The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall 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 Description

The subject K-Pack II Needles are hypodermic single lumen needles, for single use consisting of stainless steel 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 hypodermic syringe. The needle is packed in a hard pack (cap-case) made of polypropylene. The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall will be an extension of the existing K-Pack II Needles product family.

AI/ML Overview

The K-Pack II Needles are subject to a Special 510(k) submission due to the introduction of new product codes with increased cannula's inner diameter, resulting in different cannula wall types (ultra and extra thin wall versus thin wall). The device's performance was evaluated against several recognized consensus standards for hypodermic needles.

Here is a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is reported as meeting the acceptance criteria outlined by the specified standards.

Requirement	Acceptance Criteria	Reported Device Performance
1. Cleanliness	Visual inspection: free from particles and extraneous matter (normal/corrected-to-normal vision, 300-700 lx); 2.5x magnification: hub socket free from particles and extraneous matter.	Meets criteria (implied by safety and effectiveness claim)
2. Limits for acidity or alkalinity	△ pH for extract solution within 1 unit of control fluid (EN ISO 7864).	Meets criteria (implied by safety and effectiveness claim)
3. Limits for extractable metals	Extract solution content (corrected for control fluid) of Σ Pb, Sn, Zn, Fe ≤ 5 mg/l and Cd < 0.1 mg/l (EN ISO 7864).	Meets criteria (implied by safety and effectiveness claim)
4. Conical fitting	Female luer (slip and lock) connector with 6% taper compliant to EN ISO 80369-7. Taper meets gauging requirements of ISO 594-1.	Meets criteria (implied by safety and effectiveness claim)
5. Fluid leakage	No leakage forming a falling drop of water over 30-35s at 300-330 kPa (EN ISO 80369-7).	Meets criteria (implied by safety and effectiveness claim)
6. Air leakage	Leakage not more than 0.005 Pa.m³/s over 15-20s at 80.0-88.0 kPa sub-atmospheric pressure (EN ISO 80369-7).	Meets criteria (implied by safety and effectiveness claim)
7. Stress cracking	Meets fluid leakage requirements after being subjected to stresses (EN ISO 80369-7).	Meets criteria (implied by safety and effectiveness claim)
8. Resistance to separation from axial load	Does not separate from reference connector over 10-15s with disconnection force between 23-25N (luer slip) or 32-35N (luer lock) (EN ISO 80369-7).	Meets criteria (implied by safety and effectiveness claim)
9. Resistance to separation from unscrewing	Luer lock connectors do not separate from reference connector over 10-15s with unscrewing torque of 0.0198-0.0200 N.m (EN ISO 80369-7).	Meets criteria (implied by safety and effectiveness claim)
10. Resistance to overriding	Luer lock connectors do not override threads/lugs of reference connector with applied torque of 0.15-0.17 N.m over 5-10s (EN ISO 80369-7).	Meets criteria (implied by safety and effectiveness claim)
11. Stiffness test cannula	Deflection not greater than values specified in EN ISO 9626 when tested in accordance with EN ISO 9626.	Meets criteria (implied by safety and effectiveness claim)
12. Resistance to breakage	Cannula does not break when tested in accordance with EN ISO 9626.	Meets criteria (implied by safety and effectiveness claim)
13. Resistance to corrosion	Cannula shows no corrosion when tested in accordance with EN ISO 9626.	Meets criteria (implied by safety and effectiveness claim)
14. Effective needle length	Nominal length + 1 mm/-2 mm in accordance with EN ISO 7864.	Meets criteria (implied by safety and effectiveness claim)
15. Silicon amount on cannula	Uniformly lubricated, no visible droplets, quantity ≤ 0.25 mg/cm² (EN ISO 7864).	Meets criteria (implied by safety and effectiveness claim)
16. Needle Penetration Resistance	Point value ≤ 0.10 N and Drag Value ≤ 0.04 N (internal method).	Meets criteria (implied by safety and effectiveness claim)
17. Bonding strength between hub and cannula (axial)	≥ 22N (EN ISO 7864).	Meets criteria (implied by safety and effectiveness claim)
18. Patency of Lumen	Appropriate diameter stainless steel stylet passes through needle (EN ISO 7864); OR flow rate of water ≥ 80% of unprocessed needle tube of equivalent OD and length with minimum ID in accordance with ISO 9626 (internal method).	Meets criteria (implied by safety and effectiveness claim)
19. Fitting strength hub/case	Force to axially pull needle hub from case is 0.5 N to 25 N (internal method).	Meets criteria (implied by safety and effectiveness claim)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each non-clinical test. However, it indicates that "The design of the K-Pack II Needles has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized consensus standards". This implies testing was conducted by Terumo Europe N.V. in Belgium, likely as prospective testing as part of their design validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a hypodermic needle and the performance evaluation relies on standardized physical and chemical testing, not expert interpretation of results to establish ground truth in the way medical imaging or diagnostic devices would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the type of non-clinical testing performed on a hypodermic needle. The evaluation is based on objective measurements against specified criteria in international standards.

