(57 days)
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 could be divided into Model XA Pro and Model ZF.Each model has sharps protection features that it can reduce the occurrence of accidental needle sticks. The device is sterilized by Co-60 or e-beam gamma ray and for single use.The shelf life is 5 years. Model XA Pro has four versions according to the different three penetration depths, version XA1 Pro,version XA3 Pro,version XA5 Pro and version XA11 Pro. Model ZF also has four versions according to the different need type and material of slider, version ZF1,version ZF2,version ZF1 Blade and version ZF2 Blade.
Model XA Pro 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.There is an integrated automatic inactivation system to prevent lancet reuse. When the back cover is pressed down, it drives the rear spring to compress downwards. The back cover support legs are flush with the inclined surface of the protruding line head of the housing. The needle is rotated and slided downwards under the force of the rear spring until it is disengaged from the inclined surface and fired forward for blood sampling, while compressing the front spring. The needle will be retracted 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 ZF lancet is composed of spring, three-facet needle or blade, housing, and slider. The needle body with needle or blade is concealed within housing/slider. The lancets of different specifications are in different colors. There is an integrated automatic inactivation system to prevent lancet reuse. The spring is fixed at the bottom of the housing, and when the slider is pressed down, which drives the spring to compress downwards.The two locking points(blocked the needle) on the slider will be opened along the slope of the housing, the needle will be released to fire under the force of the spring for blood sampling. After the puncture is completed, the spring retracts to a relaxed state and synchronously pulls the needle body back into the housing. Therefore, the device cannot be re-used.
The provided document is a 510(k) summary for a "Safety Lancet" (K242627). It details the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device (K222090).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Requirements) | Reported Device Performance (Results) |
|---|---|---|
| Dimension | Dimension should meet the requirements. | Passed |
| Appearance | The needle holder should be smooth and free of defects such as burrs, oil stains, rust spots, and bending. The housing should be smooth, free of burrs, bubbles, impurities and cracks. With normal or corrected to normal vision, there should be no visible accumulation of lubricant on the outer surface of the needle tip. | Passed |
| Needle-tip | The tip of the lancet should have no flat head, burrs, and hooks. Penetration Force should meet the requirements. | Passed |
| Trigger force | The lancet should be activated against 2N~20N axial pressure. | Passed |
| Corrosion resistance feature | Needle should have good corrosion resistance feature. | Passed |
| Retractable | After use, the needle can be automatically retracted. | Passed |
| Penetration Depth | Penetration depth should meet the requirements. | Passed |
| Challenge Safe Mode - Resistance | Apply a 15N force horizontally at the raised platform of the lancet, and the back cover must not be detached. | Passed |
| Challenge Safe Mode - Needle Tip Exposed | After the needle tip of the lancet is retracted, the needle tip cannot be exposed. Observe the needle tip after removing the protective cap, the needle tip should not be exposed. | Passed |
| Anti-activation test | The lancet should not activate when it is mistakenly pushed the button before use. | Passed |
| Self-destruct performance test | The lancet should not be activated again after use. | Passed |
| Fall Performance | The product falls freely to a smooth hard surface at a height of 1 meter, then test the appearance, triggering force, retraction, and penetration depth should meet the requirements. | Passed |
| pH and total heavy metal content and Cd content | pH (difference of blank solution) ≤ 1, Total heavy metal content ≤ 5mg/L and Cd content ≤ 0.1mg/L | Passed |
| Sterility | After the safety lancet has been sterilized by radiation, the needle tip should be sterile. | Passed |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test within the "Performance Test" section. It broadly states that "All non-clinical bench testing performed on the subject device is to demonstrate the substantial equivalence to the predicate devices."
For the "Performance of Clinical Simulated Use Testing for Sharps Injury Protection," it states: "Select the most widely sold in the market of each model as typical product for study." This suggests a limited sample size focused on representative models, but the exact number isn't provided.
The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. Given the manufacturer is Ningbo Medsun Medical Co., Ltd. in China, it's highly likely the testing was conducted in China. The "non-clinical bench testing" and "clinical simulated use testing" imply a prospective testing approach dedicated to this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not involve expert-established ground truth in the traditional sense for diagnostic AI/software. The testing described is for a physical medical device (safety lancet) and focuses on engineering and performance criteria. The "ground truth" for the performance tests would be objective measurements and observations against pre-defined engineering and safety standards. No human expert consensus for a diagnostic outcome is relevant here.
