(263 days)
No
The device description and performance studies focus on the physical characteristics and sterility of a pen needle, with no mention of AI or ML capabilities.
No
The device is a needle intended for drug delivery, not for treating a disease or condition itself.
No
This device is a pen needle intended for drug injection, not for diagnosis. Its purpose is to deliver substances, not to identify or monitor medical conditions.
No
The device description clearly outlines a physical pen needle assembly with components like a cannula, hub, shields, and a seal. It also details non-clinical performance studies related to physical properties and sterility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of drugs." This describes a device used to administer substances into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a needle assembly designed to attach to a pen injector for drug delivery. It focuses on the physical components and their function in injection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DROPLET® PEN NEEDLE 34G does not fit this description.
N/A
Intended Use / Indications for Use
The DROPLET® PEN NEEDLE 34G is intended for use with pen injector devices for the subcutaneous injection of drugs.
Product codes
FMI
Device Description
DROPLET® PEN NEEDLES 34G are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. The pen needles are OTC devices.
The pen needle assembly consists of a double-ended into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end of the cannula are lubricated using a siliconebased lubricant for ease of injection and rubber septum penetration.
There is an inner needle shield assembled over the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-Clinical Performance Data:
DROPLET® PEN NEEDLE 34G successfully passed all the required non-clinical testing which included the following:
- Testing for compliance with the requirements of 11608-2:2012 Needle-based injection systems for medical use -Requirements and test methods -- Part 2: Needles.
The table below presents the requirements of the 11608-2:2012 Needle-based injection systems for medical use --● Requirements and test methods -- Part 2: Needles standard and the result of the testing conducted.
Biocompatibility testing:
The Biological Tests selected to be performed on the has direct contact with the end-user according to the 2016 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" contact type (externally communicating device, blood path indirect) and duration (prolonged contact (>24h to 30 days) were as follows:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Subacute/subchronic Toxicity
- Material-Mediated Pyrogenicity
- Hemocompatibility
Biocompatibility tests selected as per the requirements of 2016 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" considering contact type and duration for the DROPLET® PEN NEEDLE 34G did not show any adverse biological / biocompatibility reactions.
Sterility testing:
The DROPLET® PEN NEEDLE 34G is sterilized through Ethylene Oxide. The sterilization methodology has been validated per ISO 11 135-7:2014 overkill method (half cycle) with residuals of 0.0267 mg/device at a sterility assurance level (SAL) of 10°. The device is labeled non-pyrogenic and has been tested through LAL (USP ).
- Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16 and after accelerated aging was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the proposed device: .
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Bubble leak per ASTM 2096
- Shelf life of 5 years is validated using the FDA recognized standard Guide for Accelerated Aging of ● Sterile Barrier Systems for Medical Devices
Clinical Performance Data:
Clinical data is not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 21, 2020
HTL-Strefa S.A Aleksandra Prazmowska-Wilanowska Regulatory Affairs Director Adamowek 7 Ozorkow, 95-035 Pl
Re: K192082
Trade/Device Name: Droplet Pen Needle 34G Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 20, 2020 Received: March 23, 2020
Dear Aleksandra Prazmowska-Wilanowska:
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 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
1
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 mediation-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 CAPT Alan Stevens Assistant Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192082
Device Name DROPLET PEN NEEDLE 34G
Indications for Use (Describe)
The DROPLET® PEN NEEDLE 34G is intended for use with pen injector devices for the subcutaneous injection of drugs.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
As required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR §807.92(a).
Summary [807.92 (a)(1,2)] Date Prepared: March 20, 2020 HTL-STREFA S.A. Submitted By: ul. Adamówek 7 95-035 Ozorków POLAND Primary Contact: Aleksandra Prażmowska-Wilanowska RA Director Phone: +48 42 270 00 16 ola.prazmowska-wilanowska@htl-strefa.pl Izabela Banaś Secondary Contact: Senior RA Specialist Phone: +48 42 270 02 93 izabela.banas@htl-strefa.pl Trade Name: DROPLET® PEN NEEDLE 34G Common Name: Pen Needle Regulation Number: 21 CFR § 880.5570 Regulation Name Needle, Hypodermic, Single Lumen
4
| Product Code: | FMI |
|---|---|
| Device Classification: | II |
Review Panel: General Hospital
Predicate Device
[807.92(a)(3)]
The legally marketed device to which substantial equivalence is claimed is:
Predicate device:
| Manufacturer Name | Trade Name | 510(k) Number |
|---|---|---|
| Terumo Medical Corporation | Terumo® Pen Injector Needle 34 | K140516 |
Reference device:
| Manufacturer Name | Trade Name | 510(k) Number |
|---|---|---|
| HTL-Strefa S.A. | DROPLET® PEN NEEDLE | K171982 |
The reference device cleared under K171982 has been included in this submission to cover the indications for use of the subject device.
5
Description of Device:
[807.92(a)(4)]
DROPLET® PEN NEEDLES 34G are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. The pen needles are OTC devices.
The pen needle assembly consists of a double-ended into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end of the cannula are lubricated using a siliconebased lubricant for ease of injection and rubber septum penetration.
