirements of ISO
7886-1 and ISO 7886-
2, Sterile hypodermic
syringes for single
use - part 2: syringes
for use with power
driven syringe pump"
and in vitro bench
tests on the subject
devices, which show
the compliance with
the applicable
requirements of the
ISO 7886-1 and ISO
7886-2, (see also
Chapter 17 and
related documents) |
| Connection type | ENFit
(Dimensional
compliance
to
AAMI/CN3:2014 (PS)
Part 3 Table B.2
Female Enteral Small-
Bore Connector). | Tapered | ENFit
(Dimensional compliance
to AAMI/CN3:2014 (PS)
Part 3 Table B.2 Female
Enteral Small-Bore
Connector). | No difference,
presence of ENFit
connector is
according to
AAMI/CN3:2014 (PS)
Part 3.
No reference to the
ENFit connector in |
| | | | | K122373 is due to
the absence of
specific standards
requirements at time
of that submission. |
| Biocompatibility
requirements | The devices satisfy
the applicable
Biocompatibility
requirements
according to ISO
10993. | The devices satisfy
the applicable
Biocompatibility
requirements
according to ISO
10993. | ENFit enteral pump
syringes satisfy the
applicable Biocompatibility
requirements according to
ISO 10993. | No difference |
| Materials | Polypropylene
Ink / Colorants
Polydimethylsiloxane
Silicone | Polypropylene
Ink / Colorants
Polydimethylsiloxane
Silicone | Polypropylene
Ink / Colorants
Silicone oil
(Polydimethylsiloxane)
Latex Free, nontoxic
synthetic rubber | No relevant
differences |
| Description of
the sterilization
method | 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
6
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
7
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
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. +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
9
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. +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