(253 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and physical properties, with no mention of AI or ML.
No
The device is a safety needle intended for drug injection, designed to minimize needle stick risk, not to treat or diagnose a disease or condition.
No
The device is a pen needle intended for drug injection, not for diagnosing conditions.
No
The device description clearly outlines a physical medical device (pen needles) with mechanical components and a safety feature. There is no mention of any software component.
Based on the provided information, the DropSafe Safety Pen Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the injection of drugs using pen injector devices. This is a direct administration of a substance into the body.
- Device Description: The description focuses on the physical mechanism of the needle for injection and safety features to prevent needle sticks. It describes a device used for delivering something into the body, not for testing samples from the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The DropSafe Safety Pen Needles are a drug delivery device with a safety feature.
N/A
Intended Use / Indications for Use
The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs. DropSafe Safety Pen Needles are OTC devices intended to be used by clinical and non-clinical users. DropSafe Safety Pen Needles are offered in one gage - 31 G and in two lengths: 6mm and 8 mm. DropSafe Safety Pen Needles are gamma sterilized, non-toxic single use devices.
The device is designed to minimize the risk from accidental needle sticks with a used needle by application of a sharps injury prevention feature. Following use, the needle is locked out preventing reuse. The shield also serves to hide the needle before and after injection.
Each DropSafe safety pen needle is individually packaged in a sealed container. The DropSafe safety pen needle is used by removing the seal and attaching it to the pen injector device to administer a drug subcutaneously. While inserting the needle into the skin at a 90° angle, the slides into the shield. While the slider glides into the shield, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked.
The red safety lock indicator tells the user that the safety lock has been activated. Once the safety pen needle is in the locked mode, it cannot be reused. The safety pen needle is detached from the pen injector device and disposed of into a sharps container.
The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using an adhesive. The hub has internal threads which allows it to be screwed onto the pen injector device. This allows the cartridge end of the needle 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. An injection molded inner shield is assembled over the patient end of the cannula to prevent needle point damage and accidental needle-sticks. This needle assembly is inserted into a protective injection molded container and sealed with a peel away medical grade paper tab which provides a sterility barrier and tamper evident seal.
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
OTC devices intended to be used by clinical and non-clinical users.
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:
Verification/Validation testing was conducted in compliance with the requirements of ISO 11608- 2:2012. All testing met the applicable requirements for:
- Materials: The needle shall be made of tubing materials specified in ISO 9626. Result: Meets standard.
- Dimensions: The needles shall fit the test apparatus specified in clause 7.3 of ISO 11608-2. Result: Meets standard.
- Determination of flow rate through the needle: The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle. Result: Meets standard.
- Bond between hub and needle tube: The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. Result: Meets standard.
- Freedom from defects: The needle tube shall fulfill the requirements of ISO 7864, clause 11.3. Result: Meets standard.
- Lubrication: 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. Result: Meets standard.
- Dislocation of measuring point at patient end: Dislocation of the cannula point at the patient end shall be in accordance with Table 2 below when tested in accordance with Clause 8 (of ISO 11608-2). Result: Meets standard.
- Determination of functional compatibility with needle-based injection systems: Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11. Result: Meets standard.
- Ease of assembly and disassembly: 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. Result: Meets standard.
- Pre-conditioning of needles: All requirements of the standard related to preconditioning of needles were met. Result: Meets standard.
Clinical Performance Data:
Testing was performed to evaluate the function of the safety feature in a simulated clinical environment with the participation of both clinical and non-clinical users. The Simulated Use Study was performed to validate the Instructions For Use (IFU) with the participation of clinical and non-clinical users. As evidenced in the study, the use of this device does not affect the injection technique or the functionality of the pen injector and is safe and effective when used as per the Instructions for Use.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "ADMINISTRATION".
December 12, 2017
HTL-Strefa S.A. Aleksandra Prazmowska-Wilanowska Ouality Assurance & Regulatory Affairs Director Adamowek 7 Ozorkow. 95-035 POLAND
Re: K170988
Trade/Device Name: DropSafe Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 07, 2017 Received: November 13, 2017
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. 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
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 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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3
510(k) Summary ُ K170988
As required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR §807.92(a).
