(87 days)
No
The device is a prefilled syringe containing saline solution for flushing IV catheters and tubing, with no mention of AI/ML in the description or key terms.
No
The device is used for flushing IV catheters and tubing to maintain patency, not to treat a specific disease or condition. Its function is maintenance for other medical procedures.
No
The device is a prefilled syringe containing saline solution used for flushing IV catheters and IV tubing to maintain patency. Its intended use does not involve diagnosing medical conditions or diseases.
No
The device description clearly indicates a physical product (prefilled syringes with saline solution) and mentions hardware components like syringes, luer locks, valves, and catheters.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for flushing of IV catheters and IV tubing only." This is a therapeutic or maintenance function performed directly on the patient's vascular access system.
- Device Description: The description details a prefilled syringe containing saline solution for maintaining catheter patency via hydraulic displacement. This is a physical action within the patient's circulatory system, not a test performed on a sample taken from the body.
- Lack of Diagnostic Purpose: There is no mention of analyzing a sample (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies listed (raw material qualification, stability, sterilization, extractables/leachables) are typical for a medical device intended for direct patient use, not for an IVD which would focus on analytical performance and clinical validity.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.
Product codes
NGT
Device Description
Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling. total parenteral nutrition, or hemodialysis.
0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:
- 2.5 mL in 3 mL Syringe
- 3 mL in 10 mL Syringe ●
- 5 mL in 10 mL Syringe ●
- 10 mL in 10 mL Syringe ●
The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following studies have been performed or are being relied upon to support the safety and effectiveness of the product:
- Raw material qualification
- Stability Studies ●
- Sterilization validation
- Extractables/Leachables
Biocompatibility testing on the subject device is not required as the products are exactly the same as the predicate devices with the exception of the source of the sodium chloride raw material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
December 12, 2014
Excelsior Medical Corporation Mr. John Linfante Vice President RA/QA 1933 Heck Avenue Neptune, NJ 07753
Re: K142620
Trade/Device Name: 0.9% Sodium Chloride Injection, USP Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: September 15, 2014 Received: September 16, 2014
Dear Mr. Linfante
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
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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) K142620
Device Name
0.9% Sodium Chloride Injection, USP
(2.5 mL in 3 mL Syringe, 3 mL in 10 mL Syringe, 5 mL in 10 mL Syringe, 10 mL in 10 mL Syringe)
Indications for Use (Describe)
0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Manufacturer Name: | Excelsior Medical Corporation |
|---|---|
| Address: | 1933 Heck Avenue |
| Neptune, NJ 07753 | |
| Contact Name: | John Linfante |
| Title: | Vice President RA/QA |
| Phone Number: | 732-643-6088 |
| Fax Number: | 732-776-7600 |
| Date Prepared: | September 15, 2014 |
510(k) Summary
| Device Proprietary Name: | 0.9% Sodium Chloride Injection, USP |
|---|---|
| Device Common or Usual Name: | Saline, Vascular Access Flush |
| Classification Name: | Saline, Vascular Access Flush |
| Classification Code: | NGT |
| Regulation Number: | 21 CFR Part 880.5200 |
| Device Classification | II |
Predicate Devices:
Substantial equivalence is claimed to the following devices as related to intended use, design, and material characteristics:
- Excelsior Disposable Syringe W/Normal Saline (0.9% Sodium Chloride), Excelsior ● Medical Corp., K962938
- . Sterile Field Saline Flush Syringe(s), Excelsior Medical Corporation, K082837
Description of the Device
Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling. total parenteral nutrition, or hemodialysis.
0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:
- 2.5 mL in 3 mL Syringe
- 3 mL in 10 mL Syringe ●
- 5 mL in 10 mL Syringe ●
4
- 10 mL in 10 mL Syringe ●
The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.
Intended Use/Indications for Use
0.9% Sodium Chloride Injection, USP, prefilled syringes are intended for flushing of IV catheters and IV tubing only.
Technological Characteristics
The 0.9% Sodium Chloride Injection, USP syringes subject to this filing were previously cleared by FDA under K962938. The use of alternate syringes, application of syringe labels on nonprinted barrels, and sterilization via steam were cleared under K082837 for Excelsion's Sterile Field Flush saline syringes.
A comparison of the products is provided in the table below.
| Intended use | Saline Flush Syringe
(Subject Device) | Sterile Field Saline
Flush Syringe(s)
K082837 | Excelsior Disposable
Syringe W/ Normal
Saline
K962938 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Flushing of IV
catheters and IV
tubing only | Flushing IV catheters
and IV tubing | Flushing IV catheters
and IV tubing |
| Components | • Barrel – Medical
grade polypropylene
and silicone lubricant
• Plunger - Medical
grade polypropylene
• Piston - Latex free
isoprene rubber
• Tip Cap – Medical
grade polypropylene
and TPE plus
colorant | • Barrel – Medical
grade polypropylene
and silicone lubricant
• Plunger - Medical
grade polypropylene
• Piston - Latex free
isoprene rubber
• Tip Cap – Medical
grade polypropylene
and TPE plus
colorant | • Barrel – Medical
grade polypropylene
and silicone lubricant
• Plunger - Medical
grade polypropylene
• Piston - Latex free
isoprene rubber
• Tip Cap – Medical
grade polypropylene
and TPE plus
colorant |
| Solution | 0.9% Sodium Chloride
Injection, USP | 0.9% Sodium Chloride
Injection, USP | 0.9% Sodium Chloride
Injection, USP |
| Max. Fill
level | 10 mL | 10 mL | 10 mL |
| Sterility | Terminally sterilized by
steam 10-6 SAI | Terminally sterilized by
steam 10-6 SAL | Terminally sterilized by
gamma |
5
| Shelf Life | Intended 2 years | 2 years | 2 years |
|---|---|---|---|
| Syringe | |||
| Barrel | Not printed | ||
| Syringe Label contains: | |||
| • Graduation marks | |||
| • Lot Number | |||
| • Expiry Date | Not printed | ||
| Syringe Label contains: | |||
| • Graduation marks | |||
| • Lot Number | |||
| • Expiry Date | Pre-printed syringe barrel |
There are no differences between the subject and predicate device with respect to intended use or technology. The subject device is the exact same device as the predicate device cleared under K962938 with the following exceptions:
- Introduction of alternate sources of syringes ●
- Introduction of alternate source of saline
- Gradation markings applied via label
- Sterilization method is steam ●
These differences are addressed via material qualification, process validation, and finished product release testing. In addition, Excelsior Medical has undertaken performance testing to support that the use of an alternate source of saline does not alter the safety and effectiveness of the product.
Non-Clinical Testing
The following studies have been performed or are being relied upon to support the safety and effectiveness of the product:
- Raw material qualification
- Stability Studies ●
- Sterilization validation
- Extractables/Leachables
Biocompatibility testing on the subject device is not required as the products are exactly the same as the predicate devices with the exception of the source of the sodium chloride raw material.
Conclusion
Based on the analysis presented above and the results of the performance testing, the subject device is as safe and effective as the predicate device. No new or different questions of safety and effectiveness than the predicate device are raised by the changes.
Therefore, it is concluded that the product is substantially equivalent to the identified predicate devices.