(367 days)
No
The 510(k) summary describes a pre-filled syringe containing a heparin solution for flushing IV catheters. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies listed are standard for a medical device of this type and do not involve AI/ML model training or testing.
No
The device is described as "Flushing of IV catheters and IV tubing only" and for "maintenance of patency of intravenous injection devices." Its purpose is to prevent blockages in IV lines, not to treat a disease or condition in the patient. The description explicitly states "This device is not to be used for anticoagulant therapy."
No
The device is described as a solution for flushing IV catheters and tubing to maintain patency, not for diagnosing any condition or disease.
No
The device description clearly states it is a pre-filled syringe containing a solution, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "Flushing of IV catheters and IV tubing only" and "maintenance of patency of intravenous injection devices." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description reinforces the intended use by explaining how the solution is delivered to maintain catheter patency.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies listed focus on the safety and effectiveness of the product for its intended flushing purpose (raw material qualification, biocompatibility, stability, sterilization, extractables/leachables, testing to USP monograph). There are no studies related to diagnostic accuracy or performance.
In summary, the device's function is to maintain the functionality of an intravenous access device, which is a medical procedure, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Flush, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.
Product codes
NZW
Device Description
Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. 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.
Heparin Lock Flush, USP is available as follows:
- Heparin Lock Flush, USP, 3 USP Units per 3 mL (1 USP unit per mL); 3 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 6 USP Units per 3 mL (2 USP unit per mL); 3 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 30 USP Units per 3 mL (10 USP unit per mL); 3 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 50 USP Units per 5 mL (10 USP unit per mL); 5 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 300 USP Units per 3 mL (100 USP unit per mL); 3 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 500 USP Units per 5 mL (100 USP unit per mL); 5 mL volume in a 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
IV catheters and IV tubing (vascular access)
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)
Non-Clinical Testing:
- Raw material qualification (study type not specified, sample size not specified, data source not specified, key results not specified)
- Biocompatibility (ISO 10993-1) (study type not specified, sample size not specified, data source not specified, key results not specified)
- Stability Studies (study type not specified, sample size not specified, data source not specified, key results not specified)
- Sterilization validation (ISO 17665-1 and -2) (study type not specified, sample size not specified, data source not specified, key results not specified)
- Extractables/Leachables (study type not specified, sample size not specified, data source not specified, key results not specified)
- Testing of final product to Heparin Lock Flush Solution USP Monograph (study type not specified, sample size not specified, data source not specified, key results not specified)
Conclusion: The only change to the Heparin Lock Flush, USP products as cleared in K023749 and K061497 is the source of heparin. This change is supported by the studies cited above, and results of the testing show that there are no new questions of safety and effectiveness. Therefore, it is concluded that the product is as safe and as effective for use, and is substantially equivalent to the identified predicate devices.
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 for the subject device only
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
November 14, 2014
Excelsior Medical Corporation Mr. John Linfante Vice President RA/QA 1933 Heck Avenue Neptune, NJ 07753
Re: K133446
Trade/Device Name: Heparin Lock Flush, USP Regulation Number: 21 CFR 880.5200 Regulation Name: Heparin, Vascular Access Flush Regulatory Class: II Product Code: NZW Dated: October 16, 2014 Received: October 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) K133446
Device Name
Heparin Lock Flush, USP
Indications for Use (Describe)
Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.
Heparin Lock Flush, USP is supplied as:
- · 3 USP Units per 3 mL (1 USP unit per mL); 3 mL volume in a 10 mL syringe
- · 6 USP Units per 3 mL (2 USP unit per mL); 3 mL volume in a 10 mL syringe
- · 30 USP Units per 3 mL (10 USP unit per mL); 3 mL volume in a 10 mL syringe
- · 50 USP Units per 5 mL (10 USP unit per mL); 5 mL volume in a 10 mL syringe
- · 300 USP Units per 3 mL (100 USP unit per mL); 3 mL volume in a 10 mL syringe
- · 500 USP Units per 5 mL (100 USP unit per mL); 5 mL volume in a 10 mL syringe
| 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: | October 16, 2014 |
510(k) Summary
| Device Proprietary Name: | Heparin Lock Flush, USP |
|---|---|
| Device Common or Usual Name: | Heparin Lock Flush, USP |
| Classification Name: | Heparin, Vascular Access Flush |
| Classification Code: | NZW |
| 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:
- . Syrex Pre-Filled Syringe, 10 U/mL & 100 U/mL, Excelsior Medical Corporation, K023740
- . Syrex Heparin Lock Flush Syringe, 1 U/mL & 2 U/mL, Excelsior Medical Corporation, K061497
Description of the Device
Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. 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.
Heparin Lock Flush, USP is available as follows:
- . Heparin Lock Flush, USP, 3 USP Units per 3 mL (1 USP unit per mL); 3 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 6 USP Units per 3 mL (2 USP unit per mL); 3 mL volume ● in a 10 mL syringe
4
- Heparin Lock Flush, USP, 30 USP Units per 3 mL (10 USP unit per mL); 3 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 50 USP Units per 5 mL (10 USP unit per mL); 5 mL volume in a 10 mL syringe
- Heparin Lock Flush, USP, 300 USP Units per 3 mL (100 USP unit per mL); 3 mL ● volume in a 10 mL syringe
- Heparin Lock Flush, USP, 500 USP Units per 5 mL (100 USP unit per mL); 5 mL volume in a 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
Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Flush, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.
