NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
Device Facts
| Record ID | K113471 |
|---|---|
| Device Name | NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET |
| Applicant | Nipro Medical Corporation |
| Product Code | FPA · General Hospital |
| Decision Date | Oct 18, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
This device is intended for administration of drug solution, or blood sampling into/from a Reservoir implanted in the body.
Device Story
Nipro Huber Infusion Set is a non-coring Huber needle and administration set used to access surgically implanted subcutaneous vascular ports. The device consists of a 90-degree bent stainless steel cannula, rotating wings, clamp, tubing, and luer connector; available in 19G, 20G, and 22G sizes. It is used by healthcare professionals in clinical settings for fluid/drug infusion and blood sampling. The needle is inserted into the port reservoir; the non-coring design prevents damage to the septum. The device facilitates secure vascular access, allowing for controlled delivery of medications or withdrawal of blood samples. It is a single-use, sterile, disposable device.
Clinical Evidence
Bench testing only. Testing included flow rate, air leakage, pressure endurance, cannula/hub adhesive strength, popping needle tip inspection, tensile strength, particulate matter, and transportation testing. Biocompatibility testing was performed per ISO 10993 (parts 4, 5, 10, 11) for a prolonged duration, indirect blood path contacting device. Sterilization validation performed per ISO 11135-1.
Technological Characteristics
Materials: Stainless steel (cannula), PVC, PE, PC, POM, PP, isoprene rubber. Components: Cannula, rotating wings, clamp, tube, luer connector, optional Y-tube/injection plug. Energy: None (manual). Connectivity: None. Sterilization: Ethylene oxide. Standards: ISO 8536-4, ISO 10555-3, ISO 7864, ISO 594-1, ISO 10993 series, JIS T3221.
Indications for Use
Indicated for patients requiring administration of drug solutions or blood sampling via a surgically implanted subcutaneous vascular reservoir/port.
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 Huber Infusion Set (K895770)
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 infinity symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. Below "NIPRO" is the text "MEDICAL CORPORATION" in a smaller, sans-serif font. The logo is black and white.
3150 NW 107" Avenue, Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621
K 113471
# 510(k) Summary - NIPRO Huber Infusion Set
(21 CFR 807.92)
OCT 1 8 2012
| 1. | Submitter: | Nipro Medical Corporation<br>FDA Registration No: 1056186 |
|----|----------------------|-----------------------------------------------------------|
| | Contact Person: | Jessica Oswald |
| | Prepared on: | 21 November 2011 |
| 2. | Trade Name: | NIPRO 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 Huber Infusion Set (K895770) |
#### 4. Device Description:
The Nipro Huber Infusion Set is a standard non-coring Huber type needle and administration set. 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 device is intended for administration of drug solution, or blood sampling into/from a Reservoir implanted in the body.
#### 6. Technological Characteristics
The basic structure of the device consists of a cannula, fixing rotating wings, a clamp, tube and luer connector. This device is also available with Y- tube and a injection plug. The needle is bent at a 90° angle and is available in gauges 19, 20 and 22 and in lengths of ¾ " - 1 ½".
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### 7. Performance Testing
Testing of the NIPRO Huber Needle Infusion Set was completed in conformance with the
following standards: 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 |
| 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.
In addition, it met or exceeded the acceptance criteria for the follow in the follow In addition, it met or infasion set saccessfully hier the requirements for these standards.
In addition, it met or exceeded the acceptance criteria for the following performa
| Performance Test Name | Acceptance Criteria |
|-------------------------------------|--------------------------------------------------------------------------------------------------------|
| 1. 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 |
| 2. Air leakage – pressure endurance | Must show no signs of air leakage of<br>50 [kPa] for 15 seconds. |
| 3. Set Leakage – Endurance test | With y-site: 1.8MPa Without y-site:<br>3.7MPa |
NIPRO Huber Infusion Set
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| Performance Test Name | Acceptance Criteria |
|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| 4. Wrapping paper leakage | Must not leak under the condition of 1.1[kPa] for 10 seconds. |
| 5. Cannula/Hub adhesive strength<br>measurement | 19G: ≥ 69 N<br>20G: ≥ 54 N<br>22G: ≥ 34 N<br>24G: ≥ 22 N |
| 6. Popping needle tip inspection | No sound of puncture popping noise. |
| 7. Tensile<br>Adhesive strength<br>a. Hub / tube b. Y connector / tube c. Y connector / tube<br>d. Connecting tube / connector | Must withstand a static tensile force of 15[N] for 15 seconds. |
| 8. Test for particulate matter | Contamination Index $I = Na - Nb 90$ |
| 9. Injection Site (rubber button) | Must show no signs of air leakage of 50 [kPa] for 15 seconds. |
| 10. Transportation Testing | Withstand distribution environment |
#### 8. Substantial Equivalence
The Nipro Huber Infusion Sets are identical in physical properties, materials, configurations and having the same intended use as the predicate device (i.e., the original Exel Huber Infusion Set [K895770]). Although the manufacturing process for the needle bevel has been modified, performance testing shows that the performance of the new Nipro 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.
#### NIPRO Huber Infusion Set
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모두 - 인천 Nipro Huber Infusion Sets
사용 및 서울 대통령 및 공급 업체 및 공급 업체 및 공 Specification, pecification in the Predicate Predicate
القرن المقابل المنتجات المنتجات المتحدة المنتخب المنتجات المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاوم
| Physical and Material | | | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------|-----------------|
| Needle | Components | Materials | Components | Materials |
| | Cannula | Stainless Steel | Cannula | Stainless Steel |
| | Protector | PVC | Protector | PC |
| Wing Unit | AVF Rotary Hub | PVC | AVF Rotary Hub | PVC |
| | AVF Rotary Wing | PE | AVF Rotary Wing | PE |
| | Joint Tube | PVC | Joint Tube | PVC |
| Tube | Tube | PVC | Tube | PVC |
| | Y Tube | PC | Y Tube | PC |
| Connector | Rubber Button | 1R | Rubber Button | 1R |
| | Rubber Button | PVC | Rubber Button | PVC |
| | Cap | | Cap | |
| | Mini Clamp C | POM | Mini Clamp C | POM |
| | 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 | Type A: Y-site with rubber button | | Type A: Y-site with rubber button | |
| Configurations | 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 | | Same | |
| 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 ﻧ
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### NIPRO Huber Infusion Set
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 18 2012
Nipro Medical Corporation Ms. Jessica Oswald-McLeod Regulatory Affairs 3150 North West 107TH Avenue Miami. Florida 33172
Re: K113471
Trade/Device Name: Nipro Huber Infusion Set, Excel 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-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,
Anthony Imer
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): K113471
Device Name: NIPRO Huber Infusion Set /EXEL Huber Infusion Set
Indications for Use:
This device is intended for administration of drug solution, or blood sampling into/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)
Rldi Cl 10/17/12
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, Gental Devices
Confestion Control, Dental Devices (Division of Anesthesion of Anesthesion of Antess
Infection Control, Dental Demices of Antestion Coontrol, Infection Coontrol
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510(k) Number