5. 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

This question is not applicable. The device is a hypodermic needle, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical device (hypodermic needle), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth or evaluation benchmarks are defined by the various international consensus standards (EN ISO 7864, EN ISO 9626, EN ISO 80369-7, EN ISO 6009, EN ISO 10993, EN ISO 11135, EN 556-1) and internal Terumo specifications (for 27G extra and ultra thin walls, and for some specific tests like needle penetration resistance and bonding strength). These standards specify objective physical, chemical, and functional criteria.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 11, 2019 Terumo Europe N.V. M. Aerts VP Regulatory & Vigilance Interleuvenlaan 40 Leuven, 3001 Be

Re: K192057

Trade/Device Name: K-Pack II Needle - 27G x 1/2" Extra Thin Wall, K-Pack II Needle - 27G x 1/2" Ultra Thin Wall, K-Pack II Needle - 30G x 1/2" Extra Thin Wall, K-Pack II Needle - 30G x 1/2" Ultra Thin Wall Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 16, 2019 Received: September 23, 2019

Dear M. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192057

Device Name

The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 30G x 1/2" Extra Thin Wall, 30G x 1/2" Utra Thin Wall

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Prepared for:	TERUMO EUROPE N.V.Interleuvenlaan 40,3001 Leuven,BELGIUM
Prepared by/Contact Person:	Mrs. M.J. Aerts – VP Regulatory & VigilanceTel. (+32) 16 38 13 53Fax (+32) 16 40 02 49

October 2019

Date prepared:

Note: Class III Summary & Certification is not applicable for the submission of a Class II device

{4}------------------------------------------------

II. 510(k) SUMMARY

II.1. Submitter Information (807.92(a)(1))
II.2. Device Name (807.92(a)(2))
II.3. Predicate Devices (807.92(a)(3))
II.4. Reason for Submission
Device Description (807.92(a)(4)) II.5.
Indications for Use (807.92(a)(5)) II.6.
II.7. Substantial Equivalence Comparison (807.92(a)(6))
Non Clinical Test (807.92(b)(1)) II.8.
Clinical Test (807.92(b)(2)) II.9.
II.10. Conclusion (807.92(b)(3))

{5}------------------------------------------------

II.1. Submitter Information (807.92(a)(1))

Prepared for:	TERUMO EUROPE N.V.Interleuvenlaan 40,3001 Leuven,BELGIUM
Prepared by/Contact person:	Mrs. M.J. Aerts – VP Regulatory & VigilanceTel. (+32) 16 38 13 53Fax (+32) 16 40 02 49
Date prepared:	October 2019
II.2. Device Name (807.92(a)(2))
Proprietary Name:	K-Pack II Needles –27G x 1/2" Extra Thin Wall27G x 1/2" Ultra Thin Wall30G x 1/2" Extra Thin Wall30G x 1/2" Ultra Thin Wall
Common Name:	Needle, Hypodermic, Single Lumen
Regulation Name:	Hypodermic single lumen needle

