0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations for the appropriate device. May be placed on a sterile field.

Device Description

The 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is a sterile, single-use, prefilled 12 mL syringe containing 10 mL of 0.9% Sodium Chloride Injection, USP. The pre-filled syringes are provided in two packaging configurations: 1) single syringe or 2) two (2) syringes. The device may be used in the sterile field as they are sterilized post-packaging.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device (0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery). It details the device's description, indications for use, comparison to a predicate device, and a summary of non-clinical testing.

However, the questions you've asked (related to acceptance criteria and study design for proving device performance, especially concerning AI/human reader studies, ground truth establishment, training set size, etc.) are not covered in this document. This document focuses on the safety and effectiveness of a physical medical device (a pre-filled syringe with saline), not a diagnostic algorithm or AI-powered system.

Therefore, I cannot extract the information requested from the provided text. The document does not describe:

A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI performance. The table provided is for physical/chemical properties and sterility.
Sample sizes used for a "test set" in the context of an AI study. The sample sizes mentioned are for specific non-clinical tests (e.g., cytotoxicity, sterility).
Data provenance (country of origin, retrospective/prospective) for AI data.
Number of experts and their qualifications for establishing ground truth.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth (expert consensus, pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

The document's "Summary of Non-Clinical Testing" section outlines the tests performed to demonstrate the device's conformance to established standards for safety and performance (e.g., biocompatibility, sterility, shelf life, chemical composition). The acceptance criteria are specified for each of these physical and chemical tests, and the results uniformly state "Pass."

Summary

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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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 11, 2020

Nurse Assist, LLC Romeo Crisologo Vice President of Quality 4409 Haltom Road Haltom City, Texas 76117

Re: K201286

Trade/Device Name: 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: May 13, 2020 Received: May 14, 2020

Dear Romeo Crisologo:

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,

For CAPT Elizabeth Claverie, M.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K201286

Device Name

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/0 description: The image shows a logo for Nurse Assist, with a stylized graphic of a person lying in bed above the text "Nurse Assist". Below the logo, the text "510(k) Summary" is displayed, followed by the identifier "K201286".

I. Submitter

Nurse Assist, LLC 4409 Haltom Road Haltom City, TX 76117 Phone: 817-231-1300 Fax: 817-231-1500

Contact Person: Romeo Crisologo, Vice President of Quality Date Prepared: August 10, 2020

II. Device

Device Proprietary Name:	0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
Common or Usual Name:	Saline Intravascular Flush
Classification Name:	Saline, Vascular Access Flush
Regulation Number:	21 CFR 880.5200
Product Code:	NGT
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Praxiject™ 0.9% NaCl, K171109, MedXL Inc. ●
The following reference device is cited within the submission:
Normal Saline Flush, K150143, Nurse Assist, Inc. ●

IV. Device Description

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The device may be used in the sterile field as they are sterilized post-packaging.

V. Indications for Use

VI. Comparison of Technological Characteristics

Parameter	0.9% Sodium ChlorideI.V. Flush Syringe forSterile Delivery(K201286)	Praxiject™ 0.9% NaCl(K171109)	Comparison
Indications for Use	0.9% Sodium Chloride I.V.Flush Syringe for SterileDelivery is intended for usein flushing compatibleintravenous administrationsets and indwellingintravenous access devices.Use according to therecommendations for theappropriate device. May beplaced on a sterile field.	The Praxiject™ 0.9% NaClprefilled syringe with 0.9%Sodium Chloride Injection,USP, is intended only forflushing vascular accessdevices. May be placed on asterile field.	Similar
Design	Prefilled plastic pistonsyringe with Luer lockconnection fitting and non-vented, female Luer locktip cap	Prefilled plastic piston syringewith Luer lock connectionfitting and non-vented, femaleLuer lock tip cap	Same
Syringe Size andFill Volumes	10 mL in 12 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	Different
Fill VolumeGradations	On syringe label	On syringe label	Same
Syringe Content	0.9% Sodium ChlorideInjection, USP	0.9% Sodium ChlorideInjection, USP	Same

The table below compares key technological features between the subject and predicate devices.

