Easydrip Pen Needle, Easydrip Plus Pen Needle

• K Number: K193422
• Device Name: Easydrip Pen Needle, Easydrip Plus Pen Needle
• Manufacturer: Sandstone Medical (Suzhou) Inc.
• Date Cleared: 2021-02-02 ( 421 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Device Description

The proposed devices, Pen Needles, are a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. The proposed devices include two models, i.e. Easydrip Pen Needle and Easydrip Plus Pen Needle. Both models have the same construction, operation methods and similar materials. Both models consist of needle tubing, needle tip shield, needle base, needle container, sealing dialysis paper, glue and silicone oil. The needle base of the device can be screwed onto compatible insulin pens. The only minor differences between the Easydrip and Easydrip Plus models are the outer shape and the material of the Needle tip shield. The Easydrip Needle tip shield is slightly shorter in length and more tapered than the Easydrip Plus Needle tip shield. The material of construction of the Easydrip Needle tip shield is polyethylene, while the Easydrip Plus Needle tip shield is polypropylene. The Pen Needles are offered in various gauge sizes and needle lengths. The proposed devices are irradiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-9.

Predicate Devices

K161950

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics, materials, and functional compatibility of a simple mechanical pen needle for insulin injection. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No
The device is a pen needle, intended for use with a pen injector for subcutaneous injection of insulin. It is an accessory to a therapeutic device (the pen injector and insulin) but does not itself provide a therapeutic effect. Its function is to deliver a substance, not to treat a condition directly.

Diagnostic

No

Explanation: The device is described as a pen needle for subcutaneous injection of insulin, which is a delivery device, not a diagnostic one. Its intended use is for administering a substance, not for identifying a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (needle tubing, needle tip shield, needle base, etc.) and manufacturing processes (sterilization), indicating it is a hardware medical device, not software-only.

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." This is a direct administration of a substance into the body, not a test performed on a sample taken from the body to diagnose a condition.
• Device Description: The description details a needle designed to attach to a pen injector for delivering insulin. This is a delivery device, not a diagnostic device.
• Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This pen needle does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

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

FMI

Device Description

The proposed devices, Pen Needles, are a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. The proposed devices include two models, i.e. Easydrip Pen Needle and Easydrip Plus Pen Needle. Both models have the same construction, operation methods and similar materials. Both models consist of needle tubing, needle tip shield, needle base, needle container, sealing dialysis paper, glue and silicone oil. The needle base of the device can be screwed onto compatible insulin pens. The only minor differences between the Easydrip and Easydrip Plus models are the outer shape and the material of the Needle tip shield. The Easydrip Needle tip shield is slightly shorter in length and more tapered than the Easydrip Plus Needle tip shield. The material of construction of the Easydrip Needle tip shield is polyethylene, while the Easydrip Plus Needle tip shield is polypropylene.

The Pen Needles are offered in various gauge sizes and needle lengths. The proposed devices are irradiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-9.

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)

All non-clinical testing performed on the subject devices is to demonstrate substantial equivalence to the predicate device. Tests setup and execution are performed in accordance with applicable standards.

Test results for:

• Materials: Passed. The needle shall be made of tubing materials specified in ISO 9626.
• Dimensions: Passed. The needles shall fit the test apparatus specified in item 7.2 of ISO 11608-2.
• Flow rate through the needle: Passed. The needles were tested in accordance with Annex A to ISO 11608-2.
• Binding force between needle base and needle tubing: Passed. The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2.
• Needle tip appearance, needle tubing flawlessness, size of inside and outside diameter and puncturing force: Passed. The needle tip appearance shall fulfil the 4.5 of ISO 11608-2. The needle tubing flawlessness shall fulfil the requirements of ISO 7864:1993, 11.3.
• Dislocation of measuring point patient end: Passed. Dislocation of the cannula point at the patient end shall be in accordance with Table 2 (ISO 11688-2) when tested in accordance with Clause 8 of ISO 11608-2.
• Functional compatibility with needle-based injected systems: Passed. Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11 of ISO 11608-2.
• Ease of assemble and disassembly: Passed. 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 of ISO 11608-2.
• Cytotoxicity: Passed. ISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity.
• Sensitization: Passed. ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization.
• Irritation: Passed. ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization.
• Biocompatibility (Hemocompatibility): Passed. ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ASTM F765 Standard Practice for Assessment of Hemolytic Properties of Materials.
• Biocompatibility (System toxicity (acute)): Passed. ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
• Biocompatibility (Pyrogen): Passed. USP 40.NF 35 Pyrogen Test.
• Biocompatibility (Particulate Matter): Passed. USP Particulate Matter in Injections, Method 1: Light Obscuration Particle Count Test.

