(77 days)
No
The device description and performance studies focus on mechanical and material properties of a blood lancet, with no mention of AI or ML.
No
Explanation: This device is a safety lancet used to obtain blood samples for medical testing, which is a diagnostic purpose, not a therapeutic one. It facilitates testing rather than providing treatment or alleviating symptoms.
No
Explanation: The device is a safety lancet used to obtain capillary blood samples for medical testing, not to perform the analysis or diagnosis itself. It is an accessory for diagnostic tests, but not a diagnostic device in its own right.
No
The device description clearly indicates it is a physical lancet with different models, sterilized, and intended for single use, which are characteristics of a hardware medical device. The performance studies also focus on physical properties and biocompatibility.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used "to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood." Obtaining a biological sample for the purpose of performing medical tests is a key characteristic of devices used in IVD procedures.
- Device Description: While the description focuses on the physical aspects of the lancet, its function is directly tied to facilitating IVD testing.
- Performance Studies: The performance studies, particularly the "Performance testing-Bench," include tests like "Penetration Depth," which are relevant to ensuring the device can effectively obtain the blood sample needed for IVD tests.
- Predicate Devices: The predicate devices listed (VeriFine Safety Lancet and Surgilance® Safety Lancets) are also safety lancets used for obtaining blood samples for diagnostic testing, further supporting the classification as an IVD accessory.
While the device itself doesn't perform the diagnostic test, it is an essential tool for obtaining the sample required for the in vitro diagnostic procedure. Therefore, it falls under the scope of IVD devices as an accessory used in the collection of specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.
Product codes
FMK
Device Description
Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.
Model XY is composed of a protective cap, a slider, a front spring, housing, needle body with tri-bevel edge needle or blade, a rear spring and a back cover. The needle body with needle or blade is hidden inside the housing/slider. The housing is colour coded for different versions.
Automatic inactivation mechanism for Model XY: There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.
Model XH is composed of a protective cap, a slider, a front spring, housing, needle body with tri-bevel edge needle or blade, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.
Automatic inactivation mechanism for Model XH: There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.
Model XA is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.
Automatic inactivation mechanism for Model XA: There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.
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
Over-The-Counter Use
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-Bench: Safety Lancet with different sterilization method (Co-60 and e-beam) had been tested individually. The test items mainly include: Dimension, Appearance, Needle-tip, Trigger force, Corrosion resistance feature, Retractable, Penetration Depth, Challenge Safe Mode- Resistance, Challenge Safe Mode- Needle Tip Exposed, Anti-activation test (only for Model XH and XA), Self-destruct performance test, Sterility, pH and total heavy metal content and Cd content, and Bacterial Endotoxins.
Clinical simulated use testing for sharps injury protection for each model was completed according to ISO 23908:2011 and Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features. The test results show that the product had well sharps injury prevention feature.
Biocompatibility 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 for each model and each sterilization method (Co-60 and e-beam) individually. The testing included the following tests: In vitro cytotoxicity, Skin sensitization, Intracutaneous reactivity, Acute systemic toxicity, and Pyrogen.
Key results: Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to the predicate devices (K192666, K101145).
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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9/30/2022
Ningbo Medsun Medical Co., Ltd. Liu Ping Regulation Affairs Manager No.55 Jinxi Road, Zhenhai Ningbo, Zhejiang 315221 China
Re: K22090/S001
Trade/Device Name: Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: FMK Dated: July 11, 2022 Received: July 15, 2022
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222090
Device Name Safety Lancet
Indications for Use (Describe)
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.
| 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 11th, 2022
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
Primary correspondent: Marvin Li, Consultant
Tel:+86-15257179656 E-mail: leeking0908@126.com
Date Prepared: July 11th, 2022
3.Device
Trade Name: Safety Lancet
Common Name:Blood Lancets
Classification Name:Single Use Only Blood Lancet With An Integral Sharps Injury
Prevention Feature
Regulation Number:21 CFR 8780.4850
Regulatory Class: II
Product Code: FMK
Review Panel: General & Plastic Surgery
4.Predicate device
4.1Predicate device A
Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.
Device name: VeriFine Safety Lancet
510(k) number: K192666
4.2Predicate device B
Manufacturer: Medipurpose Pte Ltd.
Device name: Surgilance® Safety Lancets
510(k) number: K101145
4
5.Device description
Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.