21CFR, Section 880.5570

II.3. Predicate Devices (807.92(a)(3))

Regulation:

Product Code:

Classification:

The legally marketed device(s) to which substantial equivalence is claimed:

1. K-Pack II Needles (K984576)
1. 27G & 30G Thin Wall K-Pack II Needle (K110850)

FMI

Class II

II.4. Reason for 510(k) Submission

This premarket notification [Special 510(k)] is being submitted for the K-Pack II Needles, manufactured by Terumo Europe N.V., for the following modification to the current device: the introduction of new product codes for K-Pack II Needles 27G & 30G x ½" with increased cannula's inner diameter and therefore different cannula wall type designation (ultra and extra thin wall vs thin wall).

Although there are no potential issues of safety and effectiveness for K-Pack II Needles with increased cannula's inner diameter, this Special 510k is being submitted due to the fact that the new cannula wall types are out of the range of the previously cleared needles.

This 510k will provide supporting information that the K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall are an acceptable extension of the current K-Pack II Needle product line.

II.5. Device Description (807.92(a)(4))

{6}------------------------------------------------

Principle of Operation Technology

The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall are operated manually or by manual process.

Design/Construction

Specifications

The following table shows the product codes, needle length and cannula wall type that are new for this submission.

PRODUCT	NEEDLE	NEEDLE	NEEDLE	CANNULA	PACKAGING
CODE	GAUGE	LENGTH	BEVEL	WALL
KN-2713RBKTE	27	1/2"	regular	Extra Thin*	short case
KN-2713RBKTU	27	1/2"	regular	Ultra Thin*	short case
KN-3013RBKE	30	1/2"	regular	Extra Thin	short case
KN-3013RBKU	30	1/2"	regular	Ultra Thin	short case

27G: extra and ultra thin wall cannula specifications for a 27G needle are not defined in ISO 9626:2016. Therefore extra and ultra thin wall designation for the 27G K-Pack II Needles are based on Terumo internal specifications.

II.6. Indications for Use (807.92(a)(5))

Note: The intended use has not changed as a result of the modification. This is the same indication and intended use as the predicate devices, K-Pack II Needle - K984576 and 27G & 30G Thin Wall K-Pack II Needle - K110850.

II.7. Substantial Equivalence Comparison (807.92(a)(6))

The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall, the subject of this Special 510(k), are substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following cleared devices:

K-Pack II Needles (K984576) 1.
27G & 30G Thin Wall K-Pack II Needle K110850 2.

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

The similarities and differences are summarized in the table below.

{7}------------------------------------------------

Characteristics	27G x 1/2" Extra Thin Wall,27G x 1/2" Ultra Thin Wall,30G x 1/2" Extra Thin Wall30G x 1/2" Ultra Thin WallK-Pack II Needle(Terumo Europe, Belgium)(Subject of this 510k)	27G & 30G Thin Wall K-Pack II Needles(Terumo Europe, Belgium)(K110850)	K-Pack II Needles(Terumo Europe, Belgium)(K984576)	Comments
Manufacturer	Same as predicate	Terumo Europe N.V.	Terumo Europe N.V.	Unchanged
Intended Use/Indications for Use	Same as predicate	Intended to inject fluids into,or withdraw fluids from, partsof the body below the surfaceof the skin.	Intended to inject fluids into,or withdraw fluids from, partsof the body below the surfaceof the skin.	Unchanged
Materials	Same as predicateStainless SteelPolypropyleneEpoxy glueSilicone	Stainless SteelPolypropyleneEpoxy glueSilicone	Stainless SteelPolypropyleneEpoxy glueSilicone	Unchanged
Cannula
Hub
Glue
Lubricant
Design/Constructions	Same as predicate	Comprised of a stainless steeltube that is sharpened at oneend and at the other endjoined to a female luerconnector (hub) designed tobe connected with a maleconnector (nozzle) of a pistonsyringe.	Comprised of a stainless steeltube that is sharpened at oneend and at the other endjoined to a female luerconnector (hub) designed tobe connected with a maleconnector (nozzle) of a pistonsyringe.	Unchanged
Specifications	27G x 1/2" Extra Thin Wall,27G x 1/2" Ultra Thin Wall,30G x 1/2" Extra Thin Wall30G x 1/2" Ultra Thin Wall	27G x ½" Thin wall30G x ½" Thin wall	Ranging from18G – 27G3/8" - 1 ½"Regular & Thin wall	Increased cannula'sinner diameter andtherefore differentcannula wall typedesignation (ultra andextra thin wall vs thinwall).
Principle ofOperation	Same as predicate	Manually	Manually	Unchanged
Unit packaging	Hard pack consisting of capand short case	Hard pack consisting of capand short case	Hard pack consisting of capand long or short case	Unchanged
Sterilization	EtO to SAL 10-6	EtO to SAL 10-6	EtO to SAL 10-6	Unchanged
Shelf life	5 years	5 years	5 years	Unchanged