No clinical test data was included in this submission.

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.

K161950

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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February 2, 2021

Sandstone Medical (Suzhou) Inc. % Elly Xu Consultant Manager Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, 518000 Cn

Re: K193422

Trade/Device Name: Easydrip Pen Needle, Easydrip Plus Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 27, 2020 Received: December 28, 2020

Dear Elly Xu:

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,

For Rumi Young Acting 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) K193422

Device Name

Easydrip Pen Needle, Easydrip Plus Pen Needle

Indications for Use (Describe)

The Pen Needle is intended for use with pen injector device 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

510(k) Number: K193422

1. Contact Details

• 1.1 Applicant information

Applicant Name	Sandstone Medical (Suzhou) Inc.
Address	No.168 Pu TuoShan Road, New District, Suzhou 215153, China
Phone No.	86-0512-65799368
Fax No.	86-0512-65799368
Contact person	Juanjuan Sun
Contact person's e-mail	[e-mail]
Company e-mail	[e-mail]
Date Prepared	November 29, 2019
Website	www.sandstone.com

1.2 Consultant information

Name	Shenzhen Joyantech Consulting Co., Ltd
皇 in 大
Address	1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue,
	Xili Town, Nanshan District, Shenzhen, Guangdong Province, China.
Phone No.	[phone]
Contact person	Joyce Yang, Field Fu
Contact person's e-mail	[e-mail]; [e-mail]
Website	http://www.cefda.com

2. Device information

---

Trade name	Easydrip Pen Needle, Easydrip Plus Pen Needle
Common name	Insulin Pen Needle
Model	29G/30G/31G/32G/33G
Classification	II
Classification name	Needle, Hypodermic, Single Lumen
Product code	FMI
Regulation No.	21 CFR 880.5570

Legally Marketed Predicate Device 3.

Trade Name	Verifine® Common Type Insulin Pen Needle
510(k) Number	K161950
Product Code	FMI
Manufacturer	Promisemed Hangzhou Meditech Co., Ltd.

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4. Device Description

The proposed devices, Pen Needles, are a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. The proposed devices include two models, i.e. Easydrip Pen Needle and Easydrip Plus Pen Needle. Both models have the same construction, operation methods and similar materials. Both models consist of needle tubing, needle tip shield, needle base, needle container, sealing dialysis paper, glue and silicone oil. The needle base of the device can be screwed onto compatible insulin pens. The only minor differences between the Easydrip and Easydrip Plus models are the outer shape and the material of the Needle tip shield. The Easydrip Needle tip shield is slightly shorter in length and more tapered than the Easydrip Plus Needle tip shield. The material of construction of the Easydrip Needle tip shield is polyethylene, while the Easydrip Plus Needle tip shield is polypropylene.

The Pen Needles are offered in various gauge sizes and needle lengths. The proposed devices are irradiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-9.

Type	Gauge(G)	Needle OD.(mm)	Needle available length(mm)
Easydrip	29	0.33	10
	29	0.33	12
	29	0.33	12.7
	30	0.30	6
	30	0.30	8
	30	0.30	10
31	0.25	5
31	0.25	6
31	0.25	8
32	0.23	4
32	0.23	5
33	0.20	4
33	0.20	5
Easydrip Plus	29	0.33	10
	29	0.33	12
	29	0.33	12.7
	30	0.30	6
	30	0.30	8
	30	0.30	10
31	0.25	5
31	0.25	6
31	0.25	8
32	0.23	4
32	0.23	5
33	0.20	4
33	0.20	5

The dimension for both Easydrip Pen Needle and Easydrip Plus Pen Needle are shown as below.

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Intended Use/Indication for Use 5.