Technological Characteristics
The heparin lock/flush syringes subject to this filing have been previously cleared by FDA under K023740 and K061497. A comparison of the products is provided in the table below.
| 510(k) Number | K061497 | K023740 | |
|---|---|---|---|
| Device Name | Heparin Lock Flush, | ||
| USP | Syrex Heparin Lock | ||
| Flush Syringes | Syrex Pre-Filled | ||
| Syringe | |||
| Manufacturer | Excelsior Medical Corporation | ||
| Intended Use | Flushing of IV | ||
| catheters and IV | |||
| tubing only. Solution | |||
| is intended for | |||
| maintenance of | |||
| patency of | |||
| intravenous injection | |||
| devices. Prior to and | |||
| after administration | |||
| of intermittent | |||
| medication, entirely | |||
| flush the intravenous | |||
| injection device | |||
| (catheter and or | Excelsior Medical | ||
| Heparin Lock Flush | |||
| Solutions (1 Unit/mL | |||
| and 2 Units/mL) are | |||
| indicated for use in | |||
| maintaining patency | |||
| of vascular access | |||
| devices designed for | |||
| intermittent or | |||
| infusion therapy. | |||
| Prior to and after | |||
| administration of | |||
| intermittent | |||
| medication, entirely | Flushing of IV | ||
| catheters and IV | |||
| tubing only. Prior to | |||
| and after | |||
| administration of | |||
| intermittent | |||
| medication, entirely | |||
| flush the catheter | |||
| and/or tubing with | |||
| Heparin Lock Flush | |||
| Solution, either USP | |||
| 10 Units/mL, or USP | |||
| 100 Units/mL. Use | |||
| in accordance with | |||
| tubing) with Heparin | |||
| Lock Flush, USP. | |||
| Use in accordance | |||
| with any warning or | |||
| precautions | |||
| appropriate to | |||
| medication being | |||
| administered. This | |||
| device is not to be | |||
| used for anti- | |||
| coagulant therapy. | flush the vascular | ||
| access device with | |||
| Heparin Lock Flush | |||
| Solution, USP. Use | |||
| in accordance with | |||
| any warning or | |||
| precautions | |||
| appropriate to | |||
| medication being | |||
| administered. This | |||
| device is not to be | |||
| used for anti- | |||
| coagulant therapy | any warning or | ||
| precautions | |||
| appropriate to | |||
| medication being | |||
| administered. This | |||
| device is not to be | |||
| used for anti- | |||
| coagulant therapy. | |||
| Protect from freezing | |||
| and avoid excessive | |||
| heat. Store at 25°C | |||
| (77°F); excursions | |||
| permitted to 15°- | |||
| 30°C (59°-86°F). | |||
| Solution | Heparin Lock Flush | ||
| Solution, USP (0.9% | |||
| Sodium Chloride | |||
| Injection, USP) | Heparin Lock Flush | ||
| Solution, USP (0.9% | |||
| Sodium Chloride | |||
| Injection, USP) | Heparin Lock Flush | ||
| Solution, USP (0.9% | |||
| Sodium Chloride | |||
| Injection, USP) | |||
| Concentrations | 1 U/mL | ||
| 2 U/mL | |||
| 10 U/mL | |||
| 100 U/mL | 1 U/mL | ||
| 2 U/mL | |||
| N/A | |||
| N/A | N/A | ||
| N/A | |||
| 10 U/mL | |||
| 100 U/mL | |||
| Single Use | |||
| Device | Yes | Yes | Yes |
| Sterility | Terminally sterilized | ||
| via steam; SAL 10-6 | Terminally sterilized | ||
| via steam; SAL 10-6 | Terminally sterilized | ||
| via steam; SAL 10-6 | |||
| Barrel | |||
| Material | Polypropylene and | ||
| silicone lubricant | Polypropylene and | ||
| silicone lubricant | Polypropylene | ||
| Plunger Rod | |||
| Material | Medical grade | ||
| polypropylene | Medical grade | ||
| polypropylene | Medical grade | ||
| polypropylene | |||
| Piston | Synthetic isoprene | ||
| rubber | Synthetic isoprene | ||
| rubber | Synthetic isoprene | ||
| rubber | |||
| Tip Cap | Medical grade | ||
| polypropylene and | |||
| TPE plus colorant | Medical grade | ||
| polypropylene and | |||
| TPE plus colorant | Medical grade | ||
| polypropylene and | |||
| TPE plus colorant | |||
| Tip Cap | |||
| Colorants | 1 U/mL - Green | ||
| 2 U/mL - Lavender | |||
| 10 U/mL - Blue | |||
| 100 U/mL - Yellow | 1 U/mL - Green | ||
| 2 U/mL - Lavender | 10 U/mL - Blue | ||
| 100 U/mL - Yellow | |||
| Packaging | Tamper evident over- | ||
| wrap | Tamper evident over- | ||
| wrap | Tamper evident over- | ||
| wrap |
5
As seen above there are no significant differences between the subject and predicate devices. The purpose of this submission is to add alternate suppliers of the heparin sodium (USP) raw material for all of Excelsior Medical's heparin products.
6
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 ●
- Biocompatibility (ISO 10993-1) ●
- Stability Studies ●
- Sterilization validation (ISO 17665-1 and -2) ●
- Extractables/Leachables
- Testing of final product to Heparin Lock Flush Solution USP Monograph
Conclusion
As noted above, the only change to the Heparin Lock Flush, USP products as cleared in K023749 and K061497 is the source of heparin. This change is supported by the studies cited above, and results of the testing show that there are no new questions of safety and effectiveness. Therefore, it is concluded that the product is as safe and as effective for use, and is substantially equivalent to the identified predicate devices.