Product Structure of the Safety Lancet are summarized in the table below:
| Model | Design features / key functional elements |
|---|---|
| Model XY is composed of a protective cap, a slider, a front spring, housing, needle body with tri-bevel edge needle or blade, a rear spring and a back cover. The needle body with needle or blade is hidden inside the housing/slider. The housing is colour coded for different versions. | |
| Parts and components of Model XY: | |
| Image: back cover Rear spring Needle body Front spring Housing slider protective cap | |
| Model XY | Image: Model XY |
| Image: needle tip | |
| Note: The right picture shows a partial enlarged view of the needle tip which is hidden inside the housing/slider. | |
| Automatic inactivation mechanism: | |
| There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used. The automatic |
5
Image /page/5/Picture/4 description: This image shows the Model XH safety lancet. The image shows the lancet before and after use, and lists design features such as automatic needle retraction and a protective cap. The image also shows the parts and components of the lancet, including the needle tip, protective cap, front spring, housing, needle body, rear spring, and back cover.
6
which is hidden inside the housing/protective cap.
Automatic inactivation mechanism:
There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used. The automatic inactivation mechanism is illustrated below:
Before use (left) / After use (right)
Image /page/6/Picture/6 description: The image shows a close-up of a medical device, possibly a needleless connector. The device is mostly clear with blue components inside. It has a cylindrical shape with a wider top and a narrower bottom, and a spring mechanism is visible inside the clear casing.
Image /page/6/Picture/7 description: The image shows a close-up of the inner workings of a blue and clear plastic object, possibly a pen or a similar mechanical device. Inside the clear casing, there are two visible metal springs, one at the top and one at the bottom. A blue component is positioned between the springs, suggesting a mechanism for compression or extension.
Design features:
- For capillary blood sampling ●
- No pre-loading required
- . Push button activated safety lancet
- . Pre-activated safety feature
- . Automatic needle retraction immediately after use
- Automatically inactivated system to prevent lancet reuse
- Needle fully shielded before and after use
- Sterile, single use ●
Model XA Model XA is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.
Parts and components of Model XA:
7
Image /page/7/Figure/2 description: This image shows a close-up of a medical device, possibly an injector or similar instrument, with various components labeled. The device includes a back cover with a push button, a rear spring, a needle body, and a housing. Additionally, there's a front spring, a knob, and a needle tip covered by a protective cap, along with the protective cap itself. The image also shows a separate, magnified view of the needle tip.
Note: The right picture shows a partial enlarged view of the needle tip which is hidden inside the housing/protective cap.
Automatic inactivation mechanism:
There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used. The automatic inactivation mechanism is illustrated below:
Before use (left) / After use (right)
Image /page/7/Figure/7 description: The image shows two medical devices used for capillary blood sampling. The devices are transparent with blue components and contain a spring mechanism. The text highlights design features, noting that the device is for capillary blood sampling and requires no pre-loading.
8
| • Push button activated safety lancet | |
|---|---|
| • Pre-activated safety feature | |
| • Automatic needle retraction immediately after use | |
| • Automatically inactivated system to prevent lancet reuse | |
| • Adjustable penetration depth | |
| • Needle fully shielded before and after use | |
| • Sterile, single use |
6.Indications for use
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and other testing where capillary blood is required.
| Description | Subject Device | Predicate Devices A
(K192666) | Predicate Devices B
(K101145) | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Product Code | FMK | FMK | FMK | Same |
| Regulation
Number | 21CFR 8780.4850 | 21 CFR 878.4800 | 21 CFR 878.4800 | Different |
| Indications
for use | Safety Lancet is
intended to be used
to obtain capillary
blood sample to
perform medical
testing, including
blood glucose
monitoring and for
tests using small
amounts of blood. | It is intended for
capillary blood
sampling. | The SurgiLance®
Safety Lancet is a
puncture device to
obtain micro blood
samples. The
SurgiLance® Safety
Lancet has a sharp's
prevention feature to
protect the user from
a needlestick injury. | Same
(Note 1) |
| Prescription/ov
er-the counter
use | Over-the
counter use | Over-the
counter use | Over-the
counter use | Same |
| Design | There is an
integrated
automatic
inactivation system
to prevent lancet
reuse. When the
slider is pressed,
the slider pushes
the two bosses of
the needle holder
backwards. The
bosses move | These lancets are
precision
sharpened
designed for
maximum comfort
and optimal blood
flow. Safety lancets
are designed to
make taking a blood
sample simple and
easy. Safety lancets
are activated when | The Surgilance®
Safety Lancet is
safely retracted and
concealed before
and after use.The
user simply removes
the protective cap ,
places the red raised
platform end onto
the patient's test
site , and gently
push the lancet | Similar
(Note 2) |
| | 510(k) Notification document-Safety Lancet | | | K222090 |
| | backwards over the
short rib on the
inner side of the
housing, and the
rear spring is
pressed and
activated to launch
the needle forwards
for blood sampling.
