(266 days)
No
The device description and intended use clearly define a simple mechanical lancing device for obtaining blood samples. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of such algorithms. The performance studies focus on bench testing related to sharps injury prevention and special controls for blood lancets, not on algorithmic performance.
No
The device is used to obtain a blood sample, not to treat a condition. It is a diagnostic tool, not a therapeutic one.
No
Explanation: The device is a lancet used to obtain a blood sample, not to test or analyze the blood sample. Its function is descriptive (collecting), not diagnostic (interpreting).
No
The device description clearly indicates it is a physical medical device made of surgical steel and plastic, used to puncture skin. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain a capillary blood sample. It does not perform any diagnostic testing on the blood sample itself.
- Device Description: The device is a lancet, which is a tool for collecting a sample. It doesn't contain any reagents, test strips, or analytical components that would be used for in vitro diagnostic testing.
- Lack of Diagnostic Function: The description focuses on the physical act of obtaining a blood sample and the features related to that process (sterilization, safety cap, lancing device). There is no mention of any diagnostic function or analysis of the blood.
- Regulatory Classification: While not explicitly stated in the provided text, blood lancets are typically classified as Class II medical devices under the FDA's regulatory framework, but they are not classified as IVDs. The mention of "special controls (878.4850 Blood lancets)" further supports this, as this regulation specifically pertains to blood lancets, not IVDs.
In summary, the device is a tool for collecting a biological sample (blood), which can then be used for in vitro diagnostic testing, but the device itself does not perform the diagnostic test.
N/A
Intended Use / 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.
Product codes
ORK
Device Description
The SG LANSET I, SG LANCETS and SOFT LANCETS are a single use, sterilized by gamma 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
All ages
Intended User / Care Setting
Home setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 classification is based on the FDA Guidance Use of International 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".
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with 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 (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(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 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.
0
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"
1
(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
2
Enclosure
3
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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4
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 |
| 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
5
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 | |||
| (K214022) | SOFT LANCETS | Image: Accu-Chek Softclix lancing device | The lancing device uses compatible lancets | |
| to obtain a drop of blood from the | ||||
| fingertip. The penetration depth can be | ||||
| selected to match any type of skin. Lancing | ||||
| device may be adjusted penetration depth | ||||
| by turning the Comfort Dial. | ||||
| Each level marked with dots to enable you | ||||
| to precisely adjust to your individual skin | ||||
| type. The higher the number visible in the | ||||
| 2 | Suzhou Lancing Device | |||
| (K220387) | SG LANSET I, | |||
| SG LANCETS | Image: Sterilance Lancing Device | depth indicator window, the greater the | ||
| depth setting. | ||||
| Also, the lancing device is intended for use | ||||
| by a single person and is not suitable for | ||||
| testing different persons with the same | ||||
| 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
6
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
Device (K214022) | REFERENCE Device
(K220387) | Significant Difference |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SEWON MEDICAL CO. | Roche Diabetes Care,
Inc. | Suzhou Kyuan Medical
Apparatus Co., Ltd. | – |
| Trade Name | SG LANCET I, SG
LANCETS and SOFT
LANCETS | Accu-Chek Softclix
Blood Lancing System | Disposable Blood
Lancets | – |
| Regulation
Description | Single Use Only Blood
Lancet Without An
Integral Sharps Injury
Prevention Feature | Single Use Only Blood
Lancet Without An
Integral Sharps Injury
Prevention Feature | Single Use Only Blood
Lancet Without An
Integral Sharps Injury
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
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. | The Accu-Chek
Softclix Blood Lancing
System is indicated to
obtain a capillary
blood sample from
the side of a fingertip
for testing utilizing
small amounts of
blood. | The product is
intended to be used in
a hospital or at home
to obtain capillary
blood samples from
the fingertip for tests
using small amounts
of blood. The lancet is
intended to be
assembled with a
lancing device, such
that once the lancing
device is launched,
the needle of the
lancet can prick the
skin. | No difference. |
| Indications for Use | The sterile lancets for
single use are to be
used with the
reusable lancing
device that is to be
cleaned and
disinfected between
each use, and then
the lancets are to be
disposed of.
This device is for use
only on a single
patient in a home
setting.
This device is not
suitable for use by
healthcare | The sterile, single-use
lancets are to be used
with the reusable
lancing device that is
to be cleaned and
disinfected between
each use, and then
the lancets are to be
disposed of.
This system is for use
only on a single
patient in a home
setting.
