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

K201286 · Nurse Assist, LLC · NGT · Aug 11, 2020 · General Hospital

Device Facts

• Record ID: 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
• Applicant: Nurse Assist, LLC
• Product Code: NGT · General Hospital
• Decision Date: Aug 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

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 Story

The 0.9% Sodium Chloride I.V. Flush Syringe is a sterile, single-use, prefilled 12 mL syringe containing 10 mL of 0.9% Sodium Chloride Injection, USP. It is designed for use in clinical settings, including sterile fields, to flush intravenous administration sets and indwelling access devices. The device is operated by healthcare professionals. It is provided in single or dual-syringe pouches. The device functions as a manual delivery system for saline solution to maintain patency of vascular access devices. It benefits patients by ensuring the proper maintenance of intravenous lines, reducing the risk of occlusion or complications associated with indwelling catheters.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10, -11, -4), extractables/leachables (ISO 10993-18), package integrity, and real-time/accelerated stability testing. Performance metrics included USP monograph compliance for sodium chloride assay (95.0-105.0%), pH (4.5-7.0), sub-visible particulate counts (USP <788>), and bacterial endotoxin levels (≤ 0.25 EU/mL). Sterilization validation achieved 10^-6 SAL via gamma irradiation.

Technological Characteristics

Prefilled 12 mL plastic piston syringe containing 10 mL 0.9% Sodium Chloride Injection, USP. Materials: Polypropylene barrel/piston, synthetic isoprene plunger, polypropylene/EBS tip cap. Sterilization: Gamma irradiation. Connectivity: None. Form factor: Manual syringe with Luer lock connection. Standards: ISO 10993 series, USP <71>, <788>, <790>, <791>, <85>, <151>, <191>, ASTM F756, ANSI/AAMI/ISO TIR 13004.

Indications for Use

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

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

• Praxiject™ 0.9% NaCl (K171109)

Reference Devices

• Normal Saline Flush (K150143)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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)

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.

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.

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 [e-mail]

"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."

FORM FDA 3881 (7/17)

Page 1 of 1

Image /page/2/Picture/21 description: The image shows the text "Page 29 of 60". This text likely indicates the page number of a document. The document has at least 60 pages. The page number is 29.

{3}------------------------------------------------

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: [phone] Fax: [phone]

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/pouch<br>0.9% 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

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.

{4}------------------------------------------------

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

#### V. Indications for Use

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.

#### VI. Comparison of Technological Characteristics

| Parameter | 0.9% Sodium Chloride<br>I.V. Flush Syringe for<br>Sterile Delivery<br>(K201286) | Praxiject™ 0.9% NaCl<br>(K171109) | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | 0.9% Sodium Chloride I.V.<br>Flush Syringe for Sterile<br>Delivery is intended for use<br>in flushing compatible<br>intravenous administration<br>sets and indwelling<br>intravenous access devices.<br>Use according to the<br>recommendations for the<br>appropriate device. May be<br>placed on a sterile field. | The Praxiject™ 0.9% NaCl<br>prefilled syringe with 0.9%<br>Sodium Chloride Injection,<br>USP, is intended only for<br>flushing vascular access<br>devices. May be placed on a<br>sterile field. | Similar |
| Design | Prefilled plastic piston<br>syringe with Luer lock<br>connection fitting and non-<br>vented, female Luer lock<br>tip cap | Prefilled plastic piston syringe<br>with Luer lock connection<br>fitting and non-vented, female<br>Luer lock tip cap | Same |
| Syringe Size and<br>Fill Volumes | 10 mL in 12 cc syringe | 3 mL in 5 cc syringe<br>5 mL in 5 cc syringe<br>3 mL in 10 cc syringe<br>5 mL in 10 cc syringe<br>10 mL in 10 cc syringe | Different |
| Fill Volume<br>Gradations | On syringe label | On syringe label | Same |
| Syringe Content | 0.9% Sodium Chloride<br>Injection, USP | 0.9% Sodium Chloride<br>Injection, USP | Same |

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

{5}------------------------------------------------

| Parameter | 0.9% Sodium Chloride<br>I.V. Flush Syringe for<br>Sterile Delivery<br>(K201286) | Praxiject™ 0.9% NaCl<br>(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:<br>Polypropylene<br>- Plunger: Synthetic<br>isoprene (not made with<br>natural rubber latex)<br>- Tip Cap: Polypropylene<br>and EBS with white<br>colorant | - Barrel and Plunger:<br>Polypropylene<br>- Plunger: Bromobutyl rubber<br>(Not made with natural rubber<br>latex)<br>- Tip Cap: ABS with white<br>colorant | Different |
| Syringe Packaging | Plastic peel pouch (printed<br>on one side, clear on the<br>other) | Plastic peel pouch (printed on<br>one side, clear on the other) | Same |
| Content of<br>Syringe Package | One or two syringe(s) per<br>pouch | 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:

{6}------------------------------------------------

- . 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.<br>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 |

{7}------------------------------------------------

| 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<br>$\ge$ 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 ppm<br>Heavy 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.