The safety lancet consists of needle core, protective cap, plug, trigger, spring, outer case and end cap. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10^-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. The safety lancet is intended for capillary blood sampling. The device was designed to minimize the risk from accidental needle sticks with a used needle by application of a sharp injury prevention feature. The needle tip back into the safety lancet body automatically after launch and cannot be reused. The safety lancet can be disposed safely.

AI/ML Overview

This document is a 510(k) summary for a "Safety Lancet" (K223208). It aims to demonstrate substantial equivalence to a predicate device (Tianjin Huahong Safety Lancet – K220370).

Here's an analysis of the acceptance criteria and study information provided and what's missing, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might expect for a diagnostic or AI device. Instead, it discusses various performance tests and compliance with standards. The "acceptance criteria" are implied by the standards and internal requirements, and "reported device performance" is summarized as meeting these requirements.

Here's a best effort to extract and present this information based on the provided text, recognizing that specific numerical results or direct comparisons to predicate device values (beyond "same" or "similar") are often not included in 510(k) summaries unless there's a significant difference to justify.

Acceptance Criterion (Implied Standard/Requirement)	Reported Device Performance (Summary)
Physical Performance:
Cap removal force	Meets internal requirements of 3-9 N (for easy user removal).
Needle removal force/Firmness (ISO 7864:2016)	Meets ISO 7864:2016 requirements (ensuring needle firmness).
Drop testing (IEC 60068-2-32:1993)	Meets IEC 60068-2-32:1993 requirements (needle not exposed after drop).
Puncture force (ISO 7864:2016)	Meets ISO 7864:2016 requirements (force as low as possible for skin puncture).
Safety Feature testing (ISO 23908:2011, FDA Guidance Aug 9, 2005)	Verified against requirements (ensures safe use, force to activate = 8.8N).
Needle Tubing (ISO 9626:2016)	Complies with ISO 9626:2016.
Sterility & Shelf-life:
Sterilization (ISO 11737-1/2, ISO 11137-1/2/3)	SAL = 10⁻⁶ (sterilized by gamma radiation), meets standards.
Packaging (ISO 11607-1:2019)	Complies with ISO 11607-1:2019.
Accelerated Aging (ASTM F1980)	Complies, supports 5-year shelf life.
Shipping/Performance Testing (ASTM D4169-16)	Complies with ASTM D4169-16.
Sterility Test (USP <71>)	Complies with USP <71>.
Biocompatibility:
Biological evaluation (ISO 10993-1, 10993-5, 10993-10, 10993-11)	No cytotoxicity, no irritation, no skin sensitization, no acute systemic toxicity, no thermogenic reaction. Meets standards.
Bacterial Endotoxins (USP <85>)	Complies with USP <85>.
Particulate matter (USP <788>)	Complies with USP <788>.
Pyrogen tests (USP <161>)	Complies with USP <161>.
Functional/Safety Features:
Sharps injury prevention function	Verified (needle back into body automatically, cannot be reused).
Exposed needle length/penetration depth	Range 1.2-2.4 mm, within range of predicate (1.0-3.0 mm).
Simulated Clinical Use:
Safety and effectiveness in simulated conditions	Demonstrated.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The document refers to "non-clinical testing results" primarily for physical performance, sterility, shelf-life, and biocompatibility. Additionally, a "simulated clinical use study" was conducted.
Sample Size for Simulated Clinical Use Study: 500 device samples.
Data Provenance for Simulated Clinical Use Study: Not explicitly stated, but it's a "simulated clinical use study," implying it wasn't conducted on actual patients. The company is based in China, so it's likely conducted there. It is a prospective study in the sense that the testing was performed on new samples according to a protocol.
Other Testing Sample Sizes: For other physical, sterility, and biocompatibility tests, specific sample sizes are not provided in this summary, but implied by adherence to the referenced ISO and ASTM standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a medical device like a safety lancet, "ground truth" (as typically thought of in AI/diagnostic studies) isn't directly applicable in the same way. The "truth" is established by adherence to engineering standards and safety requirements (e.g., "is the needle exposed after drop test?"). The "experts" would be the engineers, quality control personnel, and lab technicians conducting the tests and interpreting results against the objective standards. Their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (physical, sterility, biocompatibility), results are typically objective measurements against a standard, rather than subjective interpretations requiring adjudication.

