(251 days)
Not Found
No
The device is a prefilled syringe for flushing vascular access devices and the description and performance studies focus on the physical and chemical properties of the syringe and saline solution, with no mention of AI or ML.
No.
The device is intended only for flushing vascular access devices, which is a supportive function and not a direct therapeutic treatment of a disease or condition.
No
The device is intended for flushing vascular access devices, which is a maintenance activity, not a diagnostic one.
No
The device description clearly states it is a physical syringe prefilled with saline, a hardware component. There is no mention of software as the primary or sole component.
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 vascular access devices." This is a 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 a physical action (flushing), not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There are no reagents, test strips, or analytical components typically associated with IVDs.
- Performance Studies: The performance studies focus on the physical and chemical properties of the syringe and saline solution, as well as biocompatibility and sterility. These are typical tests for medical devices, not IVDs which would focus on analytical performance (sensitivity, specificity, etc.).
In summary, the Praxiject™ 0.9% NaCl prefilled syringe is a medical device used for a therapeutic/procedural purpose (flushing), not for diagnosing a condition or analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
NGT
Device Description
The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled fill volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a plastic peel pouch and terminally sterilized by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The design and manufacturing of Praxiject™ 0.9% NaCl prefilled syringes are subject to verification and validation testing in conformance with regulatory guidance and recognized consensus standards.
Results:
- Solution (Sodium Chloride Injection, USP 39-NF34): Conforms
- Plastic syringe (ISO 7886-1, 0 mL average syringe induced reflux): Conforms
- Biocompatibility (ISO 10993-1): N/A
-
- Hemolysis (ISO 10993-4 (ASTM F756)): Non-hemolytic
-
- Cytotoxicity (ISO 10993-5): Non-cytotoxic
-
- Sensitization (ISO 10993-10): Non-sensitizer
-
- Irritation/Intracutaneous reactivity (ISO 10993-10): Non-irritant
-
- Acute system toxicity (ISO 10993-11): No systemic toxicity
-
- Material—mediated pyrogenity (ISO 10993-11 (USP )): No material mediated response observed
-
- Bacterial Endotoxins (USP and USP (≤ 0.5 EU/mL)): Conforms
-
- Chemical characterization (ISO 10993-18): Acceptable extractables/leachables profile
-
- Particulate matter (USP ): Conforms
The shelf life of the final finished sterilized device was evaluated using the recognized consensus standard on the requirements for materials, sterile barrier systems and packaging systems for terminally sterilized medical devices (ISO 11607-1).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
December 21, 2017
MedXL Inc. Premala Premanathan Regulatory Affairs Associate Contact Address
Re: K171109
Trade/Device Name: Praxiject™ 0.9% NaCl Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: November 28, 2017 Received: November 30, 2017
Dear Premala Premanathan:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Praxiject™ 0.9% NaCl
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the MEDXL logo in blue and red, followed by the text "510(k) Summary" in black. The MEDXL logo is a stylized version of the company name, with the "XL" portion in red and a red line extending from the "L" to the right. The text "510(k) Summary" is in a simple, sans-serif font and is positioned to the right of the logo.
December 20, 2017
| Trade Name: | Praxiject™ 0.9% NaCl |
|---|---|
| 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: | MedXL Inc. |
| Address: | 285 Av Labrosse |
| Pointe Claire, Quebec H9R 1A3, Canada | |
| Tel: (+1) 514.695.7474 Fax: (+1) 514.695.1511 | |
| Contact: | Premala Premanathan, Regulatory Affairs Associate |
This 510(k) Summary has been prepared in accordance with 21 CFR §807.92.
Predicate Device
K082837, Excelsior Saline Pre-filled Syringe(s) in Sterile Field Packaging - Excelsior Medical Corp.
Device Description
The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled fill volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a plastic peel pouch and terminally sterilized by gamma irradiation.
Intended Use / Indications for Use
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.
