Dual-Safety Pen Needle

• K Number: K191853
• Device Name: Dual-Safety Pen Needle
• Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.
• Date Cleared: 2019-09-05 ( 57 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.

Device Description

The device is a pen needle with shields at both the patient end and the pen connector end which are intended to reduce risk of needle stick before and after injections. The patient end mechanism shields the needle before and after an injection, and a second mechanism passively covers the pen connector needle following removal from the patient end shield indicates the needle has fully penetrated the skin. A second shield covers the pen connector needle when it is removed from the pen.

Predicate Devices

K161950

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical safety features and biocompatibility, with no mention of AI or ML.

Therapeutic

No.
The device is a pen needle intended for the subcutaneous injection of insulin, acting as a delivery accessory rather than having a direct therapeutic effect itself. Its function is to facilitate the administration of a therapeutic substance (insulin).

Diagnostic

No

The device is a pen needle used for subcutaneous injection of insulin, designed to reduce needle sticks. Its intended use and description focus on drug delivery and safety features, not on diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical pen needle with safety shields, not a software application. The performance studies focus on physical properties, biocompatibility, and sharps injury protection.

IVD (In Vitro Diagnostic)

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 insulin using pen injector devices. This is a direct medical intervention on the patient, not a test performed on a sample taken from the body to diagnose or monitor a condition.
• Device Description: The description focuses on the physical mechanism of the pen needle and its safety features for preventing needle sticks during injection and removal. This aligns with a device used for administering medication, not for diagnostic testing.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis, monitoring, or screening of a disease or condition.
• Performance Studies: The performance studies focus on the physical and safety aspects of the device (functionality, shelf life, biocompatibility, sharps injury protection, sterilization, packaging), not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc.

IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) outside of the body to provide information about a person's health. This pen needle is a delivery device for medication.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.

Product codes

FMI

Device Description

The device is a pen needle with shields at both the patient end and the pen connector end which are intended to reduce risk of needle stick before and after injections. The patient end mechanism shields the needle before and after an injection, and a second mechanism passively covers the pen connector needle following removal from the patient end shield indicates the needle has fully penetrated the skin. A second shield covers the pen connector needle when it is removed from the pen.

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

Clinical Simulated Use testing evaluated whether the posterior safety protective mechanism of the Dual Safety Pen Needle is effective. A total of 8 participants were selected to evaluate the subject device, and included endocrine doctors and nurses who provide training to patients in the use of pen needles for insulin injection. A total of 500 samples were tested and the evaluations resulted in zero failures of each of the Dual Safety Pen Needle.

Key Metrics

Not Found

Predicate Device(s)

K161950

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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 and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 5, 2019

Promisemed Hangzhou Meditech Co., Ltd. % John Beasley Senior Consultant MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 98015

Re: K191853

Trade/Device Name: Dual Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 10, 2019 Received: July 10, 2019

Dear John Beasley:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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Indications for Use

510(k) Number (if known) K191853

Device Name Dual Safety Pen Needle

Indications for Use (Describe)

The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.

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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510(k) Summary

