(154 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a lancing device and lancet, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to obtain a capillary blood sample for self-monitoring of blood glucose, which is a diagnostic or monitoring function, not a therapeutic one.
No
Explanation: The device, consisting of a lancet and lancing device, is used to obtain a capillary blood sample. It does not perform any diagnostic function on its own; it merely collects the sample for subsequent diagnostic testing (e.g., self-monitoring of blood glucose).
No
The device description explicitly details physical components (lancet, lancing device with various parts like needle, cap, buttons, etc.) and mentions physical performance testing (biocompatibility, bench testing for dimensions, force, etc.). This indicates it is a hardware medical device, not software-only.
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 for self-monitoring of blood glucose. It is a tool for collecting the sample, not for performing the diagnostic test itself.
- Device Description: The description focuses on the mechanical components of the lancet and lancing device, which are used for puncturing the skin and drawing blood.
- Performance Studies: The performance studies listed are related to the safety and functionality of the device for obtaining a blood sample (biocompatibility, mechanical testing, sharps injury protection). There are no studies related to the analysis of the blood sample or the diagnostic accuracy of a test.
- Lack of Diagnostic Function: The device does not perform any analysis on the blood sample. It simply provides the sample for a separate diagnostic test (in this case, likely a blood glucose meter).
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is limited to the collection of the specimen.
N/A
Intended Use / Indications for Use
Lancet: Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose.
Lancing Device: Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.
Product codes
QRK, QRL
Device Description
Lance Device have two parts, lancet and lancing device. Lancet is composed of a lancet body, a needle and a protective cap. Lancing device is mainly composed of depth adjustment tip, cap, release button, shield, rear sliding barrel and an ejector. The cover consists of inner cover, cap inner core, rear sliding barrel, inner core, buckle ring and two springs, with 12 depth adjustment gears.
The lancet is provided as sterile state and have four model: Model BYY3, Model BYY4, Model BYB and Model BYC.The lancet body of Model BYY3 and Model BYY4 is circular, and the lancet body of Model BYB and Model BYC is flat. The lancing device is provided as non-sterile state and a reusable medical device for use only on a single patient and have four model: Model CX11B1, Model CX11B2, Model CX11C1 and Model CX11C2. Model CX11 Lancing device is divided into CX11B (threaded connection) and CX11C (buckle connection) according to the different connection structures of the cap and body of the lancing device. Model CX11B is divided into CX11B1 (suitable for round lancet) and CX11B2 (suitable for flat lancet) according to the different structure of the lancet.Model CX11C is divided into CX11C1(suitable for round lancet) and CX11C2(suitable for flat lancet) according to the different structures of the lancet.
The lancet is sterilized by Gamma ray and for single use,the shelf life is 5 years. The lancing device is provided as non-sterile state,for use only on a single patient. The useful life is 5 years or 6000 times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Lay users / Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted with the following types of tests:
- Biocompatibility testing for lancet and lancing device.
- Performance testing-Bench for lancet including appearance, dimension, needle-tip, puncture force, connecting fastness, corrosion resistance feature, limits for acidity and alkalinity, total heavy metal content and Cd content, sealing strength, sterile barrier integrity, sterility.
- Performance testing-Bench for lancing device including appearance, dimension, compatibility, coaxiality, depth adjustment, packages and Labels, drop test, needle unloading thrust, torque test (for model CX11B1 and CX11B2), buckle force (for model CX11C1 and CX11C2), separating force (for model CX11C1 and CX11C2).
- Compatibility between lancet with lancing device.
- Clinical simulated use testing for sharps injury protection of lancing system based on ISO 23908:2011.
Key results:
- Biocompatibility evaluation items of proposed device were completed.
- The test results for lancet and lancing device bench testing support substantial equivalence.
- The results show that the different model lancet is well compatibility the corresponding model lancing device.
- The clinical simulated use testing results show that the product had well sharps injury prevention feature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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). 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 4, 2024
Ningbo Medsun Medical Co., Ltd. Liu Ping Regulation Affairs Manager No.55 Jinxi Road, Zhenhai, Ningbo, Zhejiang 315221 China
Re: K232330
Trade/Device Name: Lancing System Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK, QRL Dated: July 21, 2023 Received: August 3, 2023
Dear Liu Ping:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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/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.
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).
1
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.
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-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: 2024.01.04 11:53:02 -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 Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232330
Device Name Lancing System
Indications for Use (Describe)
Lancet:
Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose.
Lancing Device:
Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.
| 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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3
510(k) Summary
1.Date Prepared: July 21th, 2023
2.Submitter
Ningbo Medsun Medical Co., Ltd.
