It is intended for collection of capillary blood from the heel of newborn and premature babies. The lancet has equipped with safety protection features.

Device Description

Promisemed Heel Blood Lancet is comprised of top upper cover, bottom cover, button, safety plug, slider, rod,holder, spring, blade.The spring provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired when the spring is under pressure. The safety plug is to protect the blade from triggering before use. Promisemed Heel Blood Lancet is single use, sterile, medical devices designed to be used in collecting the blood sample. Heel Blood Lancet is intended to be used by professionals. They are offered in various lengths (0.65mm, 0.85mm, 1.50mm). The heel blood lancets are sterile (EO sterilization) and non-toxic. The product is intended for prescription (Rx) only.

AI/ML Overview

The provided text is a 510(k) summary for the Promisemed Heel Blood Lancet. This document primarily focuses on establishing substantial equivalence to a predicate device based on common intended use, technological characteristics, and performance testing. It does not describe an acceptance criteria table filled with specific performance metrics and reported device performance values for a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

The document discusses performance testing (bench testing) to verify that the subject device's performance is substantially equivalent to the predicate device in terms of critical performance characteristics. However, it lists these tests as general categories (e.g., "Material of blade," "Appearance," "Dimensions of product," "Cutting width and depth," "Safety self-locking," "Shooting performance," "Sterility," "Biocompatibility," etc.) rather than specific quantitative acceptance criteria with corresponding numerical results.

Therefore, I cannot directly extract the requested information regarding:

A table of acceptance criteria and the reported device performance: The document only lists the types of tests performed, not specific quantitative criteria or results.
Sample sizes used for the test set and the data provenance: Not mentioned. The testing described is bench testing, not a clinical study with a "test set" in the sense of patient data.
Number of experts used to establish the ground truth... and their qualifications: Not applicable. This device is a mechanical lancet, not an AI or image-based diagnostic tool requiring expert ground truth establishment for a test set.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a physical medical device, not an AI system.
Standalone (i.e., algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth for this device's performance is likely based on engineering specifications and physical properties.
The sample size for the training set: Not applicable. This is a manufactured device; there's no "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the regulatory clearance process for a physical medical device (a blood lancet) based on substantial equivalence to a predicate device, focusing on material, design, and general performance characteristics, rather than a clinical study of an AI-driven or diagnostic device.

Summary

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June 8, 2022

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

Re: K221371

Trade/Device Name: Promisemed Heel Blood Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: April 29, 2022 Received: May 12, 2022

Dear Wei 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/cdrl/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 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 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) K221371

Device Name Promisemed Heel Blood Lancet

Indications for Use (Describe)

It is intended for collection of capillary blood from the heel of newborn and premature babies. The lancet has equipped with safety protection features.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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

Date Prepared 1

June 8, 2022

Submitter's Information 2

Submission Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, 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

Trade Name, Common Name, Classification ന

Trade Name: Promisemed Heel Blood Lancet

Common Name: Infant Heel Lancet

Classification name:

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Regulation Number: 21 CFR 878.4850

Device Class: Class II

Product Code: FMK

Identification of Predicate Device(s) ব

K19009 Promisemed Heel Blood Lancet

Description of the Device 5

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Promisemed Heel Blood Lancet is single use, sterile, medical devices designed to be used in collecting the blood sample. Heel Blood Lancet is intended to be used by professionals. They are offered in various lengths (0.65mm, 0.85mm, 1.50mm). The heel blood lancets are sterile (EO sterilization) and non-toxic. The product is intended for prescription (Rx) only.

Intended Use 6

It is intended for the collection of capillary blood from the heel of newborn and premature babies. The lancet has equipped with safety protection features.

7 Similarities and Differences of the Proposed Devices to the Predicate Devices

Promisemed Heel Blood Lancet is substantially equivalent to the predicate device, K193009, in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same. The differences between the subject device and predicate device do not affect the intended use or raise new questions of safety and effectiveness.

