(330 days)
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through a surgically implanted vascular port. Secondly, it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needle stick injuries.
The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent accidental needle sticks. The device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The basic structure of the device consists of a needle tube, wing unit, needle hub, flexible tubing and luer connector. This device is also available with a clamp, Y-mixing tube and a joint tube. The needle is bent at a 90° angle and is available in gauges 19, 20, 22 and 24 and in lengths of ½" - 1 ½". The device is supplied in three basic configurations: 1. Type A: Y-site with rubber button, 2. Type B: Without Y-site, 3. Type C: Y-site with luer lock.
The NIPRO SafeTouch Huber Infusion Set successfully met the requirements for various international and national standards, as well as specific performance tests. The device demonstrates substantial equivalence to its predicate device (NIPRO SafeTouch Huber Infusion Set, K081210) based on physical properties, materials, configurations, and intended use.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Safety mechanism activation force | ≤ 8.4 N | Successfully met the requirement |
| 2. Safety mechanism activation breakage force | ≥ 25.2 N | Successfully met the requirement |
| 3. Safety mechanism deactivation force | Needle breaks before deactivation | Successfully met the requirement |
| 4. Flow rate | 19G: 41-52 ml/min20G: 24-38 ml/min22G: 10-15 ml/min24G: 4-6 ml/minPredicate Device 20G | Successfully met the requirement (implied, as stated "met or exceeded") |
| 5. Air leakage - pressure endurance | Must show no signs of air leakage50 [kPa] for 15 seconds. | Successfully met the requirement |
| 6. Set Leakage - Endurance test | With y-site: 1.8MPa Without y-site:3.7MPa | Successfully met the requirement |
| 7. Wrapping paper leakage | Must not leak under the condition of1.1[kPa] for 10 seconds. | Successfully met the requirement |
| 8. Cannula/Hub adhesive strength measurement | 19G: ≥ 69 N20G: ≥ 54 N22G: ≥ 34 N24G: ≥ 22 N | Successfully met the requirement |
| 9. Popping needle tip inspection | No sound of puncture popping noise. | Successfully met the requirement |
| 10. Tensile Adhesive strength (Hub/tube, Y connector/tube, Connecting tube/connector) | Must withstand a static tensile forceof 15[N] for 15 seconds. | Successfully met the requirement |
| 11. Test for particulate matter | Contamination Index $I = Na - Nb$ 9 | Successfully met the requirement |
| 12. Injection Site (rubber button) | Must show no signs of air leakage50 [kPa] for 15 seconds. | Successfully met the requirement |
| 13. Transportation Testing | Withstand distribution environment | Successfully met the requirement |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific performance test. It broadly states that "Testing of the NIPRO SafeTouch Huber Needle Infusion Set was completed in conformance with the following standards" and then "In addition, it met or exceeded the acceptance criteria for the following performance tests." Without specific sample numbers for each test, it's impossible to provide these details.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer to demonstrate compliance with standards and performance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing described is for a medical device (Huber Infusion Set), which involves physical and mechanical performance tests, sterility, and biocompatibility, not diagnostic or interpretive tasks that would require human expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. As mentioned above, the tests are objective mechanical, physical, and biological evaluations, not requiring human adjudication.
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:
This information is not applicable and not provided. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data, often with AI assistance. This device is a physical infusion set, not an AI-enabled diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests outlined (like flow rate, adhesive strength, leakage, etc.) is established by the specifications defined in the referenced international and national standards (e.g., ISO 8536-4, ISO 10555-3, ISO 7864, USP 31) and the specific acceptance criteria developed by the manufacturer. These are objective, measurable parameters rather than subjective expert consensus or pathology. For example, for "Safety mechanism activation force," the ground truth is simply the measured force in Newtons relative to the acceptance criterion of "≤ 8.4 N." Similarly, for "Flow rate," the ground truth is the measured flow rate in ml/min compared to the specified range for each gauge.
8. The sample size for the training set:
This information is not applicable and not provided. This device is a physical medical device that undergoes performance testing and compliance to standards, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided, for the same reasons as in point 8.
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Image /page/0/Picture/0 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, abstract symbol on the left, resembling two interlocked or overlapping shapes. To the right of the symbol is the company name, "NIPRO," in bold, sans-serif font, with "MEDICAL CORPORATION" printed in a smaller font size directly below it.
