(30 days)
The 29G x 5/16" Thin Wall K-Pack II 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.
Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.
Acceptance Criteria and Device Performance Study for K-Pack II Needle - 29G x 5/16" Thin Wall
This document describes the acceptance criteria and a summary of verification activities conducted for the K-Pack II Needle - 29G x 5/16" Thin Wall, as presented in the provided 510(k) summary. The study aims to demonstrate substantial equivalence to predicate devices (K-Pack II Needles (K984576) and 29G x 1/2" Thin Wall K-Pack II Needles (K082820)).
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE |
|---|---|---|
| 1. Visual appearance | Silicon amount on cannula not visible as droplets. | Complies |
| 2. Limits for acidity or alkalinity | $\Delta$ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Complies |
| 3. Limits for extractable metals | The extract solution of the 29G K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\Sigma Pb, Sn, Zn, Fe \le 5 mg/l$, $Cd < 0.1 mg/l$ | Complies |
| 4. Needle Penetration Resistance | The penetration resistance of cannula point and drag complies with the limits specified as follow: Point value $\le 0.10 N$ and Drag Value $\le 0.04 N$ | Complies |
| 5. Conical fitting | The taper of the hub meets the gauging requirements of ISO 594-1. | Complies |
| 6. Fitting strength hub/case | The force to pull axially the needle hub from the case is minimum 0.5 N and maximum 25 N. | Complies |
| 7. Effective needle length | The effective length = nominal length + 1 mm/-2 mm. | Complies |
| 8. Silicon amount on cannula | 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. | Complies |
| 9. Resistance to breakage | The cannula does not break when tested in accordance with EN ISO 9626. | Complies |
| 10. Stiffness test cannula | The cannula shall show a deflection not greater than 0.37 mm in accordance with EN ISO 9626. | Complies |
| 11. Corrosion Resistance (cannula) | The cannula shall show no signs of corrosion caused by the immersion in a sodium chloride solution 0.5 M. | Complies |
| 12. Bonding strength between hub and cannula | The bonding strength between hub and cannula is $\ge$ 22N. | Complies |
| 13. Liquid leakage | There is no leak of liquid at the luer (lock) fitting when the needle hub is fixed to reference control fitting in accordance with to ISO 594-1 and ISO 594-2. | Complies |
| 14. Air leakage | There is no air leakage at luer (lock) fitting when the needle hub is fixed to a reference control fitting in accordance with to ISO 594-1 and ISO 594-2. | Complies |
| 15. Flow rate | Tolerance on flow rate: between 80% and 125% of nominal value. | Complies |
| 16. Torque Force Cap-Case | The torque force required to break the label and to remove the cap from the case is not more than 25 N.cm. | Complies |
| 17. Endotoxin reaction | The device is free from endotoxin reaction in accordance with European Pharm. 2.6.14. | Complies |
| 18. Abnormal toxicity | The device is free from abnormal toxicity in accordance with European Pharm. 2.6.9. | Complies |
| 19. Sterility | The device is sterile in accordance with European Pharm. 2.6.1. | Complies |
Study Information:
Based on the provided text, the following information can be extracted regarding the study:
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for each individual test or the overall test set. The data provenance is implied to be from internal testing conducted by Terumo Europe N.V. (Belgium), as indicated by "Design verification activities were conducted for the 29G x 5/16" Thin Wall K-Pack II Needles..." and the company's location. The study type is a verification activity to demonstrate substantial equivalence, which is typically conducted in a prospective manner on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. For tests like visual appearance, penetration resistance, etc., the "ground truth" is likely established through adherence to specified engineering standards and internal quality control protocols, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set:
This information is not provided. The nature of these engineering and sterility tests suggests that adjudication methods like "2+1" or "3+1" (common in clinical image review) are not applicable. Compliance is measured against pre-defined quantitative or qualitative criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. The K-Pack II Needle is a physical medical device, and the verification activities focus on its physical and biological properties.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The K-Pack II Needle is a physical medical device, not an algorithm. The "standalone performance" here refers to the device's ability to meet its specifications independently. The verification activities described are essentially a standalone performance assessment of the device against its design requirements and relevant standards.
