(205 days)
K 201286
No
The device description and performance studies focus on the physical and chemical properties of a prefilled saline syringe, with no mention of AI or ML capabilities.
No
The device is described as "intended only for flushing in situ vascular access devices," which is a maintenance function, not a therapeutic treatment for a medical condition.
No
This device is described as a pre-filled syringe containing saline solution intended only for flushing in situ vascular access devices. Its purpose is to maintain patency of these devices, not to diagnose a condition or disease.
No
The device description clearly outlines a physical syringe containing a saline solution, which is a hardware component. The testing described also focuses on the physical and chemical properties of the syringe and solution.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "flushing in situ vascular access devices." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is a prefilled syringe containing saline solution. This is a medical device used for flushing, not for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological specimen. It does not perform any tests or provide diagnostic information.
- Predicate and Reference Devices: The predicate and reference devices listed are also prefilled saline syringes used for flushing, further supporting the non-IVD classification.
In summary, the Pentaflush saline 0.9% NaCl prefilled syringe is a medical device used for a therapeutic/procedural purpose (flushing vascular access devices), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Pentaflush saline 0.9% NaCl prefilled syringe is intended only for flushing in situ vascular access devices.
May be placed on a sterile field.
Pentaflush saline 0.9% NaCl prefilled syringe is intended for single patient and single use only.
Product codes
NGT
Device Description
The PentaFlush saline 0.9% NaCl prefilled syringe is a single-use device intended only for flushing in-situ vascular access devices. It is a polypropylene syringe containing an isotonic solution of sterile and non-pyrogenic 0.9% sodium chloride solution. These are ready for use devices that can be placed on sterile field.
The product is available in volumes of 3ml, 5ml and 10ml of saline solution in 10 ml syringes, which has a larger diameter in order to avoid that, with the same force applied on the shaft button, the higher pressure generated in the 3ml capacities may cause the vascular catheter to rupture. What differentiates the three versions is the graduated scale, whose maximum capacity coincides with the nominal capacity of each version (3ml, 5ml and 10ml).
In all capacities Luer Lock connector of the barrel is closed with a cap.
The barrel is filled with a 0.9% NaCl isotonic solution, sterile, pyrogen-free, up to the nominal capacity of the scale; an acitotoxic synthetic rubber piston is assembled to the polypropylene plunger, whose fiducial line is positioned at the nominal capacity of the syringe.
The primary packaging of PentaFlush pre-filled syringes can be in:
- a blister of medical paper and PE/PE peel, or
- b) an aluminum pouch of PET/ALL/PE peel.
PentaFlush saline 0.9% NaCl prefilled syringes are used only by healthcare professionals, is intended for single patient and single use only.
Does not contain preservatives. Not made with natural rubber latex.
Rx Only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access devices
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-clinical Testing:
The non-clinical tests performed on PentaFlush saline 0.9% NaCl prefilled syringe demonstrate the conformance of the subject device to the applicable standard.
Tests performed and results:
- Mechanical Testing/Stability:
- Visual inspection of pouch seals (ASTM F1886/F1886M-16): Conforms (No defect of the integrity of seals must be found)
- Bubble emission test of pouch (EN 868-5 Annex C): Conforms (No leaks)
- Visual inspection of prefilled syringe for damage (ISO 7886-1): Conforms (No damage, no leak (consistent with instructions for use))
- Test for liquid leakage and resistance of luer lock fitting (EN ISO 80369-7): Conforms (No leaks; no cracks)
- Test for integrity of printed label (ASTM F2250): Conforms (Print must remain defined and legible, color must not lighten, ink must not run)
- Distribution cycle (Transport) (ASTM D4169 Distribution Cycle 13, Packaging integrity ISO 11607-1): Conforms (The integrity of the packaging must be preserved)
- Chemical Testing:
- Assay of Sodium Chloride (USP monograph): Conforms (0.855 to 0.945% NaCl)
- pH (USP (791)): Conforms (4.5 to 7.0)
- Identification of Sodium and Chloride (USP (191)): Conforms (Successful identification)
- Sub-visible particulate matter (USP (788)): Conforms (>= 10µm: = 25µm:
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
July 20, 2022
Pentaferte Italia S.r.1. % Luca Giustini US Country Manager and Partner Pae Us 12300 Twinbrook Parkway, Suite 400 4th Floor Rockville, Maryland 20852
Re: K214080
Trade/Device Name: Pentaflush Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: NGT Dated: June 6, 2022 Received: June 13, 2022
Dear Luca Giustini:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214080
Device Name PentaFlush
Indications for Use (Describe)
Pentaflush saline 0.9% NaCl prefilled syringe is intended only for flushing in situ vascular access devices.
