(77 days)
Not Found
No
The summary describes a purely mechanical lancing device with no mention of AI, ML, image processing, or any data processing beyond basic mechanical function.
No.
The device is a lancing device for collecting blood samples, not for providing therapy or treatment. Its function is diagnostic in nature, facilitating blood collection for testing.
No
The device is a lancing device, which is used to collect blood samples. It does not analyze or interpret the collected blood or provide a diagnosis; it only facilitates the collection. The "blood glucose testing or other testing" mentioned refers to what the collected blood is used for after being collected by this device.
No
The device description explicitly states it is a "mechanical blood lancet holder," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is used to collect the specimen (blood), but it doesn't perform any analysis or testing on the blood itself.
- The description clearly states it's a "mechanical blood lancet holder for collecting capillary whole blood." Its function is purely mechanical for obtaining a sample.
- The intended use mentions it's for use with lancets "to collect capillary blood... for blood glucose testing or other testing utilizing small amounts of blood." This indicates the testing is done by a separate device (like a blood glucose meter), not the lancing device itself.
The lancing device is a tool used in conjunction with an IVD (like a blood glucose meter and test strips), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
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.
Product codes
ORL, QRL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip or alternate sites
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 bench testing performed verifies that the performance of the subject device is 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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
4
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®
Lancing
Ease Device,
Verifine®
Lancing
Device | Genteel Lancing Device | Comments |
| Manufacturer | Promisemed
Hangzhou Meditech
Co., Ltd | Genteel, LLC | |
| Device Class | Class II | Class I | Different
Reclassification of the device due
to regulations |
| Product Code | QRL | FMK | Different
Reclassification of the device due
to regulations |
| Regulation
number | 878.4850 | 878.4800 | Different
Reclassification of the device due
to regulations |
| Regulation
Name | Blood Lancets | Manual surgical
instrument for general
use | Different
Reclassification of the device due
to regulations |
| Intended
Use/
Indications
for Use | 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 Genteel lancing
device is used with
disposable sterile lancets
to draw capillary blood
from the fingertip or
alternate sites for blood
glucose testing or other
testing utilizing small
amounts of blood. The
Genteel lancing device is
for single patient use
only. | Same |
| Use | Reusable. The
lancing
device is for use
only
on a single patient. | Reusable. The lancing
device is for use only
on a single patient. | Same |
| Non-sterile | Yes | Yes | Same |
| Prescribed
use | Over the Counter | Over the Counter use | Same |
| Configuration
and Materials | It is primarily made
from different
plastics which are
both medical
grades. | It is primarily made from
different plastics which
are both medical grades. | Same |
| Puncture
depth
settings | Verifine® Ease | It has varying puncture | They also have varying puncture |
| | Lancing Device: It | depth settings via six | depth settings. |
| | has varying
puncture depth
settings via eight
adjustable settings
on depth adjuster.
The puncture depth
ranges between
0.15mm to
1.20mm; | interchangeable contact
tips on Genteel.
The puncture depth is
about 0.25mm to
0.55mm. | The subject device has covered
the puncture depth range of the
predicate device, with more
selectivity. And the epiderm
thickness of human is about
0.1mm. It has penetrated the
epiderm thickness to the dermis
when the penetration depth is
0.15 mm, and the dermis has
capillaries.
Additionally, the section of
"puncture depth" in the IFU
clearly states that 'it is
recommended to start the test
from the shallowest to the
deepest according to the
operating instructions for the
first use. If no blood is produced,
select the next gear until an
appropriate amount of blood is
obtained.' So the safety and
effectiveness of the subject
device will not be affected. |
| | Verifine® Lancing
Device: It has
varying puncture
depth settings via
five adjustable
settings on
adjusting caps. The
puncture depth
ranges between
0.25mm to
0.85mm. | | |
A detailed comparison to the predicate is provided in Table 1.
5
6
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
7
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.