7. The Type of Ground Truth Used:
The ground truth used for these verification activities is based on:
- Established engineering standards: e.g., ISO 594-1, ISO 594-2, EN ISO 9626, EN ISO 11135-1, EN 556-1, EN ISO 10993-7.
- Regulatory guidelines: e.g., European Pharm. 2.6.14, European Pharm. 2.6.9, FDA General Program Memorandum #G95-1 (for biological evaluation).
- Internal specifications: for properties like visual appearance, silicon amount, and effective needle length, which are likely derived from design requirements and predicate device characteristics.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical needle, and therefore, there is no "training set" in the context of machine learning or AI models. The device undergoes design, manufacturing, and verification processes based on established engineering principles and standards.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2015
Terumo Europe N.V. Mrs. M. J. Aerts Regulatory Affairs Manager Interleuvenlaan 40 3001 Leuven BELGIUM
Re: K151398
Trade/Device Name: K- Pack II Needles- 29 G x 5/16" Thin Wall Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 21, 2015 Received: May 26, 2015
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. M.J. Aerts
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. 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): K151398
Device Name: K-Pack II Needle - 29G x 5/16" Thin Wall
Indication For Use:
The 29G x 5/16" 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) 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)
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510(k) SUMMARY as required by 807.92
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: | May 2015 |
II.1. Device Name
Proprietary Name
K-Pack II Needle - 29G x 5/16" Thin Wall
Classification Name
Hypodermic Single Lumen Needle
21CFR, Section 880.5570
Classification: Class II
Product Code
FMI
II.2. Predicate Devices
The following cleared devices are selected as predicate devices:
II.3. 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 - 29G x 5/16" Thin Wall.
The 29G Thin Wall K-Pack II Needle is the same needle as the cleared 29G Thin Wall Needle covered in K082820, the only difference is that the needle length of the 29G x 5/16" Thin Wall K-Pack II Needle is shorter than what is currently cleared under the 29G x ½2" Thin Wall Needle K082820.
The packaging of the 29G x 5/16" Thin Wall K-Pack II Needle in a short case is the same as the packaging of the cleared 29G x ½" Thin Wall K-Pack II Needle covered in K082820.
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Although there are no potential issues of safety and effectiveness for a shorter length needle, this Special 510k is being submitted due to the fact that the new length is out of the range of the previously cleared needles.
This 510k will provide supporting information that the 29G x 5/16" Thin Wall K-Pack II Needles are an acceptable extension of the current K-Pack II Needle product line.
II.4. Intended Use
The 29G x 5/16" Thin Wall K-Pack II 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 and 29G x ½" Thin Wall K-Pack II Needle K082820.
II.5. Substantial Equivalence
The 29G x 5/16" Thin Wall K-Pack II Needles are substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the following cleared devices:
Differences between the devices do not raise any significant issues of safety and effectiveness.
| 29G x 5/16" Thin WallK-Pack II Needle(Terumo Europe, Belgium)(Subject of this 510k) | 29G x 1/2" Thin Wall K-Pack IINeedles(Terumo Europe, Belgium)(K082820) | K-Pack II Needles(Terumo Europe, Belgium)(K984576) | |
|---|---|---|---|
| Intended Use | Same as predicate | Intended to inject fluids into, orwithdraw fluids from, parts ofthe body below the surface of theskin. | Intended to inject fluids into, orwithdraw fluids from, parts ofthe body below the surface of theskin. |
| Materials | Same as predicate | Same as predicate | Same as predicate |
| Cannula | Stainless Steel | Stainless Steel | Stainless Steel |
| Hub | Polypropylene | Polypropylene | Polypropylene |
| Glue | Epoxy glue | Epoxy glue | Epoxy glue |
| Lubricant | Silicone | Silicone | Silicone |
| Description/Specifications | Same as predicate | Comprised of a stainless steeltube that is sharpened at one endand at the other end joined to afemale luer connector (hub)designed to be connected with amale connector (nozzle) of apiston syringe. | Comprised of a stainless steeltube that is sharpened at one endand at the other end joined to afemale luer connector (hub)designed to be connected with amale connector (nozzle) of apiston syringe. |
| Needle Gauge/ length | 29G x 5/16" | 29G x 1/2" | Ranging from 18G – 27G3/8" - 1 1/2" |
| Principle of Operation | Same as predicate | Manually | Manually |
The similarities and differences are summarized in the table below.
