K-PACK II NEEDLE- 27G & 30G THIN WALL

K110850 · Terumo Europe N.V. · FMI · Jun 9, 2011 · General Hospital

Device Facts

• Record ID: K110850
• Device Name: K-PACK II NEEDLE- 27G & 30G THIN WALL
• Applicant: Terumo Europe N.V.
• Product Code: FMI · General Hospital
• Decision Date: Jun 9, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The 27G & 30G Thin Wall K-Pack II Needles being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Device Story

Sterile, single-use hypodermic needle; consists of stainless steel cannula sharpened at one end and joined to a polypropylene female luer hub. Designed for connection to male luer nozzle of piston syringes. Used by clinicians to inject or withdraw fluids below skin surface. Thin-wall design allows for specific gauge requirements. Verification includes cleanliness, acidity/alkalinity, extractable metals, color coding, conical fitting, length, lubrication, point sharpness, bonding strength, lumen patency, and flow rate. Sterilized via ethylene oxide.

Clinical Evidence

Bench testing only. Verification performed per EN ISO 7864 (1995) including cleanliness, extractable metals, conical fitting (ISO 594-1/2), bonding strength (≥ 22N), lumen patency, and flow rate. Biocompatibility evaluated per ISO 10993-1. Sterilization validated per EN ISO 11135.

Technological Characteristics

Stainless steel cannula; polypropylene hub. 6% luer taper (ISO 594-1/2). Color coding per ISO 6009. Lubricated with silicone (≤ 0.25 mg/cm2). Sterilization: Ethylene oxide (EN ISO 11135). Externally communicating, blood-contacting, limited exposure (≤ 24 hrs).

Indications for Use

Indicated for use as a hypodermic single lumen needle for the injection of fluids into, or withdrawal of fluids from, the body below the skin surface. Intended for single use.

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

• K-Pack II Needles (K984576)
• Neolus Needles (K001572)
• 29 Gauge & 30 Gauge K-Pack II Needles (K062608)
• 29 Gauge K-Pack II Needle Thin Wall (K082820)

Submission Summary (Full Text)

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110850

JUN - 9 2011

# 510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information

#### Submitter information

| Prepared for: | TERUMO EUROPE N.V.<br>Interleuvenlaan 40,<br>3001 Leuven,<br>BELGIUM |
|-----------------------------|-------------------------------------------------------------------------------------------------|
| Prepared by/Contact person: | Mrs. M.J. Aerts – Manager Regulatory Affairs<br>Tel. [phone]<br>Fax [phone] |
| Date prepared: | March 2011 |

II.1. Device Name

# Proprietary Name K-Pack II Needle - 27G & 30G Thin Wall Classification Name Hypodermic Single Lumen Needle 21CFR, Section 880.5570 Classification: Class II

## II.2. Reason for Submission

This 510k is being submitted to extend the cleared K-Pack II Needle (K984576) product line.

The cannula wall of these 27G & 30G needles is thinner than what is currently cleared under the 510k K984576 and 510k K001572 for the 27 Gauge needle and under the 510k K062608 for the 30 Gauge needle.

Please note that the 27 Gauge needle size was added to 510k K984576 through internal documentation as specified under 510(k) Memorandum #K97-1 "Deciding When to Submit a 510(k) for a Change to an Existing Device". It was concluded that the addition of the 27 Gauge size did not significantly affect the safety or effectiveness of the device and therefore no 510(k) was submitted.

The 30G Thin Wall K-Pack II Needle can also be packaged in a short case instead of a long one as cleared under 510k K062608.

The thinner needle and the shorter case were cleared for a 29 Gauge needle under the 510k K082820 and the shorter case was cleared for the 27 Gauge needle under the 510k K984576 (internal documentation).

This Special 510k is therefore being submitted due to potential issues of safety and effectiveness specific for a thinner wall needle for the 27 and 30 Gauge needle.

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This 510k will provide supporting information that the 27G & 30G Thin Wall K-Pack II Needles are safe and effective and an acceptable extension of the current K-Pack II Needle product line.

#### II.3. Intended Use

The 27G & 30G Thin Wall K-Pack II Needles being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Note: This is the same intended use as the predicate devices, K-Pack II Needle - K984576, Neolus Needle - K001572, 29G & 30G K-Pack II Needle - K062608 and 29G K-Pack II Needle Thin Wall - K082820.

#### II.4. Description

The 27G & 30G Thin Wall K-Pack II Needles are sterile hypodermic single lumen needles, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end ioined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.

