The safety lancet is single use medical device, which is designed to collect capillary blood sample. The intended users include Healthcare personnel, patients and lay persons. According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference. For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. 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° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

AI/ML Overview

The provided text describes the 510(k) summary for a Safety Lancet device, specifically K220370. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and simulated clinical use. It is a regulatory submission for a medical device rather than a report detailing a clinical trial or an AI/software as a medical device (SaMD) study. Therefore, many of the requested details, such as the use of AI, human reader studies, and sophisticated ground truth establishment, are not applicable to this type of device submission.

However, I can extract the relevant information from the provided text regarding acceptance criteria and the studies performed for this specific medical device.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

Here's a table summarizing the acceptance criteria and reported device performance based on the "Non-Clinical Testing" section:

Items	Acceptance criteria	Reported Device Performance
Appearance	The surface shall be free of burr and no scratches.	Meet the requirement
Dimension	Product dimensions shall be consistent to the drawings.	Meet the requirement
Cleanness	No dust, no grease, no hair, no dirt.	Meet the requirement
Firmness	Needle should connect firmly with plastic handle.	Meet the requirement
Resistance to corrosion	Corrosion resistance of needle of lancet shall show no evidence of corrosion.	Meet the requirement
Acidity or Alkalinity	The pH value of an extract prepared refers to ISO 9626 Annex A shall be within one pH unit of that of the control fluid.	Meet the requirement
Limits for Extractable Metals	When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l.	Meet the requirement
Puncture depth	Use calipers to measure and meet the requirements.	Meet the requirement
Launch performance	Launch performance should be good, launch button press smoothly, no jam.	Meet the requirement
Puncture force	The needle tip of the needle should have good puncture ability.	Meet the requirement
Lubricant	Visual, should not be visible droplets.	Meet the requirement
Disposable	Safety lancet should be single use, no second launch after used.	Meet the requirement
Safety Feature	The force to activate the safety feature: 4 - 15N. Test access to the sharp: the needle shall not touch the sphere.	Meet the requirement

Summary of Device Performance Study Information:

The provided document describes physical and biological tests for a medical device (Safety Lancet), not an AI/Software as a Medical Device (SaMD). Therefore, many of the questions related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI models are not applicable.

Here's the information that is extractable from the provided text:

Sample size used for the test set and data provenance:
- Simulated Clinical Use: 500 device samples were used for the simulated clinical use study.
- Non-Clinical Testing: The sample sizes for the individual bench tests (e.g., appearance, dimension, firmness) are not explicitly stated, but it's implied that sufficient samples were tested to "Meet the requirement."
- Data Provenance: Not specified in terms of country of origin. The studies are described as "bench testing" and "simulated clinical use," implying lab-based testing rather than clinical patient data. The document is a 510(k) submission to the FDA, from a company in Tianjin, China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device's testing. Ground truth for physical characteristics (e.g., dimensions, corrosion) is established by measurement against predefined specifications, not by expert consensus in this specific case.
- For biocompatibility testing, compliance with ISO 10993 series standards is the "ground truth," evaluated by laboratory tests performed by qualified personnel, but not "experts" in the sense of radiologists.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study requiring adjudication of interpretations (e.g., imaging reads). The tests are objective measurements or categorical observations (e.g., "no burr," "no corrosion").
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. This is a physical medical device (Safety Lancet), not an AI/software. Therefore, no MRMC study with human readers was conducted or is applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The testing described is for the physical performance and safety features of the lancet itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Non-Clinical Testing (bench tests): The ground truth is based on engineering specifications, industry standards (e.g., ISO 9626 Annex A for pH, specific limits for extractable metals), and established physical or visual inspection criteria (e.g., "free of burr," "no dust," "no evidence of corrosion").
- For Biocompatibility Testing: Ground truth is established by adherence to and passing results from tests specified in ISO 10993 series standards (e.g., "No Cytotoxicity," "No Skin Sensitization").
- For Simulated Clinical Use: The ground truth is whether the device "met the pre-established criteria" for its safety mechanism, evaluated according to FDA Guidance and ISO 23908.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As noted above, there is no AI training set for this device.

