(25 days)
Not Found
No
The device description and performance studies focus on mechanical components and standard testing, with no mention of AI or ML.
No
The device is described as being used for "capillary blood sampling" and "drawing capillary blood from the fingertip" for "testing utilizing small amounts of blood." This indicates its purpose is for diagnostic blood collection, not for therapy or treatment.
No
This device, a lancet and lancing device, is intended for collecting capillary blood samples. It facilitates the collection of biological samples but does not perform any analytical function to interpret or diagnose a condition.
No
The device description explicitly details physical components made of materials like ABS, POM, PC, PS Resin, and carbon steel, indicating it is a hardware device.
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.
- Device Description: The device description focuses on the physical components and function of the lancet and lancing device for blood collection. It does not describe any components or processes for analyzing or testing the blood.
- Lack of Diagnostic Function: An IVD device is designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function stops at the point of obtaining the sample.
- Performance Studies: The performance studies described focus on the physical performance of the device (blood sampling, biocompatibility, simulated clinical use) and not on the accuracy or reliability of any diagnostic results.
- Predicate Device: The predicate device is also a Lancet and Lancing device (K220475), which are typically classified as Class II medical devices for blood collection, not IVDs.
In summary, this device is a tool for collecting a biological sample (blood), which can then be used with an IVD device for diagnostic testing. The lancet and lancing device themselves do not perform the diagnostic function.
N/A
Intended Use / Indications for Use
Lancet:
The lancet is intended for capillary blood sampling.
Lancing device:
The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII- T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)
The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)
Product codes
ORL, ORK
Device Description
Lancet
The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip.
The Lancet is composed three components: needle, main body and protective cap. Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device
Along with a lancet, the lancing device is used to obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel.
The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first.
For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first.
The Lancing Device is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm (at the base of the thumb), forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional or lay person
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)
Non-Clinical Testing:
Verification and Validation Activities - Design Changes:
- Sizes and model: Additional sizes ranging and model were introduced to meet clinical needs.
- Material: The lancet body and cap material was changed to include PE to improve manufacturing efficiency. The new material was tested and found to be biocompatible and non-toxic as per ISO 10993-1.
Testing Performed:
- Performance Testing: The lancet and lancing device underwent performance testing (reports HH-JS-RP-2024-03 and HH-JS-RP-2024-04), The testing confirmed that the lancet and lancing device meet the performance criteria outlined.
- Biocompatibility Testing: The new PE material was tested for In Vitro cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity according to ISO 10993-1 standards. The results confirmed that the material is nontoxic and safe for use in its intended application.
- Simulated Clinical Use: A simulated clinical use study was performed on 640 device samples each for the Lancet and Lancing Device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Test Results:
All verification and validation tests passed without deviations, confirming that the lancet and lancing device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 15, 2024
Tianjin Huahong Technology Co., Ltd. Ningning Wang Registered Engineer A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin, 300308 China
Re: K243306
Trade/Device Name: Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VIII, IX); Lancing device (HH-X-T. HH-XV-T. HH-XVI-T. HH-XVI-T. HH-XVIII-T. HH-XIX. HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL, ORK Dated: October 17, 2024 Received: October 21, 2024
Dear Ningning Wang:
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 (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
1
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" (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 QS 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 Rule"). 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 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
2
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,
Digitally signed by Long H. Chen
Long H. Chen -S-5
Date: 2024.11.15 10:06:41 -05'00'
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
3
Indications for Use
Submission Number (if known)
| Device Name | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX);
Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-
T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-
T, HH-XXVII-T) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use (Describe) | |
| Lancet: | The lancet is intended for capillary blood sampling. |
| Lancing device: | The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII- T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)
The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T) |
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) summary
l Submitter
Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China
Establishment Registration Number: 3009498536
Contact person: Ms. Ningning Wang Registered Engineer Tel.: +86-13021381776 E-mail: ningning.wang@hh-technology.com
Preparation date: October 17, 2024
II Proposed Device
| Trade Name of Device: | Lancet, Lancing device |
|---|---|
| Common name: | Multiple Use Blood Lancet For Single Patient Use Only |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product code: | QRL and QRK |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K220475 |
|---|---|
| Trade name: | Lancet, Lancing device |
| Classification: | Class II |
| Product Code: | QRL, QRK |
| Manufacturer: | Tianjin Huahong Technology Co., Ltd. |
IV Device description
Lancet
The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip.
