Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

K243533 · Hlb Co., Ltd. Healthcare · FMK · Jan 13, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K243533
• Device Name: Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
• Applicant: Hlb Co., Ltd. Healthcare
• Product Code: FMK · General, Plastic Surgery
• Decision Date: Jan 13, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

It is intended for capillary blood sampling.

Device Story

Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel lancets housed in plastic. The Auto Lancet features a protective cap, handle, needle, button, and internal springs; activation involves removing the cap, pressing the button against the skin, and triggering the needle, which then retracts for safety. The Lancet Plus is a manual device used alone or with a lancing device. Both are used by patients or clinicians in any setting to obtain capillary blood samples for glucose monitoring. The devices provide a sterile, single-use mechanism for skin puncture, facilitating blood collection while minimizing sharps injury risk through the Auto Lancet's retraction feature.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only, including biocompatibility (ISO 10993-1), sterilization validation (ISO 11137), and performance testing per FDA guidance for blood lancets with sharps injury prevention features.

Technological Characteristics

Materials: Stainless steel needle; HDPE/PP/PE/POM plastic components. Sensing/Actuation: Mechanical spring-loaded (Auto) or manual (Plus). Dimensions: 26G-30G needles; 1.5mm-3.0mm length. Sterilization: Electron beam (SAL 10^-6). Shelf-life: 3 years (ASTM F1980-21). Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for capillary blood sampling in patients of all ages requiring blood glucose monitoring.

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, VeriFine Mini-Safety Lancet, Promisemed Blood Lancet (K221368)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 13, 2025

HLB Co., Ltd. Healthcare % Kyung-Hwan Kim Representative Consultant. RA/OA SMB Korea Co. 7. Boramae-ro 5ga-gil, Dongjak-gu 606-ho, 607-ho Seoul. 07071 Korea, South

Re: K243533

Trade/Device Name: Sterilized Eol Auto Lancet: Sterilized Eol Lancet Plus Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK, ORK Dated: November 15, 2024 Received: November 15, 2024

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 (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/cdrb/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.

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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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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 Long H. Chen
Long H. Chen -S -s
Date: 2025.01.13 07:31:09 -05'00'

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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243533

Device Name

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

Indications for Use (Describe)

It is intended for capillary blood sampling.

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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Image /page/4/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the letters "SMB" in a bold, sans-serif font, with the word "Korea" next to it in a lighter font. Underneath the main text, in a smaller font, it says "A Member of the Consulting Expert Group."

# 510(k) Summary

[Complying with 21 CFR 807.92]

#### SUBMITTER INFORMATION l.

| Company Name: | HLB Co., LTD. Healthcare |
|------------------|------------------------------------------------------------------------------|
| Address: | 10-5, Myeonghaksandanseo-ro, Yeondong-myeon, Sejong<br>si, Republic of Korea |
| Phone: | [phone] |
| Contact Person: | Ms. Seung-won Baek, QMR |
| Cellular Phone: | [phone] |
| Email: | [e-mail] |
| 510(k) Owner: | SMB Korea Co. |
| 510(k) Preparer: | Mr. Kyung-hwan, Kim, Representative Consultant RA/QA |

#### II. DATE PREPARED

November 15, 2024

#### III. DEVICE IDENTIFICATION

| Trade or Proprietary Name: | Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Blood Lancet |
| Classification Name: | Single Use Only Blood Lancet With An Integral Sharps Injury<br>Prevention Feature,<br>Single Use Only Blood Lancet Without An Integral Sharps<br>Injury Prevention Feature |
| Regulatory Class: | II |
| Product Code: | FMK, QRK |
| Regulation Number: | 21 CFR 878.4850 |

# IV. PREDICATE DEVICE

| Trade or Proprietary Name: | VeriFine Safety Lancet, VeriFine Mini-Safety Lancet<br>Promisemed Blood Lancet |
|----------------------------|--------------------------------------------------------------------------------|
| 510(k) Number: | K221368 |
| Manufacturer: | Promisemed Hangzhou Meditech Co., Ltd. |

#### V. DEVICE DESCRIPTION

The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through

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Image /page/5/Picture/1 description: The image shows the logo for SMB Korea. The logo consists of the text "SMB Korea" in a gray, sans-serif font. A curved line extends from under the "S" in SMB to under the "K" in Korea. Below the text "SMB Korea" is the text "A Member of the Consulting Expert Group" in a smaller, sans-serif font.

irradiation. The product has a shelf life of 3 years.

The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling.

The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.

# VI. INDICATION FOR USE STATEMENT

It is intended for capillary blood sampling.

# VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON

The comparison chart below supports the determination of substantial equivalence between the Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus, and the primary predicate (K221368) regarding intended use, technological characteristics, and principles of operation.

| | SUBJECT Device | PRIMARY PREDICATE<br>Device (K221368) | Significant Difference |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HLB Co., LTD. Healthcare | Promisemed Hangzhou<br>Meditech Co., Ltd. | – |
| Trade Name | Sterilized Eol Auto Lancet | VeriFine Safety Lancet<br>VeriFine Mini-Safety<br>Lancet | – |
| Regulation Description | Single Use Only Blood<br>Lancet With An Integral<br>Sharps Injury Prevention<br>Feature | Single Use Only Blood<br>Lancet With An Integral<br>Sharps Injury Prevention<br>Feature | – |
| Regulation Number | 21 CFR 878.4850 | 21 CFR 878.4850 | No difference. |
| Product Code | FMK | FMK | No difference. |
| Class | II | II | No difference. |
| Patient Population | All ages | All ages | No difference. |
| Prescription or OTC | OTC | OTC | No difference. |
| Intended Use/<br>Indications for Use | It is intended for capillary<br>blood sampling. | It is intended for capillary<br>blood sampling. | No difference. |
| Direction for use | 1. Remove the lancet's<br>protective cap by<br>unscrewing it.<br><br>2. Draw blood from a<br>site that has been<br>sterilized with | 1. Rotate the twisting<br>cap less than half a<br>round.<br><br>2. Pull out the twisting<br>cap.<br><br>3. Place the device on | Similarly:<br>There is no significant<br>difference between<br>subject device and<br>predicate device. They<br>describe the same |
| | SUBJECT Device | PRIMARY PREDICATE<br>Device (K221368) | Significant Difference |
| | alcohol swabs. 3.<br>Press the lancet's<br>push button to<br>draw blood from<br>the desired site. | the puncture site<br>and push to start.<br>4. Discard lancet into a<br>sharp container.<br>5. Press lightly on the<br>finger toward the<br>puncture site to<br>obtain adequate<br>blood sample. | process without notable<br>distinctions. |
| Number of Uses | Single use | Single use | No difference. |
| Design and Structure | Image: Lancet | Image: VeriFine Safety Lancet | Difference:<br>The subject device has<br>minor shape changes<br>compared to predicate<br>device, but these are<br>within the acceptable<br>range and do not<br>introduce a significantly<br>different design.<br>Performance tests<br>address these<br>differences, ensuring no<br>impact on design<br>principles, usage,<br>effectiveness, or safety. |
| Material | Needle: Stainless steel<br>Spring: Galvanized steel<br>housing, hub and Safety:<br>HDPE<br>Trigger: PP<br>Lancet body, cap: PP | Needle: Stainless steel<br>Spring: Galvanized steel<br>wire<br>Shield, hub and Safety:<br>ABS<br>Trigger: POM<br>Lancet body, cap: PE | No difference. |
| Gauge | 26G, 28G, 30G | 18G, 21G, 23G, 25G, 26G | Similarly: |
| | SUBJECT Device | PRIMARY PREDICATE<br>Device (K221368) | Significant Difference |
| | | 28G, 30G | The subject device's<br>gauge is within the<br>predicate device's range. |
| Needle Length (mm) | 1.5 | 1.2, 1.4, 1.6, 1.8, 2.0, 2.2,<br>2.4, 2.6, 2.8 | Similarly:<br>The subject device's<br>gauge is within the<br>predicate device's range. |
| Sterilization Method | Electron beam | Gamma | No difference. |
| Shelf-Life | 3 years | 5 years | No difference. |
| Biocompatibility | Biocompatible according<br>to ISO 10993-1 | Biocompatible according<br>to ISO 10993-1 | No difference. |

Device Comparison Chart: Similarities and Differences – Sterilized Eol Auto Lancet

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#### HLB Co., LTD. Healthcare - K243533 Traditional 510(k) Premarket Submission Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus

Image /page/6/Picture/1 description: The image shows the logo for SMB Korea, which is part of the Consulting Expert Group. The logo features the text "SMB Korea" in a gray, sans-serif font, with a stylized swoosh graphic above the letters "MB". Below the main text, in a smaller font, is the tagline "A Member of the Consulting Expert Group."

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#### HLB Co., LTD. Healthcare - K243533 Traditional 510(k) Premarket Submission Sterilized Eol Auto Lancet, Sterilized Eol Lancet Plus

Image /page/7/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" stacked on top of the word "Korea". A curved line extends from the bottom of the "S" to the top of the "B". Below the word "Korea" is the text "A Member of the Consulting Expert Group" in a smaller font size.

