(89 days)
Not Found
No
The device is a simple mechanical lancet for blood sampling and the summary contains no mention of AI or ML.
No.
The device is used to obtain blood samples for testing, which is a diagnostic purpose, not a therapeutic one.
No
Explanation: The device is used to obtain blood samples, not to analyze them for diagnostic purposes. It is a tool for sample collection, which is a precursor to diagnosis.
No
The device description clearly outlines physical components (needle, body, cap) and performance studies related to hardware characteristics (sharpness, penetration, forces, drop testing). It is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used in vitro (outside the body) to examine specimens derived from the human body. They are used to provide information about a physiological state, health, or disease.
- This device is used to obtain a specimen (blood) from the body. It is a tool for collecting the sample, not for analyzing it.
The description clearly states the device's purpose is to "obtain capillary blood samples from fingertip." While the blood sample obtained may be used for in vitro diagnostic testing, the lancet itself is a sample collection device, not an IVD.
N/A
Intended Use / Indications for Use
The product is used to obtain capillary blood samples from fingertip in a home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.
Product codes
QRK, QRL
Device Description
The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 21G; 23G; 26G; 30G. Disposable Blood Lancets are used to obtain blood samples for testing purposes. It is sterilized by Irradiation and is a single-use product. The device is compatible with the reusable lancing device which met the specification and size requirements of the following figure in the market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, hospital
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 following performance data were provided in support of the substantial equivalence determination.
- Testing item: Appearance; Specification: Lancet should have the same color, no bubble, no flash, no slip; Result: Pass
- Testing item: Launch Length; Specification: The length of the needles in the Disposable Blood Lancets is different in different gauge. The general depth is 3.2mm; Result: Pass
- Testing item: Sharpness/Penetration testing; Specification: Penetration force ≤1.00N; Result: Pass
- Testing item: Exterior; Specification: The connection between needle and needle body should be firm; Result: Pass
- Testing item: Exterior; Specification: Cap twist should be smooth; Result: Pass
- Testing item: Initial bioburden; Specification: Initial bioburden of the device shall be less than 100CFU/g; Result: Pass
- Testing item: Sterile; Specification: The sterile blood lancet shall be sterile; Result: Pass
- Testing item: Cap removal force; Specification: The moment for breaking the safe mode should range from 30 Ncm to 35 Ncm; Result: Pass
- Testing item: Needle removal force; Specification: The bond between the lancet body and needle should be greater than or equal to 10N/15s; Result: Pass
- Testing item: Drop testing; Specification: The carton box should have no puncture after the drop test; Result: Pass
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 25, 2023
Huaian Hening Medical Instruments Co., Ltd Zhengcan Da General Manager No. 6 West Hongdou Road Economic Development Zone Huaian, Jiangsu China
Re: K223314
Trade/Device Name: Disposable Blood Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK, QRL Dated: December 29, 2022 Received: December 29, 2022
Dear Zhengcan Da:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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).
Sincerely,
Jessica Carr -S
for Long Chen, PhD Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223314
Device Name Disposable Blood Lancets
Indications for Use (Describe)
Disposable Blood Lancets
The product is used to obtain capillary blood samples from fingertip in a home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K223314 510(k) summary
l Submitter
Device submitter: HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD.
NO.6 West Hongdou Road Economic Development Zone Huaian,
Jiangsu China
Contact person: Zhengcan Da General Manager Phone: +86-13952318668 Fax: +86-517-83800501 Email: hn-lancets@vip.163.com
Date: 10/12/2022
II Device
Trade Name of Device: Disposable Blood Lancets Common Name: Blood Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Single Use Only Blood Lancet without an Integral Sharps Injury Prevention Feature Regulatory Class: II Product code: QRK; QRL Review Panel: General & Plastic Surgery
III Predicate Devices
| Trade name: | Promisemed Blood Lancet |
|---|---|
| VeriFine Safety Lancet | |
| VeriFine Mini-Safety Lancet | |
| Common name: | Blood Lancet |
| Classification: | Class I, Lancet, Blood, 21CFR 878.4800 |
| Product Code: | FMK |
| Premarket Notification: | K192666 |
| Manufacturer: | Promisemed Hangzhou Meditech Co., Ltd. |
IV Device description
The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 21G; 23G; 26G; 30G. Disposable Blood Lancets
4
are used to obtain blood samples for testing purposes. It is sterilized by Irradiation and is a single-use product. The device is compatible with the reusable lancing device which met the specification and size requirements of the following figure in the market.
Image /page/4/Picture/1 description: The image shows three diagrams of a cylindrical object with measurements. The first diagram shows the object with a ring on one end and a measurement of 32.5mm ± 0.5. The second diagram shows the object with a different end and a measurement of 22.7mm ± 0.5. The third diagram shows the object with a measurement of 3.2mm ± 0.6.
V Indications for use
The product is used to obtain capillary blood samples from fingertip in a hospital or at home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.
