(205 days)
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.
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 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.
This document describes the non-clinical testing for the PentaFlush saline 0.9% NaCl prefilled syringe. This device is an "Intravascular catheter" (Product Code: NGT) used for flushing in-situ vascular access devices. The study conducted is a non-clinical study to demonstrate conformance to applicable standards.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standards | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 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 | 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, 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 <791> | 4.5 to 7.0 | Conforms |
| Identification of Sodium and Chloride | USP <191> | Successful identification | Conforms |
| Sub-visible particulate matter | USP <788> | ≥ 10µm: ≤6000 part/syringe; ≥ 25µm: ≤ 600 part/syringe | Conforms |
| Elemental Impurities (Heavy Metals) | USP <232>/<233> | Arsenic: ≤ 1.5µg/g; Cadmium: ≤ 0.2µg/g; Mercury: ≤ 0.3µg/g; Lead: ≤ 0.5µg/g | Conforms |
| Iron | USP <24> | Iron: ≤ 2ppm | Conforms |
| Sterilization | |||
| Bacterial Endotoxins | USP <85> | ≤ 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 <151>) | 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 |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing performed on the device itself and its components. It does not refer to a "test set" in the context of patient data or clinical samples. The tests mentioned are laboratory-based and generally involve a specified number of samples of the device and its materials as required by the referenced standards. The data provenance is Pentaferte Italia S.r.l., based in Italy. The tests are prospective in the sense that they are conducted on the manufactured device to verify its compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This point is not applicable to the provided document. The study described is a non-clinical, laboratory-based testing of a medical device's physical, chemical, and biological properties according to established international standards. The "ground truth" is determined by the specific criteria outlined in each standard for each test, not by expert consensus on clinical data.
4. Adjudication method for the test set
This point is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies involving multiple readers for interpreting medical images or data. The non-clinical tests described have predefined pass/fail criteria based on the relevant standards.
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
This point is not applicable. The device is a prefilled saline syringe, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. The device is a medical product (prefilled saline syringe), not an algorithm.
7. The type of ground truth used
The ground truth used for these non-clinical tests is based on established international and national standards and monographs. For example, USP monographs for chemical assays, ISO standards for biocompatibility and sterilization, and ASTM standards for mechanical testing. These standards define the acceptable limits and methodologies against which the device performance is measured.
8. The sample size for the training set
This point is not applicable. The study is a non-clinical performance verification, not a study involving machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
This point is not applicable for the reasons mentioned in point 8.
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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
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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
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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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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
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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.
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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 PentaFlushsaline prefilled syringe(K214080) | Predicate Device Praxiject™0.9% NaCl (K192414) | Comparison |
|---|---|---|---|
| Indications for Use[Intended Use] | PentaFlush 0.9% NaClprefilled syringe is intendedonly for flushing in situvascular access devices.May be placed on a sterilefield.PentaFlush 0.9% NaClprefilled syringe is intendedfor single patient and singleuse only. | The Praxiject™ 0.9% NaClprefilled syringe with 0.9%Sodium Chloride Injection,USP, is intended only forflushing vascular accessdevices.May be placed on a sterilefield. | Same |
| Design | Prefilled plastic pistonsyringe with Luer lockconnection fitting andnonvented, female Luer locktip cap. | Prefilled plastic pistonsyringe with Luer lockconnection fitting andnonvented, female Luerlock tip cap. | Same |
