Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

Device Description

Heel Incision Safety 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. Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals. Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (Heel Incision Safety Lancet) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study proving a device meets acceptance criteria for an AI/ML-based medical device.

Therefore, many of the requested details regarding acceptance criteria, AI/ML study design, sample sizes, expert involvement, and ground truth establishment (especially for AI/ML models) are not applicable and not present in this document. This document describes a traditional medical device (a lancet) and its non-clinical performance testing.

However, I can extract the closest analogous information available from the document regarding acceptance criteria and performance for this non-AI/ML device:

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

The document provides a "Summary of non-clinical testing" with "Items" (which can be interpreted as the performance characteristics for which acceptance was sought) and "Results" (the performance shown). While explicit "acceptance criteria" values (e.g., "must be > X N Force") are not always stated, the "Results" implicitly demonstrate acceptance where they state "No failures observed", "Meet the requirement", or "Compared with equivalent devices, there was no statistical difference."

Items (Performance Characteristic)	Stated Results (Performance/Acceptance)	Implied Acceptance Criteria (Based on Results)
Material of blade	F type stainless steel materials	Blade material is F type stainless steel.
Appearance	The surface has no burr and scratch	Absence of burr and scratch on the surface.
Dimensions of product (Height)	The height of product(mm): 32±1.5	Height within 32±1.5 mm.
Dimensions of product (Width)	The width of product(mm): 35±1.5	Width within 35±1.5 mm.
Blade corrosion resistance	No blemishes	No blemishes due to corrosion.
Force to activate Safety Screw button	Compared with equivalent devices, there was no statistical difference	Performance of safety screw button activation force is statistically similar to equivalent devices.
Trigger force	Compared with equivalent devices, there was no statistical difference	Performance of trigger force is statistically similar to equivalent devices.
Safety overriding and unlocking force after activation	Compared with equivalent devices, there was no statistical difference	Performance of safety overriding and unlocking force is statistically similar to equivalent devices.
Sterility	Sterile	Device is sterile.
Limits acidity and alkalinity	Meet the requirement	Acidity and alkalinity limits are met.
Total heavy metal	Meet the requirement	Total heavy metal requirements are met.
Incision depth and length	All models have been tested within tolerances	Incision depth and length for all models are within specified tolerances.
Safety self-locking	There were no failures observed in a test run of 500 devices	No failures in safety self-locking in 500 tests.
Safety plug pullout	There were no failures observed in a test run of 500 devices	No failures in safety plug pullout in 500 tests.
Shooting performance	There were no failures observed in a test run of 500 devices	No failures in shooting performance in 500 tests.
Accidental access to sharp once in safe mode	There were no failures observed in a test run of 500 devices	No accidental access to sharp in safe mode in 500 tests.

Biocompatibility Testing:

Item (Biocompatibility Test)	Test Results (Performance/Acceptance)	Implied Acceptance Criteria (Based on Results)
In Vitro Cytotoxicity	No Cytotoxicity	Absence of cytotoxicity.
Skin Sensitization	No Skin sensitization	Absence of skin sensitization.
Intracutaneous reactivity	No irritation	Absence of irritation.
Acute Systemic Toxicity Test	No Acute Systemic Toxicity	Absence of acute systemic toxicity.
Material mediated pyrogenicity	Absence of pyrogens	Absence of pyrogens.
In vitro Hemolytic	No Hemolytic	Absence of hemolytic properties.

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

Test Set Sample Sizes: For key functional tests like "Safety self-locking," "Safety plug pullout," "Shooting performance," and "Accidental access to sharp once in safe mode," a test run of 500 devices was used, with "no failures observed." For other physical property and material tests, specific sample sizes are not explicitly stated, but are implied to be sufficient for meeting the standard/requirement (e.g., "All models have been tested within tolerances").
Data Provenance: The tests are "bench testing" and "biocompatibility evaluations" conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., based in Suzhou, Jiangsu, P.R.China. The data is prospective, generated specifically for this 510(k) submission.

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

This is not applicable as this is not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance is established by direct measurement of physical properties (e.g., dimensions, forces) and standard laboratory tests (e.g., material analysis, sterility, biocompatibility).

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML ground truth establishment where human readers might disagree. For bench testing of a physical device, results are typically objective measurements or pass/fail outcomes against defined specifications.

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

This is not applicable as this is a physical medical device, not an AI/ML-based diagnostic or assistive technology. No MRMC study was performed.

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

This is not applicable as this is a physical medical device, not an AI/ML algorithm.