# Device Comparison Chart: Similarities and Differences – Sterilized Eol Lancet Plus

| | SUBJECT Device | PRIMARY PREDICATE<br>Device (K221368) | Significant Difference |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HLB Co., LTD. Healthcare | Promisemed Hangzhou<br>Meditech Co., Ltd. | – |
| Trade Name | Sterilized Eol Lancet Plus | Promisemed® Blood<br>Lancet | – |
| Regulation 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 | – |
| Regulation Number | 21 CFR 878.4850 | 21 CFR 878.4850 | No difference. |
| Product Code | QRK | QRK | No difference. |
| Class | II | II | No difference. |
| Patient Population | All ages | All ages | No difference. |
| Prescription/OTC | OTC | OTC | No difference. |
| Intended use/<br>Indications for Use | It is intended for capillary<br>blood sampling. | It is intended for capillary<br>blood sampling. | No difference. |
| Number of Uses | Base (lancing device):<br>Not applicable<br>Lancet: single use | Base (lancing device): Not<br>applicable<br>Lancet: single use | No difference |
| Design and Component | Image: blue lancet | Image: blue lancet | Difference:<br>The subject device has<br>minor shape changes<br>compared to predicate<br>device, but these are<br>within the acceptable<br>range and do not<br>introduce a significantly<br>different design.<br>Performance tests<br>address these<br>differences, ensuring no |
| | Stainless steel needle<br>encapsulated in a plastic<br>body and cap, the cap is<br>twisted off to expose the<br>needle for use. | Stainless steel needle<br>encapsulated in a plastic<br>body and cap, the cap is<br>twisted off to expose the<br>needle for use. | |

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Image /page/8/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from the left side of the "S" in SMB, arching over the letters and ending near the "K" in Korea.

| | SUBJECT Device | PRIMARY PREDICATE<br>Device (K221368) | Significant Difference |
|----------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------|
| | | | impact on design<br>principles, usage,<br>effectiveness, or safety. |
| Material | Needle: Stainless steel<br>Handle, Protective cap:<br>PE | Needle: Stainless steel<br>Handle, Protective cap:<br>PE | No difference. |
| Gauge | 26G, 28G, 30G | 28G, 30G, 32G, 33G | Similarly:<br>The subject device's<br>gauge is within the<br>predicate device's range. |
| Needle Length (mm) | 3.0 | 3.0 | No difference. |
| Sterilization Method | Electron beam | Gamma | No difference. |
| Shelf-Life | 3 years | 5 years | No difference. |
| Biocompatibility | Biocompatible according<br>to ISO 10993-1 | Biocompatible according<br>to ISO 10993-1 | No difference. |

#### NON-CLINICAL PERFORMANCE DATA VIII.

The following tests were conducted:

# Sterilization and Shelf-Life

The sterility of the subject devices is ensured through a sterilization method validated according to ISO 11137-1:2006/AMD 2:2018, ISO 11137-2:2013/AMD 1:2022, and ISO 11137-3:2017.

The shelf life of the device is three years from the date of manufacture, as per ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices.

# Biocompatibility Testing

Biocompatibility classification follows the FDA Guidance based on ISO 10993-1:2019, which outlines the biological evaluation and testing of medical devices within a risk management framework.

The devices in question are classified as Externally Communicating Medical Devices intended for circulating blood with limited exposure (≤24 hours).

These devices have successfully completed all testing required by ISO 10993-1:2019 and the associated FDA guidance document.

# Performance testing

The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus have successfully completed comprehensive bench testing, demonstrating full compliance with safety and effectiveness requirements. The testing protocol adhered to the FDA Guidance for

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Image /page/9/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and purple. The text "SMB" is in a larger, bold font, and the text "Korea" is in a smaller, regular font. Below the text is the phrase "A Member of the Consulting Expert Group" in a smaller font.

Industry and FDA Staff on Medical Devices with Sharps Injury Prevention Features (dated August 30, 2024) and the special controls outlined in 21 CFR 878.4850 for blood lancets. Performance evaluation results confirmed that both devices successfully met all specified regulatory requirements and safety standards.

# IX. CLINICAL TESTS

Clinical performance testing was not deemed necessary as the non-clinical testing was sufficient to demonstrate substantial equivalence.

# X. CONCLUSIONS

Based on the comparison of intended use, technological characteristics, and performance testing results, the Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are substantially equivalent to the predicate device. The non-clinical test results demonstrate that the devices are as safe and effective as the predicate device. The differences in technological characteristics do not raise any new issues of safety or effectiveness. Therefore, these devices are suitable for their intended use in capillary blood sampling.