(77 days)
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.
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.
The provided document is a 510(k) summary for the Nipro Disposable Solution Infusion Set. This type of submission is for demonstrating substantial equivalence to a legally marketed device, rather than proving device performance against specific acceptance criteria through a clinical study in the way typically seen for novel or high-risk devices.
Therefore, many of the requested elements (e.g., acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI/ML) are not applicable or not provided in this type of regulatory submission because the device is a standard, well-understood medical product that has a predicate.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent due to the nature of the submission:
Acceptance Criteria and Device Performance Study for Nipro® Disposable Solution Infusion Set
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The Nipro and Gainor Medical devices are exactly the same devices, therefore, all technical characteristics are identical. |
| Safety and Effectiveness Established through Clinical Use | "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." |
Note: The document does not specify quantitative or qualitative acceptance criteria typical of performance studies (e.g., specific flow rates, burst pressures, material biocompatibility thresholds) because it relies on the predicate device's established safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. There was no specific "test set" in the context of a prospective performance study as would be conducted for an AI/ML device. The claim of equivalence is based on the technical characteristics being identical to the predicate device and historical clinical use.
- Data Provenance: The "data" provenance refers to "years of clinical use" of similar devices, implying real-world usage data, likely from various geographies where such devices are used. The specific country of origin or whether it was retrospective/prospective is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There was no "ground truth" establishment in the context of expert review for a performance study. Clinical experience with the predicate device and similar infusion sets forms the basis of the safety and effectiveness claim.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method was described as there was no test set requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a disposable solution infusion set, not an AI/ML diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Historical Clinical Outcomes: The "ground truth" for the safety and effectiveness claim relies on "years of clinical use" and the absence of reported problems for similar, legally marketed devices. This implicitly refers to real-world outcomes and user experience, rather than specific diagnostic ground truth like pathology or expert consensus on individual cases.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model, so the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established
- Not applicable. See #8.
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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-
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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.
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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
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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
§ 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.