NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE

• K Number: K113469
• Device Name: NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
• Manufacturer: NIPRO MEDICAL CORPORATION
• Date Cleared: 2012-10-18 ( 331 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

This device is intended for administration of drug solutions, or blood sampling into or from a Reservoir implanted in the body.

Device Description

This device consists of a cannula affixed to a hub with a needle cap. Both straight and 900 angled types are available.

Predicate Devices

K895769

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple mechanical device (a needle) and its performance testing against established standards. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.

Therapeutic

No.
The device is described as a needle for administering drug solutions or blood sampling, which are procedures, not a therapeutic treatment in itself.

Diagnostic

No

The device is described for administration of drug solutions or blood sampling, not for diagnosing conditions or diseases. The performance studies focus on physical properties and material standards, not diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical components (cannula, hub, needle cap) and the performance studies focus on physical properties and testing of these components, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The intended use is for the administration of drug solutions or blood sampling into or from a Reservoir implanted in the body. This involves direct interaction with the patient's body and the delivery or collection of substances in vivo (within a living organism).
• Device Description: The device is described as a needle and hub, designed for accessing an implanted reservoir. This is a medical device used for direct patient care.
• Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. The description and intended use of this device do not involve the analysis of specimens in vitro.

Therefore, this device falls under the category of a general medical device used for patient treatment and/or sample collection in vivo, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is intended for administration of drug solutions, or blood sampling into or from a Reservoir implanted in the body.

Product codes

FMI

Device Description

This device consists of a cannula affixed to a hub with a needle cap. Both straight and 900 angled types are available.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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 Test Method (No coring shall occur
Cannula/Hub measurement adhesive strength	19G: (>=) 69 N; 20G: (>=) 54 N; 22G: (>=) 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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

EXEL Huber Needle (K895769)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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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: [phone] Fax: [phone]

OCT 1 8 2012

510(k) Summary – Nipro Huber Needle

(21 CFR 807.92)

| 1. | Submitter: | Nipro Medical Corporation
FDA Registration No: 1056186 |
|----|---------------------------------|-----------------------------------------------------------|
| | Contact Person:
Prepared on: | Jessica Oswald
29 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 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 a
sterilization 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 for
Interaction with Blood
ISO 10993-10:2002	Biological Evaluation of Medical Devices - Test for Irritation and
Delayed-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 Medical
Products (Cobalt-60 Gamma Irradiation)
USP 31	Pyrogen Test (USP Rabbit Test)
USP 31	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 Test
Method (No coring shall occur

・

NIPRO Huber Needle

.

2

Performance Tests	Specification
Cannula/Hub
measurement	adhesive strength	19G: ≥ 69 N
20G: ≥ 54 N
22G: ≥ 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 | | Predicate
EXEL 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 [phone] or [phone] 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

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