(59 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a pen needle, with no mention of AI or ML.
No.
This device is a pen needle used for drug injection, which is a delivery mechanism for a drug rather than a therapeutic device that provides therapy itself.
No
The device description states that the pen needles are "intended for use with pen injector devices for the subcutaneous injection of drugs," indicating a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines physical components like cannulas, hubs, shields, and covers, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with pen injector devices for the subcutaneous injection of drugs." This describes a device used to administer medication directly into the body, not to test samples taken from the body.
- Device Description: The description details a needle assembly designed to attach to a pen injector and penetrate the skin for drug delivery. This aligns with a device used for therapeutic administration, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis or monitoring of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is purely for drug delivery.
N/A
Intended Use / Indications for Use
The DROPLET PEN NEEDLES 30G & 33G are intended for use with pen injector devices for the subcutaneous injection of drugs.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
DROPLET® PEN NEEDLES 30G & 33G 4G 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 cannula that is assembled 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 and the cartridge end of the cannula are lubricated using a silicone -based lubricant for ease of injection and rubber septum penetration.
There is an inner needle shield assembled over the patient end of 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
DROPLET® PEN NEEDLE 30G & 33G 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. All requirements of ISO 11608-2:2012 were met, including materials, dimensions, flow rate, bond between hub and needle tube, needle points, freedom from defects, lubrication, dislocation of measuring point at patient end, functional compatibility with needle-based injection systems, ease of assembly and disassembly, sterility, and pre-conditioning of needles.
Biocompatibility testing:
The Biological Tests selected to be performed on the sterile final product that 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" considering contact type and duration were as follows:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation or Intracutaneous Reactivity
-
- Acute Systemic Toxicity
-
- ISO Two Week Systemic Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts
-
- 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 30G & 33G did not show any adverse biological / biocompatibility reactions.
Clinical Performance Data:
Clinical data is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2020
HTL-Strefa S.A. Aleksandra Prazmowska-Wilanowska OA/RA Director Adamowek 7 Ozorkow. 95-035 Poland
Re: K202340
Trade/Device Name: Droplet Pen Needle 30G & 33G Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 4, 2020 Received: August 17, 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
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 CPT 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) K202340
Device Name Droplet Pen needle 30G &33G
Indications for Use (Describe)
The DROPLET PEN NEEDLES 30G & 33G are intended for use with pen injector devices for the subcutaneous injection of drugs.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K202340
| Date Prepared: | October, 7th, 2020 |
|---|---|
| Submitted By: | HTL-STREFA S.A. |
| 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 | |
| Secondary Contact: | Izabela Banaś |
| Senior RA Specialist | |
| Phone: +48 42 270 02 93 | |
| izabela.banas@htl-strefa.pl | |
| Trade Name: | DROPLET® PEN NEEDLE 30G & 33G |
| Common Name: | Pen Needle |
| Regulation Number: | 21 CFR § 880.5570 |
| Product Code: | FMI |
| Device Classification: | II |
| Review Panel: | 80 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 |
|---|---|---|
| HTL-Strefa S.A. | Droplet pen needle 34G | K192082 |
Description of Device:
4
[807.92(a)(4)]
DROPLET® PEN NEEDLES 30G & 33G 4G 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 cannula that is assembled 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 and the cartridge end of the cannula are lubricated using a silicone -based lubricant for ease of injection and rubber septum penetration.