There is an inner needle shield assembled over the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.
Indications for Use:
[807.92(a)(5)]
The DROPLET® PEN NEEDLES 34G are intended for use with pen injector devices for the subcutaneous injection of drugs.
Technological Characteristics:
[807.92(a)(6)]
A comparison of characteristics of DROPLET® PEN NEEDLE 34G, the predicate device and the reference device is shown in the table below:
6
| Feature | Subject Device
DROPLET® PEN
NEEDLE 34G | Predicate Device
Terumo® Pen Injector
Needle 34 | Reference Device
DROPLET® PEN
NEEDLE | Conclusion |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 510(k) Number | pending | K140516 | K171982 | n/a |
| Product Code | FMI | FMI | FMI | Same |
| Design | | Primary Container | | Same |
| | | Needle Shield | | Same |
| | | Needle Tube and Hub | | Same |
| Indications for use | The DROPLET® PEN
NEEDLE 34G is
intended for use with a
pen injector device for
the subcutaneous
injection of drugs. | The Terumo® Pen Injector
Needle 34 is intended for use
with a pen injector device
for the subcutaneous
injection of drugs, including
insulin. | The Droplet® Pen
Needle is intended
for use with a pen
injector device for the
subcutaneous
injection of drugs. | Similar to
predicate
Same as
reference |
| Length | 3.5mm
-0.4mm +0.5mm | 4mm ±1.25mm | 12 mm, 10 mm, 8
mm, 6mm, 5 mm,
4mm | See
Discussion |
| Feature | Subject Device
DROPLET® PEN
NEEDLE 34G | Predicate Device
Terumo® Pen Injector
Needle 34 | Reference Device
DROPLET® PEN
NEEDLE | Conclusion |
| Gage | 34G | 34G | 29G, 30G, 31G, 32G | Same as
predicate |
| Method of
attachment to pen
injector | Screw threads | Screw threads | Screw threads | Same |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Conforms to
ISO 10993-1 | Same |
| Sterility | SAL = 10-6 | SAL = 10-6 | SAL = 10-6 | Same |
| Sterilization method | EtO | E-beam radiation | Gamma irradiation | See
Discussion |
| Unit Packaging | Polypropylene container
with seal made of medical
grade paper | Polypropylene container with
seal made of medical grade
paper | Polypropylene container
with seal made of
medical grade paper | See
Discussion |
| User Packaging | Cardboard sales box | Cardboard sales box | Cardboard sales box | See
Discussion |
| Feature | Subject Device
DROPLET® PEN
NEEDLE 34G | Predicate Device
Terumo® Pen Injector
Needle 34 | Reference Device
DROPLET® PEN
NEEDLE | Conclusion |
| | | Materials | | |
| Needle Tube | Stainless steel
AISI 304L | Stainless steel | Stainless steel
AISI 304 | See
Discussion |
| Hub
Primary Container
Needle Shield | Plastic resins | Plastic resins | Plastic resins | See
Discussion |
| Lubricant | Medical grade silicone | Silicon oil | Medical grade silicone | See
Discussion |
Device Comparison between Subject Device, Predicate Device Including Indications for Use
7
8
9
Discussion of differences:
HTL-STREFA S.A. has determined that the Droplet® Pen Needle 34G is substantially equivalent to a predicate device currently cleared for marketing in the United States.
The Droplet® Pen Needle 34G is substantially equivalent to the Terumo® Pen Injector Needle 34 cleared under K140516 in terms of indications for use, compositions, material, design and performance. Specifically, the following performance comparisons were made to determine equivalence to the predicate devices pen need: length, gauge, biocompatibility, materials, shelf life and sterility. Based on the comparisons above of the predicate devices Pen Needle 34G has raised no different questions of safety and effectiveness.
The intended use of the devices are identical (the injection of fluids subcutaneously), and the indications only differ slightly between the subject device and the predicate. The subject device only differs from Terumo® Pen Injector Needle 34 cleared under K140516 in that insulin is not specified. This difference is adequate because the indications for use is within the scope of the predicate, which specifies for the delivery of drugs.
The difference in needle length between the Droplet® Pen Needle 34G and the predicate device - 3.5 mm (Droplet 34G) vs. 4 mm (Terumo 34G) has also been analyzed. Based on all available design, technological information as well as the published scientific and clinical data, we have concluded that the Droplet 34G, 3.5 mm, with tightened tolerance limits (-0.4mm +0.5mm), is within the same needle length range as the predicate 4mm (±1.25 mm) and thereby substantially equivalent. The results of the bench testing indicate that the Droplet 34G, 3.5mm needle ensures the same level of confidence for needle safety with regard to ensuring subcutaneous injection as the Terumo 34G, 4mm needle.
Finally, available scientific data confirms that a 3.5 mm needles provide reliable subcutaneous drug delivery, as confirmed in clinical study reported by de Berardis et al. in 20181.
¹ De Berardis G, Scardapane M, Lucisano G, Abbruzzese S, Bossi AC, Cipponeri E, Lancione R, Marelli G, Sciangula L, Nicolucci A. Efficacy, safety and acceptability of the new per randomized non-inferiority trial: AGO 02 study. Curr Med Res Opin. 2018 Sep:34(9):1699-1704.