4. Adjudication method for the test set
Not applicable. This is not a diagnostic study requiring human adjudication for interpretation. The performance tests involve objective physical and chemical measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a physical medical device (safety lancet), not an AI-powered diagnostic tool, and therefore an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The ground truth used for these tests are the pre-defined technical specifications, engineering requirements, and safety standards (e.g., ISO 23908:2011, ISO 10993 series, and 21 CFR 801). The "Passed" results indicate that the device met these objective criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical safety lancet.
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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 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.
October 30, 2024
Ningbo Medsun Medical Co., Ltd. Liu Ping Regulation Affairs Manager No. 298 Huangjipu Road, Jiangbei Ningbo, Zhejiang 315031 China
Re: K242627
Trade/Device Name: Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 28, 2024 Received: September 3, 2024
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/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
Digitally signed by Long H. Chen Long H. Chen-S s Date: 2024.10.30 10:36:21 -04'00'
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
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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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510(k) Summary
1.Date Prepared
Auqust 28st, 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 28st, 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 XA Pro and Model ZF.Each model has sharps protection features that it can reduce the occurrence of accidental needle sticks. The device is sterilized by Co-60 or e-beam gamma ray and for single use.The shelf life is 5 years. Model XA Pro has four versions according to the different three penetration depths, version XA1 Pro,version XA3 Pro,version XA5 Pro and version XA11 Pro. Model ZF also
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has four versions according to the different need type and material of slider, version ZF1,version ZF2,version ZF1 Blade and version ZF2 Blade.
Model XA Pro 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.There is an integrated automatic inactivation system to prevent lancet reuse. When the back cover is pressed down, it drives the rear spring to compress downwards. The back cover support legs are flush with the inclined surface of the protruding line head of the housing. The needle is rotated and slided downwards under the force of the rear spring until it is disengaged from the inclined surface and fired forward for blood sampling, while compressing the front spring. The needle will be retracted 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 ZF lancet is composed of spring, three-facet needle or blade, housing, and slider. The needle body with needle or blade is concealed within housing/slider. The lancets of different specifications are in different colors. There is an integrated automatic inactivation system to prevent lancet reuse. The spring is fixed at the bottom of the housing, and when the slider is pressed down, which drives the spring to compress downwards.The two locking points(blocked the needle) on the slider will be opened along the slope of the housing, the needle will be released to fire under the force of the spring for blood sampling. After the puncture is completed, the spring retracts to a relaxed state and synchronously pulls the needle body back into the housing. Therefore, the device cannot be re-used.
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(Model XA Pro) | Subject Device(Model ZF) | Predicate Device(K222090) | Remark |
|---|---|---|---|---|
| ProductCode | FMK | FMK | FMK | Same |
7.Comparison of Technological Characteristics With the Predicate Device
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| RegulationNumber | 21CFR 878.4850 | 21CFR 878.4850 | 21CFR 878.4850 | Same |
|---|---|---|---|---|
| Indicationsfor use | Safety Lancet isintended to be used toobtain capillary bloodsample to performmedical testing,including blood glucosemonitoring and for testsusing small amounts ofblood. | Safety Lancet isintended to be used toobtain capillary bloodsample to performmedical testing,including blood glucosemonitoring and for testsusing small amounts ofblood. | Safety Lancet isintended to be used toobtain capillary bloodsample to performmedical testing,including blood glucosemonitoring and for testsusing small amounts ofblood. | Same |
| Prescription/over-thecounter use | Over-thecounter use | Over-thecounter use | Over-thecounter use | Same |
