NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE

K113469 · Nipro Medical Corporation · FMI · Oct 18, 2012 · General Hospital

Device Facts

• Record ID: K113469
• Device Name: NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
• Applicant: Nipro Medical Corporation
• Product Code: FMI · General Hospital
• Decision Date: Oct 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

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

Device Story

NIPRO Huber Needle is a single-lumen hypodermic needle designed for accessing implanted reservoirs. Available in straight or 90° angled configurations; gauges 19, 20, and 22; lengths 3/4" to 1 1/2". Device consists of a stainless steel cannula, polypropylene hub, and needle cap (PVC for bent, PP for straight). Used by healthcare professionals in clinical settings to deliver medications or withdraw blood samples. Operates by manual insertion into an implanted reservoir. Performance features include non-coring design to maintain reservoir integrity. Benefits include reliable access to implanted ports for therapeutic administration or diagnostic sampling.

Clinical Evidence

Bench testing only. Testing included stiffness, bending breakage resistance, elasticity, bending strength, corrosion resistance, cannula dirt, and coring tests. Biocompatibility testing performed per ISO 10993 (parts 4, 5, 10, 11). Sterilization validated per ISO 11135-1 and IAEA-TECDOC-539. All tests met or exceeded specified acceptance criteria.

Technological Characteristics

Stainless steel cannula; polypropylene (PP) hub; PVC (bent) or PP (straight) needle cap. 19G, 20G, 22G gauges; 3/4"-1 1/2" lengths. Manual operation. Ethylene oxide sterilization. Conforms to ISO 8536-4, ISO 10555-3, ISO 7864, ISO 594-1, ISO 9626, and JIS T 3209 standards.

Indications for Use

Indicated for administration of drug solutions or blood sampling into or from an implanted reservoir in patients requiring such access.

Regulatory Classification

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.

Predicate Devices

• EXEL Huber Needle (K895769)

Submission Summary (Full Text)

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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<br>FDA Registration No: 1056186 |
|----|---------------------------------|-----------------------------------------------------------|
| | Contact Person:<br>Prepared on: | Jessica Oswald<br>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)<br>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,<br>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<br>other medical equipment - Part 1:General requirements |
| ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1:<br>Requirements for the development, validation, and routine control of a<br>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<br>Interaction with Blood |
| ISO 10993-10:2002 | Biological Evaluation of Medical Devices - Test for Irritation and<br>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<br>Products (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<br>(SU = 0.55 mm) |
| Bending Breakage Resistance Test | Must conform to ISO 9626<br>(Shall not break) |
| Elasticity | Must conform to JIS T 3209<br>(Shall go back to the original position) |
| Bending Strength | Must conform to JIS T 3209<br>(Shall not break) |
| Corrosive Resistance | Must conform to ISO 9626<br>(No corrosion shall be allowed) |
| Cannula Dirt Test | Must conform to the internal test<br>(No dirt shall be allowed) |
| Coring Test | Must conform to FDA Coring Test<br>Method (No coring shall occur |

・

NIPRO Huber Needle

.

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| Performance Tests | Specification | |
|-------------------------------|--------------------------------------|-------------------------------------------|
| Cannula/Hub<br>measurement | adhesive strength | 19G: ≥ 69 N<br>20G: ≥ 54 N<br>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<br>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<br>(Straight Needle) | PP | Needle Cap<br>(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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