Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical safety features (shields, springs) and does not mention any computational or data-driven components indicative of AI/ML. The performance studies are based on simulated clinical use and non-clinical testing of physical properties, not on the performance of an algorithm.

Therapeutic

No
The device is a safety pen needle intended for drug delivery via injection, and its primary function is to facilitate the subcutaneous injection of fluids and FDA-approved drugs. Its safety features are designed to prevent accidental needle sticks. It is not described as directly treating or diagnosing a medical condition.

Diagnostic

No

Explanation: The device description states its purpose is for "subcutaneous injection of fluids and FDA-approved drugs" and also mentions a "sharps injury prevention feature." There is no mention of the device being used for diagnosis or detection of any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like needles, shields, springs, and a container, indicating it is a hardware device with a sharps injury prevention feature. There is no mention of software as a component or function.

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 fluids and FDA-approved drugs" using pen injector devices. This is a direct therapeutic or delivery function, not a diagnostic test performed in vitro (outside the body).
Device Description: The description focuses on the physical components and safety features related to injection and sharps injury prevention. There is no mention of analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies described (simulated clinical use, non-clinical testing, biocompatibility, sterilization, packaging) are all relevant to a device used for drug delivery and injection safety, not for in vitro diagnostic testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or providing diagnostic results.

In summary, the device is a pen needle designed for drug delivery and sharps injury prevention, which falls under the category of a therapeutic or delivery device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.

HE Model: Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

HS Model: Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

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

FMI

Device Description

The proposed device, Safety Pen Needle, is a sterile, non-pyrogenic, single-use device, which is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. It incorporates a sharps injury prevention feature, which can reduce the occurrence of accidental needle sticks.

The proposed device is provided with two models, i.e. HE Model and HS Model. HE Model has an attached safety shield, which can automatically lock in place and reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. HS Model has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of accidental needle sticks from both ends of the needle.

Both of HE Model and HS Model contain main body, needle tube, front shield, rear shield, big spring, turning tube, container (outer cap) and peel tab (sealing paper). Both ends of the needle tube (i.e. the patient end and the pen connection end) is lubricated by silicone oil. The needle tube and the needle hub are bonded by glue. The container sealed with the peel tab constitutes the sterile barrier system. The common components of both models are almost the same in materials and structure and size, and the only difference is the structure of the rear shield. The biggest difference between the two models is that HS Model contains a small spring additionally and has a relatively more complex structure.

The specifications for each model are designated by the gauge of needle tube and needle available length. Both models have the same specifications (shown in the following table).

Specification	Needle Tube
	Gauge (G)	Designated metric size (mm)	Outer Diameter (mm)	Needle Available Length (mm)
30G×3/16" 0.30mm×5mm	30	0.30	0.298-0.320	5
30G×5/16" 0.30mm×8mm	30	0.30	0.298-0.320	8
31G×3/16" 0.25mm×5mm	31	0.25	0.254-0.267	5
31G×1/4" 0.25mm×6mm	31	0.25	0.254-0.267	6
31G×5/16" 0.25mm×8mm	31	0.25	0.254-0.267	8
32G×5/32" 0.23mm×4mm	32	0.23	0.229-0.241	4
32G×3/16" 0.23mm×5mm	32	0.23	0.229-0.241	5
32G×1/4" 0.23mm×6mm	32	0.23	0.229-0.241	6
33G×5/32" 0.20mm×4mm	33	0.20	0.203-0.216	4
33G×3/16" 0.20mm×5mm	33	0.20	0.203-0.216	5

Safety Pen Needle is used by peeling back the peel tab and screwing the needle hub onto the threaded end of the pen injector. The pen connection end of the needle tube punctures the septum of the cartridge in the pen injector. The outer protective container is then removed. When the injection is needed, the needle is vertically inserted into the chosen site. While inserting the skin, the front shield moves backward into the main body enabling the needle to penetrate the skin and the subcutaneous tissue, and the safety mechanism is activated. Then, the pen injector delivers the medicinal product through the needle.

