The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.

For use only on a single patient in a home setting.

Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Device Description

The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:

(1)TD-5010 Lancing Device

(2) Alternative Site Testing (AST) Cap

AI/ML Overview

The provided text describes the submission for a medical device (TD-5010 Lancing Device and TD-5084 Sterile Lancets) for clearance by the FDA, based on substantial equivalence to a predicate device (Accu-Chek Softclix Blood Lancing System). The document focuses on non-clinical performance testing rather than a clinical study involving human patients or an AI algorithm.

Therefore, many of the requested fields regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and statistical measures for an AI/ML-based medical device are not applicable to this submission as it pertains to a mechanical lancing device and sterile lancets. There is no AI or software component described in this submission.

However, I can extract the acceptance criteria and performance data for the mechanical and material properties of the lancing device and lancets as described in the non-clinical testing summary.

Here's the breakdown based on the provided document:

Device: TD-5010 Lancing Device and TD-5084 Sterile Lancets

Study Type: Non-clinical (bench) performance testing for substantial equivalence. This is not a study proving the efficacy of an AI model.

Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing):

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Appearance	Functional Verification	Should meet the same intended use as the predicate device and not impact safety/effectiveness.	All test results met acceptance criteria, demonstrating that the different appearance design of the candidate device (TD-5010 Lancing Device) met the same intended use as the predicate device and did not impact safety and effectiveness.
Biocompatibility	Biocompatibility Tests (TD-5010 Lancing Device)	Housing materials should not affect biocompatibility.	Results demonstrated that the housing materials of TD-5010 Lancing Device would not affect biocompatibility.
Biocompatibility	Biocompatibility Tests (TD-5084 Sterile Lancets)	Materials should not affect biocompatibility.	Results demonstrated that the materials of TD-5084 Sterile Lancets would not affect biocompatibility.
Cleaning & Disinfection	Disinfection Validation Test	Housing materials should not affect the effectiveness of cleaning and disinfection.	Results demonstrated that the housing materials of TD-5010 Lancing Device would not affect the effectiveness of cleaning and disinfection.
Puncture Depth/Needle Length	Mechanical Performance Test	Puncture depths and exposed needle length within specifications. Similar range to predicate device.	Puncture depths and exposed needle length of candidate device met its specifications. The range was similar to the predicate device.
Firmness Force	Firmness Force Test (Aging Tests)	Needle firmly fixed in lancet housing. Within acceptance criteria in accelerated and real-time aging tests.	The firmness force was within acceptance criteria in the accelerated and real-time aging tests. The needle of TD-5084 Sterile Lancets was verified to be firmly fixed in the lancet housing at each time point.
Lancet Loading	Loading Force and Pulling Force Test	Lancets can be effectively and smoothly loaded by end users.	All test results of lancet loading force met the acceptance criteria, demonstrating that the safety and effectiveness of the loading mechanism (loading force and pulling force) of the candidate device was substantially equivalent to the predicate device. Lancets can be effectively and smoothly loaded by end users.
Needle Specification (30G vs 28G)	Percussion and Firmness Force Test	Puncture depths meet specifications. Needle firmly fixed in housing.	Puncture depths of both TD-5084 Sterile Lancets (30G) and predicate device (28G) met specifications. The needle of TD-5084 Sterile Lancets (30G) was firmly fixed in lancet housing at each time point of accelerated and real-time aging tests.
Lancet Cap Removal	Lancet Cap Twist Force and Pulling Force Test	Lancet cap can be easily and safely removed by end user.	All test results met acceptance criteria, demonstrating that the lancet cap of the candidate device can be removed by end user smoothly and safely.
Drop Testing	Drop Testing	Appearance and performance meet intended use after drop forces.	All test results met acceptance criteria, demonstrating that lancing devices installed with lancets met its intended use after undergoing drop forces during operations. Appearance and performance verified after drop forces.
Storage Stability	Storage Stability Test	Safety and effectiveness suitable for use over the claimed shelf life.	Performed to ensure the safety and effectiveness were suitable for use over the shelf life of the device. (Implied: met acceptance criteria, as the conclusion states the device has a substantially equivalent safety and effectiveness profile).
Robustness	Robustness Test (Cleaning/Disinfection)	Device robust against multiple cleaning and disinfection cycles.	Demonstrated that the TD-5010 Lancing Device was robust against cleaning and disinfection procedures after multiple cleaning and disinfection cycles using EPA-registered disinfecting wipes. (Implied: met acceptance criteria, as the conclusion states the device has a substantially equivalent safety and effectiveness profile).

