(221 days)
No
The device description and performance studies focus on the physical properties, sterilization, and biocompatibility of a pre-filled saline syringe, with no mention of AI or ML technology.
No
The device is used for flushing intravenous administration sets and indwelling intravenous access devices, which is a supportive function rather than a direct therapeutic action on a disease or condition.
No
The device is described as a syringe filled with saline solution for flushing intravenous lines, not for diagnosing any medical condition.
No
The device description clearly states it is a physical syringe made of polypropylene plastic filled with saline solution, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in flushing compatible intravenous administration sets and indwelling intravenous access devices." This describes a direct interaction with the patient's circulatory system for therapeutic or maintenance purposes, not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a pre-filled syringe with saline solution. This is a medical device used for flushing, not for performing diagnostic tests on samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (within the body) for a procedural purpose.
N/A
Intended Use / Indications for Use
This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Product codes
NGT
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.
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
For prescription use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Gamma radiation sterilization has been validated for this device. This method provides an SAL of 106. The following testing was performed post-sterilization:
Package Integrity: Subject device to ISTA 2A 2005 conditioning and testing criteria. Perform 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. Results Overview: 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 and Sterility: Tryptic Soy Broth Particulate: USP . Results Overview: 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 : less than 10 ppm (0.001%) USP : 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 and ISO 10993-11:2006. Results Overview: 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 : Limulus Amebocyte Lysate (LAL) endotoxin testing using Gel Clot Method (Monograph #85). (Note: test results must be less than 0.25 EU/ml.). Results Overview: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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: (817) 231-1300 Fax: (817) 231-1500
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.
4
9. Summary of technological characteristics compared to the predicate device:
| | Proposed
device | Primary Predicate
K111034 | Reference Device
K032438 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nurse Assist
Normal Saline
Flush | AMUSA 0.9% Sodium
Chloride Flush
Syringe | Kendall Monoject
Prefill Flush
Syringe |
| Classification Product Code | NGT | NGT | NGT |
| Intended use: | This device is
intended for use in
flushing compatible
intravenous
administration sets
and indwelling
intravenous access
devices. | 0.9% Sodium Chloride
Flush Syringes are
intended for use in
flushing compatible
intravenous
administration sets and
indwelling intravenous
access devices. Use
according to the
recommendations of the
manufacture for the
appropriate device. | The syringes are
intended for flushing
compatible
intravenous tubing
systems and
indwelling
intravascular access
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
Chloride Injection,
USP | 0.9% Sodium Chloride
Injection, USP | 0.9% Sodium
Chloride Injection,
USP |
| Mechanism of dispensing | 12 mL plastic
syringe, luer lock tip | 12 mL plastic syringe,
luer lock tip | 12 mL plastic
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
Material | Polypropylene | Polypropylene | Polypropylene |
| Uses cleared syringe | Yes - K945715 | unknown | Yes - K945715 |
| Plunger Grommet Material | This product is not
made with natural
rubber latex | This product is not
made with natural
rubber latex | This product is not
made with natural
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:
5
| NAME | TEST METHOD(S) | RESULTS OVERVIEW |
|---|---|---|
| Package Integrity | Subject device to ISTA 2A 2005 conditioning and | |
| testing criteria | ||
| Perform 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 and Sterility: Tryptic Soy Broth Particulate: USP | 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 : less than 10 ppm (0.001%) USP : 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 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 : Limulus Amebocyte Lysate (LAL) endotoxin | |
| 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.