Safety Lancet

K222090 · Ningbo Medsun Medical Co., Ltd. · FMK · Sep 30, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222090
• Device Name: Safety Lancet
• Applicant: Ningbo Medsun Medical Co., Ltd.
• Product Code: FMK · General, Plastic Surgery
• Decision Date: Sep 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Device Story

Safety Lancet is a single-use, sterile, spring-loaded lancing device for capillary blood sampling. Available in three models (XY, XH, XA) with varying needle/blade gauges and penetration depths. Operation involves removing a protective cap and activating the device via a slider (Model XY) or push-button (Models XH, XA). Upon activation, an internal spring mechanism drives the needle/blade into the skin; a second spring automatically retracts the needle into the housing immediately after puncture. An integrated inactivation system prevents reuse by locking the needle in a retracted position. Used in clinical or home settings by patients or healthcare providers. The device provides a shielded needle to prevent accidental needlestick injuries. Output is a capillary blood sample for diagnostic testing.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogen), mechanical performance (dimension, trigger force, penetration depth, retraction, anti-activation, self-destruct), and clinical simulated use testing for sharps injury prevention per ISO 23908.

Technological Characteristics

Materials: medical-grade stainless steel (needle/blade), silicone oil, and plastic housing/components. Energy source: mechanical (internal springs). Sterilization: Gamma ray (Co-60) or e-beam (SAL 10^-6). Connectivity: None. Form factor: handheld, color-coded housing. Sharps protection: integrated automatic retraction and inactivation mechanism.

Indications for Use

Indicated for capillary blood sampling in patients requiring medical testing, including blood glucose monitoring and other tests requiring small blood volumes.

Regulatory Classification

Identification

The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Special Controls

*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (b) *Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (c) *Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that: (A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and (B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected. (vi) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use. (C) Handwashing instructions for the user before and after use of the device. (D) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device. (F) Instructions for the safe disposal of the device. (G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades. (H) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.” (B) “Used lancet blades must be safely discarded after a single use.” (C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.” (d) *Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class III (premarket approval).(3) *Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• VeriFine Safety Lancet (K192666)
• Surgilance® Safety Lancets (K101145)

Submission Summary (Full Text)

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9/30/2022

Ningbo Medsun Medical Co., Ltd. Liu Ping Regulation Affairs Manager No.55 Jinxi Road, Zhenhai Ningbo, Zhejiang 315221 China

Re: K22090/S001

Trade/Device Name: Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: FMK Dated: July 11, 2022 Received: July 15, 2022

Dear Liu Ping:

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 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

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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 mediation-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 Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K222090

Device Name Safety Lancet

Indications for Use (Describe)

Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

| 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.Date Prepared: July 11th, 2022

#### 2.Submitter

Ningbo Medsun Medical Co., Ltd.

No.55 Jinxi Road, Zhenhai, 315221, Ningbo, P.R.China

Contact Person: Liu Ping, Regulation Affairs Manager

Tel: [phone] Fax:[phone]

Primary correspondent: Marvin Li, Consultant

Tel:[phone] E-mail: [e-mail]

Date Prepared: July 11th, 2022

#### 3.Device

Trade Name: Safety Lancet

Common Name:Blood Lancets

Classification Name:Single Use Only Blood Lancet With An Integral Sharps Injury

Prevention Feature

Regulation Number:21 CFR 8780.4850

Regulatory Class: II

Product Code: FMK

Review Panel: General & Plastic Surgery

#### 4.Predicate device

4.1Predicate device A

Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.

Device name: VeriFine Safety Lancet

510(k) number: K192666

4.2Predicate device B

Manufacturer: Medipurpose Pte Ltd.

Device name: Surgilance® Safety Lancets

510(k) number: K101145

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#### 5.Device description

Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.

Product Structure of the Safety Lancet are summarized in the table below:

| Model | Design features / key functional elements |
|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Model XY is composed of a protective cap, a slider, a front spring, housing, needle body with tri-bevel edge needle or blade, a rear spring and a back cover. The needle body with needle or blade is hidden inside the housing/slider. The housing is colour coded for different versions. |
| | Parts and components of Model XY: |
| | Image: back cover Rear spring Needle body Front spring Housing slider protective cap |
| Model XY | Image: Model XY |
| | Image: needle tip |
| | Note: The right picture shows a partial enlarged view of the needle tip which is hidden inside the housing/slider. |
| | Automatic inactivation mechanism: |
| | There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used. The automatic |

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Image /page/5/Picture/4 description: This image shows the Model XH safety lancet. The image shows the lancet before and after use, and lists design features such as automatic needle retraction and a protective cap. The image also shows the parts and components of the lancet, including the needle tip, protective cap, front spring, housing, needle body, rear spring, and back cover.