May be placed on a sterile field.
Pentaflush saline 0.9% NaCl prefilled syringe is intended for single patient and single use only.
| 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, a company that provides medical device solutions in Italy. The logo features a stylized "P" in black and red, followed by the company name "PentaFerte" in black and red text. Below the company name, the words "ITALIA MEDICAL DEVICES SOLUTIONS" are written in black text.
510(k) SUMMARY K214080
July 19, 2022
| Device Trade Name: | PentaFlush |
|---|---|
| Common Name: | Saline Flush Syringe |
| Classification Name: | Saline, Vascular Access Flush |
| Product Code: | NGT |
| Regulation: | 21 CFR §880.5200 |
| Regulatory Class: | Class II |
| Submitter/Manufacturer: | Pentaferte Italia srl |
| Address: | Viale Piane Nocella, 23 – 64012 Campli (TE) – Italy |
| Tel: | +39.0861.560201 |
| Fax: | +39.0861.560200 |
| Contact Name: | Rosa di Gioia, Quality and Regulatory Manager |
Predicate Device and Reference Device
| Predicate device: | Praxiject 0.9% NaCl |
|---|---|
| 510(k) Number | K192414 |
| Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access Flush |
| Product Code: | NGT |
| Reference Device: | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery |
| 510(k) Number | K 201286 |
| Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access Flush |
| Product Code: | NGT |
Device description
The PentaFlush saline 0.9% NaCl prefilled syringe is a single-use device intended only for flushing in-situ vascular access devices. It is a polypropylene syringe containing an isotonic solution of sterile and non-pyrogenic 0.9% sodium chloride solution. These are ready for use devices that can be placed on sterile field.
PentaFerte Italia Srl Unipersonale - C.F.e P.IVA: IT 01866900671 - Capitale sociale: € 820.000,00 I.V. - REA: TE - 159 867 Sede legale e stabilimento: Viale Piane Nocella, 23 - 64012 Campli (TE) - Italy - PEC: pentaferteitalia@legalmail.it Uffici commerciali e amministrazione: Via Modena, 119 - 44122 Ferrara, Italy - Tel: + 39 0532 778812
4
Image /page/4/Picture/0 description: The image shows the logo for PentaFerte. The logo has a red and black design with the word "PentaFerte" in a stylized font. The first part of the word, "Penta", is in black, while the second part, "Ferte", is in red. Below the word is the text "ITALIA MEDICAL DEVICES SOLUTIONS" in a smaller font.
The product is available in volumes of 3ml, 5ml and 10ml of saline solution in 10 ml syringes, which has a larger diameter in order to avoid that, with the same force applied on the shaft button, the higher pressure generated in the 3ml capacities may cause the vascular catheter to rupture. What differentiates the three versions is the graduated scale, whose maximum capacity coincides with the nominal capacity of each version (3ml, 5ml and 10ml).
In all capacities Luer Lock connector of the barrel is closed with a cap.
The barrel is filled with a 0.9% NaCl isotonic solution, sterile, pyrogen-free, up to the nominal capacity of the scale; an acitotoxic synthetic rubber piston is assembled to the polypropylene plunger, whose fiducial line is positioned at the nominal capacity of the syringe.
The primary packaging of PentaFlush pre-filled syringes can be in:
- a blister of medical paper and PE/PE peel, or a)
- b) an aluminum pouch of PET/ALL/PE peel.
PentaFlush saline 0.9% NaCl prefilled syringes are used only by healthcare professionals, is intended for single patient and single use only.
Does not contain preservatives. Not made with natural rubber latex.
Rx Only.
Technological characteristics compared to the predicate device
The subject device has the same intended use, flushing vascular access, and uses the same technology.
Technical characteristics are the same: prefilled plastic piston syringes with Luer lock connection filled with 0.9% Sodium Chloride Injection solution, in the same syringe size and fill volumes.
