(77 days)
No
The device description and intended use are for standard intravenous fluid administration sets, and there is no mention of AI or ML capabilities.
No.
The device is an infusion set used for administering fluids, which is a supportive function rather than directly providing therapy to treat or cure a disease.
No
The device is described as an infusion set for administering intravenous fluids, which is a therapeutic function, not a diagnostic one. There is no mention of it being used to detect or identify any medical condition.
No
The device description clearly outlines physical components made of materials like PVC, PE, PP, and ABS, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "administration of intravenous fluid solution into the body" and "administering intravenous fluids to a dialysis set in conjunction with hemodialysis." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description details components like tubing, clamps, luer locks, and connectors, which are typical of devices used for fluid administration directly into the bloodstream. There is no mention of components or functions related to analyzing biological samples.
- Regulatory Classification: The device is described as "Intravascular administration sets" and references 21 CFR §880.5440. This regulation specifically covers "Intravascular administration set," which is a Class II medical device used for administering fluids intravenously, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Reagents or assays
In summary, the device's intended use, description, and regulatory classification all point to it being a device for administering fluids intravenously, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis.
Product codes
78 KOC
Device Description
Intravascular administration sets are described in 21 CFR §880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a male luer-lock conector (without injection site) and NNC-3CL has the male luer-lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site).
The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.
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
As these sets have been marketed for several years, safety and effectiveness has been established through years of clinical use. There have not been problems reported during use of the sets.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
K97 2493
Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, intertwined ribbon-like symbol on the left, followed by the word "NIPRO" in bold, sans-serif capital letters. The logo is simple and modern, with a focus on the company name.
PRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami. Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
SEP 1 8 1997
"SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® DISPOSABLE SOLUTION INFUSION SET
$807.92 (a)(1)
Contact Person:
Luis Candelario General Manager
Address:
Nipro Medical Corporation 10877 NW 33rd Street Miami. Florida 33172 (305) 599-7174 (telephone) (305) 599-8454 (fax)
Date of Summary Preparation:
July 1, 1997
$807.92 (a)(2)
Trade Name: Nipro® Disposable Solution Infusion Set
Common Name: Disposable Solution Infusion Set or I.V. Administration Set
Classification Name: Intravascular administration set (21 CFR §880.5440)
§807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: I.V. Administration Set, Gainor Medical U.S.A., Inc. (K926448) and Medistystems Dialysis Priming Set
$807.92 (a)(4)
Description of Device:
Intravascular administration sets are described in 21 CFR §880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a male luer-lock conector (without injection site) and NNC-3CL has the male luer-
1
lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site).
The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.
$807.92 (a)(5)
Intended Use:
The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis
$807.92 (a)(6)
Comparison of Technical Characteristics:
The Nipro and Gainor Medical devices are exactly the same devices, therefore, all technical characteristics are identical.
As these sets have been marketed for several years, safety and effectiveness has been established through years of clinical use. There have not been problems reported during use of the sets.
The Medisystems Dialysis Priming Set includes similar indications for use in hemodialysis.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Luis Candelario General Manager Nipro Medical Corporation 10877 N.W. 33rd Street Miami. Florida 33172
SFP 18 1997
Re: K972493 Nipro® Disposable Solution Infusion Set Dated: July 2, 1997 Received: July 3, 1997 Regulatory class: II 21 CFR §876.5820/Product code: 78 KOC
Dear Mr. Candelario:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 III (Premarket Approval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Wiliau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KY72493
Indications for Use
510(k) Number (if known): Unknown Device Name: Nipro Disposable Solution Infusion Set
Indications for Use:
The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Robert R Ratliff
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972493