(59 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is used for capillary blood sampling for diagnostic purposes, not for treating a disease or condition.
No
The device is a lancet used to collect blood samples, which are then used for diagnostic purposes. The lancet itself does not perform any diagnostic function.
No
The device description clearly outlines physical components like a needle, spring, launching part, casing, and plastic components, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for capillary blood sampling." This describes the collection of a sample, not the analysis of a sample.
- Device Description: The description focuses on the physical mechanism for puncturing the skin to obtain a blood sample. It doesn't mention any components or functions related to analyzing the blood itself.
- 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 lancet simply provides the sample; it doesn't perform any diagnostic test on the sample.
While the blood sample collected by this lancet can be used for diagnostic purposes (e.g., blood glucose testing, cholesterol testing), the lancet itself is a tool for sample collection, not a diagnostic device.
N/A
Intended Use / Indications for Use
Lianfa Safety Lancet (Five Models: NPA, PA, TPA, and APA) is a single use device indicated for capillary blood sampling.
Product codes
FMK
Device Description
Lianfa Safety Lancet is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals and home users. They are intended for over the counter use.
Lianfa Safety Lancet is 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 safety lancet is made up of a needle core, spring, a launching part, and a casing. The steel needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable of further use.
Based on the shape and design of the device, there are five different models: PA, PA2, APA, NPA, and TPA. Each model is offered with various gauges of needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professionals and home users / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench testing performed verifies that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics. These tests are as follow.
| Characteristics | Specifications | Results |
|---|---|---|
| Appearance | The surface of the device and needle shall be clean, free of burrs, scratches, rusts, and any extraneous materials. Needle should be clean, straight and without residual debris. | Meet requirement |
| Dimension | Product dimensions shall be consistent to the drawings | Meet requirement |
| Puncture Depth | Use calipers to measure and meet | Meet requirement |
| Corrosion | The steel needle shall be free of signs of corrosion | Meet requirement |
| Puncture Force | The steel needle puncture force shall be less than or equal to 2.0 N | Meet requirement |
| Connection Firmness between Needle and Handle | The steel needle and the handle shall withstand 10N axial static tension for 1min and the handle. | Meet requirement |
| Sterility | The safety needle should be sterile. | Meet requirement |
| pH | The pH value between test solution and control solution shall not be greater than 1. | Meet requirement |
| Extractable Metal | Not more than 10 µg/device | Meet requirement |
| Launch Performance | Launch performance should be good, launch button can be pressed smoothly, no jam. | Meet requirement |
| Safety Features | The force to trigger a needle launch should be between 4 and 10 N. Deactivation: the product cannot be launched after the first launch. | Meet requirement |
Biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process". The tests include the following tests:
| Item | Test method | Test results |
|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | No Cytotoxicity |
| Skin Sensitization | ISO 10993-10: 2010 | No Skin sensitization |
| Intracutaneous reactivity | ISO 10993-10: 2010 | No irritation |
| Acute Systemic Toxicity | ISO 10993-11: 2017 | No Acute Systemic Toxicity |
| Pyrogenicity | ISO 10993-11: 2017 | No thermogenic reaction |
No clinical study is included in this submission.
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
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10/3/2022
Shandong Lianfa Medical Plastic Products Co. Ltd. % Charles Shen, Ph.D. Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K222376 Trade/Device Name: Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
Regulation Number: 21 CFR 878.4800 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 5, 2022 Received: August 5, 2022
Dear Dr. Shen:
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 (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,
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) K222376
Device Name Lianfa Safety Lancet
Indications for Use (Describe)
Lianfa Safety Lancet (Five Models: NPA, PA, TPA, and APA) is a single use device indicated 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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510(K) Number: K222376
510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
I Submitter & Foreign Manufacture Identification
Shandong Lianfa Medical Plastic Products Co. Ltd. No. 1 Shuangshan Sanjian Road Zhangqiu, Jinan, Shandong Province, China, Zipcode 250200 Tel: (086) 531-61328777 Submitter's FDA Registration Number: 3003723176
Contact Person
Dr. Charles Shen, Director Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: October 3, 2022
II Device Name:
| Trade Name: | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA,
and APA) |
|------------------------|-----------------------------------------------------------------------------------|
| Common Name: | Blood Lancet |
| Classification Name: | Single Use Only Blood Lancet with An Integral Sharps
Injury Prevention Feature |
| Device Classification: | Class 2 |
| Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4850 |
| Product Code: | FMK |
III Predicate Device Information:
K220370, "Safety Lancet (8 Models: XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, (1) XXVI)", manufactured by "Tianjin Huahong Technology Co., Ltd."
