(188 days)
Not Found
No
The device is a simple mechanical lancet for blood collection and the summary contains no mention of AI or ML.
No
The device is used to obtain blood samples for diagnostic tests, not for treating any condition or disease.
No
This device is a lancet, used to obtain blood samples. It does not analyze the blood or provide any diagnostic information itself; it merely facilitates the collection of the sample for subsequent diagnostic testing.
No
The device description clearly outlines physical components (needle, body, cap) and performance testing related to these physical attributes (launch length, sharpness, exterior connection, cap twist). It also mentions sterilization and biocompatibility testing, which are associated with physical medical devices, not software-only devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Function: This device, a blood lancet, is used to obtain the blood sample. It is a tool for collecting the specimen, not for analyzing it or performing a diagnostic test on it.
- Intended Use: The intended use clearly states it's for "obtain[ing] capillary blood samples from the fingertip for tests using small amounts of blood." It facilitates the collection, but the diagnostic test itself is performed separately using the collected blood.
Therefore, while the blood collected using this lancet might be used in an IVD test, the lancet itself is a sample collection device, not an IVD.
N/A
Intended Use / Indications for Use
The product is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The lancet is intended to be assembled with a lancing device, such that once the lancing device is launched, the needle of the lancet can prick the skin.
Product codes
QRL, QRK
Device Description
The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G.
Disposable Blood Lancets are used to collect blood samples for hospital clinic test. It is sterilized by Irradiation and is a single-use product.
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
hospital or at home
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:
Non-clinical testing included Appearance (Pass), Launch Length (Pass), Sharpness (Pass), Exterior (Pass), Cap twist (Pass), Initial bioburden (Pass), Sterile (Pass).
Biocompatibility testing per ISO 10993-1:2018 included Cytotoxic test (ISO 10993-5:2009), Skin sensitization test (ISO 10993-10:2010), Intracutaneous test (ISO 10993-10:2010), Acute systemic toxicity test (ISO 10993-11:2017), Hemolysis test (ISO 10993-4:2017), Pyrogen Test (USP ).
Sterilization and shelf life testing included Irradiation sterilization validation per ISO 11173-1 and ISO 11173-3, Pyrogen testing per USP , Simulated shipping per ASTM D4169, and a 5 years shelf life based on stability study which includes ageing test.
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
August 17, 2022
Suzhou Kyuan Medical Apparatus Co., Ltd. Shi Ye Manager Beigiao Town Suzhou, Jiangsu China
Re: K220387
Trade/Device Name: Disposable Blood Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: July 18, 2022 Received: July 18, 2022
Dear Shi Ye:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
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) K220387
Device Name Disposable Blood Lancets
Indications for Use (Describe)
The product is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The lancet is intended to be assembled with a lancing device, such that once the lancing device is launched, the needle of the 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
K220387 510(k) summary
l Submitter
Device submitter: Suzhou Kyuan Medical Apparatus Co., Ltd. Beiqiao Town, Suzhou City, P.R.China
Contact person: Shi Ye General Manager Phone: +86-512 65995113 Fax: +86-512 65412778 Email: shi.ye@medi-kyuan.com
510(k) number: K220387
Date: 08/17/2022
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 (Used as predicted device |
|---|---|
| VeriFine Safety Lancet | |
| VeriFine Mini-Safety Lancet | |
| Common name: | Blood Lancets |
| 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 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G.
4
Disposable Blood Lancets are used to collect blood samples for hospital clinic test. It is sterilized by Irradiation and is a single-use product.
V Indications for use
The product is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The lancet is intended to be assembled with a lancing device, such that once the lancing device is launched, the needle of the 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 1
(Disposable Blood
Lancets) | Predicate Device
K192666
(Promisemed Blood
Lancet) | Comment |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications
for use | The product is intended
to be used in a hospital
or at home to obtain
capillary blood samples
from the fingertip for tests
using small amounts of
blood. The lancet is
intended to be
assembled with a lancing
device, such that once
the lancing device is
launched, the needle of
the lancet can prick the
skin. | It is intended for capillary
blood sampling. | Similar
Comment
1 |
| Product
code | QRK, QRL | FMK | Different
Comment
1 |
| Reuse
durability | Single use | Single use | Equivalent |
| Sterilization | Irradiation | Not available | Different |
| Device
feature | Subject Device 1
(Disposable Blood
Lancets) | Predicate Device
K192666
(Promisemed Blood
Lancet) | Comment |
| | | | Comment
2 |
| 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
twisted off to expose the
needle for
use. | Equivalent |
| Manufacturi
ng | 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 |
| Model and
Specificatio
n | 18G; 21G; 23G; 26G;
28G; 30G; 32G; 33G | BL-30 (30G)
BL-28 (28G)
(Information gathered from
Promisemed Hangzhou
Meditech Co., Ltd. official
website) | Different
Comment
3 |
| Penetration
Depth | $3.2mm\pm0.2$ | 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 |
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 diagnostic 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
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
Through comparative analysis, 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. 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 force ≤1.00N. | Pass |
| 04 | Exterior | The connection between needle and needle body
should be firm. | Pass |
Performance Testing for Disposable Blood Lancets
7
| 05 | 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 |
Biocompatibility testing
Biocompatibility of the Disposable Blood 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 10993-10:2010 |
| Intracutaneous test | ISO 10993-10:2010 |
| Acute systemic toxicity test | ISO 10993-11:2017 |
| Hemolysis test | ISO 10993-4:2017 |
| Pyrogen Test | USP |
Sterilization and shelf life testing
- Irradiation sterilization validation per ISO 11173-1 and ISO 11173-3. >
- A Pyrogen testing per USP
- A Simulated shipping per ASTM D4169
- 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 are 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.