SG Lanset I, SG Lancets, Soft Lancets

K230712 · Sewon Medical Co. · QRK · Dec 6, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230712
• Device Name: SG Lanset I, SG Lancets, Soft Lancets
• Applicant: Sewon Medical Co.
• Product Code: QRK · General, Plastic Surgery
• Decision Date: Dec 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.

Device Story

Single-use, sterile blood lancets; pointed surgical steel needle encased in plastic with protective cap. Used by diabetic patients to obtain capillary blood samples from fingertip for blood glucose monitoring. Operated by patient; requires compatible reusable lancing device (not included). Patient inserts lancet into lancing device; adjusts penetration depth via lancing device dial; triggers device to puncture skin. Lancet automatically retracts into lancing device housing after use; disposed of after single use. Benefits include safe, convenient, and portable blood sampling for home glucose management.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including dimensional analysis, surface integrity, draw testing, and biocompatibility per ISO 10993-1.

Technological Characteristics

Materials: Stainless steel needle, plastic housing. Dimensions: 25G, 28G, 30G gauges; 3-facet cut. Sterilization: Gamma radiation (ISO 11137-1/2/3) to 10^-6 SAL. Shelf-life: 5 years (ASTM F1980-21). Connectivity: None (mechanical).

Indications for Use

Indicated for patients of all ages requiring capillary blood sampling from the fingertip for diagnostic testing. Not suitable for use by healthcare professionals with multiple patients in a healthcare setting; intended for single-patient use in a home setting.

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

• Accu-Chek Softclix Blood Lancing System (K214022)

Reference Devices

• Disposable Blood Lancets (K220387)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

December 6, 2023

Sewon Medical Co. % Kyung-Hwan Kim Representative Consultant RA/QA SMB Korea #606, #607, 7, Boramae-ro 5ga-gil Donjak-gu Seoul. 07071 Korea, South

Re: K230712

Trade/Device Name: SG Lanset I, SG Lancets, Soft Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORK Dated: October 30, 2023 Received: November 6, 2023

Dear Kyung-Hwan Kim:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.12.06
10:52:58 -05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

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Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K230712

Device Name

SG LANSET I, SG LANCETS and SOFT LANCETS

Indications for Use (Describe)

The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.

Type of Use (Select one or both, as applicable)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

[Complying with 21 CFR 807.92]

#### l. SUBMISSION SPONSOR

SEWON MEDICAL CO. Na-104, 5, Garak-daero 373beon-gil, Gangseo-gu, Busan, Republic of Korea Office Phone: [phone] Fax: [phone] Contact Person: Ms. Ji-yeon, Kim, QMR

### II. SUBMISSION CORRESPONDENT

SMB Korea

#606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu, Seoul, 07071, Republic of Korea Cell Phone: [phone] Office Phone: [phone] Contact: Kyung-hwan Kim, Representative Consultant, QA Email: [e-mail]

### III. DATE PREPARED

October 30, 2023

### IV. DEVICE IDENTIFICATION

| Trade or Proprietary Name: | SG LANSET I, SG LANCETS and SOFT LANCETS |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Blood Lancet |
| Classification Name: | Single Use Only Blood Lancet Without An Integral Sharps<br>Injury Prevention Feature (878.4850) |
| Regulatory Class: | II |
| Product Code: | QRK |
| Classification Panel: | General & Plastic Surgery |

### V. LEGALLY MARKETED PREDICATE DEVICE(S)

Primary Predicate Device: K214022, Accu-Chek Softclix Blood Lancing System / Roche Diabetes Care, Inc.

Reference Device: K220387, Disposable Blood Lancets / Suzhou Kyuan Medical Apparatus Co., Ltd.

### VI. DEVICE DESCRIPTION

The SG LANSET I, SG LANCETS and SOFT LANCETS are a single use, sterilized by gamma

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radiation, which is a pointed piece of surgical steel encased in plastic, used to puncture the skin on one's finger to get a blood sample. The SG LANSET I, SG LANCETS and SOFT LANCETS can be used anytime and anywhere to obtain a blood sample form diabetic patients to measure their blood sugar level. A cap is included to protect the needle from becoming contaminated with dust, etc. The cap completely seals the needle making it impossible for any foreign material to come in contact with the needle. This ensures safe storage and easy portability.

The lancing device used with most blood lancets, offers an adjustable tip with variety depth settings for quick, comfortable and easy blood sampling.