No.55 Jinxi Road, Zhenhai, 315221, Ningbo, P.R.China
Contact Person: Liu Ping, Regulation Affairs Manager
Tel: +86-574-86301708 Fax:+86-574-86301778 E-mail: 404739678@gq.com
Consultant: Marvin Li
Date Prepared: July 21th, 2023
3.Device
Trade Name: Lancing System
Common Name:Blood Lancets
Classification Name: Multiple Use Blood Lancet For Single Patient Use Only
Regulation Number:21 CFR 8780.4850
Regulatory Class: II
Product Code: QRK, QRL
Review Panel: General & Plastic Surgery
4.Predicate device
Manufacturer: Tianjin Huahong Technology Co., Ltd.
Device name: Lancet, Lancing device
510(k) number: K220475
5.Device description
Lance Device have two parts, lancet and lancing device. Lancet is composed of a lancet body, a needle and a protective cap. Lancing device is mainly composed of depth adjustment tip, cap, release button, shield, rear sliding barrel and an ejector. The cover consists of inner cover, cap inner core, rear sliding barrel, inner core, buckle ring and two springs, with 12 depth adjustment gears.
The lancet is provided as sterile state and have four model: Model BYY3, Model BYY4,
4
Model BYB and Model BYC.The lancet body of Model BYY3 and Model BYY4 is circular, and the lancet body of Model BYB and Model BYC is flat. The lancing device is provided as non-sterile state and a reusable medical device for use only on a single patient and have four model: Model CX11B1, Model CX11B2, Model CX11C1 and Model CX11C2. Model CX11 Lancing device is divided into CX11B (threaded connection) and CX11C (buckle connection) according to the different connection structures of the cap and body of the lancing device. Model CX11B is divided into CX11B1 (suitable for round lancet) and CX11B2 (suitable for flat lancet) according to the different structure of the lancet.Model CX11C is divided into CX11C1(suitable for round lancet) and CX11C2(suitable for flat lancet) according to the different structures of the lancet.
The lancet is sterilized by Gamma ray and for single use,the shelf life is 5 years. The lancing device is provided as non-sterile state,for use only on a single patient. The useful life is 5 years or 6000 times.
Product Structure of the Lancing System are summarized in the table below:
| Model | Design features |
|---|---|
| Model | |
| BYY3 | Model BYY3 Lancet is composed of a lancet body, a needle and a protective cap. The needle is fully enclosed by the protective cap. The lancet is colour coded for different versions. The structure of the lancet is circular. |
Parts and components of Model BYY3:
Image: Lancet body and protective cap |
| Model
BYY4 | Model BYY4 Lancet is composed of a lancet body, a needle and a protective cap. The needle is fully enclosed by the protective cap. The lancet is colour coded for different versions. The structure of the lancet is circular.
Parts and components of Model BYY4: |
5.1Lancet
5
Image /page/5/Figure/2 description: The image shows two different models of lancets, labeled as Model BYB and Model BYC. Each model is composed of a lancet body, a needle, and a protective cap. The needle is fully enclosed by the protective cap, and the lancet is color-coded for different versions. The structure of the lancet is flat.
5.2Lancing Device
| Model | Design features |
|---|---|
| Model | |
| CX11B1 | Model CX11B1 Lancing device is mainly composed of a depth adjustment |
| tip, a cap, a release button, a shield, a rear sliding barrel and an ejector. The | |
| cover consists of an inner cover, a cap inner core, a rear sliding barrel, an | |
| inner core, a buckle ring, and two springs, with 12 depth adjustment gears. | |
| Model CX11B1 Lancing device is connected with thread. Model CX11B1 | |
| Lancing device will be compatible with Model BYY3 and Model BYY4 |
6
Image /page/6/Figure/2 description: The image shows the parts and components of the Model CX11B1 and Model CX11B2 lancets. The components are labeled with numbers 1 through 6, which correspond to the adjustable tip, cap, release button, shield, rear sliding barrel, and ejector. The image also includes a description of the Model CX11B2 and Model CX11C1 lancing devices, which are composed of a depth adjustment tip, cap, release button, shield, rear sliding barrel, and ejector.
7
Image /page/7/Figure/2 description: This image shows the parts and components of two lancing devices, Model CX11C1 and Model CX11C2. Each model is accompanied by a diagram illustrating its components, labeled with numbers 1 through 6, corresponding to: Adjustable Tip, Cap, Release Button, Shield, Rear Sliding Barrel, and Ejector. The diagrams also include measurements labeled as 'L' and 'D2'. The text provides additional details about the composition and compatibility of each lancing device model with different lancet types.
8
6.Indications for use
Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose.
Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.
