(331 days)
This device is intended for administration of drug solutions, or blood sampling into or from a Reservoir implanted in the body.
This device consists of a cannula affixed to a hub with a needle cap. Both straight and 900 angled types are available.
This document describes the performance testing of the NIPRO Huber Needle.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Tests | Specification | Reported Device Performance |
|---|---|---|
| Stiffness Test | Must conform to ISO 9626 (SU = 0.55 mm) | NIPRO Huber Needle successfully met the requirements. |
| Bending Breakage Resistance Test | Must conform to ISO 9626 (Shall not break) | NIPRO Huber Needle successfully met the requirements. |
| Elasticity | Must conform to JIS T 3209 (Shall go back to the original position) | NIPRO Huber Needle successfully met the requirements. |
| Bending Strength | Must conform to JIS T 3209 (Shall not break) | NIPRO Huber Needle successfully met the requirements. |
| Corrosive Resistance | Must conform to ISO 9626 (No corrosion shall be allowed) | NIPRO Huber Needle successfully met the requirements. |
| Cannula Dirt Test | Must conform to the internal test (No dirt shall be allowed) | NIPRO Huber Needle successfully met the requirements. |
| Coring Test | Must conform to FDA Coring Test Method (No coring shall occur) | NIPRO Huber Needle successfully met the requirements and was "significantly better" than the predicate device. |
| Cannula/Hub adhesive strength | 19G: ≥ 69 N; 20G: ≥ 54 N; 22G: ≥ 34 N | NIPRO Huber Needle successfully met the requirements. |
| Popping needle tip inspection | No sound of puncture popping noise. | NIPRO Huber Needle successfully met the requirements. |
| Test for particulate matter | Contamination Index i = Na - Nb ≤ 90 | NIPRO Huber Needle successfully met the requirements. |
| Transportation Testing | Withstand distribution environment | NIPRO Huber Needle successfully met the requirements. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each individual performance test. The data provenance is not specified, but the testing was conducted by Nipro Medical Corporation. As this is a 510(k) summary, the tests are typically performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for the performance tests consists of adherence to established international and internal standards (ISO, JIS, USP, FDA methods). These are objective measurements against defined criteria, not subjective expert interpretations.
4. Adjudication method for the test set:
Not applicable. The tests are objective measurements against predefined specifications, not requiring human adjudication of results in the traditional sense.
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 is not a study involving human readers or AI assistance. It is a performance evaluation of a medical device (Huber Needle).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI device; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these performance tests is based on established international and industry standards and specific quantifiable specifications. For example:
* Mechanical properties (Stiffness, Bending Breakage Resistance, Elasticity, Bending Strength, Corrosive Resistance) are measured against ISO and JIS standards.
* Biological compatibility tests are conducted according to ISO 10993 series.
* Sterilization efficacy is evaluated against ISO 11135-1.
* Coring Test follows an "FDA Coring Test Method."
* Other tests like Particulate Matter and Pyrogen tests conform to USP standards.
These are objective, measurable criteria, not subjective expert consensus or pathology.
8. The sample size for the training set:
Not applicable. This document describes performance testing for a physical medical device, not an AI/ML algorithm. There is no training set in this context.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
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K1)3469
Image /page/0/Picture/1 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, the word "NIPRO" is written in bold, sans-serif, uppercase letters. Below "NIPRO", the words "MEDICAL CORPORATION" are written in a smaller font size, also in uppercase letters.
3150 NW 107th Avenue, Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621
OCT 1 8 2012
510(k) Summary – Nipro Huber Needle
(21 CFR 807.92)
| 1. | Submitter: | Nipro Medical CorporationFDA Registration No: 1056186 |
|---|---|---|
| Contact Person:Prepared on: | Jessica Oswald29 June 2012 | |
| 2. | Trade Name: | NIPRO Huber Needle |
| Common Name: | Huber Needle | |
| Classification Name: | Needle, Hypodermic, Single Lumen | |
| Classification Code: | FMI (per 21 CFR 880.5570)Class II | |
| 3. | Predicate Device: | EXEL Huber Needle (K895769) |
ব: Device Description:
This device consists of a cannula affixed to a hub with a needle cap. Both straight and 900 angled types are available.