Substantial Equivalence Discussion

The subject K-Pack II Needles are the same needle as the cleared 27G & 30G Thin Wall Needle covered in K110850, the only difference is the introduction of new product codes for needles with increased cannula's inner diameter and therefore different cannula wall type designation (ultra and extra thin wall vs thin wall).

II.8. Non Clinical Test (807.92(b)(1))

Performance

The design of the K-Pack II Needles has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized consensus standards that have been established for hypodermic needles under FDA product code FMI and 21CFR Section 880.5570:

{8}------------------------------------------------

EN ISO 7864:2016 "Sterile hypodermic needle for Single use"

EN ISO 9626: 2016''Stainless steel needle tubing for the manufacturing of medical devices"

EN ISO 80369-7: 2017 "Small bore connectors for liquids & gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications

EN ISO 6009:2016 "Stainless steel needle tubing for the manufacturing of medical devices"

Requirement	ACCEPTANCE CRITERIA
1. Cleanliness	When inspected by normal or corrected-to-normal vision without magnificationunder an illuminance of 300 lx to 700 lx, the surface of the hypodermic needletube shall appear free from particles and extraneous matter
	When examined under 2,5x magnification, the hub socket (fluid path surface) shallappear free from particles and extraneous matter.
2. Limits for acidity or alkalinity	△ pH for K-Pack Needles extract solution is within 1 unit of the control fluidaccording to EN ISO 7864.
3. Limits for extractable metals	The extract solution of the K-Pack II Needles has a content of extractable metalswhich is, when corrected for the metal content of the control fluid according to ENISO 7864:$Σ Pb, Sn, Zn, Fe ≤ 5 mg/l$$Cd < 0.1 mg/l$
4. Conical fitting	The hub of the K-Pack II Needles is a female luer (slip and lock) connector with a6% taper compliant to EN ISO 80369-7.The taper of the hub still meets the gauging requirements of ISO 594-1.
5. Fluid leakage	The luer connector evaluated for fluid leakage performance with positive pressureliquid leakage test method shall show no signs of leakage, sufficient to form afalling drop of water, over a hold period of 30s to 35s while being subjected to anapplied pressure between 300 kPa and 330 kPa when tested according EN ISO80369-7
6. Air leakage	The luer connectors shall not leak by more than 0.005 Pa.m³/s while beingsubjected to an applied sub-atmospheric pressure between 80.0 kPa and 88.0 kPaover a hold period between 15s and 20s when tested according EN ISO 80369-7
7. Stress cracking	The luer connectors shall meet the requirements of fluid leakage (Positive pressureliquid leakage) after being subjected to stresses when tested according EN ISO80369-7.
8. Resistance to separation fromaxial load	The luer connectors shall not separate from the reference connector over a holdperiod between 10s and 15s while being subjected to a disconnection applied axialforce between:- 23N and 25N for luer slip connectors- 32N and 35N for luer lock connectors
	when tested according EN ISO 80369-7.
9. Resistance to separation fromunscrewing	The luer lock connectors shall not separate from the reference connector for a holdperiod between 10s and 15s while being subjected to an unscrewing torque ofbetween 0.0198 N.m to 0.0200 N.m when tested according EN ISO 80369-7.
10. Resistance to overriding	The luer lock connectors shall not override the threads or lugs of the referenceconnector while being subjected to an applied torque of between 0.15 N.m to 0.17
	N.m over a hold period between 5s and 10s when tested according EN ISO 80369-7.
11. Stiffness test cannula	The cannula shall show a deflection not greater than the values specified in ENISO 9626 when tested in accordance with EN ISO 9626.
12. Resistance to breakage	The cannula does not break when tested in accordance with EN ISO 9626.
13. Resistance to corrosion	The cannula shows no corrosion when tested in accordance with EN ISO 9626.
14. Effective needle length	The effective length = nominal length + 1 mm/-2 mm in accordance with EN ISO7864.
15. Silicon amount on cannula	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 inaccordance EN ISO 7864.
16. Needle PenetrationResistance	The penetration resistance of cannula point and drag complies with the limitsspecified below when tested according to internal method:
	Point value ≤ 0.10 N and Drag Value ≤ 0.04 N
17.Bonding strength betweenhub and cannula	The bonding strength between hub and cannula is ≥ 22N according to EN ISO7864.
18. Patency of Lumen	A stainless steel stylet of the appropriate diameter shall pass through the needle inaccordance with EN ISO 7864
	And/or
	The flow rate of water through the needle when tested according to an internalmethod shall not be less than 80% of an unprocessed needle tube of equivalentouter diameter and length having a minimum inner diameter in accordance withISO 9626 when tested under the same pressure.
19. Fitting strength hub/case	The force to pull axially the needle hub from the case is minimum 0.5 N andmaximum 25 N when tested according an internal method.

