(32 days)
Not Found
No
The 510(k) summary describes a modification to packaging for a saline flush syringe and explicitly states that "All other aspects of the product design remain unchanged." There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The provided text describes the device as intended for flushing IV catheters and tubing, which is a supportive function in medical procedures, not a direct therapeutic treatment.
No
Explanation: The device is described as "Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes" intended for "flushing IV catheters and IV tubing." This is a therapeutic/supportive function, not a diagnostic one. There is no mention of diagnosing conditions, analyzing biological data for diagnostic purposes, or any diagnostic claims.
No
The device is a physical medical device (syringes) and the modification described relates to its packaging, not a software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "flushing IV catheters and IV tubing." This is a direct interaction with the patient's circulatory system for maintenance and patency, not for testing a sample taken from the body.
- Device Description: The device is a syringe with a specific type of packaging. Syringes used for flushing are medical devices, but not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly intended for a therapeutic or maintenance purpose related to IV lines, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes are intended for flushing IV catheters and IV tubing.
Product codes
FOZ
Device Description
The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.
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
The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device.
Key Metrics
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
JEL 9 2005
K053/20
510(k) SUMMARY
Submitted by:
Ruben Martinez Director, Regulatory/Quality Excelsior Medical Corporation 1923 Heck Avenue Neptune, NJ 97753
Proposed Device:
Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes
Predicate Device:
Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes
Device Description and Statement of Intended Use:
The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.
Excelsior Sterile Field Saline Flush and Heparin Lock Flush Svringes are intended for flushing IV catheters and IV tubing. This is the same intended use previously cleared for the currently marketed Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes.
Summary of Technological Characteristics of New Device to Predicate Device
The technological characteristics of Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes do not differ from the currently marketed Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes. The devices use the same fundamental scientific technology and have the same intended use.
Discussion of Non-Clinical Tests; Conclusions Drawn from Nonclinical Tests
The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 9 2005
Mr. Ruben Martinez Director Regulatory/Quality Excelsior Medical Corporation 1923 Heck Avenue Neptune, New Jersey 07753
Re: K053120
K005120
Trade/Device Name: Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 28, 2005 Received: November 30, 2005
Dear Mr. Martinez:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed younge 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 Interstate conmisive prior to realism the been reclassified in accordance with the provisions of Amendinents, or to do rouses and metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include controls provisions or tregistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (FMA), it may of subject to tach ade of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 -Mr. Martinez
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 mean that I DA mas made a deters and regulations administered by other Federal agencies. of the Act of ally I ederal buter and suggest to reguirements, including, but not limited to: registration 1 ou must comply with an the Piece s ong (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 007), idoeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ajons of (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) I mis letter whi anow you to oegal finding of substantial equivalence of your device to a premarket notification. The PDF 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), IT you desire specific at rioe for Jour at (240) 276-0115. Also, please note the regulation i 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Drisker (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Gretti Y. Michael Omd.
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
3
Indications for Use Statement
510(k) Number (if known):
Device Name: Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes
Indications For Use:
Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Excelsfor Stonio Piola Salino in flushing IV catheters and IV tubing.
Shula K. Murthy, M.D. 12/7/15
Anesthesiology General Hospital
on Control, Dental Devices
K 05/3/20
AND/OR 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 ÀNOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)