[807.92 (a)(1,2)]
| Date Summary
| Prepared: | December 5, 2017 |
|---|---|
| Submitted By: | HTL-STREFA S.A. |
| ul. Adamówek 7 | |
| 95-035 Ozorków | |
| POLAND | |
| Phone: +48 42 270 00 10 | |
| Fax: +48 42 270 00 20 | |
| Primary Contact: | Aleksandra Prażmowska-Wilanowska |
| QA/RA Director | |
| ola.prazmowska-wilanowska@htl-strefa.pl | |
| Secondary Contact: | Izabela Banaś |
| Senior RA Specialist | |
| izabela.banas@htl-strefa.pl | |
| Trade Name: | DropSafe Safety Pen Needles |
| Models: | 31G x 6mm, 31G x 8 mm |
| Common Name: | Insulin Pen Needle |
| Regulation Number: | 21 CFR § 880.5570 |
| Product Code: | FMI |
| Device Classification: | II |
| Review Panel: | 80 General Hospital |
4
Predicate Device [807.92(a)(3)]
The legally marketed devices to which substantial equivalence is claimed is:
Predicate Device:
| Manufacturer | Trade Name | 510(k) Number |
|---|---|---|
| Becton Dickson & Co. | BD AUTOSHIELD | K110703 |
| DUOTM PEN NEEDLE |
Secondary Predicate Device
| Manufacturer Name | Trade Name | 510(k) Number |
|---|---|---|
| HTL-Strefa S.A. | Droplet Pen Needle | K143437 |
The secondary predicate device has been included in this submission to cover the gage and lengths of the New Device - 31G x 6mm and 31G x 8mm. The difference between the New Device and the Secondary Predicate Device is the sharps prevention feature which was added to the New Device. Otherwise, the Secondary Predicate Device and the New Device are identical with regard to raw materials, sterilization method and biocompatibility requirements. The New Device is manufactured in identical production conditions as the secondary predicate device cleared under K143437.
Description of Device: [807.92(a)(4)]
Device description
DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs. DropSafe Safety Pen Needles are OTC devices intended to be used by clinical and non-clinical users. DropSafe Safety Pen Needles are offered in one gage - 31 G and in two lengths: 6mm and 8 mm. DropSafe Safety Pen Needles are gamma sterilized, non-toxic single use devices.
The device is designed to minimize the risk from accidental needle sticks with a used needle by application of a sharps injury prevention feature. Following use, the needle is locked out preventing reuse. The shield also serves to hide the needle before and after injection.
Each DropSafe safety pen needle is individually packaged in a sealed container. The DropSafe safety pen needle is used by removing the seal and attaching it to the pen injector device to administer a drug subcutaneously. While inserting the needle into the skin at a 90° angle, the slides into the shield. While the slider glides into the shield, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked.
5
The red safety lock indicator tells the user that the safety lock has been activated. Once the safety pen needle is in the locked mode, it cannot be reused. The safety pen needle is detached from the pen injector device and disposed of into a sharps container.
The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using an adhesive. The hub has internal threads which allows it to be screwed onto the pen injector device. This allows the cartridge end of the needle 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. An injection molded inner shield is assembled over the patient end of the cannula to prevent needle point damage and accidental needle-sticks. This needle assembly is inserted into a protective injection molded container and sealed with a peel away medical grade paper tab which provides a sterility barrier and tamper evident seal.
Indications for Use: [807.92(a)(5)]
The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs.