5
The Lancet is composed three components: needle, main body and protective cap. Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device
Along with a lancet, the lancing device is used to obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel.
The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first.
For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first.
The Lancing Device is provided non-sterile.
V Indication for use
Lancet
The lancet is intended for capillary blood sampling.
Lancing Device
The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a sinqle patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T) The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T).
VI Comparison of technological characteristics with the predicate devices The comparison and discussion between the Proposed device and the predicate devices are listed in below table 1&2:
6
| Item | Predicate device
(K220475) | Proposed device | Comments on
Similarities/Differ
ences | Safety/Effectiveness
Statement |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Lancet | No Change | N/A | No new concerns.
The product name remains
unchanged |
| Product Code | QRL and QRK | No Change | N/A | No new concerns.
The product code remains
the same, reflecting no
change in device
functionality. |
| Regulation No. | 21 CFR § 878.4850 | No Change | N/A | No new concerns.
The regulation number
remains consistent. |
| Class | II | No Change | N/A | No new concerns.
The device remains in Class
II, indicating no change in
risk level. |
| Prescription/over-
the-counter use | Over-The-Counter Use | No Change | N/A | No new concerns.
The over-the-counter use
remains consistent. |
| Indication for use | The lancet is intended for
capillary blood sampling. | No Change | N/A | No new concerns.
The Indication for use
remains consistent. |
| Applicable user | Healthcare professional or lay
person | No Change | N/A | No new concerns.
The applicable user remains
consistent. |
| Reuse durability | Single use | No Change | N/A | No new concerns.
The single use remains
consistent. |
| Sterilization method
and SAL | Sterilized by Radiation
SAL=10-6 | No Change | N/A | No new concerns.
The sterilization method and
SAL remains consistent. |
| Manufacturing
aspects | For the Lancet, stainless steel
needle is fed into an injection
molding machine to over-mold
plastic material (polyethylene
(PE) and Ethylene Vinyl Acetate
(EVA) and calcium powder)
forming a body and cap,
encapsulating the stainless steel
needles. | No Change | N/A | No new concerns.
The manufacturing aspects
remains consistent. |
| Design and
Functionality
aspects | The Lancet comprises a
stainless steel needle
encapsulated with a plastic body
and cap, the cap is twisted off to
expose the needle for use | No Change | N/A | No new concerns.
The design and functionality
aspects remains consistent. |
| Needle length range | 3.2±0.3mm(Model: IA、IB、
IC、ID、IE、IK、IL、IM、
IIA、IIB、III、VI)
2.1±0.3mm (Model: V) | 3.2±0.3mm (Model:
IA、IB、IC、ID、IE、IK、
IL、IM、IIA、IIB、III、
VI、VII)
2.1±0.3mm (Model: V)
2.2±0.3mm (Model:
VIII, IX ) | New three models
of VII, VIII and IX
were added. | No new concerns.
