(56 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and performance of a hypodermic needle, with no mention of AI or ML.
No.
The device is a hypodermic needle intended for injecting or withdrawing fluids, which is an instrumental function, not a therapeutic one by itself, as it does not directly treat or cure a medical condition.
No
Explanation: The device is a hypodermic needle intended for injecting or withdrawing fluids, which are procedures for treatment or collection, not diagnosis. It does not perform any analytical or interpretive function typical of a diagnostic device.
No
The device description clearly states it is comprised of a stainless steel tube and a female luer connector, indicating it is a physical hardware device. The performance studies also focus on physical characteristics and testing of the needle itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo, not for testing samples in vitro (outside the body).
- Device Description: The description of a hypodermic needle with a luer connector is consistent with a device used for injecting or withdrawing substances from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or any other activity typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical characteristics and functionality of the needle itself (cleanliness, size, strength, flow rate, etc.), not on the accuracy or reliability of a diagnostic test.
In summary, the device is a standard hypodermic needle used for procedures performed directly on a patient, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 21G x 2" 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.
Product codes
FMI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary verification and validation tests have been performed by testing the 21G x 2" 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:
- 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.
- Limits for acidity or alkalinity: Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid.
- Limits for extractable metals: The extract solution of the 21G 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/l Cd
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure with three faces in profile, stacked on top of each other. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2015
Terumo Europe N.V. Ms. M. J. Aerts Regulatory Affairs Manager Interleuvenlaan 40 3001 Leuven BELGIUM
Re: K150263
Trade/Device Name: K-Pack II Needle - 21G x 2" Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: March 9, 2015 Received: March 12, 2015
Dear Ms. 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.
1
Page 2 - Ms. 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
2
K150263
Indication for Use
510(k) Number (if known):
Device Name: K-Pack II Needle - 21G x 2"
Indication For Use:
The 21G x 2" 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)
3
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 Affairs
Tel. (+32) 16 38 13 53
Fax (+32) 16 40 02 49 |
| Date prepared: | March 2015 |
II.1. Device Name
Proprietary Name
K-Pack II Needle - 21G x 2"
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 - 21G x 2".
The 21G x 2" K-Pack II Needle is the same needle as the cleared 21G x 2" Neolus Needle covered in K001572. The only difference is that the Neolus Needle is packed in a blister pack while the K-Pack II Needle is packed in a hard pack consisting of a cap and a case.
4
The packaging of the 21G x 2" K-Pack II Needle is the same as the packaging of the cleared K-Pack II Needles covered in K984576. The only difference is that the case is longer (50 mm) compared to what has been cleared before (25 mm and 40 mm).
The 21 x 2" Gauge needle is also the same as the cleared 21 Gauge K-Pack II Needle covered in K984576 with the only difference of having a longer needle and a longer case as the cleared needle.
This Special 510k is being submitted due to potential issues specific for the longer case of the 21G x 2" K-Pack II Needle.
This 510k will provide supporting information that the 21G x 2" K-Pack II Needles are an acceptable extension of the current K-Pack II Needle product line.
II.4. Intended Use
The 21G x 2" 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 Neolus Needle - K001572.
-
II.5. Substantial Equivalence
The 21G x 2" K-Pack II Needles 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.
-
Neolus Needles (K001572) 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.
| | 21G x 2"
K-Pack II Needle
(Terumo Europe, Belgium)
(Subject of this 510k) | Neolus Needles
(Terumo Europe, Belgium)
(K001572) | K-Pack II Needles
(Terumo Europe, Belgium)
(K984576) |
|--------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same as predicate | Intended to inject fluids into, or
withdraw fluids from, parts of
the body below the surface of the
skin. | Intended to inject fluids into, or
withdraw fluids from, parts of
the body below the surface of the
skin. |
| Materials | Same as predicate | | |
| Cannula | Stainless Steel | Stainless Steel | Stainless Steel |
| Hub | Polypropylene | Polypropylene | Polypropylene |
| Glue | Epoxy glue | Epoxy glue | Epoxy glue |
| Lubricant | | Silicone | Silicone |
5
| Silicone | |||
|---|---|---|---|
| Description/ | |||
| Specifications | Same as predicate | 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. | 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. | |||
| Needle Gauge/ length | 21G x 2" | Ranging from 18G – 27G | |
| 1/2" - 2" | Ranging from 18G – 27G | ||
| 3/8" - 1 ½" | |||
| Principle of Operation | Same as predicate | Manually | Manually |
| Unit packaging | Hard pack consisting of cap and | ||
| long case | Blister pack | Hard pack consisting of cap and | |
| long or short case | |||
| Wall Thickness | Regular Wall | Ultra thin + thin + regular 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
All necessary verification and validation tests have been performed by testing the 21G x 2" 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:
| TEST | ACCEPTANCE CRITERIA |
|---|---|
| 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. | |
| 2. Limits for acidity or alkalinity | $\triangle$ 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 21G 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 ≤ 5 mg/l | |
| Cd |