After the injection, Safety Pen Needle is withdrawn from the skin. The big spring pushes the front shield to move forward until the front shield reaches its limit position where the red band indicator on the front shield appears outside the main body and can be seen. At this time, the front shield completely covers the needle tip at the patient end and is locked in place, and Safety Pen Needle enters the patient-end protection state and it can no longer be used.

Additionally, for HS Model, when Safety Pen Needle is screwed off, the small spring pushes the rear shield to move towards the pen connection end until the rear shield reaches its limit position. At this time, the rear shield completely covers the needle tip at the pen connection end and is locked, and Safety Pen Needle enters the pen-connection-end protection state.

The proposed device is sterilized by Gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10-6.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Subcutaneous

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Professional healthcare users and non-clinical pen 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)

Simulated clinical use study was conducted to verify the safety feature per Guidance for Industry and FDA Staff - Medical Devices with Sharps Injury Prevention Features, issued on August 9, 2005. 500 subject devices were evaluated by both professional healthcare users and non-clinical pen users in the simulated clinical use study. There was no needlestick injuries occurred and zero failure of the protective feature in the study.

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.

K152514

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

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

February 17, 2022

Sandstone Medical (Suzhou) Inc. % Grace Liu Consultant Shenzhen Joyantech Consulting Co., Ltd 1713A. 17th Floor, Block A. Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K210864

Trade/Device Name: Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: January 11, 2022 Received: January 18, 2022

Dear Grace Liu:

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,

CAPT 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) K210864

Device Name Safety Pen Needle

Indications for Use (Describe)

The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.

HE Model

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

HS Model

Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needs 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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3

510(k) Summary

1. Contact Details

Applicant Name	Sandstone Medical (Suzhou) Inc.
Address	Building 6, No.168 PuTuoShan Road, New District, 215153 Suzhou,
Jiangsu Province, P.R.China
Phone No.	+86-512-65799368
Fax No.	+86-512-65799368
Contact person	Juanjuan Sun
Contact person's e-mail	juanjuans@sandstonemed.com
Date Prepared	2022-01-11
Website	www.sandstonemed.com
2. Device information
Trade name	Safety Pen Needle
Common name	Safety Pen Needle
Classification	Class II
Classification name	Needle, Hypodermic, Single Lumen

3. Legally Marketed Predicate Device

Product code | FMI Regulation No. | 880.5570

Trade Name	Clickfine AutoProtect Pen Needle
510(k) Number	K152514
Product Code	FMI
Manufacturer	Ypsomed AG

4. Device Description

The proposed device, Safety Pen Needle, is a sterile, non-pyrogenic, single-use device, which is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. It incorporates a sharps injury prevention feature, which can reduce the occurrence of accidental needle sticks.

The proposed device is provided with two models, i.e. HE Model and HS Model. HE Model has an attached safety shield, which can automatically lock in place and reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. HS Model has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of accidental needle sticks from both ends of the needle.

Both of HE Model and HS Model contain main body, needle tube, front shield, rear shield, big spring, turning tube, container (outer cap) and peel tab (sealing paper). Both ends of the needle

4

tube (i.e. the patient end and the pen connection end) is lubricated by silicone oil. The needle tube and the needle hub are bonded by glue. The container sealed with the peel tab constitutes the sterile barrier system. The common components of both models are almost the same in materials and structure and size, and the only difference is the structure of the rear shield. The biggest difference between the two models is that HS Model contains a small spring additionally and has a relatively more complex structure.

The specifications for each model are designated by the gauge of needle tube and needle available length. Both models have the same specifications (shown in the following table).