# VII. Accessories for the Product, Integral Parts of Package

All compatible accessories (i.e., lancing device) that can be used with the Blood Lancet are listed in the table below but are not included with these devices:

| No. | Model Name | Compatible Blood Lancet | Appearance | Description |
|-----|------------------------------------|----------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Accu-Chek Softclix<br>(K214022) | SOFT LANCETS | Image: Accu-Chek Softclix lancing device | The lancing device uses compatible lancets<br>to obtain a drop of blood from the<br>fingertip. The penetration depth can be<br>selected to match any type of skin. Lancing<br>device may be adjusted penetration depth<br>by turning the Comfort Dial.<br>Each level marked with dots to enable you<br>to precisely adjust to your individual skin<br>type. The higher the number visible in the |
| 2 | Suzhou Lancing Device<br>(K220387) | SG LANSET I,<br>SG LANCETS | Image: Sterilance Lancing Device | depth indicator window, the greater the<br>depth setting.<br>Also, the lancing device is intended for use<br>by a single person and is not suitable for<br>testing different persons with the same<br>device as this may lead to infections. |

#### VIII. INDICATION FOR USE STATEMENT

The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.

# IX. SUBSTANTIAL EQUIVALENT DISCUSSION

The comparison chart below provides evidence to facilitate the substantial equivalence

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determination between SG LANSET I, SG LANCETS and SOFT LANCETS to the primary predicate (K214022) and reference device (K220387) with respect to intended use, technological characteristics and principles of operation.