The needle retracts
automatically back
into the housing
after the puncture,
due to the force
from the pressed
front spring. The
needle cannot go
back to the starting
position and stays
between the
relaxed rear spring
and front spring.
Therefore, the
device cannot be
re-used. | you press the
device against your
finger. Once
activated the needle
retracts into the
body of the device
which reduces the
risk of injury as the
result if an exposed
needle. The first
spring releases the
needle into the skin
and the second
withdraws
the needle back into
the shield. | down against the
test site to activate
the lancet
mechanism. Once
the lancet is used , it
is rendered
inoperative,
providing added
safety for patient
and clinician . The
device is discarded
in a sharps container
after use | |
| Materials | The safety lancet
are composed
needle/blade,Silico
ne oil, spring and
plastic part(back
cover, slider, housing
and protective cap). | The needles all use
medical grade
stainless steel and
the rest
part(plastics for the
Shield, hub, caps,
and triggers) are
made of plastics
materials. | The needles and
blades all use
medical grade
stainless steel and
the housings are
made of plastics.
The housings, caps,
and triggers are
made of plastics
materials. | Same
(Note 3) |
| Model | The safety lancet
has Model XY,
Model XH and
Model XA. The
different model is
distinguished by the
appearance, needle
diameter/
blade, penetration
depth and color. | VeriFine Safety
Lancet offers
different gauge
(needle diameter)
options, to allow to
choose the lancet
which meets blood
volume needs. | The SurgiLance®
Safety Lancet
comes in six models:
two low flow, one
medium flow, one
medium-high flow,
and two high flows.
The six models are
differentiated by
their casing
color | Similar
(Note 4) |
| | | | | |
| Performance | Dimension,Appeara
nce,Needle-tip,Trig
ger force,Corrosion
resistance
feature,Retractable,
Penetration
Depth, Challenge
Safe Mode-
Resistance,Challen
ge Safe Mode-
Needle Tip
Exposed,
Anti-activation test,
Self-destruct
performance
test,pH and total
heavy
metal,Bacterial
Endotoxins | Visual Inspection,
Needle
Dimensions,
Chemical
properties,
Bond between
lancet body and
needle,
Resistance to
corrosion of the
needle,Locking
function,Spring
elasticity,Percussiv
e
function,Penetrate
force | / | Same as
Predicate
Devices A |
| Sterilization | Irradiation
Sterilization
SAL:10-6 | Irradiation
sterilized,
SAL: 10-6 | / | Same as
Predicate
Devices A |
| Labeling | Conform with 21
CFR 801 | Conform with 21
CFR 801 | Conform with 21
CFR 801 | Same |
| Biocompatibility | Meet the
requirements of
ISO10993 series
standards, and the
following tests are
performed:In vitro
cytotoxicity, skin
sensitization,intracu
taneous reactivity,
acute systemic
toxicity, and
pyrogen. | Conform with ISO
10993 standards,
Cytotoxicity,
Sensitization,
Irritation, were
performed to
demonstrate
Biocompatibility. | / | Similar
(Note 5) |
| Reuse or
single use | Single use | Single use | Single use | Same |
| Dimension/
gauge,
penetration
depth | Model XY
Dimension/gauge:
21G,23G,25G,26G,
28G,30G(Needle
type),1.2mm(Blade
type)
Penetration depth:
1.4mm-2.8mm(Nee
dle type), 1.6mm-
2.0mm(Blade type)
Model XH
Dimension/gauge:
18G,21G,23G,28G
(Needle type),
1.5mm (Blade type)
Penetration depth:
1.2mm-2.8mm(Nee
dle type),1.6mm
-2.0mm(Blade type)
Model XA
Dimension/gauge:
21G,23G,28G
(Needle type)
Penetration depth:
1.3mm/1.8mm/2.3m
m,1.5mm/2.0mm/2.