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which is hidden inside the housing/protective cap.

Automatic inactivation mechanism:

There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used. The automatic inactivation mechanism is illustrated below:

Before use (left) / After use (right)

Image /page/6/Picture/6 description: The image shows a close-up of a medical device, possibly a needleless connector. The device is mostly clear with blue components inside. It has a cylindrical shape with a wider top and a narrower bottom, and a spring mechanism is visible inside the clear casing.

Image /page/6/Picture/7 description: The image shows a close-up of the inner workings of a blue and clear plastic object, possibly a pen or a similar mechanical device. Inside the clear casing, there are two visible metal springs, one at the top and one at the bottom. A blue component is positioned between the springs, suggesting a mechanism for compression or extension.

### Design features:

- For capillary blood sampling ●
- No pre-loading required
- . Push button activated safety lancet
- . Pre-activated safety feature
- . Automatic needle retraction immediately after use
- Automatically inactivated system to prevent lancet reuse
- Needle fully shielded before and after use
- Sterile, single use ●

Model XA Model XA is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.

Parts and components of Model XA:

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Image /page/7/Figure/2 description: This image shows a close-up of a medical device, possibly an injector or similar instrument, with various components labeled. The device includes a back cover with a push button, a rear spring, a needle body, and a housing. Additionally, there's a front spring, a knob, and a needle tip covered by a protective cap, along with the protective cap itself. The image also shows a separate, magnified view of the needle tip.

Note: The right picture shows a partial enlarged view of the needle tip which is hidden inside the housing/protective cap.

Automatic inactivation mechanism:

There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used. The automatic inactivation mechanism is illustrated below:

Before use (left) / After use (right)

Image /page/7/Figure/7 description: The image shows two medical devices used for capillary blood sampling. The devices are transparent with blue components and contain a spring mechanism. The text highlights design features, noting that the device is for capillary blood sampling and requires no pre-loading.

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| | • Push button activated safety lancet |
|--|------------------------------------------------------------|
| | • Pre-activated safety feature |
| | • Automatic needle retraction immediately after use |
| | • Automatically inactivated system to prevent lancet reuse |
| | • Adjustable penetration depth |
| | • Needle fully shielded before and after use |
| | • Sterile, single use |

## 6.Indications for use

Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and other testing where capillary blood is required.

