(89 days)
No
The device description and performance studies focus on the physical and chemical properties of a pre-filled saline syringe, with no mention of AI or ML technologies.
No
The device is described as an I.V. flush syringe containing sodium chloride, intended for flushing intravenous administration sets and access devices, which is a maintenance activity rather than a therapeutic treatment for a medical condition.
No
Explanation: The device is a pre-filled syringe for flushing intravenous lines, not for diagnosing medical conditions. Its purpose is to deliver a sterile solution, not to provide diagnostic information.
No
The device description clearly states it is a prefilled syringe containing a liquid (0.9% Sodium Chloride Injection, USP), which is a physical, hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for flushing intravenous administration sets and indwelling intravenous access devices. This is a direct therapeutic or procedural use, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The device is a pre-filled syringe containing saline solution. This is a medical device used for a procedure, not a reagent or instrument used to analyze a biological sample for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
NGT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following non-clinical data demonstrate that the testing met the acceptance criteria of the mentioned standards shown below:
Study Type: Non-clinical testing
Sample Size: Not specified
Key Results:
- Cytotoxicity per ISO 10993-5:2009: Pass
- Irritation/Intracutaneous Reactivity per ISO 10993-10:2010: Pass
- Sensitization per ISO 10993-10:2010: Pass
- Acute Systemic Toxicity per ISO 10993-11:2017: Pass
- Material-mediated Pyrogenicity per ISO 10993-11:2017 and USP : Pass
- Hemocompatibility per ISO 10993-4:2006 and ASTM F756:2008: Pass
- Extractables/leachables per ISO 10993-18:2005: Pass
- Package integrity: Pass
- Real time and accelerated stability testing: Pass
- Fill volume/weight loss: Pass (10.4 mL +/- 0.4 mL. Weight loss over time = 0.46 lbs./in.)
- Sterility per USP : Pass (Absence of organisms)
- Visual inspection: Pass (No holes, tears, or channels in seals. No damage to syringe.)
- Color/odor: Pass (Fluid must be colorless and odorless.)
- Assay of Sodium Chloride (per USP monograph): Pass (95.0% - 105.0% NaCl)
- pH per USP : Pass (4.5 to 7.0)
- Identity per USP : Pass (Successful identification)
- Sub-visible particulate per USP : Pass (>= 10µm: = 25µm: : Pass (No visible particulate.)
- Bacterial Endotoxin per USP : Pass (
§ 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).
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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
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 (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)
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)
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FORM FDA 3881 (7/17)
Page 1 of 1
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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/pouch
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
I.V. Flush Syringe for
Sterile Delivery
(K201286) | Praxiject™ 0.9% NaCl
(K171109) | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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. | 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. | Similar |
| Design | Prefilled plastic piston
syringe with Luer lock
connection fitting and non-
vented, female Luer lock
tip cap | Prefilled plastic piston syringe
with Luer lock connection
fitting and non-vented, female
Luer lock tip cap | Same |
| Syringe Size and
Fill Volumes | 10 mL in 12 cc syringe | 3 mL in 5 cc syringe
5 mL in 5 cc syringe
3 mL in 10 cc syringe
5 mL in 10 cc syringe
10 mL in 10 cc syringe | Different |
| Fill Volume
Gradations | On syringe label | On syringe label | Same |
| Syringe Content | 0.9% Sodium Chloride
Injection, USP | 0.9% Sodium Chloride
Injection, USP | Same |
The table below compares key technological features between the subject and predicate devices.
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| Parameter | 0.9% Sodium Chloride
I.V. Flush Syringe for
Sterile 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: Synthetic
isoprene (not made with
natural rubber latex) - Tip Cap: Polypropylene
and EBS with white
colorant | - Barrel and Plunger:
Polypropylene - Plunger: Bromobutyl rubber
(Not made with natural rubber
latex) - Tip Cap: ABS with white
colorant | Different |
| Syringe Packaging | Plastic peel pouch (printed
on one side, clear on the
other) | Plastic peel pouch (printed on
one side, clear on the other) | Same |
| Content of
Syringe Package | One or two syringe(s) per
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 | To evaluate the test article for material mediated pyrogenicity. | Per ISO 10993-11:2017 and USP | 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 | 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 |
7
| Test Methodology/Standard | Purpose of the Test | Acceptance Criteria | Results |
|---|---|---|---|
| - pH per USP | 4.5 to 7.0 | Pass | |
| - Identity per USP | Successful identification | Pass | |
| - Sub-visible particulate per USP | $\ge$ 10µm: $\le$ 6000 part/syringe | ||
| $\ge$ 25µm: $\le$ 600 part/syringe | Pass | ||
| - Visible particulate per USP | No visible particulate. | Pass | |
| - Bacterial Endotoxin per USP | $\le$ 0.25 EU/mL | Pass | |
| - Iron/heavy metals | Iron, $\le$ 2 ppm | ||
| 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.