| | SUBJECT Device | Primary PREDICATE<br>Device (K214022) | REFERENCE Device<br>(K220387) | Significant Difference |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SEWON MEDICAL CO. | Roche Diabetes Care,<br>Inc. | Suzhou Kyuan Medical<br>Apparatus Co., Ltd. | – |
| Trade Name | SG LANCET I, SG<br>LANCETS and SOFT<br>LANCETS | Accu-Chek Softclix<br>Blood Lancing System | Disposable Blood<br>Lancets | – |
| Regulation<br>Description | Single Use Only Blood<br>Lancet Without An<br>Integral Sharps Injury<br>Prevention Feature | Single Use Only Blood<br>Lancet Without An<br>Integral Sharps Injury<br>Prevention Feature | Single Use Only Blood<br>Lancet Without An<br>Integral Sharps Injury<br>Prevention Feature | – |
| Regulation Number | 21 CFR 878.4850 | 21 CFR 878.4850 | 21 CFR 878.4850 | No difference. |
| Product Code | QRK | QRK, QRL | QRK, QRL | No difference. |
| Class | II | II | II | No difference. |
| Patient Population | All ages | All ages | All ages | No difference. |
| Prescription/OTC | OTC | OTC | OTC | No difference. |
| Intended use | The SG LANSET I, SG<br>LANCETS and SOFT<br>LANCETS are<br>indicated to obtain a<br>capillary blood sample<br>from the side of a<br>fingertip for testing<br>utilizing small<br>amounts of blood. | The Accu-Chek<br>Softclix Blood Lancing<br>System is indicated to<br>obtain a capillary<br>blood sample from<br>the side of a fingertip<br>for testing utilizing<br>small amounts of<br>blood. | The product is<br>intended to be used in<br>a hospital or at home<br>to obtain capillary<br>blood samples from<br>the fingertip for tests<br>using small amounts<br>of blood. The lancet is<br>intended to be<br>assembled with a<br>lancing device, such<br>that once the lancing<br>device is launched,<br>the needle of the<br>lancet can prick the<br>skin. | No difference. |
| Indications for Use | The sterile lancets for<br>single use are to be<br>used with the<br>reusable lancing<br>device that is to be<br>cleaned and<br>disinfected between<br>each use, and then<br>the lancets are to be<br>disposed of.<br>This device is for use<br>only on a single<br>patient in a home<br>setting.<br>This device is not<br>suitable for use by<br>healthcare | The sterile, single-use<br>lancets are to be used<br>with the reusable<br>lancing device that is<br>to be cleaned and<br>disinfected between<br>each use, and then<br>the lancets are to be<br>disposed of.<br>This system is for use<br>only on a single<br>patient in a home<br>setting.<br>This system is not<br>suitable for use by<br>healthcare | The product is<br>intended to be used in<br>a hospital or at home<br>to obtain capillary<br>blood samples from<br>the fingertip for tests<br>using small amounts<br>of blood. The lancet is<br>intended to be<br>assembled with a<br>lancing device, such<br>that once the lancing<br>device is launched,<br>the needle of the<br>lancet can prick the<br>skin. | No difference. |
| | SUBJECT Device | Primary PREDICATE Device (K214022) | REFERENCE Device (K220387) | Significant Difference |
| | professionals with multiple patients in a healthcare setting. | multiple patients in a healthcare setting. | | |
| Number of Uses | Base (lancing device):<br>Not applicable<br>Lancet: single use | Base (lancing device):<br>multiple use<br>Lancet: single use | Base (lancing device):<br>multiple use<br>Lancet: single use | Difference: The subject device lacks a lancing device. |
| Design and<br>Component | Lancing Device (and AST Cap):<br>Not applicable<br><br>Lancet:<br>[SG LANCET I, SG LANCETS]<br><br><br><br>[SOFT LANCETS]<br><br><br> | Lancing Device (and AST Cap):<br><br><br>Image: Accu-Chek Softclix lancing device and AST cap<br><br>Lancet:<br>Image: Lancet | Lancing Device (and AST Cap):<br><br><br>Image: Lancing device and AST cap<br><br>Lancet:<br>Image: Lancet | Difference: There are a minor shape changes in the subject device comparing to the predicate devices. However, the difference in shape is very minor, and the shape of the subject device is within the range of the predicate devices; it is not introducing s significantly different design, and this different were addressed by performance tests. This difference does not affect the basic design principle, usage, effectiveness and safety of the subject device. |
| Needle Material | Stainless Steel | Stainless Steel | Stainless Steel | No difference. |
| Needle | 0.5mm(25G);<br>0.36mm(28G);<br>0.3mm(30G); and<br>3 facets cut | 0.4mm(28G); beveled cut with 3 facets | 18G, 21G, 23G, 26G,<br>0.36mm(28G),<br>0.3mm(30G), 32G,<br>and 33G; | Similarly: There is slightly different needle length between the subject and predicate devices. However, the gauge of the subject device is within the range of the predicate devices; it is not introducing s significantly different design, and this different were addressed by performance tests. This difference does not affect the basic design principle, usage, effectiveness and safety of the subject device. |
| | SUBJECT Device | Primary PREDICATE<br>Device (K214022) | REFERENCE Device<br>(K220387) | Significant Difference |
| Depth adjustment | n/a | 11 levels by twisting cap | 10 level adjustable tip<br>for easy and<br>adjustable skin<br>penetration | subject device.<br>Difference: The<br>subject device lacks a<br>lancing device. |
| Lancet needle<br>dimensions (Needle +<br>Handle) | - Length of Lancet<br>25.22mm ~ 25.87mm | - Length of Lancet<br>25.22mm ~ 25.31mm | - Length of Lancet<br>26.38mm ~ 26.48mm | Similarly: The length<br>of the lancet is not<br>significantly different<br>between the subject<br>device and<br>predicate/reference<br>device. This difference<br>does not affect the<br>basic design principle,<br>usage, effectiveness,<br>and safety of the<br>subject device. And<br>no question is raised<br>regarding to<br>effectiveness and<br>safety. |
| Lancet needle<br>penetration depth | - SG LANCET I, SG<br>LANCETS (Used<br>with K214022<br>lancing device)<br>1step: 0.29~0.31mm;<br>2step: 0.48~0.50mm;<br>3step: 0.76~0.78mm;<br>4step: 0.86~0.88mm;<br>5step: 0.87~0.89mm;<br>and<br>6step: 0.94~0.96mm<br>- SOFT LANCETS<br>(Used with<br>K220387 lancing<br>device)<br>0.5step: 0.80mm±0.1;<br>1step: 0.95mm±0.1;<br>1.5step: 1.10mm±0.1;<br>2step: 1.25mm±0.1;<br>2.5step: 1.40mm±0.1;<br>3step: 1.55mm±0.1;<br>3.5step: 1.70mm±0.1;<br>4step: 1.85mm±0.1;<br>4.5step: 2.00mm±0.1;<br>5step: 2.15mm±0.1;<br>and<br>5.5step: 2.30mm±0.1 | - Used with<br>K214022<br>lancing device<br>0.5step: 0.80mm±0.1;<br>1step: 0.95mm±0.1;<br>1.5step: 1.10mm±0.1;<br>2step: 1.25mm±0.1;<br>2.5step: 1.40mm±0.1;<br>3step: 1.55mm±0.1;<br>3.5step: 1.70mm±0.1;<br>4step: 1.85mm±0.1;<br>4.5step: 2.00mm±0.1;<br>5step: 2.15mm±0.1;<br>and<br>5.5step: 2.30mm±0.1 | - Used with<br>K220387<br>lancing device<br>1step: 0.29~0.31mm;<br>2step: 0.48~0.50mm;<br>3step: 0.76~0.78mm;<br>4step: 0.86~0.88mm;<br>5step: 0.87~0.89mm;<br>and<br>6step: 0.94~0.96mm | Through comparative<br>analysis, while the<br>puncture depths are<br>same. Different<br>needle specification<br>will be selected by<br>physician per patient's<br>condition and this<br>different were<br>addressed by<br>performance tests.<br>This difference does<br>not affect the basic<br>design principle,<br>usage, effectiveness,<br>and safety of the<br>subject device. And<br>no question is raised<br>regarding to<br>effectiveness and<br>safety. |
| Sterilization Method | Gamma (It is provided | Gamma (It is provided | Gamma (It is provided | No difference. |
| | SUBJECT Device | Primary PREDICATE<br>Device (K214022) | REFERENCE Device<br>(K220387) | Significant Difference |
| sterility assurance | sterility assurance<br>level of 10-6,<br>validated in<br>compliance to ISO<br>11137-1/2/3.) | sterility assurance<br>level of 10-6,<br>validated in<br>compliance to ISO<br>11137-1/2/3.) | sterility assurance<br>level of 10-6,<br>validated in<br>compliance to ISO<br>11137-1/2/3.) | |
| Shelf-Life | 5 years | 5 years | 5 years | No difference. |
| Performance Testing | Dimension: Pass<br>Inner-Outer surface:<br>Pass<br>Draw test: Pass | Dimension: Pass<br>Inner-Outer surface:<br>Pass<br>Draw test: Pass | Dimension: Pass<br>Inner-Outer surface:<br>Pass<br>Draw test: Pass | No difference. |
| Biocompatibility | Biocompatible<br>according to ISO<br>10993-1 | Biocompatible<br>according to ISO<br>10993-1 | Biocompatible<br>according to ISO<br>10993-1 | No difference. |
| Prescription/OTC | OTC | OTC | OTC | No difference. |
| Sharps injury<br>prevention | Lancets are covered<br>by a sterile barrier cap<br>until twisted off<br>before use. Until<br>firing, the lancet is<br>contained within the<br>lancing device<br>housing.<br>Immediately after<br>firing, the lancet is<br>automatically<br>retracted back into<br>housing. An ejector<br>sleeve can then be<br>pulled forward for<br>contactless disposal<br>of the lancet. | Lancets are covered<br>by a sterile barrier cap<br>until twisted off<br>before use. Until<br>firing, the lancet is<br>contained within the<br>lancing device<br>housing.<br>Immediately after<br>firing, the lancet is<br>automatically<br>retracted back into<br>housing. An ejector<br>sleeve can then be<br>pulled forward for<br>contactless disposal<br>of the lancet. | Lancets are covered<br>by a sterile barrier cap<br>until twisted off<br>before use. Until<br>firing, the lancet is<br>contained within the<br>lancing device<br>housing.<br>Immediately after<br>firing, the lancet is<br>automatically<br>retracted back into<br>housing. An ejector<br>sleeve can then be<br>pulled forward for<br>contactless disposal of<br>the lancet. | No difference. |