3150 NW 107th Avenue, Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621
510(k) Summary - NIPRO SafeTouch Huber Infusion Set
(21 CFR 807.92)
| 1. | Submitter: | Nipro Medical CorporationFDA Registration No: 1056186 |
|---|---|---|
| Contact Person:Prepared on: | Jessica Oswald21 November 2011 | |
| 2. | Trade Name: | NIPRO SafeTouch Huber Infusion Set |
| Common Name: | Huber Infusion Set | |
| Classification Name: | Intravascular Administration Set | |
| Classification Code: | FPA (per 21 CFR 880.5440)Class II | |
| 3. | Predicate Device: | NIPRO SafeTouch Huber Infusion Set (K081210) |
4. Device Description:
The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent accidental needle sticks. The device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling.
5. Indication for Use:
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through a surgically implanted vascular port. Secondly, it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needle stick injuries.
6. Technological Characteristics
The basic structure of the device consists of a needle tube, wing unit, needle hub, flexible tubing and luer connector. This device is also available with a clamp, Y-mixing tube and a joint tube. The needle is bent at a 90° angle and is available in gauges 19, 20, 22 and 24 and in lengths of ½" - 1 ½".
The device is supplied in three basic configurations:
-
- Type A: Y-site with rubber button
-
- Type B: Without Y-site
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3. Type C: Y-site with luer lock
Safety Mechanism
Following conventional placement of the SafeTouch Huber Infusion Set into the implanted port and completion of either the prescribed infusion of fluids or blood sample withdrawal the device may then be withdrawn from the patient. The safety mechanism enables the clinician to retract the needle into a shield as the needle is removed from the patient. This shield locks over the needle to prevent exposure to blood borne pathogens through accidental needlestick injuries. The safety mechanism is not passive, but it is integral. For activation, place one hand on the wings of the SafeTouch Huber Infusion Set to secure the port. With the other hand grasp the lever located on top of the needle hub and pull upward. This will remove the needle from the patient and lock the needle into the safety shield. Safety Mechanism activation is verified by an audible or tactile click.
7. Performance Testing
Testing of the NIPRO SafeTouch Huber Needle Infusion Set was completed in conformance with the following standards:
| Reference Number | Standard Title |
|---|---|
| ISO 8536-4:2010 | Infusion equipment for medical use, Part 4: Infusion sets for single use, gravity feed |
| ISO 10555-3:1996 | Sterile single use catheters, Part 3: central venous catheters |
| ISO 7864:1993 | Sterile hypodermic needles for single use |
| ISO 594-1:1986 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1:General requirements |
| ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1:Requirements for the development, validation, and routine control of asterilization process for medical devices. |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Test for In Vitro Cytotoxicity |
| ISO 10993-4:2002 | Biological Evaluation of Medical Devices - Selection of Test forInteraction with Blood |
| ISO 10993-10:2002 | Biological Evaluation of Medical Devices - Test for Irritation andDelayed-Type Hypersensitivity |
| ISO 10993-11:2006 | Biological Evaluation of Medical Devices - Test for Systemic Toxicity |
| IAEA-TECDOC-539 | Guidelines for Industrial Radiation Sterilization of Disposable MedicalProducts (Cobalt-60 Gamma Irradiation) |
| USP 31 | <151> Pyrogen Test (USP Rabbit Test) |
| USP 31 | <161> Transfusion and Infusion Assemblies and Similar Medical Devices |
| JIS T3221:2005 | Single-use needle for infusion port |
| JP15 | The Japanese Pharmacopoeia, Fifteenth Edition |
| ASTM D4169-05 | Standard Practice for Performing Testing of Shipping Containers andSystems |
NIPRO SafeTouch Huber Infusion Set successfully met the requirements for these standards.