The differences:
- the predicate device has also 5 cc syringes; -
- the 0.9% Sodium Chloride Injection solution is compliant with EU Ph. (showed compliance to USP as well) in the subject device and with the USP in the predicate device;
- the shelf life of the subject device is 3 years, while the shelf life of the predicate device is 2 vears:
- the piston material, made of synthetic isoprene in the subject device and in bromobutyl rubber in the predicate device. The synthetic isoprene, however, is the same material used for the piston of the reference device K201286;
- the packaging materials: paper/plastic film vs. plastic film and multi-layer peel vs. aluminium foil for the subject device and the predicate device respectively are all these materials widely employed for such kind of applications;
- the number of syringes per case
Shown below is a side-by-side comparison of key device characteristics between the subject device and the predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for PentaFerte. The logo consists of a stylized letter "P" in black and red, followed by the word "Penta" in black and "Ferte" in red. Below the word "PentaFerte" is the text "ITALIA MEDICAL DEVICES SOLUTIONS" in a smaller font size, with the word "ITALIA" in red.
| Device Characteristic | Subject Device PentaFlush
saline prefilled syringe
(K214080) | Predicate Device Praxiject™
0.9% NaCl (K192414) | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
[Intended Use] | PentaFlush 0.9% NaCl
prefilled syringe is intended
only for flushing in situ
vascular access devices.
May be placed on a sterile
field.
PentaFlush 0.9% NaCl
prefilled syringe is intended
for single patient and single
use only. | The Praxiject™ 0.9% NaCl
prefilled syringe with 0.9%
Sodium Chloride Injection,
USP, is intended only for
flushing vascular access
devices.
May be placed on a sterile
field. | Same |
| Design | Prefilled plastic piston
syringe with Luer lock
connection fitting and
nonvented, female Luer lock
tip cap. | Prefilled plastic piston
syringe with Luer lock
connection fitting and
nonvented, female Luer
lock tip cap. | Same |
| Syringe Size and Fill
Volumes | 3 ml in 10 cc syringe
5 ml in 10 cc syringe
10 ml in 10 cc syringe | 3 mL in 5 cc syringe
5 mL in 5 cc syringe
3 mL in 10 cc syringe
5 mL in 10 cc syringe
10 mL in 10 cc syringe | Not relevant
differences: same
volumes 3, 5 and 10
ml in 10 cc syringes.
The predicate device
has also 5 cc
syringes. |
| Fill Volume
Graduations | On syringe label | On syringe label | Same |
| Syringe Content | 0.9% Sodium Chloride
Injection | 0.9% Sodium Chloride
Injection, USP | Similar
Same solution 0.9%
Sodium Chloride;
subject device is
compliant with EU
Ph and showed
compliance to USP as
well, predicate device
with USP. |
| Labeled
Non-
pyrogenic | Yes | Yes | Same |
| Single Use Only | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Device Characteristic | Subject Device PentaFlush
saline prefilled syringe
(K214080) | Predicate Device Praxiject™
0.9% NaCl (K192414) | Comparison |
| Use on Sterile Field | Yes | Yes | Same |
| Sterilization Method | Terminally sterilized by
gamma radiation, 10-6 SAL | Terminally sterilized by
gamma radiation, 10-6 SAL | Same |
| Shelf Life | 3 years | 2 years | Different
The shelf life of the
subject device is 3
years, while the
shelf life of the
predicate device is 2
years. |
| Syringe Material | -Barrel: Polypropylene
-Plunger: Polypropylene
-Piston: Synthetic isoprene
(not made with natural
rubber latex)
Tip Cap: ABS with white
colorant | -Barrel: Polypropylene
-Plunger: Polypropylene
-Piston: Bromobutyl
rubber (not made with
natural rubber latex)
Tip Cap: ABS with white
colorant | Similar
Same materials for
barrel, plunger and
tip cap.
The piston is
different: it is made
of synthetic isoprene
in the subject device
and in bromobutyl
rubber in the
predicate device.