7.Comparison of technological characteristics with the predicate device
The comparison and discussion between the subject device and the predicate devices are listed in below table 1 and 2.
| Description | Subject Device | Predicate Devices
(K220475) | Remark |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Proprietary/trade name | Lancet | Lancet | Same |
| Product Code | QRK, QRL | QRK, QRL | Same |
| Regulation Number | 21CFR 8780.4850 | 21CFR 8780.4850 | Same |
| Class | II | II | Same |
| Indications for use | Lancet is intended to be
used to obtain capillary
blood sample for
self-monitoring of blood
glucose. | It is intended for
capillary blood
sampling. | Same |
| Prescription/over-the
counter use | Over-the
counter use | Over-the
counter use | Same |
| Applicable user | Lay users | Healthcare
professional or
lay person | Different
(Note 1) |
| Reuse or single use | Single use | Single use | Same |
| Sterilization
method and
SAL | Irradiation Sterilization
SAL:10-6 | Irradiation Sterilization
SAL:10-6 | Same |
| Shelf-life | 5 years | 5 years | Same |
| Design and | For the Lancet, | For the Lancet, | Same |
| Manufacturing | stainless steel needle is fed into an injection molding machine to over-mold plastic material (polyethylene (PE) ) forming a body and cap, encapsulating the stainless steel.The Lancet comprises a stainless steel needle encapsulated with a plastic body and cap, the cap is twisted off to expose the needle for use. | stainless steel needle is fed into an injection molding machine to over-mold plastic material(polyethylene (PE) and Ethylene Vinyl Acetate (EVA) and calcium powder) forming a body and cap, encapsulating the stainless steel. The Lancet comprises a stainless steel needle encapsulated with a plastic body and cap, the cap is twisted off to expose the needle for use. | |
| Needle length range | $3.3\pm0.5mm$ | $3.2\pm0.3mm$ (Model: IA、IB、IC、ID、IE、IK、IL、IM、IIA、IIB、III、VI)
$2.1\pm0.3mm$ (Model:V ) | Different (Note 2) |
| Gauge range | 28G,29G,30G, 31G,32G,33G | $1.50\pm0.02mm (16G)$ $1.20\pm0.01mm (18G)$ $1.07\pm0.01mm (19G)$ $0.91\pm0.01mm (20G)$ $0.82\pm0.01mm (21G)$ $0.72\pm0.01mm (22G)$ $0.64\pm0.01mm (23G)$ $0.57\pm0.01mm (24G)$ $0.51\pm0.01mm (25G)$ $0.46\pm0.01mm (26G)$ $0.41\pm0.01mm (27G)$ $0.36\pm0.01mm (28G)$ $0.34\pm0.01mm (29G)$ $0.31\pm0.01mm (30G)$ $0.26\pm0.01mm (31G)$ $0.24\pm0.01mm (32G)$ $0.21\pm0.01mm (33G)$ $0.19\pm0.01mm (34G)$ | Different (Note 3) |
| Materials of parts in contact with | The Lancet has a needle that is made of stainless steel and silicone oil. The body | The Lancet has a needle that is made of stainless steel and silicone oil. | Different (Note 4) |
| | and cap are made of
polyethylene (PE). | The body and cap are
made of polyethylene
(PE) and Ethylene
Vinyl Acetate (EVA) | |
| Labeling | Conform with 21 CFR
801 | Conform with 21 CFR
801 | Same |
| Biocompatibility | Conforms to the
requirements of ISO
10993 series standards. | Conforms to the
requirements of ISO
10993 series
standards. | Same |
9
10
Table 1-General Comparison of Lancet
Note 1: The applicable user of the predicate device has both healthcare professional and lay person, but the applicable user of the subject device only has lay users.
Note 2: The needle length range of the predicate device has two dimensions, 3.2±0.3mm and 2.1±0.3mm, but the needle length range of the subject device only has one dimension, 3.3±0.5mm.Although the dimension is different, the puncture depth may be adjusted through the lancing device when the subject device is used. The difference will not effect the safety and effectiveness of the subject device.
Note 3: The gauge range of the predicate device has 18 types, but the gauge range of the subject device only has 6 types. All of the gauge range are referred to ISO 9626:2016. Note 4: The materials of parts in contact with human body of the predicate device are stainless steel,silicone oil,PE and EVA, but the materials of parts in contact with human body of the subject device are stainless steel,silicone oil and PE. The safety of materials of the subject device have been certified by biocompatibility test.
| Description | Subject Device | Predicate Devices
(K220475) | Remark |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Proprietary/trade name | Lancing Device | Lancing Device | Same |
| Product Code | QRK,QRL | QRK,QRL | Same |
| Regulation Number | 21CFR 8780.4850 | 21CFR 8780.4850 | Same |
| Class | II | II | Same |
| Indications
for use | Lancing Device is used
with lancets to draw a
capillary blood sample
for testing, utilizing
small amounts of blood.