| Description | Subject Device | Predicate Devices A<br>(K192666) | Predicate Devices B<br>(K101145) | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Product Code | FMK | FMK | FMK | Same |
| Regulation<br>Number | 21CFR 8780.4850 | 21 CFR 878.4800 | 21 CFR 878.4800 | Different |
| Indications<br>for use | Safety Lancet is<br>intended to be used<br>to obtain capillary<br>blood sample to<br>perform medical<br>testing, including<br>blood glucose<br>monitoring and for<br>tests using small<br>amounts of blood. | It is intended for<br>capillary blood<br>sampling. | The SurgiLance®<br>Safety Lancet is a<br>puncture device to<br>obtain micro blood<br>samples. The<br>SurgiLance® Safety<br>Lancet has a sharp's<br>prevention feature to<br>protect the user from<br>a needlestick injury. | Same<br>(Note 1) |
| Prescription/ov<br>er-the counter<br>use | Over-the<br>counter use | Over-the<br>counter use | Over-the<br>counter use | Same |
| Design | There is an<br>integrated<br>automatic<br>inactivation system<br>to prevent lancet<br>reuse. When the<br>slider is pressed,<br>the slider pushes<br>the two bosses of<br>the needle holder<br>backwards. The<br>bosses move | These lancets are<br>precision<br>sharpened<br>designed for<br>maximum comfort<br>and optimal blood<br>flow. Safety lancets<br>are designed to<br>make taking a blood<br>sample simple and<br>easy. Safety lancets<br>are activated when | The Surgilance®<br>Safety Lancet is<br>safely retracted and<br>concealed before<br>and after use.The<br>user simply removes<br>the protective cap ,<br>places the red raised<br>platform end onto<br>the patient's test<br>site , and gently<br>push the lancet | Similar<br>(Note 2) |
| | 510(k) Notification document-Safety Lancet | | | K222090 |
| | backwards over the<br>short rib on the<br>inner side of the<br>housing, and the<br>rear spring is<br>pressed and<br>activated to launch<br>the needle forwards<br>for blood sampling.<br>The needle retracts<br>automatically back<br>into the housing<br>after the puncture,<br>due to the force<br>from the pressed<br>front spring. The<br>needle cannot go<br>back to the starting<br>position and stays<br>between the<br>relaxed rear spring<br>and front spring.<br>Therefore, the<br>device cannot be<br>re-used. | you press the<br>device against your<br>finger. Once<br>activated the needle<br>retracts into the<br>body of the device<br>which reduces the<br>risk of injury as the<br>result if an exposed<br>needle. The first<br>spring releases the<br>needle into the skin<br>and the second<br>withdraws<br>the needle back into<br>the shield. | down against the<br>test site to activate<br>the lancet<br>mechanism. Once<br>the lancet is used , it<br>is rendered<br>inoperative,<br>providing added<br>safety for patient<br>and clinician . The<br>device is discarded<br>in a sharps container<br>after use | |
| Materials | The safety lancet<br>are composed<br>needle/blade,Silico<br>ne oil, spring and<br>plastic part(back<br>cover, slider, housing<br>and protective cap). | The needles all use<br>medical grade<br>stainless steel and<br>the rest<br>part(plastics for the<br>Shield, hub, caps,<br>and triggers) are<br>made of plastics<br>materials. | The needles and<br>blades all use<br>medical grade<br>stainless steel and<br>the housings are<br>made of plastics.<br>The housings, caps,<br>and triggers are<br>made of plastics<br>materials. | Same<br>(Note 3) |
| Model | The safety lancet<br>has Model XY,<br>Model XH and<br>Model XA. The<br>different model is<br>distinguished by the<br>appearance, needle<br>diameter/<br>blade, penetration<br>depth and color. | VeriFine Safety<br>Lancet offers<br>different gauge<br>(needle diameter)<br>options, to allow to<br>choose the lancet<br>which meets blood<br>volume needs. | The SurgiLance®<br>Safety Lancet<br>comes in six models:<br>two low flow, one<br>medium flow, one<br>medium-high flow,<br>and two high flows.<br>The six models are<br>differentiated by<br>their casing<br>color | Similar<br>(Note 4) |
| | | | | |
| Performance | Dimension,Appeara<br>nce,Needle-tip,Trig<br>ger force,Corrosion<br>resistance<br>feature,Retractable,<br>Penetration<br>Depth, Challenge<br>Safe Mode-<br>Resistance,Challen<br>ge Safe Mode-<br>Needle Tip<br>Exposed,<br>Anti-activation test,<br>Self-destruct<br>performance<br>test,pH and total<br>heavy<br>metal,Bacterial<br>Endotoxins | Visual Inspection,<br>Needle<br>Dimensions,<br>Chemical<br>properties,<br>Bond between<br>lancet body and<br>needle,<br>Resistance to<br>corrosion of the<br>needle,Locking<br>function,Spring<br>elasticity,Percussiv<br>e<br>function,Penetrate<br>force | / | Same as<br>Predicate<br>Devices A |
| Sterilization | Irradiation<br>Sterilization<br>SAL:10-6 | Irradiation<br>sterilized,<br>SAL: 10-6 | / | Same as<br>Predicate<br>Devices A |
| Labeling | Conform with 21<br>CFR 801 | Conform with 21<br>CFR 801 | Conform with 21<br>CFR 801 | Same |
| Biocompatibility | Meet the<br>requirements of<br>ISO10993 series<br>standards, and the<br>following tests are<br>performed:In vitro<br>cytotoxicity, skin<br>sensitization,intracu<br>taneous reactivity,<br>acute systemic<br>toxicity, and<br>pyrogen. | Conform with ISO<br>10993 standards,<br>Cytotoxicity,<br>Sensitization,<br>Irritation, were<br>performed to<br>demonstrate<br>Biocompatibility. | / | Similar<br>(Note 5) |
| Reuse or<br>single use | Single use | Single use | Single use | Same |
| Dimension/<br>gauge,<br>penetration<br>depth | Model XY<br>Dimension/gauge:<br>21G,23G,25G,26G,<br>28G,30G(Needle<br>type),1.2mm(Blade<br>type)<br>Penetration depth:<br>1.4mm-2.8mm(Nee<br>dle type), 1.6mm-<br>2.0mm(Blade type)<br><br>Model XH<br>Dimension/gauge:<br>18G,21G,23G,28G<br>(Needle type),<br>1.5mm (Blade type)<br>Penetration depth:<br>1.2mm-2.8mm(Nee<br>dle type),1.6mm<br>-2.0mm(Blade type)<br><br>Model XA<br>Dimension/gauge:<br>21G,23G,28G<br>(Needle type)<br>Penetration depth:<br>1.3mm/1.8mm/2.3m<br>m,1.5mm/2.0mm/2.<br>5mm(Needle type) | Gauge:<br>18G,21G,23G,25G,<br>26G,28G,30G<br>Penetration depth:<br>1.2mm, 1.4mm,<br>1.6mm, 1.8mm,<br>2.0mm, 2.2mm,<br>2.4mm, 2.6mm,<br>2.8mm | Needle type:<br>21G, 1.0mm<br>21G, 1.8mm<br>21G, 2.2mm<br>21G, 2.8mm<br>Blade type:<br>18G, 1.8mm<br>18G, 2.3mm | Similar<br>(Note 6) |

