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

K192057 · Terumo Europe N.V. · FMI · Oct 11, 2019 · General Hospital

Device Facts

• Record ID: K192057
• 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
• Applicant: Terumo Europe N.V.
• Product Code: FMI · General Hospital
• Decision Date: Oct 11, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

K-Pack II Needles are sterile, single-use hypodermic needles; stainless steel cannula sharpened at one end, attached to polypropylene female luer hub. Operated manually by clinicians to inject or withdraw fluids. Subject device extends existing product line by introducing 27G and 30G needles with extra-thin and ultra-thin wall designations, increasing inner diameter compared to predicate thin-wall versions. Packaged in polypropylene hard-pack case. Benefits include improved flow rates due to increased inner diameter while maintaining compatibility with standard luer-lock/slip syringes. No clinical data required; performance validated via bench testing against ISO standards for hypodermic needles and connectors.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against EN ISO 7864, EN ISO 9626, and EN ISO 80369-7, including testing for cleanliness, acidity/alkalinity, extractable metals, conical fitting, fluid/air leakage, stress cracking, axial load/unscrewing resistance, cannula stiffness/breakage/corrosion, needle penetration resistance, bonding strength, and patency.

Technological Characteristics

Materials: Stainless steel cannula, polypropylene hub/case, epoxy glue, silicone lubricant. Sensing/Actuation: Manual. Energy: None. Connectivity: None. Sterilization: Ethylene Oxide (EtO) to SAL 10^-6. Standards: EN ISO 7864, EN ISO 9626, EN ISO 80369-7, EN ISO 6009, EN ISO 10993-1/7, EN ISO 11135.

Indications for Use

Indicated for use as sterile, single-use hypodermic needles to inject fluids into or withdraw fluids from parts of the body below the skin surface.

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)
• 27G & 30G Thin Wall K-Pack II Needle (K110850)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 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.<br>Interleuvenlaan 40,<br>3001 Leuven,<br>BELGIUM |
|-----------------------------|------------------------------------------------------------------------------------------------|
| Prepared by/Contact Person: | Mrs. M.J. Aerts – VP Regulatory & Vigilance<br>Tel. [phone]<br>Fax [phone] |

October 2019

Date prepared:

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

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#### 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))

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

| Prepared for: | TERUMO EUROPE N.V.<br>Interleuvenlaan 40,<br>3001 Leuven,<br>BELGIUM |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared by/Contact person: | Mrs. M.J. Aerts – VP Regulatory & Vigilance<br>Tel. [phone]<br>Fax [phone] |
| Date prepared: | October 2019 |
| II.2. Device Name (807.92(a)(2)) | |
| Proprietary Name: | K-Pack II Needles –<br>27G x 1/2" Extra Thin Wall<br>27G x 1/2" Ultra Thin Wall<br>30G x 1/2" Extra Thin Wall<br>30G 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)
- 2. 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))

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# 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

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.

## 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))

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.

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.

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| Characteristics | 27G x 1/2" Extra Thin Wall,<br>27G x 1/2" Ultra Thin Wall,<br>30G x 1/2" Extra Thin Wall<br>30G x 1/2" Ultra Thin Wall<br>K-Pack II Needle<br>(Terumo Europe, Belgium)<br>(Subject of this 510k) | 27G & 30G Thin Wall K-<br>Pack II Needles<br>(Terumo Europe, Belgium)<br>(K110850) | K-Pack II Needles<br>(Terumo Europe, Belgium)<br>(K984576) | Comments |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Same as predicate | Terumo Europe N.V. | Terumo Europe N.V. | Unchanged |
| Intended Use/<br>Indications for Use | Same as predicate | Intended to inject fluids into,<br>or withdraw fluids from, parts<br>of the body below the surface<br>of the skin. | Intended to inject fluids into,<br>or withdraw fluids from, parts<br>of the body below the surface<br>of the skin. | Unchanged |
| Materials | Same as predicate<br>Stainless Steel<br>Polypropylene<br>Epoxy glue<br>Silicone | Stainless Steel<br>Polypropylene<br>Epoxy glue<br>Silicone | Stainless Steel<br>Polypropylene<br>Epoxy glue<br>Silicone | Unchanged |
| Cannula | | | | |
| Hub | | | | |
| Glue | | | | |
| Lubricant | | | | |
| Design/<br>Constructions | Same as predicate | Comprised of a stainless steel<br>tube that is sharpened at one<br>end and at the other end<br>joined to a female luer<br>connector (hub) designed to<br>be connected with a male<br>connector (nozzle) of a piston<br>syringe. | Comprised of a stainless steel<br>tube that is sharpened at one<br>end and at the other end<br>joined to a female luer<br>connector (hub) designed to<br>be connected with a male<br>connector (nozzle) of a piston<br>syringe. | Unchanged |
| Specifications | 27G x 1/2" Extra Thin Wall,<br>27G x 1/2" Ultra Thin Wall,<br>30G x 1/2" Extra Thin Wall<br>30G x 1/2" Ultra Thin Wall | 27G x ½" Thin wall<br>30G x ½" Thin wall | Ranging from<br>18G – 27G<br>3/8" - 1 ½"<br>Regular & Thin wall | Increased cannula's<br>inner diameter and<br>therefore different<br>cannula wall type<br>designation (ultra and<br>extra thin wall vs thin<br>wall). |
| Principle of<br>Operation | Same as predicate | Manually | Manually | Unchanged |
| Unit packaging | Hard pack consisting of cap<br>and short case | Hard pack consisting of cap<br>and short case | Hard pack consisting of cap<br>and 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:

