Safety Pen Needle
Device Facts
| Record ID | K210864 |
|---|---|
| Device Name | Safety Pen Needle |
| Applicant | Sandstone Medical (Suzhou), Inc. |
| Product Code | FMI · General Hospital |
| Decision Date | Feb 17, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Sterile, single-use safety pen needle for subcutaneous drug delivery via pen injectors. Features two models: HE (single patient-end safety shield) and HS (dual safety shields for patient and pen-connection ends). Operation: user screws needle onto pen; inserts needle into skin; front shield retracts during injection. Post-injection: spring-loaded shield extends and locks over needle tip, indicated by red band. HS model includes additional spring-loaded rear shield that locks upon removal from pen. Used in clinical or home settings by patients or healthcare providers. Benefits: reduces accidental needlestick injuries; hides needle tip before/after use. Sterilized via Gamma irradiation.
Clinical Evidence
Bench testing only. Simulated clinical use study evaluated 500 devices by professional and non-clinical users; zero needlestick injuries and zero protective feature failures reported. Biocompatibility testing (cytotoxicity, sensitization, reactivity, systemic toxicity, haemocompatibility, pyrogen, endotoxins, particulates) passed per ISO 10993 and USP standards.
Technological Characteristics
Materials: Stainless steel needle, PP hub, ABS/PC shields, carbon steel springs. Dimensions: 30G-33G, 4mm-8mm lengths. Principle: Spring-loaded mechanical safety shield. Sterilization: Gamma irradiation (SAL 10^-6). Connectivity: None. Standards: ISO 11608-2, ISO 7864, ISO 9626, ISO 23908, ISO 10993-1.
Indications for Use
Indicated for subcutaneous injection of fluids and FDA-approved drugs using pen injector devices. Suitable for patients requiring subcutaneous injections; no specific age or gender restrictions noted.
Regulatory Classification
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.
Predicate Devices
- Clickfine AutoProtect Pen Needle (K152514)
Submission Summary (Full Text)
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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
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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 (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
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# 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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# 510(k) Summary
# 1. Contact Details
| Applicant Name | Sandstone Medical (Suzhou) Inc. |
|-------------------------|------------------------------------------------------------------------------------------------|
| Address | Building 6, No.168 PuTuoShan Road, New District, 215153 Suzhou,<br>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
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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.
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# 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
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Product: Safety Pen Needle
| Item | Proposed Device:<br>Safety Pen Needle<br>(HE Model and HS Model)<br>(K210864) | Predicate Device:<br>Clickfine AutoProtect Pen<br>Needle<br>(K152514) | Comments | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------|
| Product Code | FMI | FMI | Same | |
| Intended use | The safety pen needle is<br>intended for use with pen<br>injector devices for<br>subcutaneous injection of fluids<br>and FDA-approved drugs.<br><br>For HE Model<br>Additionally, the attached safety<br>shield automatically locks in<br>place and reduces the<br>occurrence of accidental needle<br>sticks from the patient end of<br>the needle. The shield also<br>serves to hide the needle before<br>and after injection.<br><br>For HS Model<br>Additionally, the product has<br>two safety shields, which lock in<br>place after use (patient end)<br>and upon removal of the needle<br>from the pen (pen connection<br>end). The locked shields help<br>reduce the occurrence of<br>needle sticks from both ends of<br>the needle. | The Clickfine AutoProtect Pen<br>Needle is intended for use with<br>pen injector devices for the<br>injection of fluids, including<br>insulin and exenatide.<br><br>Additionally, the attached safety<br>shield automatically locks in<br>place and reduces the<br>occurrence of accidental needle<br>sticks from the patient end of<br>the needle. The shield also<br>serves to hide the needle before<br>and after injection. | Similar<br>(Issue 1) | |
| OTC use | Yes | Yes | Same | |
| Single use | Yes | Yes | Same | |
| Operation mode | Manual | Manual | Same | |
| Operating principle | Use the lock shields to help<br>reduce the occurrence of<br>needle sticks. | Use the lock shields to help<br>reduce the occurrence of<br>needle sticks. | Same | |
| Needle gauge | <span style="text-decoration: underline">30G</span> , 31G, 32G, <span style="text-decoration: underline">33G</span> | 29G, 30G, 31G | Different | |
| Needle length | 4mm, 5mm, 6mm, 8mm | 5mm, 6mm, 8mm | (Issue 2) | |
| Needle wall<br>thickness | Thin wall | Regular wall, Thin wall | Similar | |
| Needle grind | Front and back bevel | Front and back bevel | Same | |
| Tip geometry | 3 bevel | 3 bevel | Same | |
| Item | Proposed Device:<br>Safety Pen Needle<br>(HE Model and HS Model)<br>(K210864) | Predicate Device:<br>Clickfine AutoProtect Pen<br>Needle<br>(K152514) | Comments | |
| Method of<br>attachment to pen | "Twist-on" attachment and<br>Twist-off removal | "Snap-on" & "Twist-on"<br>attachment and Twist-off<br>removal | Different<br>(Issue 3) | |
| Sterilization | SAL: 10-6<br>Method: Gamma irradiation | SAL: 10-6<br>Method: Gamma irradiation | Same | |
| Visual indicator | Red band | Red band | Same | |
| Needle<br>tube | Stainless steel | Stainless steel | Same | |
| Need<br>hub | PP | PP | Same | |
| Needle/hub<br>bond | Adhesive bonded | Adhesive bonded | Same | |
| Main<br>body | White colored ABS | White colored PP | | |
| Front<br>shield | Transparent ABS or PC | Blue colored MBS, using the<br>Zylar 530<br>granulate | | |
| Configuration and<br>Material | Big<br>spring | Carbon steel | Stainless steel | |
| | Small<br>spring | HE Model: None<br>HS Model: Carbon steel | None | |
| | Turning<br>tube | POM | Unknown | Different<br>(Issue 4) |
| | Rear<br>shield | Red colored ABS | None | |
| | Safety<br>lock<br>indicator | Red band printed on the front<br>shield | Red colored PP | |
| | Outer<br>сар | HDPE | Blue colored PP | |
| Peel tab | Medical dialysis paper | PET | | |
| Performance | Complied with ISO 11608-2,<br>ISO 7864, ISO 9626 and ISO<br>23908. | Complied with ISO 11608-2,<br>ISO 7864, ISO 9626 and ISO<br>23908. | Same | |
| Biocompatibility | Complied with ISO 10993-1, USP | Complied with ISO10993-1 | Same | |
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Version:A/0
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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.
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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<br>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<br>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<br>devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Skin Sensitization | ISO 10993-10 Biological evaluation of medical<br>devices - Part 10: Tests for irritation and skin<br>sensitization | Pass |
| Intracutaneous Reactivity | ISO 10993-10 Biological evaluation of medical<br>devices - Part 10:Tests for irritation and skin<br>sensitization | Pass |
| Acute Systemic Toxicity | ISO 10993-11 Biological evaluation of medical<br>devices - Part 11: Tests for systemic toxicity | Pass |
| Haemocompatibility | ASTM F756 Standard Practice for Assessment<br>of Hemolytic Properties of Materials | Pass |
| Pyrogen | ISO 10993-11 Biological evaluation of medical<br>devices - Part 11: Tests for systemic toxicity<br>USP 42-NF37 <151> Pyrogen Test | Pass |
| Bacterial Endotoxins | USP42_NF37 <85> Bacterial Endotoxins Test | Pass |
| Particulates | USP <788>, Method 1 Light Obscuration Test | Pass |
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#### > 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).