This system is not
suitable for use by
healthcare | The product is
intended to be used in
a hospital or at home
to obtain capillary
blood samples from
the fingertip for tests
using small amounts
of blood. The lancet is
intended to be
assembled with a
lancing device, such
that once the lancing
device is launched,
the needle of the
lancet can prick the
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):
Not applicable
Lancet: single use | Base (lancing device):
multiple use
Lancet: single use | Base (lancing device):
multiple use
Lancet: single use | Difference: The subject device lacks a lancing device. |
| Design and
Component | Lancing Device (and AST Cap):
Not applicable
Lancet:
[SG LANCET I, SG LANCETS]
[SOFT LANCETS]
| Lancing Device (and AST Cap):
Image: Accu-Chek Softclix lancing device and AST cap
Lancet:
Image: Lancet | Lancing Device (and AST Cap):
Image: Lancing device and AST cap
Lancet:
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);
0.36mm(28G);
0.3mm(30G); and
3 facets cut | 0.4mm(28G); beveled cut with 3 facets | 18G, 21G, 23G, 26G,
0.36mm(28G),
0.3mm(30G), 32G,
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
Device (K214022) | REFERENCE Device
(K220387) | Significant Difference |
| Depth adjustment | n/a | 11 levels by twisting cap | 10 level adjustable tip
for easy and
adjustable skin
penetration | subject device.
Difference: The
subject device lacks a
lancing device. |
| Lancet needle
dimensions (Needle +
Handle) | - Length of Lancet
25.22mm ~ 25.87mm | - Length of Lancet
25.22mm ~ 25.31mm | - Length of Lancet
26.38mm ~ 26.48mm | Similarly: The length
of the lancet is not
significantly different
between the subject
device and
predicate/reference
device. This difference
does not affect the
basic design principle,
usage, effectiveness,
and safety of the
subject device. And
no question is raised
regarding to
effectiveness and
safety. |
| Lancet needle
penetration depth | - SG LANCET I, SG
LANCETS (Used
with K214022
lancing device)
1step: 0.290.31mm;0.50mm;
2step: 0.48
3step: 0.760.78mm;0.88mm;
4step: 0.86
5step: 0.870.89mm;0.96mm
and
6step: 0.94
- SOFT LANCETS
(Used with
K220387 lancing
device)
0.5step: 0.80mm±0.1;
1step: 0.95mm±0.1;
1.5step: 1.10mm±0.1;
2step: 1.25mm±0.1;
2.5step: 1.40mm±0.1;
3step: 1.55mm±0.1;
3.5step: 1.70mm±0.1;
4step: 1.85mm±0.1;
4.5step: 2.00mm±0.1;
5step: 2.15mm±0.1;
and
5.5step: 2.30mm±0.1 | - Used with
K214022
lancing device
0.5step: 0.80mm±0.1;
1step: 0.95mm±0.1;
1.5step: 1.10mm±0.1;
2step: 1.25mm±0.1;
2.5step: 1.40mm±0.1;
3step: 1.55mm±0.1;
3.5step: 1.70mm±0.1;
4step: 1.85mm±0.1;
4.5step: 2.00mm±0.1;
5step: 2.15mm±0.1;
and
5.5step: 2.30mm±0.1 | - Used with
K220387
lancing device
1step: 0.290.31mm;0.50mm;
2step: 0.48
3step: 0.760.78mm;0.88mm;
4step: 0.86
5step: 0.870.89mm;0.96mm | Through comparative
and
6step: 0.94
analysis, while the
puncture depths are
same. Different
needle specification
will be selected by
physician per patient's
condition 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. And
no question is raised
regarding to
effectiveness and
safety. |
| Sterilization Method | Gamma (It is provided | Gamma (It is provided | Gamma (It is provided | No difference. |
| | SUBJECT Device | Primary PREDICATE
Device (K214022) | REFERENCE Device
(K220387) | Significant Difference |
| sterility assurance | sterility assurance
level of 10-6,
validated in
compliance to ISO
11137-1/2/3.) | sterility assurance
level of 10-6,
validated in
compliance to ISO
11137-1/2/3.) | sterility assurance
level of 10-6,
validated in
compliance to ISO
11137-1/2/3.) | |
| Shelf-Life | 5 years | 5 years | 5 years | No difference. |
| Performance Testing | Dimension: Pass
Inner-Outer surface:
Pass
Draw test: Pass | Dimension: Pass
Inner-Outer surface:
Pass
Draw test: Pass | Dimension: Pass
Inner-Outer surface:
Pass
Draw test: Pass | No difference. |
| Biocompatibility | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | No difference. |
| Prescription/OTC | OTC | OTC | OTC | No difference. |
| Sharps injury
prevention | Lancets are covered
by a sterile barrier cap
until twisted off
before use. Until
firing, the lancet is
contained within the
lancing device
housing.
Immediately after
firing, the lancet is
automatically
retracted back into
housing. An ejector
sleeve can then be
pulled forward for
contactless disposal
of the lancet. | Lancets are covered
by a sterile barrier cap
until twisted off
before use. Until
firing, the lancet is
contained within the
lancing device
housing.
Immediately after
firing, the lancet is
automatically
retracted back into
housing. An ejector
sleeve can then be
pulled forward for
contactless disposal
of the lancet. | Lancets are covered
by a sterile barrier cap
until twisted off
before use. Until
firing, the lancet is
contained within the
lancing device
housing.
Immediately after
firing, the lancet is
automatically
retracted back into
housing. An ejector
sleeve can then be
pulled forward for
contactless disposal of
the lancet. | No difference. |
7
8
9
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
10
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.