Technological Characteristics: [807.92(a)(6)]
A comparison of characteristics of DropSafe Safety Pen Needles and the predicate device and the secondary predicate device is shown in the table below:
| Device Name | New Device | Predicate Device | Secondary Predicate
Device |
|------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Manufacturer | HTL-STREFA S.A. | BD AutoShield™ Duo Pen
Needle | Droplet Pen Needle |
| 510(k) Number | Pending | K110703 | K143437 |
| Intended use | Intended for use with
pen injector devices for
the injection of drugs | Intended for use with pen
injector devices for the
injection of drugs | Intended for use with
pen injector device for
the subcutaneous
injection of insulin |
| Operation
principle | Manual | Manual | Manual |
| Design | Needle assembly -
cannula, hub, primary
container,
seal, needle shield,
slider, spring- operated | Needle assembly -
cannula, hub, primary
container,
seal, needle shield, slider,
spring- operated | Needle assembly -
cannula, hub, primary
container, seal, needle
shield |
| Product Code | FMI | FMI | FMI |
6
| Device Name | New Device | Predicate Device | Secondary Predicate
Device |
|-----------------------------------------|----------------------------------|----------------------------------|-----------------------------------|
| Length | 6mm, 8 mm | 5mm | 4mm, 5mm, 6mm,
8mm, 10mm, 12mm |
| Gage | 31G | 31G | 29G, 31G, 32G |
| Biocompatibility | Conforms to
ISO 10993-1 | Conforms to ISO
10993-1 | Conforms to
ISO 10993-1 |
| Sterilization | Gamma radiation | Gamma radiation | Gamma radiation |
| Needle tube | Medical Grade
Stainless Steel | Medical Grade
Stainless Steel | Medical Grade
Stainless Steel |
| Hub, Primary
Container and
Shield | Plastic resin | Plastic resin | Plastic resin |
| Spring | Stainless steel wire | Stainless steel wire | n/a |
| Sharps Prevention
feature | Yes | Yes | n/a |
The new device, the predicate device and the secondary 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 indications for use of the new device and the predicate and the secondary predicate devices is identical / substantially equivalent (intended for use with pen injector devices for the injection of drugs / insulin, respectively).
The technological and design differences between the new device and the secondary predicate device do not raise any new or different questions of safety or effectiveness.
7
Non-Clinical Performance Data:
[(807.92(b)(1)]
Verification/Validation testing was conducted in compliance with the requirements of ISO 11608- 2:2012 as summarized below. All testing met the applicable requirements.
| Test parameter | Requirement – ISO 11608-2:2012 | Result |
|---|---|---|
| Materials | The needle shall be made of tubing materials specified in ISO 9626. | Meets standard |
| Dimensions | The needles shall fit the test apparatus specified in clause 7.3 of ISO 11608-2. | Meets standard |
| Determination of flow rate through the needle | The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle. | Meets standard |
| Bond between hub and needle tube | The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. | Meets standard |
| Freedom from defects | The needle tube shall fulfill the requirements of ISO 7864, clause 11.3. | Meets standard |
| Lubrication | 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 standard |
| Dislocation of measuring point at patient end | Dislocation of the cannula point at the patient end shall be in accordance with Table 2 below when tested in accordance with Clause 8 (of ISO 11608-2). | Meets standard |
| Determination of functional compatibility with needle-based injection systems | Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11. | Meets standard |
| Ease of assembly and disassembly | 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 standard |
| Pre-conditioning of needles | All requirements of the standard related to preconditioning of needles were met. | Meets standard |
8
DropSafe Safety Pen Needle & pen injector compatibility - pen injectors available and cleared in the USA:
| Manufactured by | Brand: |
|---|---|
| Eli Lilly | HumaPen® L U X U R A HD |
| Eli Lilly | HumaPen® L U X U R A |
| Eli Lilly | HumaPen® savvio |
| Eli Lilly | HumaPen® Ergo |
| Eli Lilly | HumaPen® Ergo II |
| Owen Mumford | Autopen® |
| Haselmeier | TactiPen® |
| Novo Nordisk | NovoPen® |
Clinical Performance Data: [(807.92(b)(2)]
FDA GUIDANCE Medical Devices with Sharps Injury Prevention Features (issued on August 9, 2005).
Testing was performed to evaluate the function of the safety feature in a simulated clinical environment with the participation of both clinical and non-clinical users. The Simulated Use Study was performed to validate the Instructions For Use (IFU) with the participation of clinical and non-clinical users. As evidenced in the study, the use of this device does not affect the injection technique or the functionality of the pen injector and is safe and effective when used as per the Instructions for Use.
Conclusion:
[(807.92(b)(3)]
DropSafe Safety Pen Needles are substantially equivalent in the intended use, technology/principle of operation, materials and performance to the predicate device and the secondary predicate and do not raise any new questions of safety and effectiveness.