However, the
synthetic isoprene is
the same material
used for the piston of
the reference device
K201286. |
| Device Characteristic | Subject Device PentaFlush
saline prefilled syringe
(K214080) | Predicate Device Praxiject™
0.9% NaCl (K192414) | Comparison |
| Syringe Packaging | HL60 PAPER + PET/PE
Peel (printed on one side,
clear on the other) – all sizes
and fill volumes
OR
PET12/ALL9/PE50 Peel
(printed on one side) – all
sizes and fill volumes | Plastic peel pouch (printed
on one side, clear on the
other) – all sizes and fill
volumes
OR
Aluminum foil pouch
(printed on one side) – 10
mL in 10 cc syringe | Similar
Both the devices
have two different
types of packaging
of the same design.
The materials are
different:
paper/plastic film
vs. plastic film and
multi-layer peel vs.
aluminum foil for
the subject device
and the predicate
device respectively.
However, all these
materials are widely
employed for such
kind of
applications. |
| Content of Syringe
Package | One syringe per pouch | One syringe per pouch | Same |
| Shipping Package
Configuration | 30 syringes (3, 5, 10 ml) per
case
4 cases per shipping carton –
all sizes, fill volumes and
syringe packaging | 100 syringes (10 cc) or 120
syringes
(5cc) per case / 6 cases per
shipping carton – all sizes
and fill volumes in plastic
peel pouch
OR
115 syringes per double bag
/4 double bags per shipping
carton -10 mL in 10 cc
syringe in aluminum foil
pouch | Different
The number of
syringes per case is
different. |
Page 3 of 7
PentaFerte Italia Srl Unipersonale - C.F. e P.IVA: IT 01866900671 - Capitale sociale: € 820.000,00 I.V. - REA: TE - 159 867 Sede legale e stabilimento: Viale Piane Nocella, 23 - 64012 Campli (TE) - Italy - PEC: pentaferteitalia@legalmai.it Uffici commerciali e amministrazione: Via Modena, 119 - 44122 Ferrara, Italy - Tel: + 39 0532 778811 - Fax: +39 0532 778812
6
Image /page/6/Picture/0 description: The image shows the logo for PentaFerte. The logo has a stylized letter "P" on the left, with the top part in red and the bottom part in black. To the right of the "P" is the word "PentaFerte" in black and red. Below the word "PentaFerte" is the text "ITALIA MEDICAL DEVICES SOLUTIONS".
Page 4 of 7
PentaFerte Italia Srl Unipersonale - C.F. e P.IVA: IT 01866900671 - Capitale sociale: € 820.000,00 I.V. - REA: TE - 159 867 Sede legale e stabilimento: Viale Piane Nocella, 23 - 64012 Campli (TE) - Italy - PEC: pentaferteitalia@legalmai.it Uffici commerciali e amministrazione: Via Modena, 119 - 44122 Ferrara, Italy - Tel: + 39 0532 778811 - Fax: +39 0532 778812
7
Image /page/7/Picture/0 description: The image shows the logo for PentaFerte, a company that provides medical device solutions in Italy. The logo consists of a stylized "P" in red and black, followed by the company name "PentaFerte" in black and red. Below the company name, the text "ITALIA MEDICAL DEVICES SOLUTIONS" is written in smaller letters.
The subject device has the same intended use and the same technical characteristics as the predicate device.
PentaFerte Italia Srl Unipersonale - C.F. e P.IVA: IT 01866900671 - Capitale sociale: € 820.000,00 I.V. - REA: TE - 159 867 Sede legale e stabilimento: Viale Piane Nocella, 23 - 64012 Campli (TE) - Italy - PEC: pentaferteitalia@legalmai.it Uffici commerciali e amministrazione: Via Modena, 119 - 44122 Ferrara, Italy - Tel: + 39 0532 778811 - Fax: +39 0532 778812
8
Image /page/8/Picture/0 description: The image shows the logo for PentaFerte. The logo has a red and black color scheme. The text "PentaFerte" is written in a stylized font, with the "Penta" portion in black and the "Ferte" portion in red. Below the text, there is a red banner with the words "ITALIA MEDICAL DEVICES SOLUTIONS" written in white.
