(268 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and function of a syringe containing a heparin solution, with no mention of AI or ML technology.
No.
The device is clearly stated as "not to be used for anticoagulant therapy," which indicates it is not intended for the treatment or prevention of a disease or condition. Its purpose is to maintain patency of vascular access devices.
No
The device is used for maintaining patency of vascular access devices by flushing with Heparin Lock Flush Solution, not for diagnosing a 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 maintain the patency of vascular access devices by flushing them. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a syringe containing a solution used for flushing. It does not describe any components or functions related to testing samples from the human body in vitro (outside the body).
- Lack of Diagnostic Language: The document does not mention any diagnostic tests, measurements of biological markers, or analysis of samples for diagnostic purposes.
IVD devices are used 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 purely related to maintaining the functionality of a medical device within the body.
N/A
Intended Use / Indications for Use
The Excelsior Medical Heparin Lock Flush Syringes are intended for use in flushing IV catheters and IV tubing.
To maintain patency of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush 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.
Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush 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.
Product codes (comma separated list FDA assigned to the subject device)
NZW
Device Description
Excelsior Medical Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.
Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1)a-L-iduronic acid 2 sulfate, (2)2-deoxy-2sulfamino-a-D-glucose, 6 -sulfate, (3)ß-D-glucuronic acid, (4)2-acetamido-2-deoxy- a-D-glucose, and (5) a -L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5),are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.
The Excelsior Medical Heparin Lock Flush is designed to be injected into a vascular access device. The appropriate concentration of Heparin Lock Flush Solution USP should be based on current practice standards and institutional policies and procedures.
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 Excelsior Medical Heparin Lock Flush Syringes are tested according to the specifications documented in Design Verification Testing Reports and independent laboratory testing. In all instances, the Excelsior Medical Heparin Lock Flush Syringes functioned as intended and met all pass criteria as expected.
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.
Medefil 1 U/ml Flush Syringe, Hospital filled 1 U/ml Flush Syringe
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).
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510(k) SUMMARY
Excelsior Medical Heparin Lock Flush Syringes (1 Unit per ml and 2 Units per ml)
FEB 2 3 2007
This 510(k) summary is provided as part of the Premarket Notification for Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml)
Submitter: Excelsior Medical 1933 Heck Ave. Neptune, New Jersey 07753 Phone: +1-732-776-6079 Facsimile: +1-732776-7600
Contact Person: John J. Talarico
Date Prepared: February 21, 2007
- Name of Device: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml)
Common or Usual Name: Heparin Lock Flush Syringe
Classification Name: Intravascular Catheter 21 CFR 880 5200
Predicate Devices:
Medefil 1 U/ml Flush Syringe Hospital filled 1 U/ml Flush Syringe
Intended Use / Indications for Use
A. Intended Use
The Excelsior Medical Heparin Lock Flush Syringes are intended for use in flushing IV catheters and IV tubing.
B. Indications for Use
To maintain patency of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush 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.
Excelsior Medical Heparin Lock Flush Syringes (1U/ml & 2U/ml) 510k K061497
1
C. Contraindications
- Heparin Lock Flush Solution, USP should not be used in patients with thrombocytopenia or with an uncontrollable active bleeding state. Heparin Lock Flush Solution USP for IV flush should not be used for anticoagulant therapy. Heparin Lock Flush Solution USP is not for use in patients with documented hypersensitivity to heparin or pork products.
Technological Characteristics
Excelsior Medical Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.
Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1)a-L-iduronic acid 2 sulfate, (2)2-deoxy-2sulfamino-a-D-glucose, 6 -sulfate, (3)ß-D-glucuronic acid, (4)2-acetamido-2-deoxy- a-D-glucose, and (5) a -L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5),are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.
The Excelsior Medical Heparin Lock Flush is designed to be injected into a vascular access device. The appropriate concentration of Heparin Lock Flush Solution USP should be based on current practice standards and institutional policies and procedures.
Performance Data
The Excelsior Medical Heparin Lock Flush Syringes are tested according to the specifications documented in Design Verification Testing Reports and independent laboratory testing. In all instances, the Excelsior Medical Heparin Lock Flush Syringes functioned as intended and met all pass criteria as expected.
Substantial Equivalence
The Excelsior Medical Heparin Lock Flush Syringes are as safe and effective as the Medefil's 1 U/ml Flush Syringe and Hospital pharmacy filled 1 U/ml Flush Syringes. The Excelsior Medical Heparin Lock Flush Syringes have the same
2
061497 2.38
intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Excelsior Medical Heparin Lock Flush Syringes and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the Excelsior Medical Heparin Lock Flush Syringes are as safe and effective as the Medefil's 1 U/ml Flush Syringe and Hospital pharmacy filled 1 U/ml Flush Syringe. Thus, the Excelsior Medical Heparin Lock Flush Syringes are substantially equivalent to the predicate devices in construction, materials, and intended use.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John J. Talarico Vice President & Regulatory Affairs Excelsior Medical Corporation 1933 Heck Avenue Neptune, New Jersey 07753
FEB 2 3 2007
Re: K061497
Trade/Device Name: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: December 15, 2006 Received: January 31, 2007
Dear Mr. Talarico:
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.
4
Page 2 - Mr. Talarico
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 (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. .
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
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
5
Indications for Use Statement
510(k) Number (if known): K061497
Device Name: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml)
Indications For Use: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush 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
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Shida P. Maybey, Ph Concurrence of CDRH, Office of Device Evaluation (ODE)
12-11-22 23:11
K64/447