Promisemed Triple Safety Pen Needle

• K Number: K202682
• Device Name: Promisemed Triple Safety Pen Needle
• Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.
• Date Cleared: 2020-11-24 ( 70 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.

Device Description

Promisemed Triple Safety Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually. The Promisemed Triple Safety Pen Needle consists of needle tube, trigger shield, posterior trigger/posterior trigger spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. Promisemed Triple Safety Pen Needle is the modification of Dual Safety Pen Needle cleared in K91853. The baseline location of trigger shield (patient end shield) is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. A click of the trigger shield (patient end shield) indicates the needle has fully penetrated the skin. In addition to above protective design, Promisemed Triple Safety Pen Needle retains two safety shields lock as the predicate has: the shield will lock in place (i) after use (patient-end): after the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle again and lock in place and (ii) upon removal of the needle from the pen (pen connector-end): the posterior trigger (a second shield) covers the pen connector needle when it is removed from the pen. Once the Promisemed Triple Safety Pen Needle is in the locked mode, it can no longer be used. Promisemed Triple Safety Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.

Predicate Devices

K191853

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical safety features and physical components, with no mention of AI or ML algorithms, data processing, or software-driven decision making.

Therapeutic

No
A therapeutic device is one that treats a disease or condition. This device is a pen needle used for injecting insulin, which is a drug, but the needle itself does not have a therapeutic effect. It is a medical tool for drug delivery.

Diagnostic

No
This device is a pen needle intended for the subcutaneous injection of insulin, which is a therapeutic function, not a diagnostic one. It facilitates the delivery of medication.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (needle tube, trigger shield, etc.) and describes mechanical safety features and bench testing related to physical performance characteristics, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
• This device is a pen needle intended for the subcutaneous injection of insulin. It is used to deliver a substance into the body, not to analyze a sample from the body.

The description clearly states its purpose is for "subcutaneous injection of insulin," which is a therapeutic delivery method, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

Promisemed Triple Safety Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually.

The Promisemed Triple Safety Pen Needle consists of needle tube, trigger shield, posterior trigger/posterior trigger spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. Promisemed Triple Safety Pen Needle is the modification of Dual Safety Pen Needle cleared in K91853. The baseline location of trigger shield (patient end shield) is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. A click of the trigger shield (patient end shield) indicates the needle has fully penetrated the skin.

In addition to above protective design, Promisemed Triple Safety Pen Needle retains two safety shields lock as the predicate has: the shield will lock in place (i) after use (patient-end): after the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle again and lock in place and (ii) upon removal of the needle from the pen (pen connector-end): the posterior trigger (a second shield) covers the pen connector needle when it is removed from the pen. Once the Promisemed Triple Safety Pen Needle is in the locked mode, it can no longer be used.

Promisemed Triple Safety Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.

Gauge	Length	Wall Type
29G	4,5,6,8 mm	Thin wall
30G	4,5,6,8 mm	Thin wall
31G	4,5,6,8 mm	Thin wall

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)

The bench testing performed verifies that the performance of the subject devices is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

• ISO11608-2: Needle-based injection systems for medical use Requirements and test methods — Part 2: Needles
• ISO 7864: Sterile hypodermic needles for single use Requirements and test methods
• ISO 23908: Sharps injury protection Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

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.

K191853

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

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 shows 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, which 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.

November 24, 2020

Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong 0000 China

Re: K202682

Trade/Device Name: Promisemed Triple Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 22, 2020 Received: October 26, 2020

Dear Wei Hsu:

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,

Rumi Young Acting Assistant Director Injection Team 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) K202682

Device Name

Promisemed Triple Safety Pen Needle

Indications for Use (Describe)

Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.

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 K202682

1 Date Prepared

November 20th, 2020

2 Submitter's Information

Name of Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

Address:

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China

Contact Name:

Zearou Yang

Telephone No.:

[phone]

Fax No.:

[phone]

Email Address:

[e-mail]

ന Trade Name, Common Name, Classification

Trade/Product Name: Promisemed Triple Safety Pen Needle Common Name: Insulin Pen Needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI

ldentification of Predicate Device ব

510(K) Number: K191853

Product Code: FMI

Regulation Number: 21 CFR 880.5570

Product Name: Dual Safety Pen Needle

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Description of the Device റ

Promisemed Triple Safety Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually.

The Promisemed Triple Safety Pen Needle consists of needle tube, trigger shield, posterior trigger/posterior trigger spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. Promisemed Triple Safety Pen Needle is the modification of Dual Safety Pen Needle cleared in K91853. The baseline location of trigger shield (patient end shield) is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. A click of the trigger shield (patient end shield) indicates the needle has fully penetrated the skin.