Preparation Date: 09/05/2019

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Promisemed Hangzhou Meditech Co., Ltd.
Applicant Address	Bldg. 1, No. 12, Longtan Road, Cangqian Street, Yuhang District, Hangzhou City, Zhejiang, 311121, CH
Applicant Telephone Number	865-718-8772985
Applicant Contact	Mr. Zearou Yang
Applicant Contact Email	[e-mail]
Correspondent Name	MedTech Review, LLC
Correspondent Address	257 Garnet Garden Street, Henderson, NV, 89015, US
Correspondent Telephone Number	1-612-889-5168
Correspondent Contact	Mr. John Beasley, RAC (US)
Correspondent Contact Email	[e-mail]
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Dual Safety Pen Needle
Common Name	HYPODERMIC SINGLE LUMEN NEEDLE.
Classification Name	NEEDLE, HYPODERMIC, SINGLE LUMEN
Regulation Number	880.5570
Product Code	FMI
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate [510(k)] #	Predicate Trade Name	Product Code
K161950	Verifine ® Safety Type Insulin Pen Needle	FMI
Device Description Summary		21 CFR 807.92(a)(4)
Item	Subject Device
K191853	Predicate Device
K161950	Similarities/Differences
Product Code	FMI	FMI	No difference in FDA product code.
Intended Use	The Dual Safety Pen
Needle is intended for
use with pen injector
devices for
subcutaneous injection
of insulin. The product
has two safety shields
which lock in place after
use (patient-end) and
upon removal of the
needle from the pen
(pen connector-end).
The lock shields help
reduce the occurrence
of needle sticks from
both ends of the
needle.	The Safety Type Insulin
Pen Needle is intended
for use with pen injector
devices for
subcutaneous injection
of insulin. Additionally,
after withdrawal of the
Safety Type Insulin Pen
Needle from the body,
the attached needle
safety shield
automatically covers
the needle to minimize
the risk of accidental
needlestick.	The safety pen needle products (subject
device and predicate device) help protect
against accidental needle sticks and are
substantially equivalent in their intended use.
Operating
Principle	As the user proceeds
with inserting the
needle into the skin the
shield will retract.
After the injection is
completed and needle
is removed from the
skin, the shield will
automatically extend to
cover the needle and
lock in place.
A click of the patient
end shield indicates the
needle has fully
penetrated the skin. A
second shield covers
the pen connector
needle when the needle
is removed from the
pen.
Once the Dual Safety
Pen Needle is in the
locked mode, it can no
longer be used.	As the user proceeds
with inserting the
needle into the skin the
shield will retract.
After the injection is
completed and needle
is removed from the
skin, the shield will
automatically extend to
cover the needle and
lock in place.
This product features
an audible cue (a click)
when the injection is
complete.
Once the Safety Type
Insulin Pen Needle is in
the locked mode, it can
no longer be used.	The safety pen needle products (subject
device and predicate device) use the same
operating principles: the use of lock shields
that help reduce the occurrence of needle
sticks.
Length	4 ± 0.5 mm
5 ± 0.5 mm
6 ± 0.5 mm
8 ± 1.2 mm	4 ± 0.5 mm
5 ± 0.5 mm
6 ± 0.5 mm
8 ± 1.2 mm	The needle tube lengths of the subject device
are the same as the predicate device.
Item	Subject Device
K191853	Predicate Device
K161950	Similarities/Differences
Gauge	29G*6mm
29G*8mm	29G*6mm
29G*8mm	The available needle lengths per gauge of the
subject device are the same as in the
predicate device.
	30G*4mm
30G*5mm
30G*6mm
30G*8mm
31G*4mm
31G*5mm
31G*6mm	30G*4mm
30G*5mm
30G*6mm
30G*8mm
31G*4mm
31G*5mm
31G*6mm
	31G*8mm	31G*8mm
Sharps Injury
Prevention
Features	The patient end of the
device has a
mechanism that allows
the needle to be
shielded and locked
after use.
The non-patient (pen
connection) end of the
cannula is visible prior
to attachment to the
pen injector. Following
removal of the device
from the pen injector,
the needle is shielded
with a mechanism that
is designed to reduce
the occurrence of
accidental needle stick
injuries.	The patient end of the
device has a
mechanism that allows
the needle to be
shielded and locked
after use.	The sharps injury prevention features of the
subject device includes both ends of the
needle as compared to only the patient end of
the needle in the predicate device.
Device Materials	Fixer, inside fixer:
POM
Hub: POM
Needle hub:
X5CrNi18-10
Springs:
0Cr18Mn8Ni5N
Shield: AB
Container: PP	Fixer: POM
Hub: POM
Needle tube:
X5CrNi18-10
Spring:
0Cr18Mn8Ni5N
Shield: ABS
Container: PP	The subject device contains an additional
posterior trigger spring in comparison to the
predicate device. Device materials and both
the nature of body contact and the duration of
body with the patient/user are the same.
Performance	Complies with
ISO 7864,
ISO 9626,
ISO 11608-2, and
ISO 23908	Complies with
ISO 7864,
ISO 9626,
ISO 11608-2, and
ISO 23908	The performance characteristics of the subject
device are the same as the predicate device.
Force to Activate
Sharps Injury
Prevention
Feature	Complies with ISO