	Subject Device	Predicate Device (K193009)	Similarities andDifferences
Manufacturer	Promisemed HangzhouMeditech Co., Ltd	Promisemed HangzhouMeditech Co., Ltd
Trade Name	Promisemed Heel BloodLancet	Promisemed Heel BloodLancet
Device Class	Class II	Class I	Different¹
Product Code	FMK	FMK	Same
Regulationnumber	878.8450	878.4800	Different¹
Common Name	Infant Heel Lancet	Infant Heel Lancet	Same
IntendedUse/Indicationsfor Use	It is intended forcollection of capillaryblood from the heel ofnewborn and prematurebabies. The lancet has	It is intended for collectionof capillary blood from theheel of newborn andpremature babies. Thelancet has equipped with	Same
	equipped with safety protection features.	safety protection features.
Direction for use	1 Pull out the safety plug2.Place the device on the puncture site and press the button to start3. Discard the device into a sharps container4. Using your index finger and thumb, press lightly near the puncture site to obtain an adequate blood sample	1 Pull out the safety plug2.Place the device on the puncture site and press the button to start3. Discard the device into a sharps container4. Using your index finger and thumb, press lightly near the puncture site to obtain an adequate blood sample	Same
Incision Depth/	0.65mm/1.4mm0.85mm/1.7mm	0.65mm/1.4mm0.85mm/1.7mm	Same
Incision Length	1.00mm/2.5mm1.50mm/3.0mm	1.00mm/2.5mm1.50mm/3.0mm
Biocompatibility	Biocompatibility established	Biocompatibility established	Same
Design	1.A locking mechanism to prevent accidental activation of the device.2.A housing that conceals the blade before and after the device is used.3.An internal spring that automatically retracts the blade after use.4. A stop feature that disables the device after a single use.	1.A locking mechanism to prevent accidental activation of the device.2.A housing that conceals the blade before and after the device is used.3.An internal spring that automatically retracts the blade after use.4. A stop feature that disables the device after a single use.	Same
Material	Blade: Stainless steel (X6Cr13)Hull (cover): Acrylonitrile butadiene styrene (ABS)Safety plug: Polycarbonate (PC)Button: Paraformaldehyde(POM)Slider and Rod: Polycarbonate (PC)Holder: Acrylonitrile butadiene styrene (ABS)	Blade: Stainless steel (X6Cr13)Hull (cover): Acrylonitrile butadiene styrene (ABS)Safety plug: Polycarbonate (PC)Button: Paraformaldehyde(POM)Slider and Rod: Polycarbonate (PC)Holder: Acrylonitrile butadiene styrene (ABS)	Same
Single use	Yes	Yes	Same
Sterilization	EO Sterilization	EO Sterilization	Same
Labeling	Labeling requirementlisted in blood lancetreclassification finalorder (86 FR 66180) suchas hand washinginstruction and warningstatement aresupplemented.	No include hand washinginstruction and warningstatement listed in bloodlancet reclassification finalorder (86 FR 66180).	DifferentThe differencedoes not affecttheeffectivenessand safety ofthe device.

A detailed comparison to the predicate is provided in Table 1.

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8 Performance Testing Summary

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

Material of blade
· Appearance
Dimensions of product
Blade corrosion resistance
Bond between blade and shank
Cutting width and depth
Safety self-locking
Safety plug pullout
Shooting performance
· Sterility
Limits acidity and alkalinity
Total heavy Metal
Accidental access to sharp once in safe mode
· Safety mechanism activation
Safety overriding and unlocking force after activation
· Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1:

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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

Sterility and Shelf-Life

-ISO 11135:2014, Sterilization of health-care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
-Sterile Barrier Packaging Testing performed on the proposed device:
- Visual Inspection ASTM F1886/F1886M
- Seal strength ASTM F88/F88-15
- · Dye penetration ASTM F1929-15
Shelf life of 5 years is validated using ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Conclusion の

The Promisemed Heel Blood Lancet has the same intended use, the principle of operation and technical characteristics as the predicate device. The labeling changes made to subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed 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.