(140 days)
Not Found
No
The document describes a standard pre-filled syringe for flushing IV lines and does not mention any AI or ML components or functionalities.
No
The device is described as being "intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices," which is a maintenance function, not a therapeutic treatment for a medical condition.
No
Explanation: The device is intended for flushing intravenous administration sets and indwelling intravenous access devices, not for diagnosing any medical condition.
No
The device description clearly states it is a physical syringe containing a solution, which is a hardware 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 to flush intravenous administration sets and indwelling intravenous access devices. This is a direct interaction with the patient's circulatory system, not the examination of specimens derived from the human body.
- Device Description: The device is a pre-filled syringe containing Heparin Lock Flush Solution. This is a drug delivery device, not a device used for diagnostic testing of biological samples.
- No Mention of Diagnostic Testing: The document does not mention any diagnostic purpose, analysis of biological samples, or the detection of any condition or disease.
- Anatomical Site: The anatomical site is intravenous administration sets and indwelling intravascular access devices, which are part of the patient's circulatory system, not a location for collecting or analyzing diagnostic specimens.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to maintain the patency of IV lines, which is a therapeutic/supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The AM2PAT Heparin Lock Flush Syringe and its predicate products are intended for prescription use to flush compatible intravenous administration sets and indwelling intravascular access devices.
The Heparin Flush Syringe, 10 and 100 units/mL, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Product codes (comma separated list FDA assigned to the subject device)
NGT, FOZ
Device Description
The proposed device is a sterile, single use, standard piston type syringe that is available in various fill volumes and syringe sizes containing either 10 or 100 USP u/ml Heparin Lock Flush Solution for anits Injection.
The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.
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)
Non-Clinical Testing:
The physical properties of the materials used to manufacture the Heparin Lock Flush Pre-Filled Syringe are tested by suppliers to ensure they meet either USP Class VI plastic test requirements or ISO 10993 Part 1 for all fluid path components. Materials that come into contact with the body have been tested and found to be safe and effective for their intended use. This information was submitted as part of 510 100and to be sure the EMT-Rx Syringe. These materials are widely used in similar, and other medical devices and have been cleared through FDA.
Test data have been generated for stability and containcr/closure suitability. Performance testing indicates that the proposed device meets all functional requirements and supports its suitability for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002142, K011967, K003245, K020996
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 2 3 2003
"510k Summary"
Preparation Date: July 20, 2003
AM2PAT, Inc. Submitter: 9400 Ransdell Road, Suite 10 Raleigh, NC 27603 Phone: (919) 552-9689 (919) 552-7400 Fax:
Contact: Dushyant Patel, President
Device Name: Heparin Lock Flush Syringe
Device Common/Usual Name: Heparin Lock Flush Solution, USP
Device Classification Name: Catheter, Intravascular, Therapeutic, Short Term Less Than 30 Days
Product Code: NGT – Device, Flush, Vascular Access
Substantially Equivalent Devices:
| Company | Product/Device | 510k Number |
|---|---|---|
| EMT-Rx | Saline IV Flush Syringe | K002142 |
| Becton Dickinson | BD PosiFlushTM Heparin Lock Flush Syringe | K011967 |
| Baxter Healthcare | Heparin Lock Flush Syringe | K003245 |
| Medefil, Inc | Heparin IV Flush Syringe | K020996 |
Device Description:
The proposed device is a sterile, single use, standard piston type syringe that is available in various fill volumes and syringe sizes containing either 10 or 100 USP u/ml Heparin Lock Flush Solution for anits Injection.
The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.
Intended Use:
The AM2PAT Heparin Lock Flush Syringe and its predicate products are intended for prescription use to flush compatible intravenous administration sets and indwelling intravascular access devices.
1
Comparison to legally marketed devices:
The technological characteristics of the new device to legally marketed predicate devices are the same in that:
All devices have the same intended use All devices are pre-filled with a heparin lock flush solution, USP All are single use disposable products All are sterile and pryogen free All are manufactured using an aseptic process All are available in similar syringe sizes and fill volumes All use a polypropylene piston-type syringe All are packaged in a wrapper or polybag and sealed All use manual energy
Non-Clinical Testing:
The physical properties of the materials used to manufacture the Heparin Lock Flush Pre-Filled Syringe are tested by suppliers to ensure they meet either USP Class VI plastic test requirements or ISO 10993 Part 1 for all fluid path components. Materials that come into contact with the body have been tested and found to be safe and effective for their intended use. This information was submitted as part of 510 100and to be sure the EMT-Rx Syringe. These materials are widely used in similar, and other medical devices and have been cleared through FDA.
Test data have been generated for stability and containcr/closure suitability. Performance testing indicates that the proposed device meets all functional requirements and supports its suitability for use.
Conclusion:
The Heparin Lock Flush Pre-Filled Syringe is substantially cquivalent to the predicate devices cited with respect to indications for use, device design, matcrials, and labeling.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three bars representing its wings, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using black and white, and is designed to be easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Mr. Dushvant Patel President AM2Pat, Incorporated 9400 Ransdell Road Raleigh, North Carolina 27603
Re: K032417
Trade/Device Name: Heparin Lock Flush Syringe - 10 and 100 units/mL Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 17, 2003 Received: December 18, 2003
Dear Mr. Patel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Patel
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Applicant: AM2PAT
510(k) Number (if known): N/A K 032417
Device Name: Heparin Flush Syringe - 10 and 100 units/mL
Indications for Use: Lock
Leck The Heparin Flush Syringe, 10 and 100 units/mI. is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Susanna F. Bassu D
(Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K032417
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
ાર
Over-the-Counter Use
(Per 21CFR 801.109)
AM2PAT, Inc., Heparin Lock Flush Syringe 510k