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# X. NONCLINICAL PERFORMANCE DATA

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

# Performance testing

Bench testing was performed to ensure the demonstration of safety and effectiveness of the subject device in accordance with the Guidance for Industry and FDA Staff – Medical Devices with Sharps Injury Prevention Features, issued on August 9, 2005 and special controls (878.4850 Blood lancets).

The results of the performance test demonstrated that SG LANSET I, SG LANCETS and SOFT LANCETS met the requirements.

### Biocompatibility Testing

Biocompatibility classification is based on the FDA Guidance Use of International

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Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."

The subject devices are classified as an Externally Communicating Medical Devices, Circulating blood, Limited exposure (≤24 hours).

The subject devices have fulfilled all testing required per ISO 10993-1 and FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

# Sterilization and Shelf-Life

The sterility of the subject devices is assured using a sterilization method validated in accordance with ISO 11137-1:2006/AMD 2:2018, Sterilization of health care products — Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2, ISO 11137-2:2013/AMD 1:2022, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1, and ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.

The shelf life of the subject device is five (5) years from the date of manufacture in accordance with ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices.

# XI. CLINICAL TESTS

This 510(k) does not include data from clinical tests.

### XII. CONCLUSIONS

Based on the above information, the SG LANSET I, SG LANCETS and SOFT LANCETS are substantially equivalent to the predicate devices listed above. The information contained in this submission supports the fact that the SG LANSET I, SG LANCETS and SOFT LANCETS are as safe and effective as the predicate devices.