(77 days)
It is intended to be used with disposable sterile lancets to collect capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. It is for single patient use only.
The lancing device is a mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The lancing device is used with commercially available, sterile, standard square shaft blood lancets.
The lancing device is for use only on a single patient.
I am sorry, but the provided text from the FDA 510(k) notification for the Verifine® Ease Lancing Device, Verifine® Lancing Device does not contain the type of detailed performance criteria and study results you are requesting for a device that typically involves AI or image analysis.
The document describes a lancing device, which is a mechanical tool for collecting blood. It focuses on demonstrating substantial equivalence to a predicate device (Genteel Lancing Device K153670) based on technological characteristics, intended use, and general performance aspects such as:
- Materials: Primarily made from medical-grade plastics.
- Puncture Depth Settings: Comparisons of adjustable depth ranges.
- Reusability: Both are reusable for single-patient use.
- Sterility: Both are non-sterile.
- Shipping and Shelf-Life: Verification of integrity after transportation testing (ASTM D4169) and validation of a 5-year shelf-life / 3000 uses (ASTM F1980-16).
The document explicitly states that the device is a "mechanical blood lancet holder" and its purpose is to "collect capillary blood". There is no mention of AI, image analysis, diagnostic capabilities, or a study involving human readers or expert ground truth adjudication related to disease detection or image interpretation.
Therefore, I cannot provide the information you asked for, such as:
- A table of acceptance criteria and reported device performance (for AI/image analysis): Not applicable, as this is a mechanical lancing device.
- Sample size used for the test set and data provenance: No such test set is described for AI performance.
- Number of experts used to establish ground truth & qualifications: No image-based ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable for AI/image analysis.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The performance testing mentioned in the 510(k) summary is limited to verifying mechanical aspects, shipping integrity, and shelf-life, which are typical for this type of medical device.
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February 21, 2023
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street, Cangqian Community Yuhang District Hangzhou City, Zhejiang 311121 China
Re: K223643
Trade/Device Name: Verifine® Ease Lancing Device, Verifine® Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL Dated: November 29, 2022 Received: December 6, 2022
Dear Zearou Yang:
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
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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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
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
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Indications for Use
510(k) Number (if known) K223643
Device Name
Verifine® Ease Lancing Device, Verifine® Lancing Device
Indications for Use (Describe)
It is intended to be used with disposable sterile lancets to collect capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. It is for single patient use only.
| 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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K223643 510(k) Summary
Date Prepared 1
Nov 29th, 2022
N Submitter's Information
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou
City, 311121 Zhejiang, China
Contact Name:
Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
3 Trade Name, Common Name, Classification
Trade/Product Name: Verifine® Ease Lancing Device, Verifine® Lancing Device Common Name: Lancing Device Classification name: multiple use blood lancet for single patient use only Regulation Number: 21 CFR 878.4850 Device Class: Class II Product Code: QRL
Identification of Predicate Device 4
K153670: Genteel Lancing Device
Description of the Device 5
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The lancing device is a mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The lancing device is used with commercially available, sterile, standard square shaft blood lancets.
The lancing device is for use only on a single patient.
ട് Indication
It is intended to be used with disposable sterile lancets to collect capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. It is for single patient use only.
7 Similarities and Differences of the Proposed Devices to the Predicate Devices
The Verifine® Ease Lancing Device, Verifine® Lancing Device are substantially equivalent to the predicate device, Genteel Lancing Device (K153670) in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are single patient use devices. The differences above between the subject device and predicate device do not affect the basic design principle, usage of the subject device.
| Subject Device | Predicate Device(K153670) | ||
|---|---|---|---|
| Trade Name | Verifine®LancingEase Device,Verifine®LancingDevice | Genteel Lancing Device | Comments |
| Manufacturer | PromisemedHangzhou MeditechCo., Ltd | Genteel, LLC | |
| Device Class | Class II | Class I | DifferentReclassification of the device dueto regulations |
| Product Code | QRL | FMK | DifferentReclassification of the device dueto regulations |
| Regulationnumber | 878.4850 | 878.4800 | DifferentReclassification of the device dueto regulations |
| RegulationName | Blood Lancets | Manual surgicalinstrument for generaluse | DifferentReclassification of the device dueto regulations |
| IntendedUse/Indicationsfor Use | It is intended to beused withdisposable sterilelancets to collectcapillary blood fromthe fingertip oralternate sites forblood glucosetesting or othertesting utilizingsmall amounts ofblood. It is for singlepatient use only. | The Genteel lancingdevice is used withdisposable sterile lancetsto draw capillary bloodfrom the fingertip oralternate sites for bloodglucose testing or othertesting utilizing smallamounts of blood. TheGenteel lancing device isfor single patient useonly. | Same |
| Use | Reusable. Thelancingdevice is for useonlyon a single patient. | Reusable. The lancingdevice is for use onlyon a single patient. | Same |
| Non-sterile | Yes | Yes | Same |
| Prescribeduse | Over the Counter | Over the Counter use | Same |
| Configurationand Materials | It is primarily madefrom differentplastics which areboth medicalgrades. | It is primarily made fromdifferent plastics whichare both medical grades. | Same |
| Puncturedepthsettings | Verifine® Ease | It has varying puncture | They also have varying puncture |
| Lancing Device: It | depth settings via six | depth settings. | |
| has varyingpuncture depthsettings via eightadjustable settingson depth adjuster.The puncture depthranges between0.15mm to1.20mm; | interchangeable contacttips on Genteel.The puncture depth isabout 0.25mm to0.55mm. | The subject device has coveredthe puncture depth range of thepredicate device, with moreselectivity. And the epidermthickness of human is about0.1mm. It has penetrated theepiderm thickness to the dermiswhen the penetration depth is0.15 mm, and the dermis hascapillaries.Additionally, the section of"puncture depth" in the IFUclearly states that 'it isrecommended to start the testfrom the shallowest to thedeepest according to theoperating instructions for thefirst use. If no blood is produced,select the next gear until anappropriate amount of blood isobtained.' So the safety andeffectiveness of the subjectdevice will not be affected. | |
| Verifine® LancingDevice: It hasvarying puncturedepth settings viafive adjustablesettings onadjusting caps. Thepuncture depthranges between0.25mm to0.85mm. |
A detailed comparison to the predicate is provided in Table 1.
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Discussions of differences in technological characteristics
The subject device has the same intended use and technological characteristics as the predicate device. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding effectiveness and safety. We concluded the subject device is substantially equivalent to the identified predicate device.
ಹ Performance Testing Summary
The bench testing performed verifies that the performance of the subject device is
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substantially equivalent in terms of critical performance characteristics to the predicate device.
Shipping, and Shelf-Life
- The transportation testing was conducted using lancing device product in accordance with ASTM D4169. The performance testing was conducted after simulated transportation testing. The conducted test demonstrated that there are neither damage on the packing box nor damage on the product.
- The period of validity is 5 years and it can not be used more than 3000 times, which is validated using the FDA recognized standard ASTM F1980-16.
ு Conclusion
Based on the information provided within this 510(k) submission, proposed subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.
§ 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.