(23 days)
Not Found
No
The device description details a purely mechanical lancet for blood sampling. There is no mention of software, data processing, or any technology that would involve AI or ML.
No
The device is used to obtain a blood sample, not to treat a medical condition.
No
Explanation: A diagnostic device is used to detect, diagnose, prevent, monitor, treat, or alleviate a disease or injury. This device, a safety lancet, is used to obtain a capillary blood sample, which is a step prior to medical testing, but the lancet itself does not perform any diagnostic function.
No
The device description clearly outlines a physical medical device composed of various hardware components (protective cap, slider, springs, housing, needle body, back cover). The performance studies also focus on physical characteristics and biocompatibility, not software validation.
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. The blood sample is then used for medical testing, but the lancet is only the tool for collection.
- Device Description: The description focuses on the mechanical aspects of the lancet for puncturing the skin and collecting blood. It does not describe any components or functions related to analyzing or testing the blood.
- Lack of Diagnostic Function: An IVD device is designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This lancet's function is solely to facilitate the collection of the sample.
While the blood collected using this lancet will be used for IVD testing (like blood glucose monitoring), the lancet itself is a medical device used for sample collection, not an IVD.
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.
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.
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
- Adjustable penetration depth
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
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)
The subject device has the substantially equivalent technological characteristics as the predicate device cleared under K222090. We has verified the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included appearance, needle-tip, dimension, penetrating force and penetration depth according to the following standards:
- ISO 9626 Stainless steel needle tubing for the manufacture of medical devices, and to performance
- ISO 7864 Sterile hypodermic needles for single use-Requirements and test methods
Biocompatibility Test
The subject device meets the requirements of ISO 10993 series standards, and the following items are evaluated: In vitro cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity and pyrogen. The subject device has well biocompatibility.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
August 28, 2024
Ningbo Medsun Medical Co., Ltd. Ping Liu Regulation Affairs Manager No. 298 Huangjipu Road, Jiangbei Ningbo, Zhejiang 315031 China
Re: K242316
Trade/Device Name: Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 1, 2024 Received: August 5, 2024
Dear Ping Liu:
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 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).
Sincerelv.
Long H. Chen -> Digitally signed by Long H. Chen-S
Digitally signed Date: 2024.08.28 14:10:26 -0400'
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
Submission Number (if known)
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
August 1st, 2024
2.Submitter
Ningbo Medsun Medical Co., Ltd.
No. 298 Huangjipu Road, Jiangbei, 315031,Ningbo, P.R.China
Contact Person: Liu Ping, Regulation Affairs Manager
Tel: +86-574-86301887/ Fax:+86-574-86301887
Date Prepared: August 1st, 2024
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 878.4850
Requlatory Class: II
Product Code: FMK
Review Panel: General & Plastic Surgery
4.Predicate Device
Manufacturer: Ningbo Medsun Medical Co., Ltd.
Device Name: Safety Lancet
510(k) Number: K222090
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:
4
Image /page/4/Figure/1 description: This image describes the design features and key functional elements of the Model XY safety lancet. The lancet is composed of a protective cap, slider, front spring, housing, needle body with a tri-bevel edge needle or blade, a rear spring, and a back cover. The needle body is hidden inside the housing/slider, and the housing is color-coded for different versions. The image also describes the automatic inactivation mechanism that prevents lancet reuse.
5
Image /page/5/Picture/3 description: The image shows the design features, parts, and components of the Model XH safety lancet. The lancet is designed for capillary blood sampling and has a protective cap to prevent accidental activation. The lancet also features automatic needle retraction and is sterile for single use. The components of the Model XH include a protective cap, front spring, housing, needle body, rear spring, and back cover.
6
| 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) | | |
|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | | | |
| | 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/1 description: This image shows a diagram of a needle-free injection device. The diagram labels the different parts of the device, including the back cover (push button), rear spring, needle body, housing, front spring, knob, needle tip (covered by the protective cap), protective cap, and needle tip. The device is made of clear plastic, allowing the internal components to be seen.
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/6 description: The image shows two medical devices that are designed for capillary blood sampling. The devices are clear and blue, and they have a spring mechanism inside. The text below the devices lists design features, including that they are for capillary blood sampling and that no pre-loading is required.
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 for tests using small amounts of blood.