{9}------------------------------------------------

Biocompatibility

The subject K-Pack II Needles, are categorized following the definitions in EN ISO 10993-1 as external communicating devices that can indirectly contact the blood path up to 24 hours (short term exposure). This classification is also applicable to the predicate K-Pack II Needles. Based on this classification and considering FDA Guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing within a risk management process", the applicable biological endpoints are: cytotoxicity, sensitization, intracutaneous reactivity, toxicity (acute systemic toxicity, material-induced pyrogenicity, bacterial endotoxins, abnormal toxicity) and haemocompatibility.

Sterilization

The sterility of the subject K-Pack II Needles is assured by using a validated sterilization method qualified in accordance with EN ISO 11135: "Sterilization of Health Care Products -Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".

{10}------------------------------------------------

The physical validation of the sterilizer is conducted to verify the temperature and humidity in the sterilization load and the pressure in the sterilizer during the whole cycle.

The biological validation is performed in accordance with EN ISO 11135:2014 Annex B "Conservative determination of lethal rate of the sterilization process - Overkill approach" part B.1.2.a "Half cycle approach". This resulted in a holding time of 120 min for the sterilization cycle to assure a SAL of at least 105 according to the requirements of EN ISO 11135:2014.

The products can therefore be labelled sterile in accordance with EN 556-1: "Sterilization of medical devices - Requirements for medical devices to be labelled STERILE - Part 1: Requirements for terminally sterilized medical devices".

In accordance with EN ISO 10993-7:2008 "Biological evaluation of medical devices - Part 7: Ethylene Oxide sterilization residuals" the residual ethylene oxide level after aeration does not exceed 4 mg/device/day and the ethylene chlorohydrin level does not exceed 9 mg/device/day.

II.9. Clinical Test (807.92(b)(2))

This 510(k) does not include data from clinical tests.

II.10. Conclusion (807.92(b)(3))

In summary, the K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall, the subject of this Special 510(k) 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.
1. 27G & 30G Thin Wall K-Pack II Needle - K110850

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

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).