Normal Saline Flush

• K Number: K150143
• Device Name: Normal Saline Flush
• Manufacturer: NURSE ASSIST, INC.
• Date Cleared: 2015-08-31 ( 221 days)
• Product Code: NGT
• Regulation Number: 880.5200
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K032438 , K111034
• Predicate For: N/A

Intended Use

This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Device Description

The subject device is a polypropylene plastic syringe filled with 0.9% Sodium Chloride for Injection, USP, and capped with a polypropylene plastic cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12 mL syringe with a 3 mL, 5 mL, or 10 mL fill volume.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called "Normal Saline Flush" by Nurse Assist, Inc. The purpose of the submission is to demonstrate substantial equivalence to previously marketed predicate devices. It is not a study proving clinical effectiveness of an AI device.

Therefore, many of the requested categories for describing an AI study are not applicable to this document. I will fill in the relevant information from the provided text.

1. A table of acceptance criteria and the reported device performance

Test Name	Acceptance Criteria (General)	Reported Device Performance
Package Integrity	- Visual Inspection: no major compromise of packaging - Seal Testing: no leaks (15 in-Hg for 15 minutes) - Sterility: confirmation of sterile barrier and product sterility (no growth present)	- Visual Inspection: no major compromise of packaging - Seal Testing: no leaks - Sterility: confirmation of sterile barrier and product sterility—no growth present
Shelf Life (Stability)	- Visual: no leaks, holes or cracks - Seal: no leaks - Appearance/Color: clear liquid - Odor: no objectionable or unusual odors - pH: 4.5 – 7.0 - Sodium Chloride: 0.885 – 0.945% - Heavy Metals: USP <231> & <241> limits - Sterility: confirmation of sterile barrier and product sterility (no growth present) - Particulate: USP <778> limits	- Visual: no leaks, cracks or holes - Seal: no leaks - Appearance/Color: no discoloration or cloudiness - Odor: no objectionable odors - pH: within upper and lower limits - Sodium Chloride: within upper and lower limits - Heavy metals: USP <231>: less than 10 ppm (0.001%), USP <241>: less than 2 ppm - Sterility: confirmation of sterile barrier and product sterility—no growth present - Particulate: less than 3,000 for 10 μm and 300 for 25 μm
Biocompatibility (Qualitative)	- Cytotoxicity: Grade 0 (no reactivity) - Hemocompatibility: Non-hemolytic - Acute Systemic Toxicity: Non-toxic - Intracutaneous Irritation: Non-irritant - Contact Sensitization: Non-sensitizer - Pyrogenicity: Nonpyrogenic	- Cytotoxicity: Grade 0 (no reactivity) - Hemocompatibility: Hemolytic index of 0.0% (non-hemolytic) - Acute Systemic Toxicity: Non-toxic - Intracutaneous Irritation: Non-irritant - Contact Sensitization: Non-sensitizer - Pyrogenicity: Nonpyrogenic
Endotoxin	Less than 0.25 EU/ml	All samples tested at an endpoint of 0.03 EU/ml. Sensitivity of Lysate (AntiLog10 of Mean): 0.03 EU/ml (This implies the results were below or at the detection limit, and below the acceptance criteria.)

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

This document pertains to the physical and chemical properties, and biocompatibility of a medical device (a saline flush syringe), not an AI algorithm. Therefore, there is no "test set" in the context of an AI study. The data provenance is from non-clinical laboratory testing of the device. The country of origin of the testing is not specified but is implicitly associated with the manufacturer, Nurse Assist, Inc. (Haltom City, TX 76117, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI study. The "ground truth" for these tests are laboratory standards, analytical methods, and biological responses to the device materials.

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

Not applicable. This is not an AI study.

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 not an AI study.

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

Not applicable. This is not an AI study.

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

The "ground truth" for this device consists of established scientific and regulatory standards for device safety, performance, and sterility. This includes:

• Physical integrity specifications (e.g., no leaks, cracks).
• Chemical composition standards (e.g., pH range, sodium chloride concentration, heavy metals limits).
• Sterility assurance levels (S.A.L. of $10^{-6}$).
• Biocompatibility standards (e.g., ISO, ASTM, USP guidelines for cytotoxicity, hemocompatibility, toxicity, irritation, sensitization, pyrogenicity).
• Endotoxin limits (USP <85>).

8. The sample size for the training set

Not applicable. This is not an AI study.

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

Not applicable. This is not an AI study.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 31, 2015

Nurse Assist, Inc. Mr. Brian Cox Vice President of Operations 4409 Haltom Road Haltom City, TX 76117

Re: K150143

Trade/Device Name: Normal Saline Flush Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: July 29, 2015 Received: July 30, 2015

Dear Mr. Cox,

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.

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Page 2 - Mr. Cox

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150143

Device Name Normal Saline Flush

Indications for Use (Describe)

This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

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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510(k) Summary

1. Submitter's name and address:

Nurse Assist, Inc. 4409 Haltom Road Haltom City, TX 76117

2. Submitter's telephone number and fax number:

• Tel: [phone] Fax: [phone]

3. Contact person:

Mr. Brian Cox - Vice President Operations

4. Date this 510(k) summary prepared:

05/14/15

5. Regulatory Description:

Trade name:	Normal Saline Flush
Common Name:	Saline IV Flush
Classification Name:	Saline, Vascular Access Flush
Regulation Description:	Intravascular Catheter
Regulation Number:	21 CFR 880.5200
Class:	II
Product Code:	NGT

6. Legally marketed device to which substantial equivalence is claimed:

Primary predicate - AMUSA 0.9% Sodium Chloride Flush Syringe, K111034 Reference device - Kendall Monoject Prefill Flush Syringe, K032438

7. Description of the device:

The subject device is a polypropylene plastic syringe filled with 0.9% Sodium Chloride for Injection, USP, and capped with a polypropylene plastic cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12 mL syringe with a 3 mL, 5 mL, or 10 mL fill volume.