The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

6. Product compatibility

The Pen Needle may be used with Type A compatible insulin delivery system, including:

Pen name	Pen Manufacturer
NovoPen 5	Novo Nordisk
AUTOPEN 24	Owen mumford
Gansulin Pen	Tonghua Dongbao
Ypsopen	Ypsomed AG
UNIPEN	United Laboratories
XiuLin Pen	Gan & Lee
HumaPen Ergoll	EILILILLY
Byetta	Baxter Pharmaceutical
Victoza Pen	Novo nordisk

| Item | Proposed Device:
Easydrip Pen Needle | Proposed Device:
Easydrip Plus Pen
Needle | Predicate Device:
Common Type Insulin
Pen Needle
(K161950) | Comments |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | FMI | FMI | FMI | Same |
| Indications for
Use | The Pen Needle is
intended for use with
pen injector device for
subcutaneous
injection of insulin. | The Pen Needle is
intended for use with
pen injector device for
subcutaneous
injection of insulin. | The Insulin Pen
Needle is intended for
use with pen injector
devices for the
subcutaneous
injection of insulin. | Same |
| Configuration
and Material | Needle tubing (Needle
Tube):304 Stainless
steel | Needle tubing (Needle
Tube):304 Stainless
steel | Needle tubing (Needle
Tube):304 Stainless
steel, | Same |
| | Needle tip shield
(Tube Sheath):
Polyethylene | Needle tip shield
(Tube Sheath):
Polypropylene | Needle tip shield
(Tube Sheath):
Polypropylene | Difference
#1 |
| | Needle base (Hub):
Polypropylene | Needle base (Hub):
Polypropylene | Needle hub:
Polypropylene | Same |
| | Needle container (Hub
Sheath): Polyethylene | Needle container (Hub
Sheath): Polyethylene | Needle container (Hub
Sheath): Polyethylene | Same |
| Item | Proposed Device:
Easydrip Pen Needle | Proposed Device:
Easydrip Plus Pen Needle | Predicate Device:
Common Type Insulin Pen Needle
(K161950) | Comments |
| Sealing dialysis paper
(Sealed Paper):
Sealing dialysis paper | Sealing dialysis paper
(Sealed Paper):
Sealing dialysis paper | Sealing dialysis paper
(Sealed Paper):
Sealing dialysis paper | Sealing dialysis paper
(Sealed Paper):
Sealing dialysis paper | Same |
| Operation mode | Manual | Manual | Manual | Same |
| Needle Gauge | 29G/30G/31G/32G/33G | 29G/30G/31G/32G/33G | 29G/30G/31G/32G/33G | Same |
| Needle length | 4mm, 5mm, 6mm,
8mm, 10mm,12mm,
12.7mm | 4mm, 5mm, 6mm,
8mm, 10mm,12mm,
12.7mm | 4mm, 5mm, 6mm,
8mm,12mm | Difference #2 |
| Design of the
needle base | Image: Easydrip Pen Needle base | Image: Easydrip Plus Pen Needle base | Image: Common Type Insulin Pen Needle base | Same |
| Sterilization | SAL: 10-6
Method: Irradiation
Sterilized | SAL: 10-6
Method: Irradiation
Sterilized | SAL: 10-6
Method: EO Sterilized | Difference #3 |
| Performance | Complied with ISO
7864, ISO 9626, and
ISO 11608-2 | Complied with ISO
7864, ISO 9626, and
ISO 11608-2 | Complied with ISO
7864, ISO 9626, and
ISO 11608-2 | Same |
| Shelf Life | 5 years | 5 years | 5 years | Same |
| Single Use | Yes | Yes | Yes | Same |
| Biocompatibility | Complied with ISO
10993 series
standards | Complied with ISO
10993 series
standards | Complied with ISO
10993 series
standards | Same |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Skin Irritation | No evidence of skin
irritation | No evidence of skin
irritation | No evidence of skin
irritation | Same |
| Skin Sensitization | No evidence of
sensitization | No evidence of
sensitization | No evidence of
sensitization | Same |
| Acute Systemic Toxicity | No systemic toxicity | No systemic toxicity | No systemic toxicity | Same |
| Hemolysis | No evidence of
hemolysis | No evidence of
hemolysis | No evidence of
hemolysis | Same |
| Pyrogen | No pyrogen | No pyrogen | No pyrogen | Same |

7. Substantial Equivalence Comparison

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8. Substantial Equivalence Discussion

Difference #1 - Needle tip shield material

The needle tip shield of the Easydrip Pen Needle is different from that of the predicate. However, the difference in material is addressed through biocompatibility testing according to ISO 10993 series standards. The biocompatibility testing demonstrates that the difference in material does not affect the safety and effectiveness of the device.

