Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, nonmechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.

VeriFine Safety lancet and VeriFine Mini-Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are 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.

Both single-use Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini--Safety Lancet offers different gauge (needle diameter) options, to allow to choose the lancet which meets blood volume needs.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding Promisemed Hangzhou Meditech Co., Ltd.'s blood lancet devices. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report like those typically found in clinical efficacy studies for AI/software devices.

Therefore, the information requested in your prompt related to AI/software device performance metrics (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) will not be present.

However, I can extract the information relevant to the device performance verification tests that were conducted to establish substantial equivalence.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria values (e.g., minimum tensile strength, maximum penetration force) or quantitative reported device performance results. Instead, it lists the types of performance tests conducted and states that the results "verifies that the performance of the subject devices are substantially equivalent" and "met their intended use and performs as well as or better than the legally marketed predicate device."

Acceptance Criteria Category (Test Performed)	Reported Device Performance Summary (Qualitative)
Visual Inspection	"substantially equivalent"
Needle Dimensions	"substantially equivalent"
Chemical properties	"substantially equivalent"
Bond between lancet body and needle	"substantially equivalent"
Resistance to corrosion of the needle	"substantially equivalent"
Lancing device compatibility test (Promisemed Blood Lancet only)	"substantially equivalent"
Locking function *	"substantially equivalent"
Spring elasticity *	"substantially equivalent"
Percussive function *	"substantially equivalent"
Penetrate force *	"substantially equivalent"
Biocompatibility (ISO 10993-1, -5, -10)	"comparable to the predicate and support a determination of substantial equivalence"

*These tests (Locking function, Spring elasticity, Percussive function, Penetrate force) were performed for VeriFine Safety Lancet and VeriFine Mini-Safety Lancet only.

The study that "proves the device meets the acceptance criteria" is the series of bench tests summarized in Section 8 of the 510(k) Summary.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for each of the bench tests (e.g., how many lancets were subjected to bond strength testing or corrosion resistance). It also does not explicitly state the provenance of data for these tests (e.g., whether the test materials were from a specific country of origin or if the tests were retrospective or prospective). Given these are bench tests on physical devices, the "data" would represent measurements taken from the manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the type of device and testing described. The "ground truth" for a physical medical device in bench testing is typically defined by engineering specifications, material standards, and performance characteristics (e.g., a specific bond strength in Newtons, a certain needle diameter in millimeters). Experts involved would be qualified engineers and technicians performing the tests and comparing results against established standards. However, the document does not detail their numbers or qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not applicable here. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., images) by multiple human readers to establish a consensus ground truth. The tests described are objective, measurable physical and chemical properties of the device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretative devices, which these blood lancets are not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests conducted on these blood lancets would be based on engineering specifications, recognized international standards (e.g., ISO for biocompatibility), and performance characteristics of the predicate device. For example, "Needle Dimensions" would be compared against specified tolerances, and "Resistance to corrosion" against a defined standard. Biocompatibility was assessed against ISO standards.

8. The sample size for the training set

This information is not applicable. There is no AI algorithm being trained for this device.

9. How the ground truth for the training set was established

This information is not applicable. There is no AI algorithm being trained for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

December 2, 2019

Promisemed Hangzhou Meditech Co., Ltd. % Wei-Shan Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, China

Re: K192666

Trade/Device Name: Promisemed Blood Lancet, VeriFine Safety Lancet. VeriFine Mini-Safety Lancet Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: FMK Dated: November 15, 2019 Received: November 15, 2019

Dear Wei-Shan Hsu:

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.

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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 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 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.