23908. The force to
       activate the sharps
       injury prevention
       feature is 1N to 5N for
       both ends of the Dual
       Safety Pen Needle. | Complies with ISO
23909. The force to
       activate the sharps
       injury prevention
       feature is 1N to 5N for
       the Safety Type Insulin
       Pen Needle. | The forces for activate the patient-end sharps
       injury prevention feature of the subject device
       are the same as the predicate device. The
       predicate device does not have a pen-end
       sharps prevention feature. |
       | Item | Subject Device
       K191853 | Predicate Device
       K161950 | Similarities/Differences |
       | Force to
       Override Sharps
       Injury Prevention
       Feature | Complies with ISO
23910. The force
       required to override the
       sharps injury prevention
       feature greater than
       20N for both ends of
       the Dual Safety Pen
       Needle. | Complies with ISO
23911. The force
       required to override the
       sharps injury prevention
       feature is greater than
       20N for the Safety Type
       Insulin Pen Needle. | The forces for overriding the patient-end
       sharps injury prevention feature of the subject
       device are the same as the predicate device.
       The predicate device does not have a pen-
       end sharps prevention feature. |
       | Sterilization | SAL: 10-6
       Ethylene Oxide
       Sterilization | SAL: 10-6
       Gamma Radiation
       Sterilization | The sterilization methods of the subject and
       predicate devices are different; however, both
       are traditional methods of processing medical
       devices so as to provide sterility assurance
       levels of 10-6. |
       | Shelf Life | 5 years | 5 years | Device stability and expiry date of the subject
       device are the same as the predicate device. |
       | Single Use | Yes | Yes | The safety pen needle products (subject
       device and predicate device) are single use
       devices. |
       | Biocompatibility | Complies with ISO
       10993 Series
       Standards for
       • Cytotoxicity
       • Skin Irritation
       • Skin Sensitization
       • Acute Systemic
       • Toxicity
       • Hemolysis
       • Non pyrogenic
       (material mediated
       pyrogenicity) | Complies with ISO
       10993 Series
       Standards for
       • Cytotoxicity
       • Skin Irritation
       • Skin Sensitization
       • Acute Systemic
       • Toxicity
       • Hemolysis
       • Non pyrogenic
       (material mediated
       pyrogenicity) | The biological safety of the subject device is
       identical to the predicate device. |
       | | Non Clinical and/or Clinical Tests Summary & Conclusions | | 21 CFR 807.92(b) |

The device is a pen needle with shields at both the patient end and the pen connector end which are intended to reduce risk of needle stick before and after injections. The patient end mechanism shields the needle before and after an injection, and a second mechanism passively covers the pen connector needle following removal from the patient end shield indicates the needle has fully penetrated the skin. A second shield covers the pen connector needle when it is removed from the pen.

Intended Use/Indications for Use

The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.

Indications for Use Comparison

Promisemed adds an additional safety shield to the predicate device such that the subject device's two safety shields lock in place (i) after use (patient-end) and (ii) upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle. This additional protection does not constitute a new intended use. However, the Indications For Use' has been revised to reflect the additional safety shield. Both safety pen needle products (the predicate device and the subject device) help protect against accidental needle sticks.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(5)

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Technological Comparison

21 CFR 807.92(a)(6)

For both the subject and predicate devices, the non-patient (pen connector) ends of the cannula are visible prior to attachment to the pen injector. However, the predicate device is modified such that following removal of the subject device from the pen injector, its needle is shielded with a mechanism designed to reduce the occurrence of accidental needle stick injuries.

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Non-Clinical Summary:

Product functionality: After sterilization, the device meets criteria specified in ISO 11608-2.

Shelf life: Sterile devices meet criteria specified in ISO 11608-2 after accelerated aging. The product is labeled with an expiry date of 5 years.

Biocompatibility: Device meets cytotoxicity requirements of ISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity

Biocompatibility: Device meets sensitization requirements of ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization.

Biocompatibility: Device meets intracutaneous reactivity requirements of ISO 10993-10 Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization.

Biocompatibility: Device meets hemocompatibility requirements of both ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood and ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials

Biocompatibility: Device meets system toxicity requirements of ISO 10993-11:2006(R)2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

Sharps injury protection: Device meets safety mechanism activation requirements as per ISO 23908.internal protocol and test results

Sharps injury protection: Device meets safety overriding/unlocking force after activation requirements as per ISO 23908, internal protocol and test results

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Clinical Simulated Use testing evaluated whether the posterior safety protective mechanism of the Dual Safety Pen Needle is effective. A total of 8 participants were selected to evaluate the subject device, and included endocrine doctors and nurses who provide training to patients in the use of pen needles for insulin injection. A total of 500 samples were tested and the evaluations resulted in zero failures of each of the Dual Safety Pen Needle.

Sterilization: A Sterility Assurance Level (SAL) of 10° has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.

LAL Pyrogen Testing: Device meets endotoxin requirements of USP39_NF34 Bacterial Endotoxins Test.

Packaging: Shipping package meets requirements of ISTA 3A. Unit package functionality meets acceptance criteria specified in ASTM F1929-98 (2004) for dye penetration and peel strength after EO sterilization. The unit package also provides a seal having a microbial barrier that meets log reduction value (LRV) requirements of ASTM F1608-16.

Conclusion:

Based on device comparison information and functional performance bench testing, the proposed device is substantially equivalent to the legally marketed predicate device (K161950).