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In addition, it met or exceeded the acceptance criteria for the following performance tests:
| Performance Test Name | Acceptance Criteria |
|---|---|
| 1. Safety mechanism activation force | ≤ 8.4 N |
| 2. Safety mechanism activationbreakage force | ≥ 25.2 N |
| 3. Safety mechanism deactivation force | Needle breaks before deactivation |
| 4. Flow rate | 19G: 41-52 ml/min20G: 24-38 ml/min22G: 10-15 ml/min24G: 4-6 ml/minPredicate Device 20G |
| 5. Air leakage - pressure endurance | Must show no signs of air leakage50 [kPa] for 15 seconds. |
| 6. Set Leakage - Endurance test | With y-site: 1.8MPa Without y-site:3.7MPa |
| 7. Wrapping paper leakage | Must not leak under the condition of1.1[kPa] for 10 seconds. |
| 8. Cannula/Hub adhesive strengthmeasurement | 19G: ≥ 69 N20G: ≥ 54 N22G: ≥ 34 N24G: ≥ 22 N |
| 9. Popping needle tip inspection | No sound of puncture popping noise. |
| 10. TensileAdhesive strengtha. Hub / tube b. Y connector / tube c. Yconnector / tubed. Connecting tube/ connector | Must withstand a static tensile forceof 15[N] for 15 seconds. |
| 11. Test for particulate matter | Contamination Index $I = Na - Nb$ 9 |
| 12. Injection Site (rubber button) | Must show no signs of air leakage50 [kPa] for 15 seconds. |
| 13. Transportation Testing | Withstand distribution environment |
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8. Substantial Equivalence
The Nipro SafeTouch Huber Infusion Sets are identical in physical properties, materials, configurations and having the same intended use as the predicate device (i.e., the original Nipro SafeTouch Huber Needle Infusion Set). Although the manufacturing process for the needle bevel has been modified, performance testing shows that the performance of the new Nipro SafeTouch Huber Infusion Sets is similar in most performance test and is significantly better in the Coring Test. Therefore, no new issues of safety or effectiveness are introduced by these changes.
| Specification | 510(k) | Predicate | ||
|---|---|---|---|---|
| Nipro SafeTouch Huber Infusion Sets | Nipro SafeTouch Huber Infusion Sets | |||
| Physical and Material | ||||
| Needle | Components | Materials | Components | Materials |
| Cannula | Stainless Steel | Cannula | Stainless Steel | |
| Hub | PVC | Hub | PVC | |
| Needle Tube Cap | PP | Needle Tube Cap | PP | |
| Sharp InjuryPrevention | Wing Unit | PP | Wing Unit | PP |
| Over Cap | PP | Over Cap | PP | |
| Protector | PC | Protector | PC | |
| Tube | Tube | PVC | Tube | PVC |
| Clamp | POM | Clamp | POM | |
| Connector | Rubber Button | IR | Rubber Button | IR |
| Rubber ButtonCap. | PVC | Rubber ButtonCap | PVC | |
| Luer Connector | PC | Luer Connector | PC | |
| Leur Cap | PP | Leur Cap | PP | |
| Bond | Epoxide-based adhesive | Epoxide-based adhesive | ||
| Urethane-based adhesive | Urethane-based adhesive | |||
| Lubricants | Silicone oil | Silicone oil | ||
| AvailableConfigurations | Type A: Y-site with rubber button | Type A: Y-site with rubber button | ||
| Type B: Without Y-Site | Type B: Without Y-Site | |||
| Type C: Y-site with luer lock | Type C: Y-site with luer lock | |||
| Mechanical | ||||
| Instructions forUse | Same | Same | ||
| Operational | ||||
| Device Type | Standard non-coring Huber needle withan integrated safety mechanism. | Same | ||
| Safety Mechanism | For activation, place one hand on thewings of the SafeTouch Huber InfusionSet to secure the port. With the otherhand grasp the lever located on top ofthe needle hub and pull upward This | Same |
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| Specification | 510(k)Nipro SafeTouch Huber Infusion Sets | PredicateNipro SafeTouch Huber Infusion Sets |
|---|---|---|
| will remove the needle from the patientand lock the needle into the safetyshield. Safety Mechanism activation isverified by an audible or tactile click. | ||
| Biological | Biocompatibility tests were performedaccording to ISO 10993 Parts 4, 5, 10and 11 as a prolonged duration, indirectblood path contacting device. | Same |
| SterilizationMethod | Ethylene oxide | Same |
PVC: polyvinyl chloride, PE: polyethylene, PP: polypropylene, POM: polyoxymethylene, PC: polycarbonate, IR: isoprene rubber PEI: polyetherimide
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned above a wavy line, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nipro Medical Corporation
Ms. Jessica Oswald
Regulatory Affairs
3150 North West 107$^{TH}$ Avenue
Miami, Florida 33172
Re: K113470
Trade/Device Name: Nipro SafeTouch Huber Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 10, 2012 Received: October 11, 2012
Dear Ms. Oswald:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
OCT 1 7 2012
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Page 2- Ms. Oswald
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R. Stete
updatid
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: NIPRO SafeTouch Huber Infusion Set
Indications for Use:
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ___x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
Mili Clyn
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
-. Number. K113470
-4.1-
§ 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.