There is an inner needle shield assembled over the patient end of 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 30G & 33G 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 30G, 33G and the predicate device is shown in the table below:
Device Comparison between Subject Device and Predicate Device Including Indications for Use
| Feature | Subject Device
DROPLET® PEN
NEEDLE 30G | Subject Device
DROPLET® PEN
NEEDLE 33G | Predicate Device
DROPLET® PEN
NEEDLE 34G | Conclusion |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k)
Number | K202340 | K202340 | K192082 | |
| Product Code | FMI | FMI | FMI | Same |
| Feature | Subject Device
DROPLET® PEN
NEEDLE 30G | Subject Device
DROPLET® PEN
NEEDLE 33G | Predicate Device
DROPLET® PEN
NEEDLE 34G | Conclusion |
| Primary
Container | Image: Primary Container for DROPLET® PEN NEEDLE 30G | Image: Primary Container for DROPLET® PEN NEEDLE 33G | Image: Primary Container for DROPLET® PEN NEEDLE 34G | Same |
| Design
Needle Shield | Image: Needle Shield for DROPLET® PEN NEEDLE 30G | Image: Needle Shield for DROPLET® PEN NEEDLE 33G | Image: Needle Shield for DROPLET® PEN NEEDLE 34G | Same |
| Needle Tube and
Hub | Image: Needle Tube and Hub for DROPLET® PEN NEEDLE 30G | Image: Needle Tube and Hub for DROPLET® PEN NEEDLE 33G | Image: Needle Tube and Hub for DROPLET® PEN NEEDLE 34G | Different
No impact
on safety
or
effective |
| Indications
for use | The DROPLET®
PEN NEEDLE
30G is intended
for use with a pen
injector device
for the
subcutaneous
injection of | The DROPLET®
PEN NEEDLE
33G is intended
for use with a pen
injector device
for the
subcutaneous
injection of | The DROPLET®
PEN NEEDLE
34G is intended
for use with a pen
injector device
for the
subcutaneous
injection of | Same |
| Length | 8 mm | 4 mm | 3.5 mm | Different
No
impact
on safety |
| Gage | 30G | 33G | 34G | Different
No
impact
on safety |
| Method of
attachment
to pen
injector | Screw threads | Screw threads | Screw threads | Same |
| Feature | Subject Device
DROPLET® PEN
NEEDLE 30G | Subject Device
DROPLET® PEN
NEEDLE 33G | Predicate Device
DROPLET® PEN
NEEDLE 34G | Conclusion |
| Biocompatibi
lity | 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 | EtO | EtO | Same |
| 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 | Same |
| User
Packaging | Cardboard sales box | Cardboard sales box | Cardboard sales box | Substantially
equivalent |
| | Materials | | | |
| Needle Tube | Stainless steel
AISI 304L | Stainless steel
AISI 304L | Stainless steel
AISI 304L | Same |
| Hub
Primary
Container
Needle
Shield | Plastic resins | Plastic resins | Plastic resins | Same |
| Lubricant | Medical grade
silicone | Medical grade
silicone | Medical grade
silicone | Same |
5
6
HTL-STREFA S.A. has determined that the Droplet® Pen Needle 30G & 33G is substantially equivalent to a predicate device currently cleared for marketing in the United States.
The subject device and the predicate device are classified under 21 CFR 880.5570, which states: "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 Droplet® Pen Needle 30G&33G is substantially equivalent to the Droplet® Pen Needle 34G cleared under K192082 in terms of indications for use, compositions, material, design and performance. Specifically, the following performance comparisons were made to determine equivalence to the predicate device pen needles referenced: length, gauge, biocompatibility,
7
materials, shelf life and sterility. Based on the comparisons above of the predicate devices the Droplet® Pen Needle 30G & 34G has raised no different questions of safety and effectiveness.
The difference in needle hub color between the proposed device and the predicate device - 30G x 8 mm and 33G x 4 mm vs. 34G x 3.5 mm has been analyzed. The different colored hubs were introduced for easy needle size identification (color coding for the user). The hubs, irrespective of their color, are made of the same raw materials and were assessed with regard to biocompatibility. No negative biological reaction is expected to occur as a result of the different color. Consequently, the hub color is considered not to have any impact on safety or performance of the proposed device.
The difference in needle gage and length between the proposed device and the predicate device - 30G x 8 mm and 33G x 4 mm vs. 34G x 3.5 mm has also been analyzed. Based on all available design, technical and technological information as well as the published scientific and clinical data and based on information on pen needles by other manufacturers available in the USA, we have concluded that the two proposed needle gages and lengths ensure the same level of confidence for device safety and performance with regard to ensuring subcutaneous injection. They are being introduced to meet individual needs of patients based on their skin type. BMI, and drug dosing and treatments.
Based on the above analysis of the needle length, it has been concluded that difference in needle gage or length between the Droplet 30G & 33G and the Droplet 34G device does not impact safety or performance of the former device and raises no different questions of safety and performance.
The proposed device and the predicate device are classified under 21 CFR 880.5570, which states: "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 subject device and the predicate device use statements similar to the underlined portion of the excerpt from the regulation.
HTL-STREFA S.A. has determined that the Droplet® Pen Needle 30G and 33G 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 30G & 33G 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
8
- 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.
| 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 | ||
| 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 11. | Meets | |
| requirements | ||
| Sterility | 4.11 The needle in its unit packaging shall has 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 |
9
Biocompatibility testing:
Selection of Biological Evaluation Tests
The Biological Tests selected to be performed on the sterile final product that 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" considering contact type and duration were as follows:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation or Intracutaneous Reactivity
-
- Acute Systemic Toxicity
-
- ISO Two Week Systemic Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts
-
- 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 30G & 33G did not show any adverse biological / biocompatibility reactions.
Clinical Performance Data:
[(807.92(b)(2)]
Clinical data is not required.
Conclusion:
[(807.92(b)(3)]
DROPLET® PEN NEEDLE 30G & 33G concluded to be substantially equivalent in the intended use, technology/principle of operation, materials and performance to the legally market predicate device.