In addition to above protective design, Promisemed Triple Safety Pen Needle retains two safety shields lock as the predicate has: the shield will lock in place (i) after use (patient-end): after the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle again and lock in place and (ii) upon removal of the needle from the pen (pen connector-end): the posterior trigger (a second shield) covers the pen connector needle when it is removed from the pen. Once the Promisemed Triple Safety Pen Needle is in the locked mode, it can no longer be used.

Promisemed Triple Safety Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.

Gauge	Length	Wall Type
-------	--------	-----------

5

29G	4,5,6,8 mm	Thin wall
30G	4,5,6,8 mm	Thin wall
31G	4,5,6,8 mm	Thin wall

6 Intended Use

Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.

7 Similarities and Differences of the Proposed Device to the Predicate Device

The Promisemed Triple Safety Pen Needle is substantially equivalent to the predicate device, the Dual Safety Pen Needle (K191853) in that these devices have similar designs, methods of construction and operation, and indications for use. The differences from the predicate is the change of assembled position of trigger shield, the performance of which was verified and validated through ISO 7864, ISO23908, and ISO 11608-2 testing (See Section 8). The differences above between the subject device and predicate device do not affect the basic design principle, usage of the subject device.

| | Subject Device | Predicate Device
(K191853) | | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Promisemed Triple
Safety Pen Needle | Dual Safety Pen Needle | Comments | |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Promisemed Hangzhou
Meditech Co., Ltd | | |
| Device Class | Class II | Class II | Same | |
| Product Code | FMI | FMI | Same | |
| Regulation number | 880.5570 | 880.5570 | Same | |
| Regulation
Name | Needle, Hypodermic,
Single Lumen | Needle, Hypodermic,
Single Lumen | Same | |
| Intended Use/
Indications for
Use | Promisemed Triple
Safety Pen Needle is
intended for use with
pen injector devices for
subcutaneous injection
of insulin. | 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 | Different
The Subject device
has one more
protective design
compared to
predicate device
that the needle
tube is covered | |
| | | (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. | thoroughly by
trigger shield before
use.
The difference in
the protective
mechanism to the
predicate did not
affect the
substantially
equivalence on safety
and effectiveness of
the device | |
| Operating
Principle | The needle tube is
covered by trigger shield
and is not exposed
before usage.
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 again 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 Promisemed
Triple 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. 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. | Different
The needle tube in
the subject device
is covered by trigger
shield and is not
exposed before
usage. While the
predicate the
needle is not
covered before
usage. However, the
difference in the
covering of the
needle tube does
not affect the
substantially
equivalence on the
safety and
effectiveness | |
| Gauge | G29, G30, G31 | G29, G30, G31 | Same | |
| Needle Length | 4mm,5mm,6mm,8mm | 4mm,5mm,6mm,8mm | Same | |
| Needle
wall
thickness | Thin Wall | Thin Wall | Same | |
| Lubricant | Silicone Oil | Silicone Oil | Same | |
| Adhesive | UV glue | UV glue | Same | |
| Sharps Injury
Prevention
Features | The needle tip is
covered by trigger shield
and is not exposed
before use.
The patient end of the
device has a mechanism
that allows the needle
to be shielded and
locked after use. The
non-patient (pen | 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 | Similar