Model VII can only be used
in conjunction with our
company's HH-XXV-T
lancing device. After the
performance test and the
matching test, the product
can be guaranteed to be
safe and effective. Model VIII
can only be used in
conjunction with our
company's HH-XXIX-T
lancing device. After the
performance test and the
matching test, the product
can be guaranteed to be
safe and effective. Model IX
can only be used in
conjunction with our
company's HH-XXX-T
lancing device. After the |
| | | | | performance test and the
matching test, the product
can be guaranteed to be
safe and effective. Model IX
is a little smaller than model
VIII. |
| | 1.50±0.02mm (16G) | 1.50±0.02mm (16G) | | |
| | 1.20±0.01mm (18G) | 1.40±0.02mm (17G) | | |
| | 1.07±0.01mm (19G) | 1.20±0.01mm (18G) | | |
| | 0.91±0.01mm (20G) | 1.07±0.01mm (19G) | | |
| | 0.82±0.01mm (21G) | 0.91±0.01mm (20G) | | |
| | 0.72±0.01mm (22G) | 0.82±0.01mm (21G) | | |
| | 0.64±0.01mm (23G) | 0.72±0.01mm (22G) | New three size of | No new concerns. |
| Gauge range | 0.57±0.01mm (24G) | 0.64±0.01mm (23G) | 17G, 35G and 37G
were added. | The added sizes are within
the original approved sizes. |
| | 0.51±0.01mm (25G) | 0.57±0.01mm (24G) | | |
| | 0.46±0.01mm (26G) | 0.51±0.01mm (25G) | | |
| | 0.41±0.01mm (27G) | 0.46±0.01mm (26G) | | |
| | 0.36±0.01mm (28G) | 0.41±0.01mm (27G) | | |
| | 0.34±0.01mm (29G) | 0.36±0.01mm (28G) | | |
| | 0.31±0.01mm (30G) | 0.34±0.01mm (29G) | | |
| | 0.26±0.01mm (31G) | 0.31±0.01mm (30G) | | |
| | | | | |
| | 0.24±0.01mm (32G) | 0.26±0.01mm (31G) | | |
| | 0.21±0.01mm (33G) | 0.24±0.01mm (32G) | | |
| | 0.19±0.01mm (34G) | 0.21±0.01mm (33G) | | |
| | 0.17±0.01mm (36G) | 0.19±0.01mm (34G) | | |
| | 0.15±0.01mm (38G) | 0.18±0.01mm (35G) | | |
| | | 0.17±0.01mm (36G) | | |
| | | 0.16±0.01mm (37G) | | |
| | | 0.15±0.01mm (38G) | | |
| Shelf-life | 5 years | No Change | N/A | No new concerns.
The shelf-life aspects
remains consistent. |
| Materials of parts in
contact with human
body | The Lancet has a needle that is
made of stainless steel and a
body and a cap that are made of
polyethylene and Ethylene Vinyl
Acetate (EVA) and calcium
powder. | The Lancet has a needle
that is made of stainless
steel and a body and a
cap that are made of
polyethylene and Ethylene
Vinyl Acetate (EVA) and
calcium powder. | Material of body
and a cap is added
the PE which is
only contact intact
skin. | No new concerns.
The raw materials added this
time are the same as in
K220475, all are PE, only the
grades are different, and the
human body surface is in
contact with the complete
skin, reviewed geometric
changes per CDRH's
Biocompatibility Guidance,
That these materials pose a |
| | | | | very low biocompatibility risk,
and we have done the
appropriate biological tests
for this purpose, and the test
results show that it meets the
requirements. |
| Biocompatibility | Conforms to the requirements of
ISO 10993 series standards. | No Change | N/A | No new concerns.
The biocompatibility remains
consistent. |
| Performance
requirements | Remain no change | No Change | N/A | No new concerns.
Performance requirements
remain unchanged, ensuring
consistent functionality. |
| Label/Labeling | Complied with 21 CFR part 801 | No Change | N/A | No new concerns.