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| Unit packaging | Hard pack consisting of cap andshort case | Hard pack consisting of cap andshort case | Hard pack consisting of cap andlong or short case |
|---|---|---|---|
| Wall Thickness | Thin Wall | Thin wall | Ultra thin + thin + regular wall |
| Sterilization | EtO to SAL 10-6 | EtO to SAL 10-6 | EtO to SAL 10-6 |
| Shelf life | 5 years | 5 years | 5 years |
II.6. Summary of Verification Activities
Design verification activities were conducted for the 29G x 5/16" Thin Wall K-Pack II Needles to demonstrate substantial equivalence to the predicate devices. This is for confirmation purpose only.
Summary of the verification activities including acceptance criteria is given in the table below:
| TEST | ACCEPTANCE CRITERIA |
|---|---|
| 1. Visual appearance | Silicon amount on cannula not visible as droplets. |
| 2. Limits for acidity or alkalinity | $\Delta$ 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 29G K-Pack II Needles has a content of extractable metalswhich is, when corrected for the metal content of the control fluid:$\Sigma Pb, Sn, Zn, Fe \le 5 mg/l$$Cd < 0.1 mg/l$ |
| 4. Needle Penetration Resistance | The penetration resistance of cannula point and drag complies with the limits specifiedas follow: $Point value \le 0.10 N$ and $Drag Value \le 0.04 N$ |
| 5. Conical fitting | The taper of the hub meets the gauging requirements of ISO 594-1. |
| 6. Fitting strength hub/case | The force to pull axially the needle hub from the case is minimum 0.5 N and maximum25 N. |
| 7. Effective needle length | The effective length = nominal length + 1 mm/-2 mm. |
| 8. 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. |
| 9. Resistance to breakage | The cannula does not break when tested in accordance with EN ISO 9626. |
| 10. Stiffness test cannula | The cannula shall show a deflection not greater than 0.37 mm in accordance with ENISO 9626. |
| 11. Corrosion Resistance(cannula) | The cannula shall show no signs of corrosion caused by the immersion in a sodiumchloride solution 0.5 M. |
| 12.Bonding strength between huband cannula | The bonding strength between hub and cannula is $\ge$ 22N. |
| 13. Liquid leakage | There is no leak of liquid at the luer (lock) fitting when the needle hub is fixed toreference control fitting in accordance with to ISO 594-1 and ISO 594-2. |
| 14. Air leakage | There is no air leakage at luer (lock) fitting when the needle hub is fixed to a referencecontrol fitting in accordance with to ISO 594-1 and ISO 594-2. |
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| 15. Flow rate | Tolerance on flow rate: between 80% and 125% of nominal value. |
|---|---|
| 16. Torque Force Cap-Case | The torque force required to break the label and to remove the cap from the case is notmore than 25 N.cm. |
| 17. Endotoxin reaction | The device is free from endotoxin reaction in accordance with European Pharm. 2.6.14. |
| 18. Abnormal toxicity | The device is free from abnormal toxicity in accordance with European Pharm. 2.6.9. |
| 19. Sterility | The device is sterile in accordance with European Pharm. 2.6.1. |
II.7. Additional Information
The sterility of the 29G x 5/16" 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 29G x 5/16" 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 29G x 5/16" Thin Wall K-Pack II Needles has been established at 5 years which is the same as the cleared K-Pack II Needles.
II.8. Conclusion
In summary, the 29G x 5/16" Thin Wall K-Pack II Needles are substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:
Differences between the devices do not raise any new issues of safety or effectiveness.
§ 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).