Specification	Needle Tube
	Gauge (G)	Designated metric size (mm)	Outer Diameter (mm)	Needle Available Length (mm)
30G×3/16" 0.30mm×5mm	30	0.30	0.298-0.320	5
30G×5/16" 0.30mm×8mm	30	0.30	0.298-0.320	8
31G×3/16" 0.25mm×5mm	31	0.25	0.254-0.267	5
31G×1/4" 0.25mm×6mm	31	0.25	0.254-0.267	6
31G×5/16" 0.25mm×8mm	31	0.25	0.254-0.267	8
32G×5/32" 0.23mm×4mm	32	0.23	0.229-0.241	4
32G×3/16" 0.23mm×5mm	32	0.23	0.229-0.241	5
32G×1/4" 0.23mm×6mm	32	0.23	0.229-0.241	6
33G×5/32" 0.20mm×4mm	33	0.20	0.203-0.216	4
33G×3/16" 0.20mm×5mm	33	0.20	0.203-0.216	5

Safety Pen Needle is used by peeling back the peel tab and screwing the needle hub onto the threaded end of the pen injector. The pen connection end of the needle tube punctures the septum of the cartridge in the pen injector. The outer protective container is then removed. When the injection is needed, the needle is vertically inserted into the chosen site. While inserting the skin, the front shield moves backward into the main body enabling the needle to penetrate the skin and the subcutaneous tissue, and the safety mechanism is activated. Then, the pen injector delivers the medicinal product through the needle.

After the injection, Safety Pen Needle is withdrawn from the skin. The big spring pushes the front shield to move forward until the front shield reaches its limit position where the red band indicator on the front shield appears outside the main body and can be seen. At this time, the front shield completely covers the needle tip at the patient end and is locked in place, and Safety Pen Needle enters the patient-end protection state and it can no longer be used.

Additionally, for HS Model, when Safety Pen Needle is screwed off, the small spring pushes the rear shield to move towards the pen connection end until the rear shield reaches its limit position. At this time, the rear shield completely covers the needle tip at the pen connection end and is locked, and Safety Pen Needle enters the pen-connection-end protection state.

The proposed device is sterilized by Gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10-6.

5

5. Intended Use/Indication for Use

The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.

HE Model

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

HS Model

Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

6. Substantial Equivalence Comparison

6

Product: Safety Pen Needle

| Item | Proposed Device:
Safety Pen Needle
(HE Model and HS Model)
(K210864) | Predicate Device:
Clickfine AutoProtect Pen
Needle
(K152514) | Comments | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------|
| Product Code | FMI | FMI | Same | |
| Intended use | The safety pen needle is
intended for use with pen
injector devices for
subcutaneous injection of fluids
and FDA-approved drugs.

For HE Model
Additionally, the attached safety
shield automatically locks in
place and reduces the
occurrence of accidental needle
sticks from the patient end of
the needle. The shield also
serves to hide the needle before
and after injection.

For HS Model
Additionally, the product has
two safety shields, which lock in
place after use (patient end)
and upon removal of the needle
from the pen (pen connection
end). The locked shields help
reduce the occurrence of
needle sticks from both ends of
the needle. | The Clickfine AutoProtect Pen
Needle is intended for use with
pen injector devices for the
injection of fluids, including
insulin and exenatide.

7

Version:A/0

8

Product: Safety Pen Needle

lssue 1:

Both of the proposed devices and the predicate device are intended for subcutaneous injection.

HS Model of the proposed device incorporates an additional safety shield compared with the predicated device such that HS Model has two safety shields lock in place: (1) 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 indication for use describes this additional safety shield. Both of the proposed devices and the predicate device help protect against accidental needle sticks.

lssue 2:

Compared with the predicate device, the proposed device has two additional needle gauges of 32G and 33G and two additional needle lengths of 4mm and 5mm. The difference in needle gauge and length does not impact safety or performance and raises no new questions of safety and performance. The subject device and predicate are both intended for subcutaneous injection. In this case, the difference is still intended for subcutaneous tissue, which is the same tissue as the predicate. The additional needle gauge and length are being introduced to meet individual needs of patients based on their skin type, BMI, and drug dosing and treatments.

lssue 3:

The predicate device is snapped firstly and then screwed onto the threaded end of the pen injector, while the proposed device is screwed onto the threaded end of the pen injector. Eventually, both devices are secured on the pen injector by the fit between threads. Moreover, the performance testing of the proposed device has demonstrated that the "Twist-on" attachment can meet the requirements in the compatibility with needle-based injection system test. Therefore, the difference on the method of attachment to pen doesn't affect the substantial equivalence.

lssue 4:

The difference on the configuration between the proposed device and the predicate device mainly results from the different safety mechanisms. The differences do not raise new questions of safety and effectiveness.