4
IV Device Description:
Lianfa Safety Lancet is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals and home users. They are intended for over the counter use.
Lianfa Safety Lancet is 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 safety lancet is made up of a needle core, spring, a launching part, and a casing. The steel needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable of further use.
Based on the shape and design of the device, there are five different models: PA, PA2, APA, NPA, and TPA. Each model is offered with various gauges of needle.
V Indications for Use:
Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is a single use device indicated for capillary blood sampling.
VI Comparison of Technological Characteristics with the Predicate Device
The comparison and discussion between the subject device and the predicate device are listed in below Table 1:
| Description | Subject Device | Predicate Device (K220370) |
|---|---|---|
| Product Name | Lianfa Safety Lancet | Safety Lancet |
| Indication for Use | The safety lancet is a single use device | |
| indicated for capillary blood sampling. | The safety lancet is intended for | |
| capillary blood sampling. | ||
| Regulation Number | 21 CFR § 878.4850 | 21 CFR § 878.4850 |
| Product Code | FMK | FMK |
| Basic Design | Needle, housing, protective cap, spring, | |
| button | Needle, housing, protective cap, spring, | |
| button |
Table 1: General Comparison of Safety Lancet
5
| Materials | Stainless steel, carbon steel, plastics | Stainless steel, carbon steel, plastics |
|---|---|---|
| Safety Features | Deactivated after first use | Deactivated after first use |
| Dimension | Various | Various |
| Compatible Gauges | 17G, 18G, 21G, 23G, 25G, 26G, 28G, 30G | |
| (for all five models) | This information is not publicly | |
| available for predicate device | ||
| Range of Puncture | ||
| Depth/Needle | ||
| Length | Model NPA: 1.5 mm to 2.2 mm | |
| Model PA: 1.5 mm to 2.2 mm | ||
| Model PA2: 1.5 mm to 2.2 mm | ||
| Model APA: 1.0 mm to 2.2 mm | ||
| Model TPA: 1.6 mm to 1.8 mm | This information is not publicly | |
| available for predicate device | ||
| Single Use | Yes | Yes |
| Shelf Life | 5 years | 5 years |
| Sterile | SAL 10-6 | SAL 10-6 |
| Prescription/OTC | OTC | OTC |
| Biocompatibility | Conforms to the requirements of ISO | |
| 10993 series standards. | Conforms to the requirements of ISO | |
| 10993 series standards. | ||
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 |
Conclusion: Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate device.
VII Non-Clinical Testing
The bench testing performed verifies that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics. These tests are as follow.
| Characteristics | Specifications | Results |
|---|---|---|
| Appearance | The surface of the device and needle shall be | |
| clean, free of burrs, scratches, rusts, and any | ||
| extraneous materials |
Needle should be clean, straight and without
residual debris. | Meet
requirement |
| Dimension | Product dimensions shall be
consistent to the drawings | Meet requirement |
| Puncture Depth | Use calipers to measure and meet | Meet requirement |
| Corrosion | The steel needle shall be free of signs of
corrosion | Meet requirement |
| Puncture Force | The steel needle puncture force shall be less
than or equal to 2.0 N | Meet requirement |
| Connection Firmness
between Needle and | The steel needle and the handle shall
withstand 10N axial static tension for 1min | Meet requirement |
6
| Handle | and the handle. | |
|---|---|---|
| Sterility | The safety needle should be sterile. | Meet requirement |
| pH | The pH value between test solution and | |
| control solution shall not be greater than 1. | Meet requirement | |
| Extractable Metal | Not more than 10 µg/device | Meet requirement |
| Launch Performance | Launch performance should be good, launch | |
| button can be pressed smoothly, no jam. | Meet requirement | |
| Safety Features | The force to trigger a needle launch should be | |
| between 4 and 10 N. | ||
| Deactivation: the product cannot be launched | ||
| after the first launch. | Meet requirement |
Biocompatibility Testing:
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" . The tests include the following tests:
| Item | Test method | Test results |
|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | No Cytotoxicity |
| Skin Sensitization | ISO 10993-10: 2010 | No Skin sensitization |
| Intracutaneous reactivity | ISO 10993-10: 2010 | No irritation |
| Acute Systemic Toxicity | ISO 10993-11: 2017 | No Acute Systemic Toxicity |
| Pyrogenicity | ISO 10993-11: 2017 | No thermogenic reaction |
VIII Clinical Testing
No clinical study is included in this submission.
IX Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.