(14 days)
Not Found
No
The summary describes a mechanical safety lancet for blood sampling and does not mention any AI or ML components or functionalities.
No
The device is used for collecting capillary blood samples, which is a diagnostic procedure, not a therapeutic intervention to treat a disease or condition.
No
The device, a safety lancet, is used for capillary blood sampling, not for diagnosing. It collects a sample that might then be used in diagnostic procedures, but the lancet itself does not perform the diagnosis.
No
The device description explicitly states it consists of physical components (needle core, button, housing, spring) and is a single-use medical device for capillary blood sampling, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for capillary blood sampling." This describes a device used to collect a sample, not to analyze it or perform a diagnostic test on it.
- Device Description: The description focuses on the physical mechanism of the lancet for obtaining blood. It doesn't mention any components or functions related to analyzing the blood sample.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of test, measurement, or analysis on the blood sample itself. IVD devices are designed to be used in vitro (outside the body) to examine specimens for diagnostic purposes.
The safety lancet is a tool for obtaining a biological sample, which might then be used in an IVD test, but the lancet itself is not the diagnostic device.
N/A
Intended Use / Indications for Use
The safety lancet is intended for capillary blood sampling.
Product codes
FMK
Device Description
The safety lancet is single use medical device, which is designed to collect capillary blood sample.
Model XXXV, the safety lancets consist of needle core, button, housing and spring.
The sterile part of the safety lancet is the needle tip.
The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only.
The shelf-life of the product is 5 years.
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
Healthcare personnel, patients and lay persons.
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
Bench testing was performed to verify the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device:
- Launch performance: Should be good, launch button press smoothly, no jam. Met the requirement.
- Puncture force: The needle tip of the needle should have good puncture ability. Met the requirement.
- Lubricant: Visual, should not be visible droplets. Met the requirement.
- Disposable: Safety lancet should be single use, no second launch after used. Met the requirement.
- Safety Feature: The force to activate the safety feature: 4 - 15N. Test access to the sharp: the needle shall not touch the sphere. Met the 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".
- 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.
A simulated clinical use study was performed on 300 device samples for the Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908. The results demonstrated that the proposed device met the pre-established criteria. No clinical study is included in this submission.
Key Metrics
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 & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
June 20, 2024
Tianjin Huahong Technology Co., Ltd. Ningning Wang, Registered Engineer A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park) Tianiin, 300308 China
Re: K241627
Trade/Device Name: Safety Lancet (Model XXXV) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: June 6, 2024 Received: June 6, 2024
Dear Ningning Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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.
Long H. Chen -> Digitally signed by Long H.Chen-S
Long H. Chen -> Digitally signed by 12:01:35 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
safety lancet (XXXV)
Indications for Use (Describe)
The 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) summary
I Submitter
Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China
Establishment Registration Number: 3009498536
Contact person: Ms. Ningning Wang Registered Engineer Tel.: +86-13021381776 E-mail: ningning.wang@hh-technology.com
Preparation date: June 6, 2024
II Proposed Device
| Trade Name of Device: | Safety Lancet (XXXV) |
|---|---|
| Common name: | Single Use Only Blood Lancet With An Integral Sharps Injury |
| Prevention Feature | |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product code: | FMK |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) | K220370 |
|---|---|
| Number: | |
| Trade name: | Safety Lancet |
Classification: Class II Product Code: FMK
Manufacturer Tianjin Huahong Technology Co., Ltd.
4
IV Device description
The safety lancet is single use medical device, which is designed to collect capillary blood sample.
The intended users include Healthcare personnel, patients and lay persons.
Model XXXV, the safety lancets consist of needle core, button, housing and spring.
The sterile part of the safety lancet is the needle tip.
The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only.
The shelf-life of the product is 5 years.
V Indication for use
The safety lancet is intended forcapillary blood sampling.
VI Comparison of technological characteristics with the predicate devices
The comparison and discussion between the subject device and the predicate device are listed in below table 1:
| Item | Proposed device | Predicate device
(K220370) | Discussion |
|---------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|------------|
| Product name | Safety Lancet | Safety Lancet | Same |
| Product Code | FMK | FMK | Same |
| Regulation No. | 21 CFR § 878.4850 | 21 CFR § 878.4850 | Same |
| Class | II | II | Same |
| Prescription/ove
r-the-counter use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Indication for
use | The safety lancet is intended
for capillary blood sampling. | The safety lancet is intended
for capillary blood sampling. | Same |
| Safety
protection
features | Yes | Yes | Same |
Table 1 General Comparison of Safety Lancet
5
510(k) Summary
| 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 (contain | ||
| needle): PE, PP, Calcium | |||
| powder, stainless steel | |||
| (needle), silicone oil | |||
| (needle); |
Housing, Button: ABS, PS,
PP and Calcium powder | Needle core (contain
needle): PE, PP, Calcium
powder, stainless steel
(needle), silicone oil (needle);
Housing, Button, Bottom,
Small lid, Depth adjuster ring,
Protective cap: ABS, PS | Similar1 |
| Biocompatibility | Conforms to the
requirements of ISO 10993
series standards. | Conforms to the requirements
of ISO 10993 series
standards. | Same |
| Label/Labeling | Complied with 21 CFR part
801 | Complied with 21 CFR part
801 | Same |
1 The raw materials of proposed devices may be different from the predicate devices. However, all the materials are known biocompatible materials that have been used in lancets or other similar medical devices.
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.
6
510(k) Summary
| Launch performance | Launch performance should begood,
launch button press
smoothly, no jam | Meet the
requirement |
|--------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Puncture force | The needle tip of the needle should
have good puncture ability. | Meet the
requirement |
| Lubricant | Visual, should not be visible
droplets. | Meet the
requirement |
| Disposable | Safety lancet should be single use,
no second launch after used. | Meet the
requirement |
| Safety Feature | The force to activate the safety
feature : 4 - 15N
Test access to the sharp: the
needle shall not touch the sphere. | Meet the
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:
The formulation, processing, sterilization, geometry in the previously approved safety lancet products (K220370) are the same, and the nature and duration of contact with the patient are also the same.
| 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 |
Simulated Clinical Use
A simulated clinical use study was performed on 300 device samples each for the Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
7
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 safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.