(30 days)
The NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS-5 device may aid in the prevention of needle stick injuries.
Not Found
This FDA letter (K053129) indicates a "substantial equivalence" determination for the NexusTKO Needleless Access Device, Model NIS-5. Historically, 510(k) clearances, especially for devices like this from 2005, primarily relied on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive direct clinical outcome studies or established acceptance criteria with detailed statistical performance metrics in the same manner as a pre-market approval (PMA) application.
Therefore, the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert validation for this specific 510(k) clearance (K053129) will likely not be explicitly detailed in the provided documents. The letter primarily confirms the administrative clearance based on equivalence.
However, I can provide a general interpretation based on typical 510(k) requirements for similar devices during that period and what can be inferred from the "Indications for Use" stating "may aid in the prevention of needle stick injuries."
General Interpretation based on typical 510(k) process for Needleless Access Devices:
For a device like the NIS-5, demonstrating substantial equivalence typically involves showing that the device is as safe and effective as a legally marketed predicate device. This often involves:
- Performance Testing: Bench testing for fluid flow rates, leak integrity, pressure resistance, connection integrity, and potentially microbiology (e.g., bacterial ingress/egress).
- Biocompatibility: Tests according to ISO 10993 for materials in contact with fluids/blood.
- Sterilization Validation: Ensuring the device can be sterilized effectively.
- Human Factors/Usability: To ensure the device can be used safely and effectively by healthcare professionals.
Regarding the "prevention of needle stick injuries" claim: This specific claim would have likely been supported by either:
1. Design features explicitly eliminating needles or
2. Comparative bench testing or simulated use studies demonstrating reduced risk compared to traditional methods requiring needles (e.g., during IV line access or drug administration).
Unable to Fulfill Specific Data Request from Provided Documents:
Based solely on the provided FDA letter and "Indications for Use," the following information cannot be extracted or inferred:
- A table of acceptance criteria and the reported device performance: This detail is not part of an FDA clearance letter.
- Sample sizes used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Highly unlikely for this type of device and 510(k) submission from 2005. MRMC studies are typical for imaging AI.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a mechanical device, not an AI algorithm.
- The type of ground truth used: Not explicitly stated, but for a mechanical device, ground truth would be based on engineering specifications, validated test methods (e.g., flow rate measurements, leak tests), and potentially microbiological culture results.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided FDA letter for K053129 is an administrative document confirming "substantial equivalence." It does not contain the detailed technical specifications, acceptance criteria, or study results that would be part of the actual 510(k) submission. To obtain the specific data you're asking for, one would need to access the full 510(k) submission (if publicly available, often summarized, or through a Freedom of Information Act request), which would contain the performance data, test reports, and rationale for demonstrating substantial equivalence.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC 8
2005
Mr. AL Boedeker Director of Quality Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215
Re: K053129
Trade/Device Name: NexusTKO Needleless Access Device, Model NIS-5 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 25, 2005 Received: November 8, 2005
Dear Mr. Boedeker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have revealy one and have determined the device is substantially cquivalent (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 mendments, or to devices that have been reclassified in accordance with the provisions of / Innendments, or to do rooms act (Act) that do not require approval of a premarket the Fought F 600; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 MA), it may of subject to back of federal Regulations, Title 21, Parts 800 to 898. In your device ear. 80 rear over announcements concerning your device in the Ecderal Register.
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Page 2 - Mr. Boedeker
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 modi that 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the Fet of any - with all the Act's requirements, including, but not limited to: registration 1 ou Intilet compry was a 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 certer as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as be forth in are quartion 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 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), rr you desire spbeint at 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 maj South 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,
Souite y. Michie 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
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Indications for Use
510(k) Number (if known): HO53129
Device Name: NIS-5
Indications for Use:
The NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS-5 device may aid in the prevention of needle stick injuries.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PILEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) for MD2
October 2005 Nexus Medical LLC: NIS-5 Childsion Sign-Off)
City sion of Anesthesiology, General Hos in coron Control, Danial Devices
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1 10(k) Number __
§ 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.