10
Based on the above analysis of the needle length, it has been concluded that difference in needle length between the Droplet 34G device and the Terumo 34G device does not impact safety or performance of the former device and raises no different questions of safety and performance.
The difference in sterilization was addressed through validation per ISO 11135-7:2014 and reaching assurance level(SAL) of 10-6. The ethylene oxide residual levels were found to be 0.0268 mg/device, an acceptable level for the device type and use duration.
The difference in materials of construction were addressed through biocompatibility testing leveraged from the reference device per ISO 10993-1.
HTL-STREFA S.A. has determined that the Droplet® Pen Needle 34G is substantially equivalent to a predicate device currently cleared for marketing in the United States.
Non-Clinical Performance Data:
[(807.92(b)(1)]
DROPLET® PEN NEEDLE 34G successfully passed all the required non-clinical testing which included the following:
- · Testing for compliance with the requirements of 11608-2:2012 Needle-based injection systems for medical use -Requirements and test methods -- Part 2: Needles
- The table below presents the requirements of the 11608-2:2012 Needle-based injection systems for medical use --● Requirements and test methods -- Part 2: Needles standard and the result of the testing conducted.
11
| Test Parameter | Clause no. & requirement of ISO 11608-2:2012 | Result |
|---|---|---|
| Materials | 4.1 The needle shall be made of tubing materials specified in ISO 9626. | Meets requirements |
| Dimensions | 4.2 The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. | Meets requirements |
| Determination of flow | ||
| rate through the needle | 4.3 The needle was tested in accordance with Annex A to ISO 11608-2 to determine | |
| flow rate through the needle. | Meets requirements | |
| Bond between hub and | ||
| needle tube | 4.4 The union of the hub and needle tube shall not break when tested in accordance with | |
| Clause 9 of ISO 11608-2. | Meets requirements | |
| Needle points | 4.5 When examined under a magnification of x2,5, needle points shall appear sharp and | |
| free from feather edges, burrs and hooks. | Meets requirements | |
| Freedom from defects | 4.6 The needle tube shall fulfill the requirements of ISO 7864, 11.3. | Meets requirements |
| Lubrication | 4.7 The needle tube should be lubricated at both the patient end and the cartridge end. | |
| The lubricant shall not, under normal or corrected-to-normal vision, be visible as | ||
| droplets of fluid on the outside surface of the needle tube. | Meets requirements | |
| Dislocation of measuring | ||
| point at patient end | 4.8 Dislocation of the cannula point at the patient end shall be in accordance with Table | |
| 2 below when tested as per Clause 8 (of ISO 11608-2). | Meets requirements | |
| Determination of | ||
| functional compatibility | ||
| with needle-based | ||
| injection systems | 4.9 Compatibility with any NIS shall be claimed only after testing in accordance with | |
| Clause 11. | Meets requirements | |
| Test Parameter | Clause no. & requirement of ISO 11608-2:2012 | Result |
| Ease of assembly and | ||
| disassembly | 4.10 Attachment of the needle shall be possible without removing the needle from its | |
| opened unit packaging. Compliance is checked according to the requirements of Clause |
-
| Meets requirements |
| Sterility | 4.11 The needle in its unit packaging shall have been subjected to a validated
sterilization process. | Meets requirements |
| Pre-conditioning of
needles | 6 All requirements of the standard related to preconditioning of needles were met. | Meets requirements |
12
Biocompatibility testing:
Selection of Biological Evaluation Tests
The Biological Tests selected to be performed on the has direct contact with the end-user according to the 2016 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" contact type (externally communicating device, blood path indirect) and duration (prolonged contact (>24h to 30 days) were as follows:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation or Intracutaneous Reactivity
-
- Acute Systemic Toxicity
-
- Subacute/subchronic Toxicity
-
- Material-Mediated Pyrogenicity
-
- Hemocompatibility
Biocompatibility tests selected as per the requirements of 2016 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" considering contact type and duration for the DROPLET® PEN NEEDLE 34G did not show any adverse biological / biocompatibility reactions.
13
Sterility testing:
The DROPLET® PEN NEEDLE 34G is sterilized through Ethylene Oxide. The sterilization methodology has been validated per ISO 11 135-7:2014 overkill method (half cycle) with residuals of 0.0267 mg/device at a sterility assurance level (SAL) of 10°. The device is labeled non-pyrogenic and has been tested through LAL (USP ).
- . Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16 and after accelerated aging was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the proposed device: .
- 0 Seal strength ASTM F88/F88-15
- o Dye penetration ASTM F1929-15
- o Bubble leak per ASTM 2096
- Shelf life of 5 years is validated using the FDA recognized standard Guide for Accelerated Aging of ● Sterile Barrier Systems for Medical Devices
Clinical Performance Data:
[(807.92(b)(2)]
Clinical data is not required.
Conclusion:
[(807.92(b)(3)]
DROPLET® PEN NEEDLE 34G is concluded to be substantially equivalent in the intended use, technology/principle of operation. materials and performance to the predicate device.