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.

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called Praxiject™ 0.9% NaCl, which is a prefilled syringe. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through clinical studies or AI algorithm validation studies.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes, and expert ground truth are not applicable to this document as it pertains to a traditional medical device (a prefilled syringe) and not an AI/ML-driven diagnostic or treatment device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the context of an AI algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it presents performance standards and results for the physical and chemical characteristics of the prefilled syringe.

Device / Performance Characteristic	Performance Standard	Reported Device Performance (Results)
Solution	Sodium Chloride Injection, USP 39-NF34	Conforms
Plastic syringe	ISO 7886-1, 0 mL average syringe induced reflux	Conforms
Biocompatibility - Hemolysis	ISO 10993-4 (ASTM F756)	Non-hemolytic
Biocompatibility - Cytotoxicity	ISO 10993-5	Non-cytotoxic
Biocompatibility - Sensitization	ISO 10993-10	Non-sensitizer
Biocompatibility - Irritation/Intracutaneous reactivity	ISO 10993-10	Non-irritant
Biocompatibility - Acute system toxicity	ISO 10993-11	No systemic toxicity
Biocompatibility - Material—mediated pyrogenity	ISO 10993-11 (USP <151>)	No material mediated response observed
Biocompatibility - Bacterial Endotoxins	USP <85> and USP <161> (≤ 0.5 EU/mL)	Conforms
Biocompatibility - Chemical characterization	ISO 10993-18	Acceptable extractables/leachables profile
Biocompatibility - Particulate matter	USP <788>	Conforms
Shelf life	ISO 11607-1	2 years (mentioned in comparison table, not directly in performance results table but implied by "evaluated using the recognized consensus standard")

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes testing for a physical medical device (syringe), not an AI algorithm. The "test set" would refer to samples of the manufactured syringes and their components, tested in a laboratory setting according to the listed standards. There is no mention of "country of origin of the data" or "retrospective/prospective" as these pertain to clinical data for AI/ML validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth in the context of this document refers to established standards and laboratory measurements for chemical and physical properties, not expert clinical interpretation. The "experts" would be laboratory technicians and chemists performing the tests according to standardized protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept pertains to resolving discrepancies among expert readers in AI/ML validation studies. For direct physical and chemical testing, the results are typically objectively measured against pre-defined specifications in the performance 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

Not applicable. This is a traditional medical device (syringe), not an AI/ML system, so such a study would not be performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by conformance to recognized consensus standards (e.g., USP, ISO standards) and laboratory testing methods that define acceptable ranges and limits for physical, chemical, and biological properties. This is an objective, standardized ground truth based on scientific principles and established testing methodologies.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI algorithm, this question does not apply.

Summary

{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 LabrossePointe Claire, Quebec H9R 1A3, CanadaTel: (+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

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}------------------------------------------------

DeviceCharacteristic	Predicate Device (K082837)	Praxiject™ 0.9% NaCl
Indicationsfor Use	Excelsior Sterile Field Saline FlushSyringe(s) are intended for use influshing IV catheters and IV tubing.	The Praxiject™ 0.9% NaCl prefilledsyringe with 0.9% Sodium ChlorideInjection, USP, is intended only forflushing vascular access devices.May be placed on a sterile field.
Design	Prefilled plastic piston syringe withLuer lock connection fitting andnon-vented, female Luer lock tip cap	Prefilled plastic piston syringe withLuer lock connection fitting andnon-vented, female Luer lock tip cap.
Syringe Size andFill Volumes	10 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
Fill VolumeGraduations	On syringe label	On syringe label
Syringe Content	0.9% Sodium Chloride Injection, USP	0.9% Sodium Chloride Injection, USP
LabeledNon-pyrogenic	Yes	Yes
Single Use Only	Yes	Yes
Sterile	Yes	Yes
Use on Sterile Field	Yes	Yes
SterilizationMethod	Terminally sterilized bysteam, 10-6 SAL	Terminally sterilized bygamma radiation, 10-6 SAL
Shelf Life	2 years	2 years
Syringe Material	- Barrel and Plunger: Polypropylene- Plunger: Isoprene rubber (Not madewith natural rubber latex)- Tip Cap: Polypropylene with whitecolorant	- Barrel and Plunger: Polypropylene- Plunger: Bromobutyl rubber (Notmade with natural rubber latex)- Tip Cap: ABS with white colorant
Syringe Packaging	Plastic peel pouch (printed on oneside, clear on the other)	Plastic peel pouch (printed on oneside, clear on the other)
Content of SyringePackage	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 / PerformanceCharacteristic	Performance Standard	Results
Solution	Sodium Chloride Injection,USP 39-NF34	Conforms
Plastic syringe	ISO 7886-1, 0 mL average syringeinduced 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/Intracutaneousreactivity	ISO 10993-10	Non-irritant
- Acute system toxicity	ISO 10993-11	No systemic toxicity
- Material—mediatedpyrogenity	ISO 10993-11 (USP <151>)	No material mediatedresponse observed
- Bacterial Endotoxins	USP <85> and USP <161>(≤ 0.5 EU/mL)	Conforms
- Chemicalcharacterization	ISO 10993-18	Acceptableextractables/leachables profile
- Particulate matter	USP <788>	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.

Regulation Number and Section

§ 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).