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

510(k) Number (if known) K192666

Device Name Promisemed Blood Lancet VeriFine Safety Lancet VeriFine Mini-Safety Lancet

Indications for Use (Describe) It 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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510(k) Summary

1 Date Prepared

Nov 27, 2019

2 Submitter's Information

Submission Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

No. 12, Longtan Road, Cangqian Street, Yuhang District,

Hangzhou City,311121 Zhejiang, China

Contact: Zearou Yang

Telephone No.: +86 571 88772985

Fax No.:+86 571 88772985

Email: zearou.yang@promisemed.ca

Submission Correspondent:

Vee Care (Asia) Limited

17F Chung Pont Commercial Building, 300 Hennessy Road,

Hong Kong, China

Contact: Wei-Shan Hsu

E-mail: ws@vee.com.hk

ന Trade Name, Common Name, Classification

Trade/Product Name:

Promisemed Blood Lancet

VeriFine Safety Lancet

VeriFine Mini-Safety Lancet

Common Name:

Blood Lancet

Classification name:

Lancet, Blood (21 CFR 878.4800, Product code FMK)

Device Class:

Class I

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ldentification of Predicate Device(s) ব

K113513 PLANCET blood lancet

K101145 SurgiLance® Safety Lancet

Description of the Device 5

Intended Use 6
It is intended for capillary blood sampling.
Similarities and Differences of the Proposed Devices to 7 the Predicate Devices

Promisemed Blood Lancet

Manufacturing aspects:

For the Promisemed Blood Lancet, stainless steel needle is fed into an injection molding machine to over-mold plastic material (polyethylene)

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forming a body and cap, encapsulating the stainless steel needles. Terminal sterilization process is performed to ensure sterility of an entire product.

The manufacturing process of the predicate device, K113513 PLANCET blood lancet, comprises injection molding of plastic needle and plastic overmolding using polyethylene (exactly the same process as involved in Promisemed Blood Lancet). The plastic needle instead of stainless steel needle is used in PLANCET blood lancet.

Design and Functionality aspects:

The Promisemed Blood Lancet comprises a stainless steel needle encapsulated with a plastic body and cap, the cap is twisted off to expose the needle for use. The predicate device, K113513 PLANCET blood lancet, has the exact same design and functionality as compared with Blood Lance and Safety Lancet. The difference will be instead of twisting off the cap to expose the needle, the predicate device requires the end user to pull off the cap.

Material aspects:

The Promisemed Blood Lancet has a needle that is made of stainless steel and a body and a cap that are made of polyethylene (PE). The stainless steel material is bio-compatible. Both the needle and the body/cap of the predicate device, K113513 PLANCET blood lancet, are made of polyethylene (PE).

VeriFine Safety Lancet and VeriFine Mini-Safety Lancet

Design and Functionality aspects:

Both VeriFine Safety Lancet/VeriFine Mini-Safety Lancet and its predicate device, SurgiLance® Safety Lancet, are spring-loaded lancet and have the same basic technology characteristics for a lancet with sharps injury prevention. They are intended for piercing the skin and the indications for use are the same.

Material aspects:

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The materials are comparable in that the needles all use medical grade stainless steel and the rest part are made of plastics materials. VeriFine Safety Lancet/VeriFine Mini-Safety Lance utilizes some of the same materials, specifically the use of medical grade stainless steel for the lancet needles, but may use different types or grades of plastics for the Shield, hub, caps, and triggers. All the materials are known biocompatible materials that have been used in lancets or other similar medical devices.

Performance Testing Summary 8

The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

Visual Inspection
Needle Dimensions
Chemical properties
Bond between lancet body and needle
Resistance to corrosion of the needle
Lancing device compatibility test (Promisemed Blood Lancet only)
Locking function
Spring elasticity*
· Percussive function*
Penetrate force*
- (* VeriFine Safety Lancet and VeriFine Mini-Safety Lancet only)
Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization

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The testing performed verifies that the performance of the subject devices is substantially equivalent in terms of critical performance characteristics to the predicate device.

Cytotoxicity, Sensitization, Irritation, were performed to demonstrate biocompatibility of the patient contacting materials. Overall, the results are comparable to the predicate and support a determination of substantial equivalence.

Conclusion の

Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet has the same intended use and technological characteristics as the predicate. Test results demonstrate that the subject devices meet their intended use and performs as well as or better than the legally marketed predicate device. It is for these reasons that the subject devices can be found substantially equivalent.

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.