| Design | There is an integratedautomatic inactivationsystem to prevent lancetreuse. The spring is fixedat the bottom of thehousing, and when theslider is pressed down,which drives the springto compressdownwards.The twolocking points(blockedthe needle) on the sliderwill be opened along theslope of the housing, theneedle will be releasedto fire under the force ofthe spring for bloodsampling. After thepuncture is completed,the spring retracts to arelaxed state andsynchronously pulls theneedle body back intothe housing. Therefore,the device cannot bere-used. | There is an integratedautomatic inactivationsystem to prevent lancetreuse. When the backcover is pressed down,it drives the rear springto compressdownwards. The backcover support legs areflush with the inclinedsurface of the protrudingline head of the housing.The needle is rotatedand slided downwardsunder the force of therear spring until it isdisengaged from theinclined surface andfired forward for bloodsampling, whilecompressing the frontspring. The needle willbe retractedautomatically back intothe housing after thepuncture due to theforce from the pressedfront spring. The needlecannot go back to thestarting position andstays between the | There is an integratedautomatic inactivationsystem to preventlancet reuse. When theslider is pressed, theslider pushes the twobosses of the needleholder backwards. Thebosses movebackwards over theshort rib on the innerside of the housing, andthe rear spring ispressed and activatedto launch the needleforwards for bloodsampling. The needleretracts automaticallyback into the housingafter the puncture, dueto the force from thepressed front spring.The needle cannot goback to the startingposition and staysbetween the relaxedrear spring and frontspring. Therefore, thedevice cannot bere-used. | Similar(Note 1) |
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| 510(k) Submission Documents-Safety Lancet - K242627 | ||||
|---|---|---|---|---|
| relaxed rear spring andfront spring. Therefore,the device cannot bere-used. | ||||
| Materialsandcomposition | Safety lancet iscomposed of aprotective cap, a knob(for depth settings), afront spring, housing,needle body withtri-bevel edge needle, arear spring and a backcover (push button). | Safety lancet lancet iscomposed of spring,three-bevel edge needleor blade, housing, andslider. | The safety lancet arecomposed needle/blade,silicone oil,springand plastic part(backcover,slider,housingand protective cap). | Similar(Note 2) |
| Version | XA1 Pro, XA3 Pro,XA5 Pro, XA11 Pro | ZF1,ZF2,ZF1 Blade, ZF2 Blade | XY1,XY1 Blade,XH1,XH1 Blade,XA1 | Different(Note 3) |
| Performance | Dimension,Appearance,Needle-tip,Dropperformance,Triggerforce, Corrosionresistance feature,Retractable,PenetrationDepth,Challenge SafeMode-Resistance,Challenge Safe Mode-Needle Tip Exposed,Anti-activation test,Self-destructperformance test,Fallperformance test,pH and total heavy metal | Dimension,Appearance,Needle-tip,Dropperformance, Triggerforce, Corrosionresistance feature,Retractable,PenetrationDepth,Challenge SafeMode-Resistance,Challenge Safe Mode-Needle Tip Exposed,Anti-activation test,Self-destructperformance test,Fallperformance test,pH and total heavymetal | Dimension, Appearance,Needle-tip,Dropperformance,Triggerforce, Corrosionresistance feature,Retractable,PenetrationDepth,Challenge SafeMode- Resistance,Challenge Safe Mode-Needle Tip Exposed,Anti-activation test,Self-destructperformance test,Fallperformance test,pH and total heavymetal | Same |
| Sterilization | Irradiation SterilizationSAL:10-6 | Irradiation SterilizationSAL:10-6 | Irradiation sterilized,SAL: 10-6 | Same |
| Labeling | Conform with 21 CFR801 | Conform with 21 CFR801 | Conform with 21 CFR801 | Same |
| 510(k) Submission Documents-Safety Lancet - K242627 | ||||
| Biocom-patibility | Meet the requirements ofISO10993 seriesstandards,bocompatibility has beenevaluated in K222090. | Meet the requirementsof ISO10993 seriesstandards, and thefollowing tests areperformed:In vitrocytotoxicity, skinsensitization,intracutaneous reactivity, acutesystemic toxicity, andpyrogen. | Meet the requirementsof ISO10993 seriesstandards, and thefollowing tests areperformed:In vitrocytotoxicity, skinsensitization,intracutaneous reactivity, acutesystemic toxicity, andpyrogen. | Same |
| Reuse orsingle use | Single use | Single use | Single use | Same |
| Dimension/gauge | 18G,19G,20G,21G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G,31G,32G,33G(Needle type) | 21G,22G,23G,24G,25G,26G,27G,28G,29G, 30G(Needle type)0.8mm,0.9mm,1.1mm,1.2mm,1.5mm(Bladetype) | Model XY:21G,23G,25G,26G,28G,30G(Needle type),1.2mm(Blade type)Model XH:18G,21G,23G,28G(Needle type), 1.5mm(Blade type)Model XA:21G,23G,28G(Needletype) | Different(Note 4) |
| Penetrationdepth | 1.4mm/1.8mm/2.2mm,1.6mm/2.0mm/2.4mm,1.3mm/1.8mm/2.3mm,1.5mm/2.0mm/2.5mm | 1.2mm-2.8mm(Needle type)1.8 mm-2.0mm(Blade type) | Model XY:1.4mm-2.8mm(Needletype), 1.6mm-2.0mm(Blade type)Model XH:1.2mm-2.8mm(Needletype),1.6mm-2.0mm(Blade type)Model XA:1.3mm/1.8mm/2.3mm,1.5mm/2.0mm/2.5mm(Needle type) | Different(Note 5) |
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Note 1:The design of the subject device is similar as the predicate device. Although the designs of the Model XA Pro, Model ZF and the predicate device have some differences, all models are used the elasticity of spring to launch a needle puncture for blood sampling. The performance of the subject device has been tested in the bench testing.Therefore,the difference will not affect the safety and effectiveness of the product.