VI Comparison of technological characteristics with the predicate devices
The Disposable Blood Lancets have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Disposable Blood Lancets and predicate devices do not alter suitability of the proposed device for its intended use.
| Device feature | Subject Device
(Disposable Blood
Lancets) | Predicate Device
K192666
(Promisemed
Blood
Lancet) | Comment |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indications for use | The product is used to
obtain capillary blood
samples from fingertip in a
hospital or at home. The
lancet is assembled with
lancing device, once the
lancing device is launched,
the needle of lancet can
prick the skin. | It is intended for
capillary blood
sampling. | Similar
Comment 1 |
| Product code | QRK, QRL | FMK | Different
Comment 1 |
| Safety protection
features | No | Yes | Different |
| Device feature | Subject Device
(Disposable Blood
Lancets) | Predicate Device
K192666
(Promisemed
Blood
Lancet) | Comment |
| Reuse durability | Single use | Single use | Equivalent |
| Sterilization | Irradiation | Not available | Different
Comment 2 |
| Model | 21G; 23G; 26G; 28G; 30G | BL-30 (30G)
BL-28 (28G)
(Information
gathered from
Promisemed
Hangzhou
Meditech Co.,
Ltd. official
website) | Different
Comment 3 |
| Launch length | 3.2mm±0.6 | 3mm
(Information
gathered from
Promisemed
Hangzhou
Meditech Co.,
Ltd. official
website) | |
| Materials of parts
in contact with
human body | Lancet needle: stainless
steel;
Body and cap: PE | Lancet needle:
stainless steel;
Body and cap: PE | Equivalent |
| Principle of
Operation | The Disposable Blood
Lancets comprises a
stainless steel needle
encapsulated with a plastic
body and cap, the cap is
twisted off to expose the
needle for use. | The Promisemed
Blood Lancet
comprises a
stainless steel
needle
encapsulated with
a plastic body and
cap, the cap is | Equivalent |
| Device feature | Subject Device
(Disposable Blood
Lancets) | Predicate Device
K192666
(Promisemed
Blood
Lancet) | Comment |
| | | twisted off to
expose the
needle for use. | |
| Manufacturing | Stainless steel needle is
fed into an injection
molding machine to over-
mold plastic material
(polyethylene) forming a
body and cap,
encapsulating the stainless
steel needles. Terminal
sterilization process is
performed to ensure
sterility of an entire
product. | For the
Promisemed
Blood Lancet,
stainless steel
needle is fed into
an injection
molding machine
to over-mold
plastic material
(polyethylene)
forming a body
and cap,
encapsulating the
stainless steel
needles. Terminal
sterilization
process is
performed to
ensure sterility of
an entire product. | Equivalent |
5
6
Discussion:
Comment 1
The subject device and the predicate device have the same intended use, to puncture the skin to obtain drops of blood for testing purposes. While the Disposable Blood Lancets have no sharp's prevention features and without the intended use of protecting the user from a needlestick injury. This difference does not affect the clinical safety of the subject device.
Comment 2
7
The sterilization method of predicate device is not available. However, the subject device was ensured sterility by sterilization validation. Therefore, the differences on sterilization do not raise new questions about safety and effectiveness.
Comment 3
The models and Launch length of subject device are different from the predicate device. The model was more than as the predicated products, while the puncture depths are same. Different models are only different in the outer diameter of the needle, which allowed to choose to meet blood volume needs. Different needle specification will be selected by physician per patient's condition and this different were addressed by performance tests. Testing of performance shows no impact of launch length on the sharpness /penetration force or bond between the lancet body and needle because the puncture depth is tuned by the lancing device, not the lancet itself, this difference does not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
VII Summary of non-clinical testing
The following performance data were provided in support of the substantial equivalence determination.
| No | Testing item | Specification | Result |
|---|---|---|---|
| 01 | Appearance | Lancet should have the same color, no | |
| bubble, no flash, no slip. | Pass | ||
| 02 | Launch Length | The length of the needles in the Disposable | |
| Blood Lancets is different in different | |||
| gauge. The general depth is 3.2mm | Pass | ||
| 03 | Sharpness/Penetration | ||
| testing | Penetration force ≤1.00N. | Pass | |
| 04 | Exterior | The connection between needle and | |
| needle body should be firm. | Pass | ||
| 05 | Exterior | Cap twist should be smooth. | Pass |
| 06 | Initial bioburden | Initial bioburden of the device shall be less | |
| than 100CFU/g | Pass | ||
| 07 | Sterile | The sterile blood lancet shall be sterile | Pass |
| 08 | Cap removal force | The moment for breaking the safe mode | |
| should range from 30 Ncm to 35 Ncm. | Pass | ||
| 09 | Needle removal force | The bond between the lancet body and | |
| needle should be greater than or equal to | |||
| 10N/15s. | Pass |
8
| 10 | Drop testing | The carton box should have no puncture
after the drop test. | Pass |
| ---- | -------------- | ---------------------------------------------------------------- | ------ |
|---|
Biocompatibility testing
Biocompatibility of the Disposable Blood Lancets and Disposable Safety Lancets were evaluated in accordance with ISO 10993-1:2018 for the body contact category. The following tests were performed, as recommended:
| Cytotoxic test | ISO 10993-5:2009 |
|---|---|
| Skin sensitization test | ISO 10993-23:2021 |
| Intracutaneous test | ISO 10993-10:2021 |
| Acute systemic toxicity test | ISO 10993-11:2017 |
| Hemolysis test | ISO 10993-4:2017 |
| Pyrogen Test | ISO 10993-11:2017 |
Sterilization and shelf life testing
- A Irradiation sterilization validation per ISO 11137-1 and ISO 11137-3.
- Pyrogen testing per ISO 10993-11:2017 A
-
Transportation test per ISTA 2A:2011
- A The 5 years shelf life of the device is determined based on stability study which includes ageing test.
VIII Conclusion
The Disposable Blood Lancets is substantially equivalent to its predicate device (Promisemed Blood Lancet). The differences between the predicate and subject device do not raise any new or different questions of safety or effectiveness. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.