Summary

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May 19, 2022

Tianjin Huahong Technology Co., Ltd. % Ms. Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555. Jingan District Shanghai, 200072 China

Re: K220370

Trade/Device Name: Safety Lancet (8 Models: XIII, XVII, XXII, XXIII, XXIV, XXV, XXVI) Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class II Product Code: FMK Dated: April 18, 2022 Received: April 18, 2022

Dear Ms. Situ:

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): 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 (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) K220370

Device Name Safety Lancet (8 models: XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXV, XXVI)

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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510(k) summary-K220370

l Submitter

Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China

Establishment Registration Number: 3009498536

Primary Contact person

Ms. Ying Yuan Quality Manager Tel.: +86-15302127671 E-mail: ying.yuan@hh-technology.com

Submission Correspondent

Ms. Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Tel.: +86-13636633633 E-mail: stuart.situ@landlink-healthcare.com

Preparation date: Jan 28, 2022

II Proposed Device

Trade Name of Device:	Safety Lancet (8 models: XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
Common name:	Single Use Only Blood Lancet With An Integral Sharps InjuryPrevention Feature
Regulation Number:	21 CFR 878.4850
Regulatory Class:	Class II
Product code:	FMK
Review Panel	General & Plastic Surgery

III Predicate Devices

510(k) Number: K192666

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Trade name:	VeriFine Safety Lancet
Classification:	Class I
Product Code:	FMK
Manufacturer	Promisemed Hangzhou Meditech Co., Ltd.

IV Device description

The safety lancet is single use medical device, which is designed to collect capillary blood sample.

The intended users include Healthcare personnel, patients and lay persons.

According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference.

For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. 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° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

V Indication for use

The safety lancet is intended for capillary blood sampling.

VI Comparison of technological characteristics with the predicate devices

The comparison and discussion between the subject device and the predicate devices are listed in below table 1:

Item	Proposed device	Predicate device(K192666)	Discussion
Product name	Safety Lancet	VeriFine Safety Lancet	Same
Product Code	FMK	FMK	Same

Table 1 General Comparison of Safety Lancet

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RegulationNo.	21 CFR § 878.4850	21 CFR § 878.4800	Similar¹
Class	II	I	Similar¹
Prescription/over-the-counter use	Over-The-Counter Use	Over-The-Counter Use	Same
Indication foruse	The safety lancet is intendedfor capillary blood sampling.	It is intended for capillaryblood sampling.	Same
Safetyprotectionfeatures	Yes	Yes	Same
Reusedurability	Single use	Single use	Same
Sterilizationmethod andSAL	Sterilized by RadiationSAL=10-6	Sterilized by RadiationSAL=10-6	Same
Self-life	5 years	5 years	Same
Materials ofparts incontact withhuman body	Needle core ( containneedle ) : PE,PP, Calciumpowder(main ingredient:calcium carbonate),stainless steel (needle) ,silicone oil (needle);Housing, Button, Bottom,Protective cap, Small lid,Depth adjuster ring: ABS,PS	Needle: stainless steelOther parts: plasticsmaterials	Similar2
Biocompatibility	Conforms to therequirements of ISO 10993series standards.	Conforms to therequirements of ISO 10993series standards.	Same
Label/Labeling	Complied with 21 CFR part801	Complied with 21 CFR part801	Same

1 The classification and Regulation number are different because FDA issued the

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final order about Reclassification of Blood Lancets on 11/22/2021.

² The raw materials of proposed devices may be different from the predicate devices. However, all the materials are known biocompatible materials that have been used in lancets or other similar medical devices.

VII Non-Clinical 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	Acceptance criteria	Results
Appearance	The surface shall be free of burr and no scratches.	Meet the requirement
Dimension	Product dimensions shall be consistent to the drawings	Meet the requirement
Cleanness	No dust, no grease, no hair, no dirt	Meet the requirement
Firmness	Needle should connect firmly with plastic handle:	Meet the requirement
Resistance to corrosion	Corrosion resistance of needle of lancet shall show no evidence of corrosion.	Meet the requirement
Acidity or Alkalinity	The pH value of an extract prepared refers to ISO 9626 Annex A shall be within one pH unit of that of the control fluid.	Meet the requirement
Limits for Extractable Metals	When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l.	Meet the requirement
Puncture depth	Use calipers to measure and meet the requirements.	Meet the requirement
Launch performance	Launch performance should be good, launch button press smoothly, no jam	Meet the requirement
Puncture force	The needle tip of the needle should have good puncture ability.	Meet the requirement
Lubricant	Visual, should not be visible droplets.	Meet the requirement

Disposable	Safety lancet should be single use, no second launch after used.	Meet the requirement
Safety Feature	The force to activate the safety feature : 4 - 15N	Meet the requirement
	Test access to the sharp: the needle shall not touch the sphere.

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Biocompatibility Testing:

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	ISO 10993-11: 2017	No Acute SystemicToxicity
Pyrogenicity	ISO 10993-11: 2017	no thermogenic reaction

Simulated Clinical Use

A simulated clinical use study was performed on 500 device samples each for the Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

VIII Clinical Testing

No clinical study is included in this submission.

IX Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated K220370

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device. Accordingly, the proposed device is substantially equivalent to the 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.