The Lancing Device is
intended for use by a
single patient and
should not be shared. | The Lancing Device is
used with lancets to
draw capillary blood
from the fingertip, for
testing utilizing small
amounts of blood. The
Lancing Device is
intended to be used
by a single patient and
should not be shared. | Same |
| Prescription/over-the
counter use | Over-the
counter use | Over-the
counter use | Same |
| Puncture device to
obtain micro blood
samples | Yes | Yes | Same |
| Lancet retracted
after use to prevent
sharp injure | Yes | Yes | Same |
| Device
penetration
depth range | $0~1.8mm±0.5mm$ | $0.85mm(0.30mm)~2.20mm(±0.30mm)$
(Model: HH-X-T);
$0.60mm(0.30mm)~2.00mm(±0.30mm)$
(Model HH-XIII-T、
HH-XXII-T);
$0.50mm(0.30mm)~1.70mm(±0.30mm)$
(Model HH-XV-T);
$0.60mm(0.30mm)~1.95mm(±0.30mm)$
(Model HH-XVI-T、
HH-XXI-T、
HH-XXIII-T、
HH-XXIV-T);
$0.60mm(0.30mm)~1.80mm(±0.30mm)$
(Model HH-XVII-T、
HH-XIX);
$0.60mm(0.30mm)~2.10mm(±0.30mm)$
(Model HH-XVIII-T) | Different
(Note 5) |
| Mechanical loading
and firing function | Cocking barrel with
releasing button | Cocking barrel with
releasing button | Same |
| Reuse or
single use | .Reuse,for use only
on a single patient. | Reusable,Single
Patient Use Only | Same |
| Sterilization
method and
SAL | N/A | N/A | Same |
| Materials | ABS, POM and
PC Resin | ABS, POM and
PC Resin | Same |
| Labeling | Conform with 21 CFR
801 | Conform with 21 CFR
801 | Same |
| Biocompatibility | Conforms to the
requirements of ISO
10993 series standards. | Unknown | Different
(Note 6) |
11
12
510(k) Notification documents-Lancing System
Table 2-General Comparison of Lancing device
Note 5: The device penetration depth range of the predicate device has different dimensions for different models. The device penetration depth range of the subject device also has different dimensions,the max range is 1.8mm±0.5mm for each model of subject device, which can be turned 12 kinds different penetration depth range from 0- 1.8mm±0.5mm for patient. It will reduce the pain of puncture when the appropriate gear is selected. Note 6: The biocompatibility of predicate device is unknown. The biocompatibility of the subject device is met the ISO 10993 series standards.
8.Performance testing summary
The following performance data were provided in support of the substantial equivalence determination.
8.1Biocompatibility testing
Per FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued on September 4, 2020. The biocompatibility evaluation items of proposed device were completed.
The testing of lancet included the following tests:
- . In vitro cytotoxicity
- Skin sensitization .
13
- . Intracutaneous reactivity
- . Acute systemic toxicity
- Pyrogen
The testing of lancing device included the following tests:
- . In vitro cytotoxicity
- . Skin sensitization
- . Skin Irritation
8.2Performance testing-Bench
Lancet with sterilization had been tested.The test items mainly include the following
contents.
- . Appearance
- . Dimension
- . Needle-tip
- Puncture force ●
- Connecting fastness .
- Corrosion resistance feature ●
- Limits for acidity and alkalinity
- . Total heavy metal content and Cd content
- Sealing strength
- . Sterile barrier integrity
- . Sterility
Lancing device had been tested. The test items mainly include the following contents.
- . Appearance
- Dimension ●
- . Compatibility
- . Coaxiality
- . Depth adjustment
- Packages and Labels ●
- Drop test .
- Needle unloading thrust ●
14
- Torque test(for model CX11B1 and CX11B2) .
- . Buckle force(for model CX11C1 and CX11C2)
- . Separating force(for model CX11C1 and CX11C2)
8.3Compatibility between lancet with lancing device
The compatibility between lancet with lancing device have been studied. The results show that the different model lancet is well compatibility the corresponding model lancing device. The information is as the follow and printed on the label:
| Lancet | Compatible Lancing Device |
|---|---|
| Model BYY3 | Model CX11B1,CX11C1 |
| Model BYY4 | Model CX11B1,CX11C1 |
| Model BYB | Model CX11B2,CX11C2 |
| Model BYC | Model CX11B2,CX11C2 |
8.4Clinical simulated use testing
Beside, according to ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling and Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features, we have completed the test of clinical simulated use testing for sharps injury protection of lancing system. The test results show that the product had well sharps injury prevention feature.
9.Conclusions
Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to the predicate devices (K220475).