5mm(Needle type) | Gauge:
18G,21G,23G,25G,
26G,28G,30G
Penetration depth:
1.2mm, 1.4mm,
1.6mm, 1.8mm,
2.0mm, 2.2mm,
2.4mm, 2.6mm,
2.8mm | Needle type:
21G, 1.0mm
21G, 1.8mm
21G, 2.2mm
21G, 2.8mm
Blade type:
18G, 1.8mm
18G, 2.3mm | Similar
(Note 6) |
7.Comparison of technological characteristics with the predicate device
9
10
11
Note 1:The indications for use statements are not identical in wording, however, demonstrate the same desired intended use. Both devices are intended for use for obtaining blood samples. The overarching principal nature of the lancing devices is to obtain blood samples. Both the predicates and subject device have this goal as the main aspect of the indication for use statement. It is also important to note both the subject device and predicate B state the inclusion of a sharps safety prevention feature into the product design. Note 2: Model XY has the same design with predicate device A and B, lancet is activated when press the device's slider against the body site. Model XH and Model XA have the different feature is that lancet is activated when press the device's push button(back cover). Although there are slight differences in design, they all use the elasticity of springs and the structure of plastic parts to realize their functions. All of the models have been testing for the safety and effectiveness.
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Note 3: The subject device and predicate device B all have needle/blade type, but the predicate device A only has needle type. Predicate device B has marketed for many years, it indicates that the blade type is safe and effective.
Note 4: All the devices have different models, only there are some differences in the way of distinguishing models. Besides, subject device has three model:Model XY,Model XH and Model XA. They are have different appearance, the needle body with needle or blade is hidden inside the housing/slider of Model XY, the needle body with needle or blade is hidden inside the housing/protective cap of Model XH and Model XA. The Model XA can adjustable the penetration depth, and the Model XY and Model XH can not adjustable the penetration depth.
Note 5: The predicate device A was tested Cytotoxicity, Sensitization and Irritation to demonstrate biocompatibility. The subject device was tested In vitro cytotoxicity, skin sensitization.intracutaneous reactivity, acute systemic toxicity and pyrogen to demonstrate biocompatibility. The test content of the subject devices is more strict than the predicate device A.
Note 6: The needle of subject device and predicate device B have two types, needle type and blade type. The needle of predicate device A only has needle type .The needles are all solid cylindrical needles. The difference of the needle type is tri-bevel edge needle tip and blade type is two-bevel edge needle tip. Dimension/gauge of the needles all meet the requirements ISO 9626:2016. Therefore, the 1.2mm blade type needle of subject device is equal to 18G, 1.5mm blade type needle of subject device is equal to 17G. The subject device has 18G(1.2mm),21G,23G,25G,26G,28G,30G needle, which is same as the predicate device A, excpet 17G(1.5mm). According to ISO 9626:2016, the most thickest needle reaches to 10G, so the 17G(1.5mm) needle can be used clinically. Additional, the 17G(1.5mm) needle of the subject device havs been marketed on EU market and no adverse event was collected. The subject device and predicate device A/B all have different penetration depth.But the range of the subject device's penetration depth is from 1.2mm to 2.8mm, which is the same as the penetration depth of predicate device A(1.2mm-2.8mm).
8.Performance testing summary
The following performance data were provided in support of the substantial equivalence determination.
6-10
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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 for each model and each sterilization method(Co-60 and e-beam) individually. The testing included the following tests:
- In vitro cytotoxicity
- Skin sensitization
- Intracutaneous reactivity
- . Acute systemic toxicity
- . Pyrogen
8.2Performance testing-Bench
Safety Lancet with different sterilization method(Co-60 and e-beam) had been tested individually. The test items mainly include the following contents.
- . Dimension
- Appearance ●
- Needle-tip ●
- Trigger force ●
- Corrosion resistance feature
- Retractable .
- Penetration Depth
- . Challenge Safe Mode- Resistance
- . Challenge Safe Mode- Needle Tip Exposed
- . Anti-activation test(only for Model XH and XA)
- Self-destruct performance test
- Sterility
- pH and total heavy metal content and Cd content
- . Bacterial Endotoxins
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
14
Staff-Medical Devices with Sharps Injury Prevention Features, we have completed the test of clinical simulated use testing for sharps injury protection for each model. 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 (K192666, K101145).