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 device is a mechanical safety lancet and does not involve AI or "human readers" in the context of interpretation of diagnostic images or data.

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 device is a mechanical safety lancet and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Adherence to recognized international and national standards: ISO standards (e.g., for needle tubing, sterility, biocompatibility), ASTM standards (e.g., for packaging), and USP standards (e.g., for sterility, endotoxins).
Manufacturer's internal requirements: For specific features like cap removal force (3-9 N).
FDA Guidance Documents: Particularly for sharps injury prevention features.
Objective measurements and observations: Such as force measurements, visual inspections after drop tests, biological test results (e.g., "no cytotoxicity").

Essentially, the ground truth is defined by the fulfillment of these established safety and performance benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device 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 information is not applicable and therefore not provided. As above, there is no "training set" for a physical medical device.

Summary

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February 10, 2023

Suzhou Zhenwu Medical Co., Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai. 201114 China

Re: K223208

Trade/Device Name: Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: January 19, 2023 Received: January 19, 2023

Dear Evan Hu:

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.

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

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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,

Jessica Carr -S

for Long Chen, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K223208

Device Name Safety Lancet

Indications for Use (Describe)

The safety lancet is intended for capillary blood sampling.

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

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

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K223208 510(K) SUMMARY

1. Preparation date: 1/27/2023

2. Submitter

Manufacturer: Suzhou Zhenwu Medical Co., Ltd. Address: No.248, Chijiawan Road, Beishe Town, Fenhu Development Area, Wujiang District, Suzhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Contact person: Kai Xu, General Manager, Tel: +86051263230688, zhenwu999xk@163.com Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net

3. Device

Trading name: Safety Lancet Common name: Safety Lancet Classification Name: Single Use Only Blood Lancet With an Integral Sharps Injury Prevention Feature Classification: Class II Product code: FMK

4. Predicate device

Predicate device: Tianjin Huahong Safety Lancet– K220370

5. Device description

The safety lancet is intended for capillary blood sampling. The device was designed to minimize the risk from accidental needle sticks with a used needle by application of a sharp injury prevention feature. The needle tip back into the safety lancet body automatically after launch and cannot be reused. The safety lancet can be disposed safely.

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Image /page/4/Picture/0 description: The image shows a diagram of a device being assembled in four steps. In the first step, a rectangular piece is being placed on top of a cylindrical device. In the second step, the rectangular piece is being pushed down into the cylindrical device. In the third step, a small object is being inserted into the rectangular piece. In the fourth step, the device is fully assembled.

Figure 1. Schematic diagram of the working principle

No.	Gauge	Needle Diameter(mm)		Exposed Needle Length(mm)		Color
		ODMIN	ODMAX	Length	Tolerance
1	30G	0.298	0.320	1.2	$\pm$ 0.3	peacock blue
2	30G	0.298	0.320	1.6	$\pm$ 0.3	peacock blue
3	30G	0.298	0.320	1.8	$\pm$ 0.3	peacock blue
4	28G	0.349	0.370	1.8	$\pm$ 0.3	purple
5	26G	0.440	0.470	1.8	$\pm$ 0.3	yellow
6	23G	0.600	0.673	1.8	$\pm$ 0.3	Orange
7	23G	0.600	0.673	2.2	$\pm$ 0.3	Orange
8	23G	0.600	0.673	2.4	$\pm$ 0.3	Orange
9	21G	0.800	0.830	1.8	$\pm$ 0.3	Blue
10	21G	0.800	0.830	2.0	$\pm$ 0.3	Blue
11	21G	0.800	0.830	2.2	$\pm$ 0.3	Blue
12	21G	0.800	0.830	2.4	$\pm$ 0.3	Blue
13	21G Blade	0.800	0.830	2.0	$\pm$ 0.3	Bottle green
14	21G Blade	0.800	0.830	2.2	$\pm$ 0.3	Bottle green
15	21G Blade	0.800	0.830	2.4	$\pm$ 0.3	Bottle green
16	18G	1.200	1.300	2.0	$\pm$ 0.3	Rose
17	18G	1.200	1.300	2.2	$\pm$ 0.3	Rose
18	18G	1.200	1.300	2.4	$\pm$ 0.3	Rose
19	18G Blade	1.200	1.300	2.0	$\pm$ 0.3	Light green
20	18G Blade	1.200	1.300	2.2	$\pm$ 0.3	Light green
21	18G Blade	1.200	1.300	2.4	$\pm$ 0.3	Light green