| Description | Subject Device | Predicate Device
(K222090) | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Product Code | FMK | FMK | Same |
| Regulation
Number | 21CFR 878.4850 | 21CFR 878.4850 | Same |
| 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. | 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. | Same |
| Prescription/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
backwards over the short
rib on the inner side of the
housing, and the rear
spring is pressed and
activated to launch the | 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 | Same |
| | | | |
| | 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. | 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. | |
| Materials | The safety lancet are
composed needle/
blade,silicone oil,spring
and plastic part(back
cover,slider,housing
and protective cap). | The safety lancet are
composed needle/
blade,silicone oil,spring
and plastic part(back
cover,slider,housing
and protective cap). | Same |
| 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. | 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. | Same |
| Performance | Dimension,Appearance,N
eedle-tip,Drop
performance,Trigger
force,Corrosion
resistance feature,
Retractable,Penetration
Depth,Challenge Safe
Mode-Resistance,
Challenge Safe Mode-
Needle Tip Exposed,
Anti-activation test,
Self-destruct
performance test,pH and
total heavy metal,Bacterial
Endotoxins | Dimension,Appearance,N
eedle-tip,Drop
performance,Trigger
force,Corrosion
resistance feature,
Retractable,Penetration
Depth,Challenge Safe
Mode- Resistance,
Challenge Safe Mode-
Needle Tip Exposed,
Anti-activation test,
Self-destruct
performance test,pH and
total heavy metal,Bacterial
Endotoxins | Same |
| Sterilization | Irradiation Sterilization
SAL:10-6 | Irradiation sterilized,
SAL: 10-6 | Same |
| Labeling | 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,intracutaneo
us reactivity, acute
systemic toxicity, and
pyrogen. | Meet the requirements of
ISO10993 series
standards, and the
following tests are
performed:In vitro
cytotoxicity, skin
sensitization,intracutaneo
us reactivity, acute
systemic toxicity, and
pyrogen. | Same |
| Reuse or
single use | Single use | Single use | Same |
| | Model XY
Dimension/gauge:
21G,23G,25G,26G,28G,
30G(Needle type),
1.2mm(Blade type)
Penetration depth:
1.4mm-2.8mm(Needle
type), 1.6mm-2.0mm
(Blade type) | Model XY
Dimension/gauge:
21G,23G,25G,26G,28G,
30G(Needle type),
1.2mm(Blade type)
Penetration depth:
1.4mm-2.8mm(Needle
type), 1.6mm-2.0mm
(Blade type) | Same |
| Dimension/
gauge,
penetration
depth | Model XH
Dimension/gauge:
18G,19G,20G,21G,22G,
23G,24G,25G,26G,27G,
28G,29G,30G,31G,32G,
33G(Needle type), 1.5mm
(Blade type)
Penetration depth:
0.7mm-2.8mm(Needle
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(Needle
type), 1.6mm
-2.0mm(Blade type) | Different
(Note 1) |
| | Model XA
Dimension/gauge:
18G,19G,20G,21G,22G,
23G,24G,25G,26G,27G,
28G,29G,30G,31G,32G,
33G(Needle type)
Penetration depth: | Model XA
Dimension/gauge:
21G,23G,28G
(Needle type)
Penetration depth:
1.3mm/1.8mm/2.3mm,1.5
mm/2.0mm/2.5mm(Needle | Different
(Note 2) |
7.Comparison of Technological Characteristics With the Predicate Device
9
10
11
| 1.3mm/1.8mm/2.3mm,1.5mm/2.0mm/2.5mm(Needle type);
The specification of 1.3mm/1.8mm/2.3mm penetration depth is named version XA5;
The specification of 1.5mm/2.0mm/2.5mm penetration depth is named version XA11. | e type);
The two specifications of penetration depth is named version XA1. |
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Note 1: The dimension/gauge of the subject device is more than the predicate device. The version XH1 of the predicate device is not including 19G/20G/22G/24G/25G/26G/ 27G/29G/ 30G/31G/32G/33G, which are including in the version XH1 of the subject device.The needle gauge of subject device is a widely used in the market and meet the requirements ISO 9626:2016. The penetration depth of the subject device is getting shorter than the predicate device. The shortest penetration depth is changed from 1.2mm to 0.7mm, it means the The length of puncture entering the skin is shorter, which will reduce patient's pain and there is no standard for regulating the penetration depth.Therefore,the difference will not affect the safety and effectiveness of the product.
Note 2:The predicate device of Model XA only has one version XA1, which has two specifications(each specification has three penetration depth that can be adjusted, 1.3mm/1.8mm/ 2.3mm and 1.5mm/2.0mm/ 2.5mm). The subject device of Model XA has two versions-XA5 and XA11. The version XA5 has the specification of 1.3mm/1.8mm/ 2.3mm penetration depth, the version XA11 has the specification of 1.5mm/2.0mm/ 2.5mm penetration depth. This is a change of name rule, which is more clear for version. Other, The dimension/gauge of the subject device is more than the predicate device. The version XA1 of the predicate device is not including 18G/19G/20G/22G/24G/27G/29G/30G/ 31G/32G/33G, which are including in the version XA5/XA11of the subject device.The needle gauge of subject device is a widely used in the market and meet the requirements ISO 9626:2016. Therefore, the difference will not affect the safety and effectiveness of the product.
8.Performance Testing Summary
9/10
12
Performance Test
The subject device has the substantially equivalent technological characteristics as the predicate device cleared under K222090.We has verified the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included appearance,needle-tip,dimension,penetrating force and penetration depth according to the following standards:
▲ ISO 9626 Stainless steel needle tubing for the manufacture of medical devices, and to performance
ISO 7864 Sterile hypodermic needles for single use-Requirements and test methods Biocompatibility Test
The subject device meets the requirements of ISO 10993 series standards, and the following items are evaluated:In vitro cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity and pyrogen. The subject device has well biocompatibility.
Therefore,the change of this 510(k) does not introduce critical differences or new risks to the intended use of the device.
9.Conclusions
Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to the predicate devices (K222090).