Difference #2 - Needle length

Compared to the predicate device, the proposed device has an additional 12.7mm needle length. The bench tests of the needle with 12.7mm needle length demonstrated conformance to ISO 7864, ISO 9626, and ISO 11608-2. Therefore, the additional needle length does not affect the safety and effectiveness of the device.

Difference #3 - Sterilization method

The subject device is irradiation sterilized while the predicate device is Ethylene Oxide sterilized. While the sterilization methods between the proposed device and the predicate device are different, validation testing was performed to validate the sterilization method. The sterilization report showed that the sterilization effect of the proposed device can achieve a Sterility Assurance Level (SAL) of 10°, and the radiation dose audit test reports showed that the minimum gamma radiation dose to achieve a 10° SAL was acceptable according to ISO 11737-2:2012. Therefore, the difference in sterilization does not affect the safety and effectiveness of the device.

Non-clinical Testing 9.

All non-clinical testing performed on the subject devices is to demonstrate substantial equivalence to the predicate device. Tests setup and execution are performed in accordance with applicable standards.

Test	Requirements	Results
Materials	The needle shall be made of tubing materials
specified in ISO 9626.	Passed
Dimensions	The needles shall fit the test apparatus
specified in item 7.2 of ISO 11608-2.	Passed
Flow rate through the needle	The needles were tested in accordance with
Annex A to ISO 11608-2.	Passed
Binding force between needle base and
needle tubing	The union of the hub and needle tube shall not
break when tested in accordance with Clause 9
of ISO 11608-2.	Passed
Test	Requirements	Results
Needle tip appearance, needle tubing
flawlessness, size of inside and outside
diameter and puncturing force	The needle tip appearance shall fulfil the 4.5 of
ISO 11608-2.
The needle tubing flawlessness shall fulfil the
requirements of ISO 7864:1993, 11.3.	Passed
Dislocation of measuring point patient
end	Dislocation of the cannula point at the patient
end shall be in accordance with Table 2 (ISO
11688-2) when tested in accordance with
Clause 8 of ISO 11608-2.	Passed
Functional compatibility with
needle-based injected systems	Compatibility with any NIS shall be claimed
only after testing in accordance with Clause 11
of ISO 11608-2.	Passed
Ease of assemble 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 of
ISO 11608-2.	Passed
Cytotoxicity	ISO 10093-5 Biological evaluation of medical
devices -Part 5: Tests for in vitro cytotoxicity	Passed
Sensitization	ISO 10993-10 Biological evaluation of medical
devices -Part 10:Tests for irritation and skin
sensitization	Passed
Irritation	ISO 10993-10 Biological evaluation of medical
devices -Part 10:Tests for irritation and skin
sensitization	Passed
Biocompatibility	Hemocompatibility	ISO 10993-4 Biological evaluation of medical
devices Part 4: Selection of tests for
interactions with blood
ASTM F765 Standard Practice for Assessment
of Hemolytic Properties of Materials	Passed
	System toxicity
(acute)	ISO 10993-11:2006/(R)2010, Biological
evaluation of medical devices - Part 11: Tests
for systemic toxicity.	Passed
	Pyrogen	USP 40.NF 35 Pyrogen Test.	Passed
	Particulate Matter	USP Particulate Matter in Injections,
Method 1: Light Obscuration Particle Count Test	Passed

The following performance data was provided to support a substantial equivalence determination.

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10. Clinical Testing

No clinical test data was included in this submission.

11. Conclusions

Based on device comparison information and non-clinical bench testing, the Pen Needle and the predicate device have the same indication for use, similar materials of construction, and similar specifications. The bench tests and biocompatibility tests support that the proposed device is as safe and effective as the predicate device, and the differences between them do not raise any new

9

questions of safety and effectiveness. Therefore, the proposed device is determined to be

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Substantially Equivalent to legally marketed predicate device.