Comparison of Technological Characteristics
The Praxiject™ 0.9% NaCl prefilled syringe is substantially equivalent to the predicate device in fundamental technology, product design and materials, operating principles, and performance characteristics for the intended use. The differences between the two devices have been addressed by material and device component qualification, process and packaging validation, and finished product release testing in conformance with recognized consensus standards.
4
| Device
| Characteristic | Predicate Device (K082837) | Praxiject™ 0.9% NaCl |
|---|---|---|
| Indications | ||
| for Use | Excelsior Sterile Field Saline Flush | |
| Syringe(s) are intended for use in | ||
| flushing IV catheters and IV tubing. | 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. | ||
| Design | Prefilled plastic piston syringe with | |
| Luer lock connection fitting and | ||
| non-vented, female Luer lock tip cap | Prefilled plastic piston syringe with | |
| Luer lock connection fitting and | ||
| non-vented, female Luer lock tip cap. | ||
| Syringe Size and | ||
| Fill Volumes | 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 | ||
| Fill Volume | ||
| Graduations | On syringe label | On syringe label |
| Syringe Content | 0.9% Sodium Chloride Injection, USP | 0.9% Sodium Chloride Injection, USP |
| Labeled | ||
| Non-pyrogenic | Yes | Yes |
| Single Use Only | Yes | Yes |
| Sterile | Yes | Yes |
| Use on Sterile Field | Yes | Yes |
| Sterilization | ||
| Method | Terminally sterilized by | |
| steam, 10-6 SAL | Terminally sterilized by | |
| gamma radiation, 10-6 SAL | ||
| Shelf Life | 2 years | 2 years |
| Syringe Material | - Barrel and Plunger: Polypropylene |
- Plunger: Isoprene rubber (Not made
with natural rubber latex) - Tip Cap: Polypropylene with white
colorant | - Barrel and Plunger: Polypropylene - Plunger: Bromobutyl rubber (Not
made with natural rubber latex) - Tip Cap: ABS with white colorant |
| Syringe Packaging | Plastic peel pouch (printed on one
side, clear on the other) | Plastic peel pouch (printed on one
side, clear on the other) |
| Content of Syringe
Package | One or two syringes per pouch | One syringe per pouch |
A side-by-side comparison of key device characteristics is presented in the following table.
5
Summary of Non-Clinical Testing
The design and manufacturing of Praxiject™ 0.9% NaCl prefilled syringes are subject to verification and validation testing in conformance with regulatory guidance and recognized consensus standards.
| Device / Performance
| Characteristic | Performance Standard | Results |
|---|---|---|
| Solution | Sodium Chloride Injection, | |
| USP 39-NF34 | Conforms | |
| Plastic syringe | ISO 7886-1, 0 mL average syringe | |
| induced reflux | Conforms | |
| Biocompatibility | ISO 10993-1 | N/A |
| - Hemolysis | ISO 10993-4 (ASTM F756) | Non-hemolytic |
| - Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| - Sensitization | ISO 10993-10 | Non-sensitizer |
| - Irritation/Intracutaneous | ||
| reactivity | ISO 10993-10 | Non-irritant |
| - Acute system toxicity | ISO 10993-11 | No systemic toxicity |
| - Material—mediated | ||
| pyrogenity | ISO 10993-11 (USP ) | No material mediated |
| response observed | ||
| - Bacterial Endotoxins | USP and USP | |
| (≤ 0.5 EU/mL) | Conforms | |
| - Chemical | ||
| characterization | ISO 10993-18 | Acceptable |
| extractables/leachables profile | ||
| - Particulate matter | USP | Conforms |
The shelf life of the final finished sterilized device was evaluated using the recognized consensus standard on the requirements for materials, sterile barrier systems and packaging systems for terminally sterilized medical devices (ISO 11607-1).
Substantial Equivalence Conclusion
The results of the above described non-clinical testing demonstrate that the Praxiject™ 0.9% NaCl prefilled syringe fulfills the established performance criteria and it is substantially equivalent to the predicate device.