Normal Saline Flush

K150143 · Nurse Assist, Inc. · NGT · Aug 31, 2015 · General Hospital

Device Facts

• Record ID: K150143
• Device Name: Normal Saline Flush
• Applicant: Nurse Assist, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Aug 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Indications for Use

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

Device Story

The Normal Saline Flush is a pre-filled, single-use, sterile polypropylene syringe containing 0.9% Sodium Chloride for Injection, USP. It is designed for manual operation by healthcare professionals to flush intravenous administration sets and indwelling access devices. The device is available in 12 mL syringe sizes with fill volumes of 3 mL, 5 mL, or 10 mL. It features a luer lock tip for secure connection to IV access points. By maintaining patency of IV lines, the device helps ensure the delivery of medications or fluids to the patient. It is terminally sterilized via gamma radiation and is not made with natural rubber latex.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included package integrity (ISTA 2A), shelf-life stability (pH, sodium chloride concentration, heavy metals, particulate matter), and biocompatibility (ISO 10993-5, -4, -11, -10; USP <151>). Results confirmed the device is non-hemolytic, non-toxic, non-irritant, non-sensitizer, and non-pyrogenic. Endotoxin levels were <0.03 EU/ml (limit <0.25 EU/ml). Sterility was confirmed with SAL of 10^-6.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, tip cap). Dimensions: 12 mL syringe with 3 mL, 5 mL, or 10 mL fill volumes. Principle: Manual fluid displacement via luer lock tip. Sterilization: Gamma radiation (SAL 10^-6). Connectivity: None. Software: None.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravenous access devices in patients requiring intravenous therapy.

Regulatory Classification

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.

Predicate Devices

• AMUSA 0.9% Sodium Chloride Flush Syringe (K111034)

Reference Devices

• Kendall Monoject Prefill Flush Syringe (K032438)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

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:

| | Proposed<br>device | Primary Predicate<br>K111034 | Reference Device<br>K032438 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nurse Assist<br>Normal Saline<br>Flush | AMUSA 0.9% Sodium<br>Chloride Flush<br>Syringe | Kendall Monoject<br>Prefill Flush<br>Syringe |
| Classification Product Code | NGT | NGT | NGT |
| Intended use: | This device is<br>intended for use in<br>flushing compatible<br>intravenous<br>administration sets<br>and indwelling<br>intravenous access<br>devices. | 0.9% Sodium Chloride<br>Flush Syringes are<br>intended for use in<br>flushing compatible<br>intravenous<br>administration sets and<br>indwelling intravenous<br>access devices. Use<br>according to the<br>recommendations of the<br>manufacture for the<br>appropriate device. | The syringes are<br>intended for flushing<br>compatible<br>intravenous tubing<br>systems and<br>indwelling<br>intravascular access<br>devices. |
| 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% Sodium<br>Chloride Injection,<br>USP | 0.9% Sodium Chloride<br>Injection, USP | 0.9% Sodium<br>Chloride Injection,<br>USP |
| Mechanism of dispensing | 12 mL plastic<br>syringe, luer lock tip | 12 mL plastic syringe,<br>luer lock tip | 12 mL plastic<br>syringe, 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, Bag<br>Material | Polypropylene | Polypropylene | Polypropylene |
| Uses cleared syringe | Yes - K945715 | unknown | Yes - K945715 |
| Plunger Grommet Material | This product is not<br>made with natural<br>rubber latex | This product is not<br>made with natural<br>rubber latex | This product is not<br>made with natural<br>rubber 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 and<br>testing criteria<br>Perform post-conditioning testing:<br>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<br>(Stability) | Post Sterility Testing at T=0, T=1 and T=2 (Note:<br>Accelerated aging for T=1 and T=2):<br>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<br>(limited to ≤ 24 hours). The following tests were performed:<br>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) endotoxin<br>testing 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.