Table 1. Device models

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6. Indications for use/Intended use

The safety lancet is intended for capillary blood sampling.

7. Comparison of technological characters between proposed and predicate devices

Characters	Proposed device(K223208-Safety Lancet)	Predicate device(K220370-Safety Lancet)	Remark
Product code	FMK	FMK	Same
Regulation No.	21 CFR 878.4850	21 CFR 878.4850	Same
Classification	Class II	Class II	Same
Indications for use	The safety lancet is intendedfor capillary blood sampling.	The safety lancet is intendedfor capillary blood sampling.	Same
Intendedpopulation	Adults and pediatrics. If useris under the age of 18, thesafety lancet must be used byan adult or under thesupervision of an adult.	Adults and pediatrics.	Same
Type of use	over-the-counter	over-the-counter	Same
Configuration andmaterials	Needle core: PENeedle: SUS304Outer case, End case, Tigger:ABSPlug: TPESpring: SWC	Needle core: PE, PP, CalciumpowderNeedle: stainless steel,silicone oilHousing, Button, Bottom,Protective cap, Small lid,Depth adjuster ring: ABS,PS	Similar#1
Needle Gauge	Normal: 30G, 28G, 26G, 23G,21G, 18GBlade: 21G, 18G	Normal: 30G, 28G, 26G,23G, 21G	Similar#2
Sterilization andSAL	Sterilized by gammaradiationSAL = $10^{-6}$	Sterilized by gammaradiationSAL = $10^{-6}$	Same
Single-use	Single use on one patient, nomore than one use	Single use on one patient,no more than one use	Same
Sharp injuryprotectionfunction	The puncture function canbe only used after the capwas pulled off	The puncture function canbe only used after the capwas twisted off	Similar#3

Safety feature	Lancet retracts into body of device after activation.The force to activate the safety feature: round 8.8NTest access to the sharp: the needle shall not touch the sphere.	Lancet retracts into body of device after activation.The force to activate the safety feature: 4-15NTest access to the sharp: the needle shall not touch the sphere.	Same
Exposed needlelength/penetrationdepth (max)	1.2~2.4 mm30G: 1.2, 1.6, 1.8 mm28G: 1.8 mm26G: 1.8 mm23G: 1.8, 2.2, 2.4 mm21G: 1.8, 2.0, 2.2, 2.4 mm21G(Blade): 2.0, 2.2, 2.4 mm18G: 2.0, 2.2, 2.4 mm18G(Blade): 2.0, 2.2, 2.4 mm	1.0~3.0 mm30G: 1.0, 1.6 mm28G: 1.8 mm26G: 1.8 mm23G: 1.8 mm21G: 2.2, 2.8, 3.0mm	Similar#4
Cap removal	Pull offForce: 3~9N	Twist offForce: Not revealed	Different#5
Shelf-life	5 years	5 years	Same
Biocompatibility	No cytotoxicityNo irritationNo skin sensitizationNo acute systemic toxicityNo pyrogens	No cytotoxicityNo irritationNo skin sensitizationNo acute systemic toxicityNo thermogenic reaction	Same

Table 2. Characters comparison

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Similar #1

The safety lancet typically comprises three components, housing, needle, and spring. The component of the housing is mainly plastic. The component of the needle is stainless steel, and the spring consists of steel. Although the proposed and predicate devices use different materials, the types of components are unchanged. Besides, the performance testing reports, and biocompatibility testing reports show all the testing items meet requirements. This difference on materials has a minimal impact on the performance of the products.