(111 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and standard biocompatibility/sterility testing, with no mention of AI/ML terms or functionalities.
No
The device is described as being for "capillary blood sampling," which is a diagnostic or monitoring function, not a therapeutic one. It's used to collect a sample, not to treat a condition.
No
The device is described as a "Disposable Safety Lancet" intended for "capillary blood sampling." It is a tool for collecting blood, not for analyzing or interpreting medical conditions.
No
The device description clearly describes a physical, spring-loaded lancet with different needle sizes, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "capillary blood sampling." This describes the collection of a sample, not the testing or analysis of that sample.
- Device Description: The description focuses on the mechanism for obtaining the blood sample (spring-loaded lancet, needle retraction). It does not mention any components or functions related to analyzing the blood.
- Lack of Diagnostic Function: An IVD device is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's sole purpose is to obtain the specimen.
While the blood collected by this device could be used in an IVD test, the lancet itself is a tool for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Safety Lancet is intended for capillary blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The Disposable Safety Lancet is intended for capillary blood sampling.
The Disposable Safety Lancet include eleven models as IV, V, W2, M3, M3 PLUS, M4, M5, M5 MINI, M6, M7, E1.
The model "IV" of Disposable Safety Lancet include different needle core sizes: 21G,23G, 25G, 26G, 27G, 28G, 30G.
The model "V" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "W2" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M3" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M3 PLUS" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M4" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M5" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M5 MINI" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M6" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M7" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "E1" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capillary blood sampling
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-4:2017, Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
USP34, Rabbit Pyrogen Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
November 29, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Beijing Ruicheng Medical Supplies Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K222408
Trade/Device Name: Disposable Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 8, 2022 Received: August 10, 2022
Dear Ray 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
for Long Chen 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) K222408
Device Name Disposable Safety Lancet
| Indications for Use ( Describe ) |
|---|
| The Disposable Safety Lancet is intended for capillary blood sampling. |
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K222408
-
- Date of Preparation: 08/10/2022
-
- Sponsor
Beijing Ruicheng Medical Supplies Co., Ltd.
No.13 Yanqi Ave, Yanqi Economic Development Zone, Huairou District, Beijing China,101400 Contact Person: Yuechao Li Position: General Manager Tel: +86-18910106615 Fax: +86-10-61678702 Email: lily@ruichengmedical.com
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email:information@believe-med.com
-
- Proposed Device Identification
Trade Name: Disposable Safety Lancet. Common Name: Disposable Safety Lancet. Regulatory Information: Classification: II Product Code: FMK Regulation Number: 21 CFR 878.4850 Review Panel: General & Plastic Surgery
- Proposed Device Identification
4
Indication for Use Statement: The Disposable Safety Lancet is intended for capillary blood sampling.
-
న్. Predicate Device Identification
510(k) Number: K221368 Product Name: VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Manufacturer: Promisemed Hangzhou Meditech Co., Ltd -
Device Description 6.
The Disposable Safety Lancet is intended for capillary blood sampling.
The Disposable Safety Lancet include eleven models as IV, V, W2, M3, M3 PLUS, M4, M5, M5 MINI, M6, M7, E1.
The model "IV" of Disposable Safety Lancet include different needle core sizes: 21G,23G, 25G, 26G, 27G, 28G, 30G.
The model "V" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "W2" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M3" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M3 PLUS" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M4" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M5" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M5 MINI" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M6" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "M7" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
The model "El" of Disposable Safety Lancet include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed
- Non-Clinical Test Conclusion
5
device complies with the following standards:
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-4:2017, Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
USP34, Rabbit Pyrogen Test
6
8. Substantially Equivalent Comparison Conclusion
| ITEM | Proposed Device | Predicate Device K221368 | Remark |
|---|---|---|---|
| Product name | Disposable Safety Lancet | VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | SIMILAR |
| Product code | FMK | FMK | SAME |
| Regulation | |||
| number | 878.4850 | 878.4850 | SAME |
| Class | II | II | SAME |
| Prescription/over-the-counter use | Over-The-Counter Use | Over-The-Counter Use | SAME |
| Intended Use | The Disposable Safety Lancet is intended for capillary blood | ||
| sampling. | It is intended for capillary blood sampling. | SAME | |
| Direction for use | 1.Twist off the lancet protective cap clockwise or | ||
| counterclockwise. | |||
| 2.Grip the two side face of the lancet with thumb and middle | |||
| finger respectively. |
- Use lancet against the skin of the blood sampling site,
then press down the gland with the index finger quickly to
eject.
4.Put the used lancet into dedicated recycling utensil. | 1. Rotate the twisting cap less than half a round - Pull out the twisting cap
- Place the device on the puncture site and push to start
- Discard lancet into a sharp container
- Press lightly on the finger toward the puncture site to
obtain adequate blood sample | SIMILAR |
| Gauge | 21G,23G,25G,26G,28G,30G | 18G,21G,23G,25G,26G,28G,30G | SIMILAR |
| Needle Length
(mm) | 1.2, 1.5, 1.8, 2.1,2.4 | 1.2, 1.4, 1.6, 1.8, 2.0,2.2, 2.4, 2.6, 2.8 | SIMILAR |
| Structure/Design | Disposable Safety Lancet are spring-loaded lancet.
Disposable Safety Lancet are activated when you press the
device against your finger. | VeriFine Safety Lancet and VeriFine Mini-Safety Lancet are
spring-loaded lancet.
VeriFine Safety lancet/VeriFine Mini-Safety Lancet are | SIMILAR |
| | Once activated the needle retracts into the body of the device
which reduces the risk of injury as the result if an exposed
needle. | activated when you press the device against your finger.
Once activated the needle retracts into the body of the device
which reduces the risk of injury as the result if an exposed
needle. The first spring releases the needle into the skin and
the second withdraws the needle back into the shield. | |
| Safety protection
features | Yes | Yes | SAME |
| Reuse durability | Single use | Single use | SAME |
| Sterilization
method and SAL | Sterilized by Radiation SAL=10-6 | Sterilized by Radiation SAL=10-6 | SAME |
| Self-life | 5 years | 5 years | SAME |
| Materials of parts
in contact with
human body | Needle core: SUS304
Excitation set:PS
Shell:PP | Needle: Stainless steel
Spring: Galvanized steel wire
Shield, hub and Safety: ABS
Trigger POM
Lancet body cap: PE | ANALYSIS 1 |
| Biocompatibility | Biocompatibility established | Biocompatibility established | SAME |
| Label/Labelin | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | SAME |
7
Analysis 1: The raw naterials of proposed devices may be predicate devices. However, all the materials are known biocompatible materials that have been used in lancets or other similar medical devices.
8
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, VeriFine Safety Lancet cleared under K221368.