8. Intended use and indication for use:

For prescription use: This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

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9. Summary of technological characteristics compared to the predicate device:

	Proposeddevice	Primary PredicateK111034	Reference DeviceK032438
	Nurse AssistNormal SalineFlush	AMUSA 0.9% SodiumChloride FlushSyringe	Kendall MonojectPrefill FlushSyringe
Classification Product Code	NGT	NGT	NGT
Intended use:	This device isintended for use influshing compatibleintravenousadministration setsand indwellingintravenous accessdevices.	0.9% Sodium ChlorideFlush Syringes areintended for use influshing compatibleintravenousadministration sets andindwelling intravenousaccess devices. Useaccording to therecommendations of themanufacture for theappropriate device.	The syringes areintended for flushingcompatibleintravenous tubingsystems andindwellingintravascular accessdevices.
Use on sterile field?	No	No	Unknown
Prescription only?	Yes	Yes	Yes
Sterile?	Yes	Yes	Yes
Single use only?	Yes	Yes	Yes
Method of Sterilization	Radiation	Radiation	Steam Autoclave
Shelf life	2 years	2 years	2 years
Chemical composition	0.9% SodiumChloride Injection,USP	0.9% Sodium ChlorideInjection, USP	0.9% SodiumChloride Injection,USP
Mechanism of dispensing	12 mL plasticsyringe, luer lock tip	12 mL plastic syringe,luer lock tip	12 mL plasticsyringe, luer lock tip
Fill Volumes	3 mL, 5 mL, 10 mL	3 mL, 5 mL, 10 mL	3 mL, 5 mL, 10 mL
Barrel, Plunger, Tip Cap, BagMaterial	Polypropylene	Polypropylene	Polypropylene
Uses cleared syringe	Yes - K945715	unknown	Yes - K945715
Plunger Grommet Material	This product is notmade with naturalrubber latex	This product is notmade with naturalrubber latex	This product is notmade with naturalrubber latex

10. Non-Clinical Performance Data

Gamma radiation sterilization has been validated for this device. This method provides an SAL of 106. The following testing was performed post-sterilization:

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NAME	TEST METHOD(S)	RESULTS OVERVIEW
Package Integrity	Subject device to ISTA 2A 2005 conditioning andtesting criteriaPerform post-conditioning testing:Visual Inspection of packaging: confirm package integrity Seal (vacuum) testing: 15 in-Hg for 15 minutes and verify no leaks Sterility: Tryptic Soy Broth & Fluid Thioglycollate Medium	Visual Inspection of packaging: no major compromise of packaging Seal testing: no leaks Sterility: confirmation of sterile barrier and product sterility—no growth present
Shelf Life(Stability)	Post Sterility Testing at T=0, T=1 and T=2 (Note:Accelerated aging for T=1 and T=2):Visual: confirm no leaks, holes or cracks Seal (vacuum) testing: 15 in-Hg for 15 minutes and verify no leaks Appearance/Color: verify clear liquid Odor: confirm objectionable or unusual odors are not present pH: 4.5 – 7.0 Sodium Chloride: 0.885 – 0.945% Heavy Metals: USP <231> and <241> Sterility: Tryptic Soy Broth Particulate: USP <778>	Visual: no leaks, cracks or holes Seal: no leaks Appearance/Color: no discoloration or cloudiness Odor: no objectionable odors pH: within upper and lower limits Sodium Chloride: within upper and lower limits Heavy metals: USP <231>: less than 10 ppm (0.001%) USP <241>: less than 2 ppm Sterility: confirmation of sterile barrier and product sterility—no growth present Particulate: less than 3,000 for 10 μm and 300 for 25 μm
Biocompatibility	The classification of the device is: Blood Path, Indirect(limited to ≤ 24 hours). The following tests were performed:Cytotoxicity: ISO 10993-5:2009 Hemocompatibility: ASTM 7756:2008 and ISO 10993-4:2006 Acute Systemic Toxicity: ISO 10993-11:2006 Intracutaneous Irritation: ISO 10993-10:2010 (modified for a chemical solution) Contact Sensitization: ISO 10993-10:2010 Pyrogenicity: USP <151> and ISO 10993-11:2006	Cytotoxicity: Grade 0 (no reactivity) Hemocompatibility: Hemolytic index of 0.0% (non-hemolytic) Acute Systemic Toxicity: Non-toxic Intracutaneous Irritation: Non-irritant Contact Sensitization: Non-sensitizer Pyrogenicity: Nonpyrogenic
Endotoxin	USP <85>: Limulus Amebocyte Lysate (LAL) endotoxintesting using Gel Clot Method (Monograph #85). (Note: test results must be less than 0.25 EU/ml.)	All samples tested at an endpoint of 0.03 EU/ml Sensitivity of Lysate (AntiLog10 of Mean): 0.03 EU/ml

The test results demonstrate that the device is non-hemolytic, non-toxic, a non-irritant, non-sensitizer, and non-pyrogenic. In addition to the test results noted and highlighted above, the results also demonstrate that packaging integrity and sterility were maintained, and as such, the device met specifications throughout the noted shelf life.

11. Conclusion

The above summarized characteristics and comparisons demonstrate that the Nurse Assist Normal Saline Flush device is as safe and effective as the predicate and reference devices. In summary, the Nurse Assist Normal Saline Flush described in this submission is substantially equivalent to the predicate and reference devices.

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).