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Parameter	0.9% Sodium ChlorideI.V. Flush Syringe forSterile Delivery(K201286)	Praxiject™ 0.9% NaCl(K171109)	Comparison
Labeled Non-Pyrogenic	Yes	Yes	Same
Single Use Only	Yes	Yes	Same
Sterile	Yes	Yes	Same
Use in sterile field	Yes	Yes	Same
Sterilization Method	Gamma irradiation	Gamma irradiation	Same
Shelf Life	2 years	2 years	Same
Syringe Material	- Barrel and piston:Polypropylene- Plunger: Syntheticisoprene (not made withnatural rubber latex)- Tip Cap: Polypropyleneand EBS with whitecolorant	- Barrel and Plunger:Polypropylene- Plunger: Bromobutyl rubber(Not made with natural rubberlatex)- Tip Cap: ABS with whitecolorant	Different
Syringe Packaging	Plastic peel pouch (printedon one side, clear on theother)	Plastic peel pouch (printed onone side, clear on the other)	Same
Content ofSyringe Package	One or two syringe(s) perpouch	One syringe per pouch	Different

Discussion

The 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery and the predicate devices share the following characteristics:

. intended use;
. design;
fill volume; ●
syringe content; ●
sterilization method; and ●
syringe packaging. ●

The 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is technologically different from the predicate devices as follows:

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. syringe size;
syringe materials; and
. content of syringe packaging.

Summary of Non-Clinical Testing VII.

The following non-clinical data demonstrate that the testing met the acceptance criteria of the mentioned standards shown below:

Test Methodology/Standard	Purpose of the Test	Acceptance Criteria	Results
Cytotoxicity per ISO 10993-5:2009	To determine cytotoxic potential of the test article.	Per ISO 10993-5:2009	Pass
Irritation/Intracutaneous Reactivity per ISO 10993-10:2010	To evaluate the test article for irritation/intracutaneous reactivity.	Per ISO 10993-10:2010	Pass
Sensitization per ISO 10993-10:2010	To evaluate the test article for sensitization.	Per ISO 10993-10:2010	Pass
Acute Systemic Toxicity per ISO 10993-11:2017	To evaluate the test article for systemic toxicity.	Per ISO 10993-11:2017	Pass
Material-mediated Pyrogenicity per ISO 10993-11:2017 and USP <151>	To evaluate the test article for material mediated pyrogenicity.	Per ISO 10993-11:2017 and USP <151>	Pass
Hemocompatibility per ISO 10993-4:2006 and ASTM F756:2008	To evaluate the test article for hemolysis.	Per ISO 10993-4:2006 and ASTM F756:2008	Pass
Extractables/leachables per ISO 10993-18:2005	To evaluation the test article for extractables/leachables	Acceptable extractable/leachable profile	Pass
Package integrity	To verify pouch seal integrity	No visible damage/degradation of seal.	Pass
Real time and accelerated stability testing	To verify that product conforms to established specifications through its labeled shelf life.	See below for individual test acceptance criteria	Pass
- Fill volume/weight loss		10.4 mL +/- 0.4 mL. Weight loss over time ≤ 10%	Pass
- Pouch seal strength		≥ 0.46 lbs./in.	Pass
- Sterility per USP <71>		Absence of organisms	Pass
- Visual inspection		No holes, tears, or channels in seals.No damage to syringe.	Pass
- Color/odor		Fluid must be colorless and odorless.	Pass
- Assay of Sodium Chloride (per USP monograph)		95.0% - 105.0% NaCl	Pass

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Test Methodology/Standard	Purpose of the Test	Acceptance Criteria	Results
- pH per USP <791>		4.5 to 7.0	Pass
- Identity per USP <191>		Successful identification	Pass
- Sub-visible particulate per USP <788>		$\ge$ 10µm: $\le$ 6000 part/syringe$\ge$ 25µm: $\le$ 600 part/syringe	Pass
- Visible particulate per USP <790>		No visible particulate.	Pass
- Bacterial Endotoxin per USP <85>		$\le$ 0.25 EU/mL	Pass
- Iron/heavy metals		Iron, $\le$ 2 ppmHeavy metals, $\le$ 10 ppm	Pass
Sterilization Validation in accordance with ANSI/AAMI/ISO TIR 13004:2013	To establish the minimum irradiation dose required to achieve sterility.	10-6 SAL	Pass

VIII. Conclusion

The non-clinical tests demonstrate that the 0.9% Sodium Chloride I.V. Flush Syringe is as safe, as effective, and performs as well as or better than the legally marketed 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).