K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE

K110527 · Terumo Europe N.V. · FMI · Jun 6, 2011 · General Hospital

Device Facts

• Record ID: K110527
• Device Name: K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
• Applicant: Terumo Europe N.V.
• Product Code: FMI · General Hospital
• Decision Date: Jun 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K-Pack Surshield™ Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection as well as for injection in infusion lines.

Device Story

K-Pack Surshield™ Needle is a sterile, single-use hypodermic needle featuring a passive sharps protection mechanism. Device consists of a stainless steel cannula attached to a polypropylene female luer hub. Designed for use with standard piston syringes for subcutaneous/intramuscular injections or infusion line access. Passive safety feature automatically and permanently covers the cannula post-use to prevent needlestick injuries. Visual indicator (light blue) confirms readiness; absence of color indicates locked safety state. Used in clinical settings by healthcare professionals. Benefits include reduced risk of accidental sharps injury to the operator.

Clinical Evidence

Bench testing only. Verification activities included cleanliness, acidity/alkalinity, extractable metals, size designation, color coding, conical fitting, effective length, lubrication, needle point sharpness, bonding strength, lumen patency, flow rate, and safety feature activation/challenge forces. All tests met acceptance criteria per EN ISO 7864 and ISO/FDIS 23908.

Technological Characteristics

Stainless steel cannula; polypropylene hub. 6% luer taper (ISO 594-1/2). Passive sharps protection mechanism. Sterilized via Ethylene Oxide (EN ISO 11135-1). Biocompatibility tested per ISO 10993. Lubricated with silicone (max 0.25 mg/cm²).

Indications for Use

Indicated for patients requiring subcutaneous or intramuscular injections or injections into infusion lines. No specific age or gender restrictions. Contraindications not specified.

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

• NovoFine® Autocover® 30G x 8 mm (K050106)
• Terumo Surguard®2 Safety Needle (K051865)

Submission Summary (Full Text)

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JUN - 6 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/:<br>Contact Person | Mrs. M.J. Aerts - Manager Regulatory Affairs<br>Tel. [phone]<br>Fax [phone] |
| Date prepared: | February 2011 |

#### II.1. Device Name

#### Proprietary Name

K-Pack Surshield™ Needle

Classification Name Hypodermic Single Lumen Needle 21CFR, Section 880.5570 Classification: Class II

## II.2. Reason for Submission

New Device

#### II.3. Intended Use

The K-Pack Surshield™ Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection as well as for injection in infusion lines.

## II.4. Description

The 25G K-Pack Surshield™ Needle is a hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe. Furthermore the needle has a passive sharps protection feature that covers the cannula immediately and permanently after use. The K-Pack Surshield™ Needle is packed in a hard pack (cap - case) which is sealed with a perforated self-adhesive paper label.

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## · II.5. Substantial Equivalence

The "K-Pack Surshield", Needle", manufactured by Terumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following cleared devices:

- 1. NovoFine® Autocover® 30G x 8 mm (K050106) manufactured by Novo Nordisk inc., used as predicate for the sharps protection feature.
- 2. Terumo Surguard®2 Safety Needle (K051865) manufactured by Terumo Philippines Corporation, used as predicate for the functionality of the needle. The difference between this predicate and the proposed device is that the proposed device contains a passive sharps protection feature while the predicate contains an active sharps protection feature.

Any 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 K-Pack Surhield™ Needle 25G x 5/8" - 0.5 x 16 mm in accordance with EN ISO 7864 (1995) and ISO/FDIS 23908 (2010). Summary of the verification activities including acceptance criteria is given in the table below:

| TEST | ACCEPTANCE CRITERIA |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Cleanliness | Inspected by normal or corrected-to-normal vision without magnification under<br>an illuminance of 300 lx, the surface of the hypodermic needle tube shall appear<br>free from particles and extraneous matter.<br>When examined under x2.5 magnification, the hub socket shall appear free<br>from particles and extraneous matter. |
| 2. Limits for acidity or alkalinity | A 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 K-Pack Surshield Needles has a content of<br>extractable metals which is, when corrected for the metal content of the control<br>fluid:<br>$\u03a3$ 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/-2 mm |
| 8. Lubricant | Needles are uniformly lubricated and the silicone is not visible as droplets on<br>the outside surface of the needle, the quantity will not exceed 0.25 mg/cm² |
| 9. Needle point | The needle point of the K-Pack Surshield Needles is in the center of the bevel,<br>is sharp and is free from extraneous matter, burr, edges and hooks. |

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| TEST | ACCEPTANCE CRITERIA |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| 10. Bonding strength<br>between hub and cannula | The bonding strength between hub and cannula for this K-Pack Surshield<br>Needle is $\ge$ 22N. |
| 11. Patency of lumen | A stylet with a diameter of 0.23 mm is passing through the needle. |
| 12. Flow rate | The flow rate for this needle is 3.0 ml/min. |
| 13. Visual marking indicating<br>status of safety feature | Visual indication :<br>Light blue = Ready for use<br>No colour = Shield already locked |
| 14. Forces for activating the<br>sharps injury protection<br>feature | The force to activate the safety feature of the device is maximum 2.16 N.<br>The force during use of the device is maximum 3.20 N. |
| 15. Forces for challenging the<br>safety feature | Once in the safe mode, the safety feature shall withstand 10 cycles of a<br>minimum overriding force of 80 N. |
| 16. Challenging the safety feature<br>once in safe mode | Once in safe mode, the cannula tip cannot be accessed when the device is<br>stressed during a 10 cycle procedure of minimum 80 N compressive load. |

# 11.7. Additional Safety Information

The sterility of the K-Pack Surshield 100 Needle is assured by using a validated sterilization method qualified in accordance with EN ISO 11135-1:2007 "Sterilization of health care products – Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" 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 K-Pack Surshield™ Needle is an External Communicating Device, that can contact tissue, bone or dentine or that can indirectly contact the blood path. Limited Exposure (≤ 24 hrs). The devices' 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, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing".

The expiration dating for the K-Pack Surshield™ Needle has been established at 5 years.

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# II.8. Conclusion

The K-Pack Surshield™ Needle manufactured by Terumo Europe N.V. and submitted in this 51(k) file is substantially equivalent in intended use, descriptions, and technology/principles of operation, materials and performance to the following cleared devices:

- 1. NovoFine® Autocover® 30G x 8 mm (K050106) manufactured by Novo Nordisk inc., which is used as predicate for the sharps protection feature.
- 2. Terumo Surguard®2 Safety Needle (K051865) manufactured by Terumo Philippines Corporation, which is used as predicate for the functionality of the needle. The difference between this predicate and the proposed device is that the proposed device contains a passive sharps protection feature and the predicate an active sharps protection feature.

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

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

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

Re: K110527

Trade/Device Name: K-Pack SurshieldTM Needle, Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 2, 2011 JUN - 6 2011 Received: May 6, 2011

Dear Ms. 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- Ms. 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 (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/ ucm 1 15809.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,

Anthony D. Mure

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 Surshield™ Needle

Indication For Use:

The K-Pack Surshield™ Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection as well as for injection in infusion lines.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off 6/2/4

Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K110527

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