Summary of Non-clinical Testing
The non-clinical tests performed on PentaFlush saline 0.9% NaCl prefilled syringe demonstrate the conformance of the subject device to the applicable standard as shown below:
| Test | Standards | Acceptance Criteria | Results |
|---|---|---|---|
| Mechanical Testing/Stability | |||
| Visual inspection of pouch | |||
| seals | ASTM F1886/F1886M-16 | No defect of the integrity of | |
| seals must be found | Conforms | ||
| Bubble emission test of | |||
| pouch | EN 868-5 Annex C | No leaks | Conforms |
| Visual inspection of prefilled | |||
| syringe for damage | ISO 7886-1 | No damage, no leak | |
| (consistent with | |||
| instructions for use) | Conforms | ||
| Test for liquid leakage and | |||
| resistance of luer lock | |||
| fitting | EN ISO 80369-7 | No leaks; no cracks | Conforms |
| Test for integrity of printed | |||
| label | ASTM F2250 | Print must remain defined | |
| and legible, color must not | |||
| lighten, ink must not run | Conforms | ||
| Distribution cycle | |||
| (Transport) | ASTM D4169 | ||
| Distribution Cycle 13 | |||
| Packaging integrity ISO 11607-1 | The integrity of the | ||
| packaging must be | |||
| preserved | Conforms | ||
| Chemical Testing | |||
| Assay of Sodium Chloride | USP monograph | 0.855 to 0.945% NaCl | Conforms |
| pH | USP | 4.5 to 7.0 | Conforms |
| Identification of Sodium | |||
| and Chloride | USP | Successful identification | Conforms |
| Sub-visible particulate | |||
| matter | USP | ≥ 10µm: ≤6000 | |
| part/syringe | |||
| ≥ 25µm: ≤ 600 | |||
| part/syringe | Conforms | ||
| Elemental Impurities | |||
| (Heavy Metals) | USP / | Arsenic: ≤ 1.5µg/g | |
| Cadmium: ≤ 0.2µg/g | |||
| Mercury: ≤ 0.3µg/g | |||
| Lead: ≤ 0.5µg/g | Conforms | ||
| Iron | USP | Iron: ≤ 2ppm | Conforms |
| Sterilization | |||
| Bacterial Endotoxins | USP | ≤ 0.5 EU/mL | Conforms |
| Sterilization Validation | ISO 11137-2 | 10-6 SAL | Conforms |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Conforms |
| Skin-sensitization | ISO 10993-10 | Non-sensitizer | Conforms |
| Intracutaneous Reactivity | ISO 10993-10 | Non-irritant | Conforms |
| Acute systemic toxicity | ISO 10993-11 | No systemic toxicity | Conforms |
| Pyrogenicity | |||
| (material-mediated) | ISO 10993-11 (USP ) | No material mediated | |
| response observed | Conforms | ||
| Hemolysis | ISO 10993-4 (ASTM F756-17) | Non-hemolytic | Conforms |
| Tests for interaction | |||
| with blood | ISO 10993-4 | No interaction with blood | Conforms |
Page 6 of 7
PentaFerte Italia Srl Unipersonale - C.F.e P.IVA: IT 01866900671 - Capitale sociale: € 820.000,00 I.V. - REA: TE - 159 867 Sede legale e stabilimento: Viale Piane Nocella, 23 - 64012 Campli (TE) - Italy - PEC: pentaferteitalia@legalmai.it Uffici commerciali e amministrazione: Via Modena, 119 - 44122 Ferrara, Italy - Tel: + 39 0532 778812
9
Image /page/9/Picture/0 description: The image is a logo for PentaFerte, an Italian medical device solutions company. The logo features a stylized "P" symbol in red and black, followed by the company name "PentaFerte" in black and red. Below the company name, there is a red banner with the text "ITALIA MEDICAL DEVICES SOLUTIONS" in white.
Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the PentaFlush saline 0.9% NaCl prefilled syringe is as safe, as effective, and performs as well as or better than the legally marketed predicate device Praxiject™ 0.9% NaCl.
PentaFerte Italia Srl Unipersonale - C.F. e P.VA: IT 01866900671 - Capitale sociale: € 820.000,00 I.V. - REA: TE - 159 867 Sede legale e stabilimento: Viale Piane Nocella, 23 - 64012 Campli (TE) - Italy - PEC: pentaferteitalia@legalmai.it Uffici commerciali e amministrazione: Via Modena, 119 - 44122 Ferrara, Italy - Tel: + 39 0532 778812