5. Indication for Use:
·
This device is intended for administration of drug solutions, or blood sampling into or from a Reservoir implanted in the body.
6. Technological Characteristics
The basic structure of the device consists of a needle hub and needle cap. The needle is either bent at a 90° angle and is available in gauges 19, 20 and in lengths of ¾" - 1 ½" or straight type and is available in gauges 19, 20 and 22 and in lengths 1" – 1 ½ ".
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7. Performance Testing
. .
·Testing of the NIPRO Huber Needle 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 certainother 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 |
NIPRO Huber Needle successfully met the requirements for these standards. In addition, it met or exceeded the acceptance criteria for the following performance tests:
| Performance Tests | Specification |
|---|---|
| Stiffness Test | Must conform to ISO 9626(SU = 0.55 mm) |
| Bending Breakage Resistance Test | Must conform to ISO 9626(Shall not break) |
| Elasticity | Must conform to JIS T 3209(Shall go back to the original position) |
| Bending Strength | Must conform to JIS T 3209(Shall not break) |
| Corrosive Resistance | Must conform to ISO 9626(No corrosion shall be allowed) |
| Cannula Dirt Test | Must conform to the internal test(No dirt shall be allowed) |
| Coring Test | Must conform to FDA Coring TestMethod (No coring shall occur |
・
NIPRO Huber Needle
.
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| Performance Tests | Specification | |
|---|---|---|
| Cannula/Hubmeasurement | adhesive strength | 19G: ≥ 69 N20G: ≥ 54 N22G: ≥ 34 N |
| Popping needle tip inspection | No sound of puncture popping noise. | |
| Test for particulate matter | Contamination Index $i$ = Na - Nb 90 | |
| Transportation Testing | Withstand distribution environment |
8. Substantial Equivalence
The NIPRO Huber Needle are identical in physical properties, materials, configurations and having the same intended use as the predicate device (i.e., the original EXEL Huber Needle [K895769]). Although the manufacturing process for the needle bevel has been modified, performance testing shows that the performance of the new NIPRO Huber Needle 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 | NIPRO Huber Needle | PredicateEXEL Huber Needle | ||
|---|---|---|---|---|
| Physical and Material | ||||
| Needle | Components | Materials | Components | Materials |
| Cannula | Stainless Steel | Cannula | Stainless Steel | |
| Hub | PP | Hub | PP | |
| Needle Cap (Bent Needle) | PVC | Needle Tube Cap | PVC | |
| Needle Cap(Straight Needle) | PP | Needle Cap(Straight Needle) | PP | |
| Instructions for Use | Same | Same | ||
| Operational | ||||
| Device Type | Standard non-coring Huber needle | Same | ||
| Biological | Biocompatibility tests were performed according to ISO 10993 Parts 4, 5, 10 and 11 as a prolonged duration, indirect blood path contacting device. | Same | ||
| Sterilization Method | Ethylene oxide | Same |
PVC:polyvinyl chloride
PP: polypropylene
NIPRO Huber Needle
-5.3-
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nipro Medical Corporation
Ms. Jessica Oswald-McLeod
Regulatory Affairs
3150 North West 107$^{TH}$ Avenue
Miami, Florida 33172
OCT 1 8 2012
Re: K113469
Trade/Device Name: Nipro Huber Needle/EXEL Huber Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 10, 2012 Received: October 11, 2012
Dear Ms. Oswald-McLeod:
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.
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Page 2- Ms. Oswald-McLeod
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,
A. 14. 2023
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 (if known): K113469
Device Name: NIPRO Huber Needle/EXEL Huber Needle
Indications for Use:
This device is intended for administration of drug solutions, or blood sampling into or from a Reservoir implanted in the body.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
th Ch 10/17/12
(Division Sign-Off)
Division of Anestheslology, General Hospital
Clivision of Anestheslology, General Devices Division of Anesthesions of Anesthesion of Antection Control, Infection Control,
510(k) Number: K 11376
Page 1 of 1
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).