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.

Device Description

The 27G 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.

AI/ML Overview

The manufacturer of the 27G x ½" K-Pack Surshield™ Needle established acceptance criteria and performed verification activities to prove its compliance.

1. Table of Acceptance Criteria and Reported Device Performance (Summary of Verification Activities):

TEST	ACCEPTANCE CRITERIA	Reported Device Performance*
1. Cleanliness	Inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under x2.5 magnification, the hub socket shall appear free from particles and extraneous matter.	The device met the acceptance criteria. (Implied by the submission of the 510(k) and general statement "All necessary verification and validation tests have been performed..." - Specific numerical results are not provided in the document for each test).
2. Limits for acidity or alkalinity	A pH for K-Pack Needles extract solution is within 1 unit of the control fluid.	The device met the acceptance criteria.
3. Limits for extractable metals	The extract solution of the K-Pack Surshield Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\sum$ Pb, Sn, Zn, Fe $\le$ 5 mg/l; Cd < 0.1 mg/l.	The device met the acceptance criteria.
4. Size designation	Outside diameter and nominal length are expressed in mm (and G x ").	The device met the acceptance criteria.
5. Colour coding	Hub and label are colour coded following ISO 6009.	The device met the acceptance criteria.
6. Conical fitting	6% luer taper, compliant with requirements of ISO 594-1 and ISO 594-2.	The device met the acceptance criteria.
7. Effective needle length	The effective length = nominal length + 1 mm/-2 mm.	The device met the acceptance criteria.
8. Lubricant	Needles are uniformly lubricated and the silicone is not visible as droplets on the outside surface of the needle, the quantity will not exceed 0.25 mg/cm².	The device met the acceptance criteria.
9. Needle point	The needle point of the K-Pack Surshield Needles is in the center of the bevel, is sharp and is free from extraneous matter, burr, edges and hooks.	The device met the acceptance criteria.
10. Bonding strength between hub and cannula	The bonding strength between hub and cannula for this K-Pack Surshield Needle is $\ge$ 22N.	The device met the acceptance criteria.
11. Patency of lumen	A stylet with a diameter of 0.15 mm is passing through the needle.	The device met the acceptance criteria.
12. Flow rate	The flow rate for this needle is 0.82 ml/min.	The device met the acceptance criteria.
13. Visual marking indicating status of safety feature	Visual indication: Light blue = Ready for use; No colour = Shield already locked.	The device met the acceptance criteria.
14. Forces for activating the sharps injury protection feature	The force to activate the safety feature of the device is maximum 2.16 N. The force during use of the device is maximum 3.20 N.	The device met the acceptance criteria.
15. Forces for challenging the safety feature	Once in the safe mode, the safety feature shall withstand 10 cycles of a minimum overriding force of 80 N.	The device met the acceptance criteria.
16. Challenging the safety feature once in safe mode	Once in safe mode, the cannula tip cannot be accessed when the device is stressed during a 10 cycle procedure of minimum 80 N compressive load.	The device met the acceptance criteria.

Note: The document states "All necessary verification and validation tests have been performed by testing the K-Pack Surhiela™ Needle 27G x 1/2" - 0.4 x 12 mm in accordance with EN ISO 7864 (1995) and ISO 23908 (2011)." and "Summary of the verification activities including acceptance criteria is given in the table below." This implies that the device met all stated acceptance criteria, although specific numerical results for each test are not explicitly enumerated as "reported device performance."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the sample size (number of units tested) for each specific test. However, it indicates that "All necessary verification and validation tests have been performed."
Data Provenance: The tests were performed in accordance with international standards EN ISO 7864 (1995) and ISO 23908 (2011). The manufacturing and submission of the device are from Terumo Europe N.V. in Belgium. The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This document describes performance testing for a medical device (hypodermic needle) against engineering and material standards, not an AI/imaging diagnostic device. Therefore, the concept of "ground truth established by experts" in the context of diagnostic interpretation is not applicable here. The "ground truth" for these tests is defined by the objective, quantifiable acceptance criteria established by the relevant ISO and EN standards.

4. Adjudication Method for the Test Set:

Not applicable. This is not an adjudicative process for diagnostic interpretation but direct measurement and inspection against predefined engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, not for the performance testing of a hypodermic needle.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This is not an algorithm-based device. The "performance" described refers to the physical and functional characteristics of the needle itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests used here are the objective, quantifiable specifications and limits defined by international standards (EN ISO 7864, ISO 23908, ISO 6009, ISO 594-1, ISO 594-2, EN ISO 11135-1, EN 556-1, EN ISO 10993-7). These are engineering and material science standards for hypodermic needles. For biological evaluation, the ground truth is against the recommendations in FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as a training set is not part of this device's development or validation.