### 7.Comparison of technological characteristics with the predicate device

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K222090

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K222090

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Note 1:The indications for use statements are not identical in wording, however, demonstrate the same desired intended use. Both devices are intended for use for obtaining blood samples. The overarching principal nature of the lancing devices is to obtain blood samples. Both the predicates and subject device have this goal as the main aspect of the indication for use statement. It is also important to note both the subject device and predicate B state the inclusion of a sharps safety prevention feature into the product design. Note 2: Model XY has the same design with predicate device A and B, lancet is activated when press the device's slider against the body site. Model XH and Model XA have the different feature is that lancet is activated when press the device's push button(back cover). Although there are slight differences in design, they all use the elasticity of springs and the structure of plastic parts to realize their functions. All of the models have been testing for the safety and effectiveness.

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Note 3: The subject device and predicate device B all have needle/blade type, but the predicate device A only has needle type. Predicate device B has marketed for many years, it indicates that the blade type is safe and effective.

Note 4: All the devices have different models, only there are some differences in the way of distinguishing models. Besides, subject device has three model:Model XY,Model XH and Model XA. They are have different appearance, the needle body with needle or blade is hidden inside the housing/slider of Model XY, the needle body with needle or blade is hidden inside the housing/protective cap of Model XH and Model XA. The Model XA can adjustable the penetration depth, and the Model XY and Model XH can not adjustable the penetration depth.

Note 5: The predicate device A was tested Cytotoxicity, Sensitization and Irritation to demonstrate biocompatibility. The subject device was tested In vitro cytotoxicity, skin sensitization.intracutaneous reactivity, acute systemic toxicity and pyrogen to demonstrate biocompatibility. The test content of the subject devices is more strict than the predicate device A.

Note 6: The needle of subject device and predicate device B have two types, needle type and blade type. The needle of predicate device A only has needle type .The needles are all solid cylindrical needles. The difference of the needle type is tri-bevel edge needle tip and blade type is two-bevel edge needle tip. Dimension/gauge of the needles all meet the requirements ISO 9626:2016. Therefore, the 1.2mm blade type needle of subject device is equal to 18G, 1.5mm blade type needle of subject device is equal to 17G. The subject device has 18G(1.2mm),21G,23G,25G,26G,28G,30G needle, which is same as the predicate device A, excpet 17G(1.5mm). According to ISO 9626:2016, the most thickest needle reaches to 10G, so the 17G(1.5mm) needle can be used clinically. Additional, the 17G(1.5mm) needle of the subject device havs been marketed on EU market and no adverse event was collected. The subject device and predicate device A/B all have different penetration depth.But the range of the subject device's penetration depth is from 1.2mm to 2.8mm, which is the same as the penetration depth of predicate device A(1.2mm-2.8mm).

#### 8.Performance testing summary

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

6-10

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#### 8.1Biocompatibility testing

Per FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued on September 4, 2020. The biocompatibility evaluation items of proposed device were completed for each model and each sterilization method(Co-60 and e-beam) individually. The testing included the following tests:

- In vitro cytotoxicity
- Skin sensitization
- Intracutaneous reactivity
- . Acute systemic toxicity
- . Pyrogen

#### 8.2Performance testing-Bench

Safety Lancet with different sterilization method(Co-60 and e-beam) had been tested individually. The test items mainly include the following contents.

- . Dimension
- Appearance ●
- Needle-tip ●
- Trigger force ●
- Corrosion resistance feature
- Retractable .
- Penetration Depth
- . Challenge Safe Mode- Resistance
- . Challenge Safe Mode- Needle Tip Exposed
- . Anti-activation test(only for Model XH and XA)
- Self-destruct performance test
- Sterility
- pH and total heavy metal content and Cd content
- . Bacterial Endotoxins

Beside, according to ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling and Guidance for Industry and FDA

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Staff-Medical Devices with Sharps Injury Prevention Features, we have completed the test of clinical simulated use testing for sharps injury protection for each model. The test results show that the product had well sharps injury prevention feature.

#### 9.Conclusions

Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to the predicate devices (K192666, K101145).