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 describes a 510(k) premarket notification for a medical device called the "Promisemed Heel Blood Lancet." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the information you're requesting regarding acceptance criteria, a study that proves the device meets them, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not explicitly present in this type of FDA submission for a Class I device seeking substantial equivalence.

Instead, the document details bench testing to show the new device performs comparably to the predicate device.

Here's a breakdown of what can be extracted and the limitations:

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

No such table is provided. The acceptance criteria for Class I devices like this are generally based on meeting recognized consensus standards and performance characteristics comparable to predicates, primarily through bench testing.

The document lists performance characteristics tested:

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 (based on ISO 10993)

The "reported device performance" is broadly stated as "the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device" and that "Test results demonstrate that the subject device meets its intended use and performs as well as or better than the legally marketed predicate device." No quantitative results or comparative data are provided in this summary.

2. Sample sizes used for the test set and the data provenance:

Sample Size for Test Set: Not specified. For bench testing, samples are usually a specific number of units, but this detail is not included in the summary.
Data Provenance: The tests were "bench testing performed" internally or by a contracted lab. There is no mention of geographical data provenance (e.g., country of origin) or whether it was retrospective or prospective, as these are typically considerations for clinical data, not bench tests.

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

This concept of "experts establishing ground truth" is not applicable here. Ground truth is typically established in clinical studies (e.g., for diagnostic AI where an expert's diagnosis is the truth). For a mechanical device like a lancet, the "truth" is whether it functions according to its specifications and relevant standards. This is evaluated through engineering and quality control tests, not by expert consensus on clinical findings.

4. Adjudication method for the test set:

Not applicable, as it's not a clinical study involving human interpretation.

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:

Not applicable. This device is a manual surgical instrument (a lancet), not an AI-powered diagnostic tool requiring human-in-the-loop studies.

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

Not applicable, as it's not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for this device would be its adherence to engineering specifications, performance standards, and regulatory requirements (e.g., sterility, precise dimensions, safety features functioning as intended). This is verified through objective measurements and validated test methods (bench testing).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

In summary:

This 510(k) summary focuses on demonstrating that the Promisemed Heel Blood Lancet is substantially equivalent to a predicate device (K130132 BabyLance Heel Incision Device) based on shared technology, intended use, and materials, validated by bench testing for critical performance characteristics and biocompatibility. It does not present clinical trial data or performance metrics in the way one would for a novel diagnostic or AI-powered device.

Summary

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December 3, 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: K193009

Trade/Device Name: Promisemed Heel Blood Lancet Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: FMK Dated: October 15, 2019 Received: October 28, 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) K193009

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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared 1

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

3 Trade Name, Common Name, Classification

Trade Name:

Promisemed Heel Blood Lancet

Common Name:

Infant Heel Lancet

Classification name:

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

Device Class:

Class I

ব Identification of Predicate Device(s)

K130132 BabyLance Heel Incision Device

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5 Description of the Device

6 Intended Use

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

Similarities-

The Promisemed Heel Blood Lancet employs the same technology and use comparable blade and housing materials as the predicate device. Differences-

Though Promisemed Heel Blood Lancet utilizes different materials, they deliver the same safety and performance features. The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

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Performance Testing Summary 8

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: 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

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

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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.

の Conclusion

The Promisemed Heel Blood Lancet has the same intended use, the principle of operation and technical characteristics as the predicate device. Test results demonstrate that the subject device meets its intended use and performs as well as or better than the legally marketed predicate device. It is for these reasons that the subject device 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.