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Note 2:The materials and composition of the subject device are similar as the predicate device. For Model XA Pro, the materials and composition is same as the Model XA,except that the three indicator bars(indicated the penetration depth). The three indicator bars is on the knob of Model XA Pro(subject device), the three indicator bars is on the housing of Model XA(predicate device). The materials and composition of the predicate device has one more spring than Model ZF, the performance of the Model ZF has been tested in the bench testing. Therefore,the difference will not affect the safety and effectiveness of the product.
Note 3:The version of the subject device is different as the predicate device. The version is named as the different penetration depth, different needle type/blade type and material of slider. The version do no affect the safety and effectiveness of the product.
Note 4:Model XA Pro only has needle type, Model ZF has needle type and blade type. The subject device has needle type and blade type. The dimension/gauge of Model XA Pro is 18G-33G, the predicate device is not including 19G/20G/22G/24G/27G/29G/31G/32G/33G. The dimension/gauge of Model ZF is 21G-30G(Needle type) and 0.8mm,0.9mm,1.1mm,
1.2mm,1.5mm(Blade type), the predicate device is not including 22G/24G/27G/29G(Needle type) and 0.8mm,0.9mm,1.1mm(Blade type).The needle gauge of subject device is a widely used in the market and meet the requirements ISO 9626:2016, the different blade width of subject device is smaller than the predicate device. The dimension/gauge of the subject device also has been tested in the bench testing.Therefore,the difference will not affect the safety and effectiveness of the product.
Note 5: Model XA Pro has four versions, which have three penetration depths for depth setting ,the range of penetration depth is 1.3mm-2.5mm. The penetration depth range of Model XA(subject device) is 1.3mm-2.5mm. Therefore, their extreme depth is the same. The penetration depth of Model ZF is 1.2mm-2.8mm(Needle type) and 1.8 mm-2.0mm (Blade type), the penetration depth range of the predicate device is 1.2mm-2.8mm(Needle type) and 1.6mm-2.0mm(Blade type). The range of penetration depth for the blade type subject device is getting shorter than the predicate device.It means the the length of puncture entering the skin is not longer, which will not increase 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.
6/8
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8.Performance Testing Summary
Performance Test
All non-clinical bench testing performed on the subject device is to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with corporate standard, which is formulated according to relevant standards and product characteristics. Results of the testing are demonstrating the compliance to the standards and matching the performance of the subject device to the predicate devices.
The following data of non-clinical performance bench testing are provided in support of the substantial equivalence determination.
| Items | Requirements | Results |
|---|---|---|
| Dimension | Dimension should meet the requirements. | Passed |
| Appearance | The needle holder should be smooth andfree of defects such as burrs, oil stains, rustspots, and bending. The housing should besmooth, free of burrs, bubbles, impuritiesand cracks. With normal or corrected tonormal vision, there should be no visibleaccumulation of lubricant on the outersurface of the needle tip. | Passed |
| Needle-tip | The tip of the lancet should have no flathead, burrs and hooks.Penetration Forceshould meet the requirements. | Passed |
| Trigger force | The lancet should be activated against2N~20N axial pressure. | Passed |
| Corrosionresistance feature | Needle should have good corrosionresistance feature. | Passed |
| Retractable | After use, the needle can be automaticallyretracted. | Passed |
| Penetration Depth | Penetration depth should meet therequirements. | Passed |
| Challenge Safe Mode-Resistance | Apply a 15N force horizontally at the raisedplatform of the lancet, and the back covermust not be detached. | Passed |
| Challenge Safe Mode-Needle Tip Exposed | After the needle tip of the lancet isretracted, the needle tip cannot beexposed. Observe the needle tip afterremoving the protective cap, the needle tipshould not be exposed. | Passed |
| Anti-activation test | The lancet should not activate when it ismistakenly pushed the button before use. | Passed |
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| Self-destructperformance test | The lancet should not be activated againafter use. | Passed |
|---|---|---|
| Fall Performance | The product falls freely to a smooth hardsurface at a height of 1 meter, than test theappearance,triggering force,retraction andpenetration depth should meet therequirements. | Passed |
| pH and total heavymetal content and Cd content | pH(difference of blank solution)≤1,Totalheavy metal content≤5mg/L and Cdcontent ≤0.1mg/L | Passed |
| Sterility | After the safety lancet has been sterilizedby radiation, the needle tip should besterile. | Passed |
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 results show that the product has good biocompatibility.
Performance of Clinical Simulated Use Testing for Sharps Injury Protection
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.
Select the most widely sold in the market of each model as typical product for study.The results show that the product has 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 (K222090).
§ 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.