7. Non-clinical Testing

All non-clinical testing performed on the proposed device is to demonstrate the substantial equivalence to the predicate device. Tests are performed in accordance with the applicable standards. Results of the testing demonstrate the compliance with the standards.

The following performance data is provided in support of the substantial equivalence determination.

9

Product: Safety Pen Needle

Test	Requirements	Results
Materials	Clause 4.1 of ISO 11608-2	Pass
Tubing dimensions	Clause 4.2.1 of ISO 11608-2 and
Clause 5.6 of ISO 9626	Pass
Dimensions for needles	Clause 4.2.2 of ISO 11608-2	Pass
Flow rate through needle	Clause 4.3 of ISO 11608-2	Pass
Bond between hub and needle tube	Clause 4.4 of ISO 11608-2 and
Clause 4.12 of ISO 7864	Pass
Needle points	Clause 4.5 of ISO 11608-2	Pass
Freedom from defects	Clause 4.6 of ISO11608-2	Pass
Lubrication	Clause 4.7 of ISO 11608-2	Pass
Dislocation of measuring point at patient end	Clause 4.8 of ISO 11608-2	Pass
Compatibility with needle-based injection system and Ease of assembly and disassembly	Clause 11 of ISO 11608-2	Pass
Stiffness of needle tubing	Clause 5.8 of ISO 9626	Pass
Resistance to breakage of needle tubing	Clause 5.9 of ISO 9626	Pass
Activation of the sharps injury protection feature	Clause 4.2 of ISO 23908	Pass
Challenging the device in safe mode	Clause 4.3 of ISO 23908	Pass

The following biocompatibility data is provided in support of the substantial equivalence > determination.

Test	Requirements	Results
In vitro Cytotoxicity	ISO 10093-5 Biological evaluation of medical
devices - Part 5: Tests for in vitro cytotoxicity	Pass
Skin Sensitization	ISO 10993-10 Biological evaluation of medical
devices - Part 10: Tests for irritation and skin
sensitization	Pass
Intracutaneous Reactivity	ISO 10993-10 Biological evaluation of medical
devices - Part 10:Tests for irritation and skin
sensitization	Pass
Acute Systemic Toxicity	ISO 10993-11 Biological evaluation of medical
devices - Part 11: Tests for systemic toxicity	Pass
Haemocompatibility	ASTM F756 Standard Practice for Assessment
of Hemolytic Properties of Materials	Pass
Pyrogen	ISO 10993-11 Biological evaluation of medical
devices - Part 11: Tests for systemic toxicity
USP 42-NF37 Pyrogen Test	Pass
Bacterial Endotoxins	USP42_NF37 Bacterial Endotoxins Test	Pass
Particulates	USP , Method 1 Light Obscuration Test	Pass

10

> Simulated clinical use study

Simulated clinical use study was conducted to verify the safety feature per Guidance for Industry and FDA Staff - Medical Devices with Sharps Injury Prevention Features, issued on August 9, 2005. 500 subject devices were evaluated by both professional healthcare users and non-clinical pen users in the simulated clinical use study. There was no needlestick injuries occurred and zero failure of the protective feature in the study.

Sterilization
A Sterility Assurance Level (SAL) of 10-6 has been validated in accordance with the requirements of ISO 11137 series standards.
A Packaging and shelf life
Accelerated packaging testing was performed to assure a 5 year shelf life.

8. Clinical Testing

Substantial equivalence does not depend on the clinical test data.

9. Conclusions

Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate device (K152514).