| Syringe Size and FillVolumes | 3 ml in 10 cc syringe5 ml in 10 cc syringe10 ml in 10 cc syringe | 3 mL in 5 cc syringe5 mL in 5 cc syringe3 mL in 10 cc syringe5 mL in 10 cc syringe10 mL in 10 cc syringe | Not relevantdifferences: samevolumes 3, 5 and 10ml in 10 cc syringes.The predicate devicehas also 5 ccsyringes. |
| Fill VolumeGraduations | On syringe label | On syringe label | Same |
| Syringe Content | 0.9% Sodium ChlorideInjection | 0.9% Sodium ChlorideInjection, USP | SimilarSame solution 0.9%Sodium Chloride;subject device iscompliant with EUPh and showedcompliance to USP aswell, predicate devicewith USP. |
| LabeledNon-pyrogenic | Yes | Yes | Same |
| Single Use Only | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Device Characteristic | Subject Device PentaFlushsaline prefilled syringe(K214080) | Predicate Device Praxiject™0.9% NaCl (K192414) | Comparison |
| Use on Sterile Field | Yes | Yes | Same |
| Sterilization Method | Terminally sterilized bygamma radiation, 10-6 SAL | Terminally sterilized bygamma radiation, 10-6 SAL | Same |
| Shelf Life | 3 years | 2 years | DifferentThe shelf life of thesubject device is 3years, while theshelf life of thepredicate device is 2years. |
| Syringe Material | -Barrel: Polypropylene-Plunger: Polypropylene-Piston: Synthetic isoprene(not made with naturalrubber latex)Tip Cap: ABS with whitecolorant | -Barrel: Polypropylene-Plunger: Polypropylene-Piston: Bromobutylrubber (not made withnatural rubber latex)Tip Cap: ABS with whitecolorant | SimilarSame materials forbarrel, plunger andtip cap.The piston isdifferent: it is madeof synthetic isoprenein the subject deviceand in bromobutylrubber in thepredicate device.However, thesynthetic isoprene isthe same materialused for the piston ofthe reference deviceK201286. |
| Device Characteristic | Subject Device PentaFlushsaline prefilled syringe(K214080) | Predicate Device Praxiject™0.9% NaCl (K192414) | Comparison |
| Syringe Packaging | HL60 PAPER + PET/PEPeel (printed on one side,clear on the other) – all sizesand fill volumesORPET12/ALL9/PE50 Peel(printed on one side) – allsizes and fill volumes | Plastic peel pouch (printedon one side, clear on theother) – all sizes and fillvolumesORAluminum foil pouch(printed on one side) – 10mL in 10 cc syringe | SimilarBoth the deviceshave two differenttypes of packagingof the same design.The materials aredifferent:paper/plastic filmvs. plastic film andmulti-layer peel vs.aluminum foil forthe subject deviceand the predicatedevice respectively.However, all thesematerials are widelyemployed for suchkind ofapplications. |
| Content of SyringePackage | One syringe per pouch | One syringe per pouch | Same |
| Shipping PackageConfiguration | 30 syringes (3, 5, 10 ml) percase4 cases per shipping carton –all sizes, fill volumes andsyringe packaging | 100 syringes (10 cc) or 120syringes(5cc) per case / 6 cases pershipping carton – all sizesand fill volumes in plasticpeel pouchOR115 syringes per double bag/4 double bags per shippingcarton -10 mL in 10 ccsyringe in aluminum foilpouch | DifferentThe number ofsyringes per case isdifferent. |
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
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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
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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
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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 pouchseals | ASTM F1886/F1886M-16 | No defect of the integrity ofseals must be found | Conforms |
| Bubble emission test ofpouch | EN 868-5 Annex C | No leaks | Conforms |
| Visual inspection of prefilledsyringe for damage | ISO 7886-1 | No damage, no leak(consistent withinstructions for use) | Conforms |
| Test for liquid leakage andresistance of luer lockfitting | EN ISO 80369-7 | No leaks; no cracks | Conforms |
| Test for integrity of printedlabel | ASTM F2250 | Print must remain definedand legible, color must notlighten, ink must not run | Conforms |
| Distribution cycle(Transport) | ASTM D4169Distribution Cycle 13Packaging integrity ISO 11607-1 | The integrity of thepackaging must bepreserved | Conforms |
| Chemical Testing | |||
| Assay of Sodium Chloride | USP monograph | 0.855 to 0.945% NaCl | Conforms |
| pH | USP<791> | 4.5 to 7.0 | Conforms |
| Identification of Sodiumand Chloride | USP <191> | Successful identification | Conforms |
| Sub-visible particulatematter | USP <788> | ≥ 10µm: ≤6000part/syringe≥ 25µm: ≤ 600part/syringe | Conforms |
| Elemental Impurities(Heavy Metals) | USP <232>/<233> | Arsenic: ≤ 1.5µg/gCadmium: ≤ 0.2µg/gMercury: ≤ 0.3µg/gLead: ≤ 0.5µg/g | Conforms |
| Iron | USP <24> | Iron: ≤ 2ppm | Conforms |
| Sterilization | |||
| Bacterial Endotoxins | USP <85> | ≤ 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 <151>) | No material mediatedresponse observed | Conforms |
| Hemolysis | ISO 10993-4 (ASTM F756-17) | Non-hemolytic | Conforms |
| Tests for interactionwith 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
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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
§ 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).