Summary

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K 111794

SEP 2 2 2011

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

Submitter information

Prepared for:	TERUMO EUROPE N.V.Interleuvenlaan 403001 LeuvenBELGIUM
Prepared by/ :Contact Person	Mrs. M.J. Aerts - Manager Regulatory AffairsTel. (+32) 16 38 13 53Fax (+32) 16 40 02 49
Date prepared:	June 2011

II.1. Device Name

Proprietary Name

27G x ½" K-Pack Surshield™ Needle

Classification Name

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

11.2. Reason for Submission

This premarket notification [510(k)] is being submitted for the 27G x 1/2' K-Pack Surshield '10 Needle which is an addition to the existing K-Pack Surshield™ Needle manufactured by Terumo Europe N.V. The size of the 27G x 1/2" needle is smaller than what is currently cleared under the 25 G x 5/8" K-Pack Surshield™ Needle (K 110527). The proposed 27G x ½³ K-Pack Surshield™ Needle has a regular wall and the cleared predicated device 25 G x 5/8" K-Pack Surshield 100 Needle has a thin wall. This Special 510k is being submitted because of potential issues of safety and effectiveness specific for a smaller needle with a regular wall. This 510k will provide supporting information that the 27G x 1/2" K-Pack Surshield" Needle is safe and effective and an acceptable addition to the existing K-Pack SurshieldTM Needle.

II.3. Intended Use

A single use injection needle with an integrated passive sharps protection feature designed to reduce needle stick injury and to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection.

11.4. Description

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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.

II.5. Substantial Equivalence

The "27 G x 1/2" 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: - 25G x 5/8" K-Pack Surshield™ Needle (K110527)

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 Surhiela™ Needle 27G x 1/2" - 0.4 x 12 mm in accordance with EN ISO 7864 (1995) and ISO 23908 (2011). 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 underan illuminance of 300 lx, the surface of the hypodermic needle tube shall appearfree from particles and extraneous matter.When examined under x2.5 magnification, the hub socket shall appear free fromparticles 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 ofextractable metals which is, when corrected for the metal content of the controlfluid:$Σ$ Pb, Sn, Zn, Fe ≤ 5 mg/lCd < 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 theoutside 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, issharp and is free from extraneous matter, burr, edges and hooks.

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TEST	ACCEPTANCE CRITERIA
10. Bonding strengthbetween hub and cannula	The bonding strength between hub and cannula for this K-Pack SurshieldNeedle is $\geq$ 22N.
11. Patency of lumen	A stylet with a diameter of 0.15 mm is passing through the needle.
12. Flow rate	The flow rate for this needle is 0.82 ml/min.
13. Visual marking indicatingstatus of safety feature	Visual indication :Light blue = Ready for useNo colour = Shield already locked
14. Forces for activating thesharps injury protectionfeature	The force to activate the safety feature of the device is maximum 2.16 N.The force during use of the device is maximum 3.20 N.
15. Forces for challenging thesafety feature	Once in the safe mode, the safety feature shall withstand 10 cycles of aminimum overriding force of 80 N.
16. Challenging the safety featureonce in safe mode	Once in safe mode, the cannula tip cannot be accessed when the device isstressed during a 10 cycle procedure of minimum 80 N compressive load.

II.7. Additional Safety Information

The sterility of the 27G x ½2" K-Pack Surshield™ 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: Reguirement, validation and routine control of a sterilization process for medical devices" to a sterility assurance level (SAL) of 10th 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 x 1/2" 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 27G x 1/2" K-Pack Surshield " Needle has been established at 5 years.

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II.8. Conclusion

The 27G x ½" K-Pack Surshield™ Needle manufactured by Terumo Europe N.V. and submitted in this 510(k) file is substantially equivalent in intended use, description, specifications, and technology/principles of operation, materials and performance to the following cleared devices: - 25G x 5/8" K-Pack Surshield™ Needle (K110527)

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 U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a person with outstretched arms.

Public Health Service

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

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

SEP 2 2 2011

Re: K111797

Trade/Device Name: 27 G x ½ * K-Pack Surshield ™Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 24. 2011 Received: August 29, 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53) -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-live 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 D. matt

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): K/11797

Device Name: 27 G x ½" K-Pack Surshield™ Needle

Indication For Use:

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)

9/22/11

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

510(k) Number: K111797

Page 1 of 1

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).