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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Safety Lancet (Model XXXV).

The document is a 510(k) summary for a medical device called "Safety Lancet (Model XXXV)" submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a predicate device already legally marketed in the US. This type of submission generally relies on non-clinical testing rather than extensive clinical trials for devices like lancets.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Launch Performance	Should be good; launch button press smooth, no jam. Met the requirement.
Puncture Force	Needle tip should have good puncture ability. Met the requirement.
Lubricant	Visual, should not be visible droplets. Met the requirement.
Disposable	Single use, no second launch after use. Met the requirement.
Safety Feature	Force to activate the safety feature: 4 - 15N. Test access to the sharp: the needle shall not touch the sphere. Met the requirement.
Biocompatibility	Conforms to ISO 10993 series standards. Specifically: - In Vitro Cytotoxicity: No Cytotoxicity (ISO 10993-5: 2009) - Skin Sensitization: No Skin sensitization (ISO 10993-10: 2010) - Intracutaneous Reactivity: No irritation (ISO 10993-10: 2010) - Acute Systemic Toxicity: No Acute Systemic Toxicity (ISO 10993-11: 2017) - Pyrogenicity: No thermogenic reaction (ISO 10993-11: 2017)
Sterilization Method & SAL	Sterilized by Radiation, SAL = 10^-6. Same as predicate.
Shelf-life	5 years. Same as predicate.
Reuse Durability	Single use. Same as predicate.
Label/Labeling	Complied with 21 CFR part 801. Same as predicate.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: The document does not specify a separate "test set" sample size for the core performance criteria (launch, puncture force, lubricant, disposable, safety feature) beyond indicating that these tests were performed and met requirements.
- Biocompatibility Testing: Not specified for individual tests.
- Simulated Clinical Use Study: 300 device samples were used.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from a Chinese manufacturer (Tianjin Huahong Technology Co., Ltd.) to the US FDA, the testing was likely conducted in accordance with international standards to satisfy US regulatory requirements.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided. For device performance testing of this nature (bench tests for physical characteristics and biocompatibility), "experts" in the sense of clinical decision-makers establishing ground truth for disease states are typically not involved. The "ground truth" is established by predefined engineering specifications, regulatory standards (e.g., ISO, FDA guidance), and objective measurements.
Adjudication Method for the Test Set:
- Not applicable as the testing involves objective measurements against pre-defined engineering and regulatory standards rather than subjective human interpretation requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-assisted diagnostic devices where human readers provide interpretations. This device is a simple mechanical blood sampling device.
Standalone (Algorithm Only) Performance:
- Not applicable. This device is a mechanical medical device, not an algorithm or AI product.
Type of Ground Truth Used:
- Bench Testing: Engineering specifications, objective measurements, and compliance with general safety and performance requirements (e.g., smooth operation, proper safety mechanism function).
- Biocompatibility Testing: Results of standardized in-vitro and in-vivo tests according to ISO 10993 series standards, demonstrating absence of cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity.
- Simulated Clinical Use: Pre-established criteria defined by FDA Guidance and ISO 23908 for evaluating the safety mechanism of sharps injury prevention features.
Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.

Summary

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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).

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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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241627

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.

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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 InjuryPrevention 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.

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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/over-the-counter use	Over-The-Counter Use	Over-The-Counter Use	Same
Indication foruse	The safety lancet is intendedfor capillary blood sampling.	The safety lancet is intendedfor capillary blood sampling.	Same
Safetyprotectionfeatures	Yes	Yes	Same

Table 1 General Comparison of Safety Lancet

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510(k) Summary

Reuse durability	Single use	Single use	Same
Sterilizationmethod andSAL	Sterilized by RadiationSAL=10-6	Sterilized by RadiationSAL=10-6	Same
Self-life	5 years	5 years	Same
Materials ofparts in contactwith humanbody	Needle core (containneedle): PE, PP, Calciumpowder, stainless steel(needle), silicone oil(needle);Housing, Button: ABS, PS,PP and Calcium powder	Needle core (containneedle): PE, PP, Calciumpowder, stainless steel(needle), silicone oil (needle);Housing, Button, Bottom,Small lid, Depth adjuster ring,Protective cap: ABS, PS	Similar1
Biocompatibility	Conforms to therequirements of ISO 10993series standards.	Conforms to the requirementsof ISO 10993 seriesstandards.	Same
Label/Labeling	Complied with 21 CFR part801	Complied with 21 CFR part801	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.

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510(k) Summary

Launch performance	Launch performance should begood,launch button presssmoothly, no jam	Meet therequirement
Puncture force	The needle tip of the needle shouldhave good puncture ability.	Meet therequirement
Lubricant	Visual, should not be visibledroplets.	Meet therequirement
Disposable	Safety lancet should be single use,no second launch after used.	Meet therequirement
Safety Feature	The force to activate the safetyfeature : 4 - 15NTest access to the sharp: theneedle shall not touch the sphere.	Meet therequirement

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 SystemicToxicity
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.

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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.

Regulation Number and Section

§ 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.