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
Indications for 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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +82-51-264-0668 Fax: +82-51-264-7133 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: +82-10-2247-5579 Office Phone: +82-6241-9001 Contact: Kyung-hwan Kim, Representative Consultant, QA Email: info@smbkorea.com
### 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.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
