The 27G x 3/4" 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.

Device Description

The 27G x 3/4" 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 joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the K-Pack II Needle - 27G x ¾" Thin Wall, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device passed all validation activities as indicated by the submission of the 510(k), which implies that the reported device performance met the specified acceptance criteria. The summary states: "All necessary verification and validation tests have been performed by testing the 27G x ½" Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995)."

TEST	ACCEPTANCE CRITERIA	Reported Device Performance (Implied)
1. Cleanliness	Inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 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.	Met Criteria
2. Limits for acidity or alkalinity	Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid.	Met Criteria
3. Limits for extractable metals	The extract solution of the 27G Thin Wall K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid:$Σ$ Pb, Sn, Zn, Fe ≤ 5 mg/lCd < 0.1 mg/l	Met Criteria
4. Size designation	Outside diameter and nominal length are expressed in mm (and G x ")	Met Criteria
5. Colour coding	Hub and label are colour coded following ISO 6009	Met Criteria
6. Conical fitting	6% luer taper, compliant with requirements of ISO 594-1 and ISO 594-2	Met Criteria
7. Effective needle length	The effective length = nominal length + 1 mm/-2 mm	Met 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	Met Criteria
9. Needle point	The needle point of the 27G Thin Wall K-Pack II Needle is in the center of the bevel, is sharp and is free from extraneous matter, burr, edges and hooks.	Met Criteria
10. Bonding strength between hub and cannula	The bonding strength between hub and cannula is ≥ 22N.	Met Criteria
11. Patency of lumen	A stylet with a diameter of 0.19 mm is passing through the needle.	Met Criteria
12. Flow rate	Tolerance on flow rate: between 80% and 125% of nominal value	Met Criteria

Study Details

The provided document describes a submission for a hypodermic single lumen needle. This is a physical medical device, not an AI/software device. Therefore, many of the typical questions related to AI studies (e.g., sample size for AI test sets, data provenance, expert ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this 510(k) submission.

The "study" in this context refers to the verification and validation (V&V) testing performed on the physical needle device itself.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided summary. Device manufacturers typically perform V&V testing on a statistically significant number of samples, but the exact count is not detailed here.
- Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable in the context of physical product testing. The testing was conducted by Terumo Europe N.V., presumably in their facilities or by contracted labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a physical device like a needle is based on objective measurements and established engineering/medical device standards (e.g., EN ISO 7864 for hypodermic needles, ISO 594 for luer fittings). There isn't a "ground truth" established by human experts in the way it applies to AI diagnostic outputs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in AI or clinical study contexts. For physical device testing, results are typically objective measurements against a standard.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical hypodermic needle, not an AI software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical hypodermic needle, not an AI algorithm. The device's performance is inherently "standalone" in the sense that its physical properties are tested directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or more accurately, the reference standard) for this device is based on international and national standards for medical devices, specifically:
  - EN ISO 7864 (1995): "Sterile hypodermic needles for single use"
  - ISO 6009: "Hypodermic needles for single use - Colour coding for identification"
  - ISO 594-1 and ISO 594-2: "Conical fittings with a 6 % (Luer) taper for syringes, needles, and certain other medical equipment"
  - EN ISO 11135-1: "Sterilization of Health Care Products - Ethylene oxide"
  - EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE""
  - EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals'"
    The biological evaluation also references FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993-1.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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

Submitter information

Prepared for:	TERUMO EUROPE N.V.Interleuvenlaan 40,3001 Leuven,BELGIUM
Prepared by/Contact person:	Mrs. M.J. Aerts – Manager Regulatory AffairsTel. (+32) 16 38 13 53Fax (+32) 16 40 02 49
Date prepared:	July 2013

II.I. Device Name

Proprietary Name

. K-Pack II Needle - 27G x ¾¨ Thin Wall

Classification Name

Hypodermic Single Lumen Needle

21CFR, Section 880.5570

Classification: Class II

11.2. Reason for Submission

This 510k is being submitted to extend the cleared K-Pack II Needle (K984576) product line with the K-Pack II Needle - 27G x 34" Thin Wall.

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 cannula wall of this 27G x ¾" needle is thinner than what is currently cleared for the 27 Gauge needle under the 510k K984576 and 510k K001572. The thinner needle is cleared for the 27G x 1/2" needle under the 510k K 110850.

The % " needle length was cleared for the 27 Gauge needle under the 510k K001572.

This Special 510k is being submitted due to potential issues of safety and effectiveness specific for the longer length of the 27 Gauge thin wall needle.

This 510k will provide supporting information that the 27G x ¾' Thin Wall K-Pack II Needles are safe and effective and an acceptable extension of the current K-Pack II Needle product line.

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11.3. Intended Use

The 27G x 3/" Thin Wall K-Pack 11 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, 1 Neolus Needle - K001572 and 27G x ½" & 30G x ½" K-Pack II Needle Thin Wall -KI10850.

11.4. Description

The 27G x 4" 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 joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.

11.5. Substantial Eguivalence

The 27G x 3/7 Thin Wall K-Pack II Needles are substantially cquivalent 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.
27G x ½¨ & 30G x ½¨ K-Pack II Needles Thin Wall (K 110850) 3.

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

11.6. Summary of Verification Activities

All necessary verification and validation tests have been performed by testing the 27G x ½" 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 anilluminance of 300 lx to 700 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	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 Thin Wall K-Pack II Needles has a content ofextractable metals which is, when corrected for the metal content of the control fluid:$Σ$ 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 27G Thin Wall K-Pack II Needle is in the center of the bevel, issharp and is free from extraneous matter, burr, edges and hooks.
10. Bonding strength betweenhub and cannula	The bonding strength between hub and cannula is ≥ 22N.
11. Patency of lumen	A stylet with a diameter of 0.19 mm is passing through the needle.
12. Flow rate	Tolerance on flow rate: between 80% and 125% of nominal value

. .

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II.7. Additional Safety Information

The sterility of the 27G x %" Thin Wall K-Pack II Needles is assured by using a validated sterilization method qualified in accordance with EN ISO 11135-1: "Sterilization of Health Care Products - Ethylene oxide - Part 1: Requirements for the 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 27G x ¾" 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 x %" Thin Wall K-Pack II Needles has been established at 5 years which is the same as the cleared K-Pack II Needles.

11.8. Conclusion

In summary, the 27G x ¾" Thin Wall K-Pack II Needles are substantially equivalent in intended use, design, technology/principal of operation, and performance to the following cleared devices:

K-Pack II Needles (K984576) l .
1. Neolus Needles (K001572)
27G x ½" & 30G x ½¨ K-Pack II Needles Thin Wall (K110850) 3.

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

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

September 6, 2013

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

Re: K132233

Trade/Device Name: K-Pack II Needle - 27G x %" Thin Wall Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 12, 2013 Received: August 7, 2013

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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 i 32233

Device Name: K-Pack II Needle - 27G x ¼" Thin Wall Indication For Use:

The 27G x 1/2" 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)

Sajjad H. Digitaly signed by Sabled H. Synd u=HHZ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Syed Date: 2013.09.04 12:27:23 -04'00' ... .. ...

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

.10(k) Number: K132233

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).