#### II.5. Substantial Equivalence

The 27G & 30G Thin Wall K-Pack II Needles are substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:

- K-Pack II Needles (K984576) 1.
- 2. Neolus Needles (K001572)
- 29 Gauge & 30 Gauge K- Pack II Needles (K062608) 3.
- 29 Gauge K-Pack II Needle Thin Wall (K082820) 4.

Differences between the devices do not raise any significant issues of safety and effectiveness.

#### II.6. Summary of Verification Activities

All necessary verification and validation tests have been performed by testing the 27G & 30G Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995). Summary of the verification activities including acceptance criteria is given in the table below:

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| TEST | ACCEPTANCE CRITERIA |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Cleanliness | Inspected by normal or corrected-to-normal vision without magnification under an<br>illuminance of 300 lx, the surface of the hypodermic needle tube shall appear free from<br>particles and extraneous matter.<br>When examined under x2.5 magnification, the hub socket shall appear free from<br>particles and extraneous matter. |
| 2. Limits for acidity or alkalinity | Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. |
| 3. Limits for extractable metals | The extract solution of the 27G & 30G Thin Wall K-Pack II Needles has a content of<br>extractable metals which is, when corrected for the metal content of the control fluid:<br>$Σ Pb, Sn, Zn, Fe ≤ 5 mg/l$<br>Cd < 0.1 mg/l |
| 4. Size designation | Outside diameter and nominal length are expressed in mm (and G x ") |
| 5. Colour coding | Hub and label are colour coded following ISO 6009 |
| 6. Conical fitting | 6% luer taper, compliant with requirements of ISO 594-1 and ISO 594-2 |
| 7. Effective needle length | The effective length = nominal length + 1 mm $\pm$ 2 mm |
| 8. Lubricant | Needles are uniformly lubricated and the silicone is not visible as droplets on the<br>outside surface of the needle, the quantity will not exceed 0.25 mg/cm2 |
| 9. Needle point | The needle point of the 27G & 30G Thin Wall K-Pack II Needles is in the center of the<br>bevel, is sharp and is free from extraneous matter, burr, edges and hooks. |
| 10. Bonding strength between<br>hub and cannula | The bonding strength between hub and cannula is ≥ 22N. |
| 11. Patency of lumen | 27G: A stylet with a diameter of 0.19 mm is passing through the needle.<br>30G: A stylet with a diameter of 0.13 mm is passing through the needle. |
| 12. Flow rate | 27G: ≥ 2.72 and ≤ 4.25 ml/min<br>30G: ≥ 0.73 and ≤1.14 ml/min |

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#### II.7. Additional Safety Information

The sterility of the 27G & 30G Thin Wall K-Pack II Needles is assured by using a validated sterilization method qualified in accordance with EN ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 10° as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices".

Ethylene oxide residual levels resulting from EtO sterilization are in compliance with EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals"

The 27G & 30G Thin Wall K-Pack II Needle, like the standard K-Pack II Needle (K984576), is an Externally Communicating device, Contacting Circulating Blood, Limited Exposure (≤ 24 hrs). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing".

The expiration dating for the 27G & 30G Thin Wall K-Pack II Needles has been established at 5 years which is the same as the cleared K-Pack II Needles.

Il.8. Conclusion

In summary, the 27G & 30G Thin Wall K-Pack II Needles are substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:

- K-Pack II Needles (K984576) 1.
- Neolus Needles (K001572) 2.
- 3. 29 Gauge & 30 Gauge K- Pack II Needles (K062608)
- 29 Gauge K-Pack II Needle Thin Wall (K082820) 4.

Differences between the devices do not raise any new issues of safety or effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 wing and tail feathers. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mrs. M.J. Aerts Regulatory Affairs Manager Terumo Europe N.V. Interleuvenlaan 40 Leuven Belgium 3001

JUN - 9 2011

Re: K110850

Trade/Device Name: K-Park II Needle-27G & 30G Thin Wall Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May26, 2011 Received: May 27, 2011

Dear Mrs. Aerts:

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- Mrs. Aerts

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 (OS) 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/SafetyReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nh for

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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# Indication for Use

510(k) Number (if known):

Device Name: K-Pack II Needle - 27G & 30G Thin Wall Indication For Use:

The 27G & 30G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D) Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nuhul Alha ACTING for
RICHARD CHAPMAN

(Division Sign-91) (Crision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Numbe

510(k) Number: _______________________________________________________________________________________________________________________________________________________________