The labeling remains
consistent. |
Table 1 General Comparison of Lancet
7
8
9
10
7
11
12
| Table 2 General Comparison of Lancing device | ||||
|---|---|---|---|---|
| Item | Predicate device | |||
| (K220475) | Proposed device | Comments on | ||
| Similarities/Differ | ||||
| ences | Safety/Effectiveness | |||
| Statement | ||||
| Product name | Lancing device | No Change | N/A | No new concerns. |
| The product name remains | ||||
| unchanged | ||||
| Product Code | QRL | No Change | N/A | No new concerns. |
| The product code remains | ||||
| the same, reflecting no | ||||
| change in device | ||||
| functionality. | ||||
| Regulation No. | 21 CFR § 878.4850 | No Change | N/A | No new concerns. |
| The regulation number | ||||
| remains consistent. | ||||
| Class | II | No Change | N/A | No new concerns. |
| The device remains in | ||||
| Class II, indicating no | ||||
| change in risk level. | ||||
| Prescription/over- | ||||
| the-counter use | Over-The-Counter Use | No Change | N/A | No new concerns. |
| The over-the-counter use | ||||
| remains consistent. | ||||
| Indication for use | The Lancing Device is used with | |||
| lancets to draw capillary blood | ||||
| from the fingertip, for testing | ||||
| utilizing small amounts of blood. | ||||
| The Lancing Device is intended to | ||||
| be used by a single patient and | ||||
| should not be shared. | The Lancing Device is used with | |||
| lancets to draw capillary blood | ||||
| from the fingertip, for testing | ||||
| utilizing small amounts of blood. | ||||
| The Lancing Device is intended to | ||||
| be used by a single patient and | ||||
| should not be shared. (HH-X-T, | ||||
| HH-XV-T, HH-XVI-T, HH-XVII-T, | ||||
| HH-XVIII-T, HH-XIX, HH-XXI-T, | ||||
| HH-XXII-T, HH-XXIII-T, HH-XXIV- | ||||
| T, HH-XXV-T, HH-XXVI-T, HH- | ||||
| XXVII-T, HH-XXVIII-T, HH-XXIX-T, | ||||
| HH-XXX-T, HH-XIII-T) | ||||
| The Lancing Device is used with | ||||
| lancets to draw capillary blood | ||||
| from the fingertip, palm (at the | ||||
| base of the thumb) or forearm, for | ||||
| testing utilizing small amounts of | ||||
| blood. The Lancing Device is | ||||
| intended to be used by a single | ||||
| patient and should not be shared. | ||||
| (HH-XXVII-T) | Increase in | |||
| Indication for Use | ||||
| (add palm and | ||||
| forearm) of the | ||||
| new model HH- | ||||
| XXVII-T | No new concerns because | |||
| the additional intended use | ||||
| site of HH-XXVII-T (palm | ||||
| and forearm) was covered | ||||
| by the predicate | ||||
| device(K113332) of our | ||||
| predicate device (K220475) | ||||
| Puncture device to | ||||
| obtain micro blood | ||||
| samples | Yes | No Change | N/A | No new concerns. |
| The function is the same. | ||||
| Lancet retracted | ||||
| after use to prevent | ||||
| sharp injure | Yes | No Change | N/A | No new concerns. |
| The prevent sharp injure is | ||||
| the same. | ||||
| Device penetration | ||||
| depth range | 0.85~2.20 $\pm$ 0.30mm (model HH-X-T) | |||
| 0.60~2.00 $\pm$ 0.30mm (model HH-XIII-T、HH-XXII-T) | ||||
| 0.50~1.70 $\pm$ 0.30mm (model HH-XV-T) | ||||
| 0.60~1.95 $\pm$ 0.30mm (model HH-XVI-T、HH-XXI-T、HH-XXIII-T、HH-XXIV-T) | ||||
| 0.60~1.80 $\pm$ 0.30mm (model HH-XVII-T、HH-XIX) | ||||
| 0.60~2.10 $\pm$ 0.30mm (model HH-XVIII-T) | 0.85~2.20 $\pm$ 0.30mm (model HH-X-T) | |||
| 0.60~2.00 $\pm$ 0.30mm (model HH-XIII-T、HH-XXII-T、HH-XXVI-T、HH-XXVII-T、HH-XXVIII-T) | ||||
| 0.50~1.70 $\pm$ 0.30mm (model HH-XV-T) | ||||
| 0.60~1.95 $\pm$ 0.30mm (model HH-XVI-T、HH-XXI-T、HH-XXIII-T、HH-XXIV-T) | ||||
| 0.60~1.80 $\pm$ 0.30mm (model HH-XVII-T、HH-XIX、HH-XXV-T、HH-XXIX-T、HH-XXX-T) | ||||
| 0.60~2.10 $\pm$ 0.30mm (model HH-XVIII-T) | New six models of | |||
| HH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T, | ||||
| HH-XXIX-T, and | ||||
| HH-XXX-T were | ||||
| added. | No new concerns. | |||
| The newly added models | ||||
