NIPRO SAFE TOUCH HUBER INFUSION SET

K113470 · Nipro Medical Corporation · FPA · Oct 17, 2012 · General Hospital

Device Facts

• Record ID: K113470
• Device Name: NIPRO SAFE TOUCH HUBER INFUSION SET
• Applicant: Nipro Medical Corporation
• Product Code: FPA · General Hospital
• Decision Date: Oct 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

NIPRO SafeTouch Huber Infusion Set is a non-coring Huber needle and administration set for accessing surgically implanted subcutaneous vascular ports; used for fluid/drug infusion and blood sampling. Device features integrated, non-passive safety mechanism; clinician activates by pulling lever on needle hub upward after withdrawal, retracting needle into locking shield. Audible/tactile click confirms activation. Used in clinical settings by healthcare professionals. Safety mechanism protects clinicians from blood-borne pathogens via accidental needlestick injuries. Available in gauges 19-24 and lengths 1/2"-1 1/2"; configurations include Y-site with rubber button, no Y-site, or Y-site with luer lock.

Clinical Evidence

Bench testing only. Device met requirements for ISO 8536-4, ISO 10555-3, ISO 7864, ISO 594-1, ISO 11135-1, ISO 10993 (parts 4, 5, 10, 11), IAEA-TECDOC-539, USP <151>/<161>, JIS T3221, JP15, and ASTM D4169. Performance tests included safety mechanism activation/breakage/deactivation forces, flow rates, air leakage, set leakage, cannula/hub adhesive strength, and particulate matter testing.

Technological Characteristics

Non-coring Huber needle; materials: stainless steel (cannula), PVC (hub/tube/cap), PP (needle cap/wing/luer cap), PC (protector/luer connector), POM (clamp), IR (rubber button). Epoxide/urethane-based adhesives; silicone oil lubricant. Sterilization: Ethylene oxide. Gauges: 19, 20, 22, 24. Lengths: 1/2"-1 1/2". Integrated mechanical safety shield.

Indications for Use

Indicated for administration of fluids/drugs or blood sampling via surgically implanted vascular ports in patients requiring such access. Includes integrated safety mechanism to prevent accidental needlestick injuries.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NIPRO SafeTouch Huber Infusion Set (K081210)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

# 510(k) Summary - NIPRO SafeTouch Huber Infusion Set

(21 CFR 807.92)

| 1. | Submitter: | Nipro Medical Corporation<br>FDA Registration No: 1056186 |
|----|---------------------------------|-----------------------------------------------------------|
| | Contact Person:<br>Prepared on: | Jessica Oswald<br>21 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)<br>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:

- 1. Type A: Y-site with rubber button
- 2. 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:<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 |
| 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 and<br>Systems |

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 activation<br>breakage force | ≥ 25.2 N |
| 3. Safety mechanism deactivation force | Needle breaks before deactivation |
| 4. Flow rate | 19G: 41-52 ml/min<br>20G: 24-38 ml/min<br>22G: 10-15 ml/min<br>24G: 4-6 ml/min<br>Predicate Device 20G |
| 5. Air leakage - pressure endurance | Must show no signs of air leakage<br>50 [kPa] for 15 seconds. |
| 6. Set Leakage - Endurance test | With y-site: 1.8MPa Without y-site:<br>3.7MPa |
| 7. Wrapping paper leakage | Must not leak under the condition of<br>1.1[kPa] for 10 seconds. |
| 8. Cannula/Hub adhesive strength<br>measurement | 19G: ≥ 69 N<br>20G: ≥ 54 N<br>22G: ≥ 34 N<br>24G: ≥ 22 N |
| 9. Popping needle tip inspection | No sound of puncture popping noise. |
| 10. Tensile<br>Adhesive strength<br>a. Hub / tube b. Y connector / tube c. Y<br>connector / tube<br>d. Connecting tube<br>/ connector | Must withstand a static tensile force<br>of 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 leakage<br>50 [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 Injury<br>Prevention | 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 Button<br>Cap. | PVC | Rubber Button<br>Cap | 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 | |
| Available<br>Configurations | 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 for<br>Use | Same | | Same | |
| Operational | | | | |
| Device Type | Standard non-coring Huber needle with<br>an integrated safety mechanism. | | Same | |
| Safety Mechanism | For activation, place one hand on the<br>wings of the SafeTouch Huber Infusion<br>Set to secure the port. With the other<br>hand grasp the lever located on top of<br>the needle hub and pull upward This | | Same | |

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| Specification | 510(k)<br>Nipro SafeTouch Huber Infusion Sets | Predicate<br>Nipro SafeTouch Huber Infusion Sets |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | will remove the needle from the patient<br>and lock the needle into the safety<br>shield. Safety Mechanism activation is<br>verified by an audible or tactile click. | |
| Biological | Biocompatibility tests were performed<br>according to ISO 10993 Parts 4, 5, 10<br>and 11 as a prolonged duration, indirect<br>blood path contacting device. | Same |
| Sterilization<br>Method | 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 [phone] or [phone] 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

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