An additional
protective design is
introduced in
subject device
which prevent
accidental needle
sticks during the
interval after the | |
| | 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. | 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. | needle container is
removed and before
inserting the needle
into the skin. | |
| Trigger force | $≤$ 0.7N | Not applicable | An additional
protective design is
introduced in the
subject device
which prevent
accidental needle
sticks during the
interval after the
needle container is
removed and before
inserting the needle
into the skin .
Tested in
accordance to ISO
7864:2016, Annex D
to ensure that the
trigger shield will
retact during
injection and after
injection | |
| Method of
attachment to
the pen injector | (a) Removed the seal
from the needle
container.
(b) Push the needle
straight on to the pen
injector and screw until
it is tight | (a) Removed the seal
from the needle
container.
(b) Push the needle
straight on to the pen
injector and screw until
it is tight | Same | |
| Angle of
insertion | 90 $^{\circ}$
vertical to
the
desired injection site | No particular angle | Different
Since the needle of
subject device is
inside the shield
before use, the
insertion angle of
90 $^{\circ}$ vertical is
recommended to
make sure the
needle inserts to
the desired
position. The
difference did not
affect the
substantially
equivalence on | |
| | | | safety and
effectiveness. | |
| | | | Different
The needle tube is
not exposed in
subject device.
While in the
predicate it is
exposed before
usage | |
| Configuration
and Material | Image: [purple needle] | Image: [blue needle] | | |
| | Needle Tube: X5CrNi18-
10 | Needle Tube: X5CrNi18-
10 | Same | |
| | Needle Hub:
Polyformaldehyde (POM) | Needle Hub:
Polyformaldehyde
(POM) | Same | |
| | Fixer: Polyformaldehyde
(POM) | Fixer: Polyformaldehyde
(POM) | Same | |
| | Spring: 0Cr18Mn8Ni5N | Spring: 0Cr18Mn8Ni5N | Same | |
| | Needle container:
Polypropylene (PP) | Needle container:
Polypropylene (PP) | Same | |
| | Posterior Trigger:
Acrylonitrile Butadiene
Styrene (ABS) and
Pigment red 122(CAS:
980-26-7) | Posterior Trigger:
Acrylonitrile Butadiene
Styrene (ABS) and
Pigment red 122(CAS:
980-26-7) | Same | |
| | Trigger shield A:
Acrylonitrile Butadiene
Styrene (ABS) and color
additive [Green:
Chromium(III) oxide(CAS
1308-38-9); Violet: P.V
23 (CAS 6358-30-1);
Orange: Nickel Antimony
Titanate Yellow (CAS
8007-18-9); Blue:
Pigment Blue 29 (CAS
57455-37-5)] | Trigger shield A:
Acrylonitrile Butadiene
Styrene (ABS) and color
additive [Green:
Chromium(III) oxide(CAS
1308-38-9); Violet: P.V
23 (CAS 6358-30-1);
Orange: Nickel
Antimony Titanate
Yellow (CAS 8007-18-9);
Blue: Pigment Blue 29
(CAS 57455-37-5)] | Material is the
same.
The location slot in
subject device is
moved downward.
This change makes
the baseline
position of trigger
shield move upward
in finished subject
device which
allowing the needle
tube be covered
thoroughly. | |
| | Trigger shield B:
Acrylonitrile Butadiene
Styrene (ABS) | Trigger shield B:
Acrylonitrile Butadiene
Styrene (ABS) | Same | |
| Trigger
Shield
Slot | | Lower | Higher | Different
The location of the
slot in subject
device is moved
downward. This
change allows the
trigger shield cover
the needle tip |
| | | | completely before
use. Does not affect
the safety and
effectivity of the
device or the
substantially
equivalence to the
predicate. | |
| Unit Packaging | Sterile barrier system is
consisting of needle
container and seal
(Medical grade glue
dialyzing paper) | Sterile barrier system is
consisting of needle
container and seal
(Medical grade glue
dialyzing paper) | Same | |
| Box | Paper board | Paper board | Same | |
| Performance | Complied with ISO 7864,
ISO 9626, ISO 11608-2
and ISO 23908 | Complied with ISO 7864,
ISO 9626, ISO 11608-2
and ISO 23908 | Same | |
| Sterilization | EO Sterilization
SAL:10-6 | EO Sterilization
SAL:10-6 | Same | |
| Shelf Life | 5 years | 5 years | Same | |
| Single use | Yes | Yes | Same | |
| Biocompatibility | Complied with ISO10993
series standards, and
the following tests are
performed

• Cytotoxicity: No
  cytotoxicity
• Skin Irritation: No
  evidence of skin
  irritation
• Skin Sensitization: No
  evidence of sensitization
  -Acute Systemic
  Toxicity:No systemic
  toxicity
  -Hemolysis: No evidence
  of hemolysis
  -Pyrogen: No pyrogenic | Complied with ISO10993
  series standards, and
  the following tests are
  performed
• Cytotoxicity: No
  cytotoxicity
• Skin Irritation: No
  evidence of skin
  irritation
• Skin Sensitization: No
  evidence of
  sensitization
  -Acute Systemic
  Toxicity:No systemic
  toxicity
  -Hemolysis: No evidence
  of hemolysis
  -Pyrogen: No pyrogenic | Same | |

A detailed comparison to the predicate is provided in Table 1.

6

7

8

9

Performance Testing Summary 8

The bench testing performed verifies that the performance of the subject devices is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

• · ISO11608-2: Needle-based injection systems for medical use Requirements and test methods — Part 2: Needles

10

• ISO 7864: Sterile hypodermic needles for single use Requirements and test methods
• · ISO 23908: Sharps injury protection Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• の Conclusion

Based on the information provided within this 510(k) submission, proposed Promisemed Triple Safety Pen Needle is substantially equivalent to the predicate device (K191853) and does not raise different questions of safety or effectiveness.