| are only changed in | ||||
| appearance and | ||||
| dimensions compared to | ||||
| K220475. | ||||
| Mechanical loading | ||||
| and firing function | Cocking barrel with releasing | |||
| button | No Change | N/A | No new concerns. | |
| The mechanical loading | ||||
| and firing function remains | ||||
| consistent. | ||||
| Materials | ABS, POM, PC | ABS, POM, PC and PS | Increase in raw | |
| material PS | No new concerns. | |||
| This addition of raw | ||||
| material PS will only come | ||||
| into contact with complete | ||||
| skin on the surface of the | ||||
| human body, reviewed | ||||
| geometric changes per | ||||
| CDRH's Biocompatibility | ||||
| Guidance, That these | ||||
| materials pose a very low | ||||
| biocompatibility risk | ||||
| because they have a long | ||||
| history of safe use in legally | ||||
| marketed medical devices | ||||
| that contact intact skin. | ||||
| Reuse durability | Reusable | |||
| Single Patient Use Only | No Change | N/A | No new concerns. | |
| The reuse durability | ||||
| remains consistent. | ||||
| Sterilization method | ||||
| and SAL | NA | NA | N/A | N/A |
| Performance | ||||
| requirements | Remain no change | No Change | N/A | No new concerns. |
| Performance requirements | ||||
| remain unchanged, | ||||
| ensuring consistent | ||||
| functionality. | ||||
| Label/Labeling | Complied with 21 CFR part 801 | No Change | N/A | No new concerns. |
| The labeling remains | ||||
| consistent. |
Table 2 General Comparison of Lancing device
13
14
15
16
17
VII Non-Clinical Testing
To support substantial equivalence to the predicate device, Tianjin Huahong Technology Co., Ltd. completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.
Verification and Validation Activities - Design Changes:
Sizes and model: Additional sizes ranging and model were introduced to meet clinical needs.
Material: The lancet body and cap material was changed to include PE to improve manufacturing efficiency. The new material was tested and found to be biocompatible and non-toxic as per ISO 10993-1.
Testing Performed:
Performance Testing: The lancet and lancing device underwent performance testing (reports HH-JS-RP-2024-03 and HH-JS-RP-2024-04), The testing confirmed that the lancet and lancing device meet the performance criteria outlined.
Biocompatibility Testing: The new PE material was tested for In Vitro cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity according to ISO 10993-1 standards. The results confirmed that the material is nontoxic and safe for use in its intended application.
Simulated Clinical Use
A simulated clinical use study was performed on 640 device samples each for the Lancet and Lancing Device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Test Results:
All verification and validation tests passed without deviations, confirming that the lancet and lancing device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.
Conclusions:
Based on the results of the non-clinical verification and validation activities, it can be concluded that the modified lancet and lancing device are substantially equivalent to
18
the predicate device K220475. The changes, including the addition of new needle sizes and the material change, have been thoroughly evaluated and verified to meet all applicable performance and safety standards. Therefore, the device is as safe and effective as the predicate device for its intended use, and no new risks have been introduced.
VIII Clinical Testing
No clinical study is included in this submission.
Conclusion when compared to the predicate devices have been successfully evaluated through appropriate safety and performance testing which demonstrates that the proposed device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, the proposed device have been determined to be substantially equivalent to the predicate devices.