(59 days)
Not Found
No
The summary describes a standard intravascular catheter and does not mention any AI or ML components or functionalities.
No
The device is described as an intravascular catheter intended for short-term use to sample blood or administer fluids intravenously, not to treat or cure a disease or condition.
No.
The device is described as an intravascular catheter for administering fluids or sampling blood, not for diagnosing a condition.
No
The device description clearly states it is an intravascular catheter, 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 to be inserted into a patient's vascular system for sampling blood or administering fluids intravenously. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The device is described as an intravascular catheter, which is a device used to access the vascular system in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside of the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used on specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device is used directly on the patient.
N/A
Intended Use / Indications for Use
The Nipro Bio-Flex Catheter is intended to be inserted into a patient's vascular system for short-term use to sample blood or administer fluids intravenously.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are similar to those already marketed by Nipro Medical Corporation under K960051.
Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 11/2 to 21/2 inches long and Type S have needles ¾ to 1¼ inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
Performance tests demonstrated that the devices are substantially equivalent.
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.
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
OCT 1 8 2002
Image /page/0/Picture/2 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, abstract symbol to the left of the word "NIPRO" in bold, sans-serif font. Below "NIPRO" is the text "MEDICAL CORPORATION" in a smaller, sans-serif font.
50 N.W. 107 Avent liami. Florida 33172 ലി.: (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO BIO-FLEX CATHETER
$807.92 (a)(1)
Contact Person:
Luis Candelario President
August 16, 2002 Date of Summary Preparation:
$807.92 (a)(2)
Trade Name:
Nipro Bio-Flex Catheter
Intravascular catheter Common Name:
Intravascular catheter (for short-term use) (§880.5200) Classification Name:
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Nipro Safelet Cath, Nipro Medical Corporation (K960051)
$807.92 (a)(4)
Description of Device:
The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are similar to those already marketed by Nipro Medical Corporation under K960051.
Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 11/2 to 21/2 inches long and Type S have needles ¾ to 1¼ inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
1
$807.92 (a)(5)
- Intended Use: The Nipro Safelet Cath is intended for use to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
§807.92 (a)(6)
Comparison of Technical Characteristics:
The Nipro subject and predicate devices are very similar except for one material change discussed within this application. Performance tests demonstrated that the devices are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with three curved lines above them. The lines appear to represent movement or energy, and the profiles suggest a focus on people and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2002
Ms. Kaelyn B. Hadley Consultant Nipro Medical Corporation 1384 Copperfield Court Lexington, Kentucky 40514-1268
Re: K022756
Trade/Device Name: Nipro® Bio-Flex Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: 80 FOZ Dated: August 16, 2002 Received: August 20, 2002
Dear Ms. Hadley:
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.
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.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothee A. Ulatowski
A. Ulatowski Timoth 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 Statement
510(k) number (if known): K02----
Device name: Nipro® Bio-Flex Catheter
Indications for use: The Nipro Bio-Flex Catheter is intended to be inserted into a patient's vascular system for short-term use to sample blood or administer fluids intravenously.
voa Nakhl/Aria for FXC
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: 022756
(Do not write below this line- continue on another page if needed.)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Prescription Use ✔ (Per 21 CFR 801.109) Over-The- Counter-Use (optional Format 1-2-9 )
Nipro Bio-Flex Catheter