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

As explained, for this physical device, the "ground truth" for performance is established by:

Direct physical measurements (e.g., dimensions, force values).
Standardized analytical tests (e.g., material composition, sterility).
Biocompatibility tests according to ISO standards.
Pass/fail criteria based on safety and functional requirements.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

Summary

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August 26, 2021

SteriLance Medical (Suzhou) Inc. % Joyce Yang, Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K210745

Trade/Device Name: Heel Incision Safety Lancet Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: FMK Dated: July 8, 2021 Received: July 26, 2021

Dear Joyce Yang:

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/cfpm/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 and Part 809); medical device reporting (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 (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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210745

Device Name Heel Incision Safety Lancet

Indications for Use (Describe)

Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 201 Subpart D)
☐ Over-The-Counter Use (21 CFR Part 330)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

510(k) Number: K210745

Date of Summary prepare: August 11, 2021

1. Submission Sponsor

Applicant Name	SteriLance Medical(Suzhou) Inc.
Address	No.168 PuTuoShan Road, NewDistrict,215153 Suzhou, Jiangsu, P.R.China
Contact person	Yuan Jie
Phone	+86-512-65799308

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	1713A, 17th Floor, Block A, ZhongguanTimes Square, Nanshan District, Shenzhen
Post Code	518000
Phone No.	+86-755-86069197
Contact Person	Joyce Yang
Email	joyce@cefda.com

3. Device Identification

Type of 510(k) submission:	Traditional
Trade Name:	Heel Incision Safety Lancet
Common name:	Lancet, Blood
Regulation name:	Manual Surgical Instrument for General Use
Review Panel:	General & Plastic Surgery
Product Code:	FMK
Device Class:	I
Regulation Number:	21 CFR 878.4800

4. Legally Marketed Predicate Device

Trade Name	Promisemed Heel Blood Lancet
Regulation number	21 CFR 878.4800
Regulation class	I
Regulation name	Manual Surgical Instrument for General Use
510(k) Number	K193009
Product Code	FMK
Manufacturer	Promisemed Hangzhou Meditech Co., Ltd.

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Device Description 5.

Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals.

Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.

6. Intended Use/ Indications for Use

Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

Comparisonitem	Subject Device: Heel IncisionSafety Lancet	Predicate Device: PromisemedHeel Blood Lancet (K193009)
ProductCode	FMK	FMK
RegulationNumber	21 CFR § 878.4800	21 CFR § 878.4800
Classification	Class I	Class I
Type of use	Prescription Use	Prescription Use
Intendeduse &Indications for Use	Heel Incision Safety Lancet isintended for the collection of capillaryblood from the heel of newborn,preemie, and toddler. The lancet hasequipped with safety protectionfeatures.	It is intended for collection of capillaryblood from the heel of newborn andpremature babies. The lancet hasequipped with safety protectionfeatures.
Applicableuser	Newborn, preemie,and toddler	Newborn, preemie
Safetyprotectionfeatures	Yes	Yes
Reusedurability	Single use	Single use
Sterilizationmethod andSAL	Sterilized by RadiationSAL=10-6	Sterilized by ethylene oxideSAL=10-6

7. Technological characteristics comparison

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Comparisonitem	Subject Device: Heel IncisionSafety Lancet	Predicate Device: PromisemedHeel Blood Lancet (K193009)
Self life	5 Years	5 Years
Incisionlength anddepth	DepthLength:0.651.40mm,0.851.75mm,1.002.50mm,1.142.80mm,2.003.00mm	DepthLength:0.651.50mm,0.851.75mm,1.002.50mm,1.50*3.00mm
Component	1. Triggering button2. Safety button/Screw button3. Spring4. Cam5. Lancet core6. Shell7. Blade8. Swing arm	1. Top upper cover2. Bottom cover3. Button4. Safety plug5. Slider6. Rod7. Holder8. Spring9. blade
Materials ofparts incontact withhuman body	Blade: 304 stainless steelShell: ABSTriggering button: ABSSafety button: ABS	Blade: 304 stainless steelShell: ABSTriggering button: ABSSafety button: ABS

The subject device and the predicate device have the same intended use, similar technology characteristics, and similar ingredients. The differences will not cause safety and effectiveness problems for proposed device, and does not affect the equality.

8. Summary of non-clinical testing

*Performance 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.

Items	Results
Material of blade	F type stainless steel materials
Appearance	The surface has no burr and scratch
Dimensions of product	The height of product(mm): 32±1.5The width of product(mm): :35±1.5
Blade corrosion resistance	No blemishes
Force to activate Safety Screw button	Compared with equivalent devices, there was

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Items	Results
Trigger force	Compared with equivalent devices, there wasno statistical difference
Safety overriding and unlocking forceafter activation	Compared with equivalent devices, there wasno statistical difference
Sterility	Sterile
Limits acidity and alkalinity	Meet the requirement
Total heavy metal	Meet the requirement
Incision depth and length	All models have been tested within tolerances
Safety self-locking	There were no failures observed in a test runof 500 devices
Safety plug pullout	There were no failures observed in a test runof 500 devices
Shooting performance	There were no failures observed in a test runof 500 devices
Accidental access to sharp once insafe mode	There were no failures observed in a test runof 500 devices

*Biocompatibility

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:

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 Test	ISO 10993-11: 2017	No Acute Systemic Toxicity
Material mediated	USP<151>	Absence of pyrogens

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K210745

pyrogenicity
In vitro Hemolytic	ASTM F756-17	No Hemolytic

9. Brief discussion of clinical tests

No clinical tests were performed.

10. Conclusions

The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Heel Incision Safety Lancets are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K193009.

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.