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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 magnification<br>under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle<br>tube shall appear free from particles and extraneous matter |
| | When examined under 2,5x magnification, the hub socket (fluid path surface) shall<br>appear 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 fluid<br>according to EN ISO 7864. |
| 3. Limits for extractable metals | The extract solution of the K-Pack II Needles has a content of extractable metals<br>which is, when corrected for the metal content of the control fluid according to EN<br>ISO 7864:<br>$Σ Pb, Sn, Zn, Fe ≤ 5 mg/l$<br>$Cd < 0.1 mg/l$ |
| 4. Conical fitting | The hub of the K-Pack II Needles is a female luer (slip and lock) connector with a<br>6% taper compliant to EN ISO 80369-7.<br>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 pressure<br>liquid leakage test method shall show no signs of leakage, sufficient to form a<br>falling drop of water, over a hold period of 30s to 35s while being subjected to an<br>applied pressure between 300 kPa and 330 kPa when tested according EN ISO<br>80369-7 |
| 6. Air leakage | The luer connectors shall not leak by more than 0.005 Pa.m³/s while being<br>subjected to an applied sub-atmospheric pressure between 80.0 kPa and 88.0 kPa<br>over 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 pressure<br>liquid leakage) after being subjected to stresses when tested according EN ISO<br>80369-7. |
| 8. Resistance to separation from<br>axial load | The luer connectors shall not separate from the reference connector over a hold<br>period between 10s and 15s while being subjected to a disconnection applied axial<br>force between:<br>- 23N and 25N for luer slip connectors<br>- 32N and 35N for luer lock connectors |
| | when tested according EN ISO 80369-7. |
| 9. Resistance to separation from<br>unscrewing | The luer lock connectors shall not separate from the reference connector for a hold<br>period between 10s and 15s while being subjected to an unscrewing torque of<br>between 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 reference<br>connector 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-<br>7. |
| 11. Stiffness test cannula | The cannula shall show a deflection not greater than the values specified in EN<br>ISO 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 ISO<br>7864. |
| 15. Silicon amount on cannula | 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 in<br>accordance EN ISO 7864. |
| 16. Needle Penetration<br>Resistance | The penetration resistance of cannula point and drag complies with the limits<br>specified below when tested according to internal method: |
| | Point value ≤ 0.10 N and Drag Value ≤ 0.04 N |
| 17.Bonding strength between<br>hub and cannula | The bonding strength between hub and cannula is ≥ 22N according to EN ISO<br>7864. |
| 18. Patency of Lumen | A stainless steel stylet of the appropriate diameter shall pass through the needle in<br>accordance with EN ISO 7864 |
| | And/or |
| | The flow rate of water through the needle when tested according to an internal<br>method shall not be less than 80% of an unprocessed needle tube of equivalent<br>outer diameter and length having a minimum inner diameter in accordance with<br>ISO 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 and<br>maximum 25 N when tested according an internal method. |

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#### 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".

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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.
- 2. 27G & 30G Thin Wall K-Pack II Needle - K110850

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