Study Details:

Sample Size used for the test set and the data provenance:
- The document describes bench testing of physical devices and components, not a "test set" in the context of an AI/ML algorithm.
- Specific numbers of devices or lancets tested for each non-clinical test (e.g., how many lancet caps twisted, how many devices dropped) are not explicitly stated. The provenance is implied to be laboratory testing conducted by the manufacturer. It is non-clinical/bench data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical device, not an AI model requiring expert ground truth for image interpretation or diagnosis. Ground truth is based on engineering specifications and physical measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no human interpretation or adjudication process described for the device's mechanical performance.
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. No AI component. No human reader study described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" or reference standards are the engineering specifications, physical measurements, and established testing protocols (e.g., for sterilization, biocompatibility, mechanical forces, and material properties) for lancing devices, often guided by relevant ISO standards (though not explicitly cited for each test, 21 CFR 878.4850 is mentioned).
The sample size for the training set:
- Not applicable. There is no AI component and thus no "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 20, 2023

GOSTAR Co., Ltd. Pei-Fen Yang President 2F, No.65, Wuquan 7nd Rd. New Taipei City, Wugu District 248020 Taiwan

Re: K221419

Trade/Device Name: TD-5010 Lancing Device and TD-5084 Sterile Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: December 12, 2022 Received: December 14, 2022

Dear Pei-Fen 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/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) 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,

Jessica Carr -S

for 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221419

Device Name

TD-5010 Lancing Device and TD-5084 Sterile Lancets

Indications for Use (Describe)

For use only on a single patient in a home setting.

Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K221419

510(k) Summary

In accordance with the requirements of 21 CFR 807.92, this summary is being provided to serve as the basis for the substantial equivalence determination.

1. 510(k) Owner Information

Correspondent	GOSTAR CO., LTD.
Address	2F., No. 65, Wuquan 7th Rd., Wugu Dist., 248020 NewTaipei City, TAIWAN
Correspondent Contact	Pei-Fen Yang, Ph.D.
Title	President
Phone	+886-2-2298-1927
E-mail	ra.cert@gostarmed.com
Date Prepared	May 13, 2022

2. Candidate Device Information

Proprietary Name	TD-5010 Lancing Device and TD-5084 Sterile Lancets
Common Name	Lancing device; Lancets
Classification Product Code	QRL
Subsequent Product Code	QRK
510(k) Number	K221419
Review Panel	General & Plastic Surgery
Classification	2
Regulation Number	21 CFR 878.4850

3. Predicate Device Information

Manufacturer	Roche Diabetes Care, Inc.
Proprietary Name	Accu-Chek Softclix Blood Lancing System
Classification Product Code	QRL
Subsequent Product Code	QRK
510(k) Number	K214022
Review Panel	General & Plastic Surgery
Classification	2
Regulation Number	21 CFR 878.4850

{4}------------------------------------------------

4. Intended Use

The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.

For use only on a single patient in a home setting.

Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

5. Device Description Summary

The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:

(1)TD-5010 Lancing Device

(2) Alternative Site Testing (AST) Cap

6. Comparison to Predicate Device

6.1 Intended Use Comparison
The intended use of the candidate device is the same as the predicate device, including the testing sites and environment of use.

6.2 Technological Comparison

The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets are substantially equivalent to the predicate device in terms of technological characteristics, including their intended use, function and design.

{5}------------------------------------------------

	Predicate Device- K214022	Candidate Device- K221419
Characteristic	Accu-Chek Softclix Blood Lancing	TD-5010 Lancing Device and	Remark
	System	TD-5084 Sterile Lancets
DeviceDescription	• The Accu-Chek Softclix LancingDevice uses compatible Accu-Chek Softclix Lancets to obtain adrop of blood from a fingertip oralternative sites using the Accu-Chek Softclix Alternative SiteTesting (AST) Cap.• The sterile, single-use lancets areto be used with the reusablelancing device that is to becleaned and disinfected betweeneach use, and then the lancets areto be disposed of.• This system is for use onlyon a single patient in a homesetting.• This system is not suitablefor use by healthcareprofessionals with multiplepatients in a healthcaresetting.	• The TD-5010 Lancing Deviceuses compatible TD-5084Sterile Lancets to obtain a dropof blood from a fingertip oralternative sites using theAlternative Site Testing (AST)Cap.• The single-use TD-5084 SterileLancets are to be used with thereusable TD-5010 LancingDevice that is to be cleaned anddisinfected between each use,and then the TD- 5084 SterileLancets are to be disposed of.• For use only on a single patientin a home setting. Not suitablefor use by healthcareprofessionals with multiplepatients in a healthcare setting.	Identical
Intended Use	The Accu-Chek Softclix BloodLancing System is intended for thehygienic collection of capillary bloodfor testing purposes from the side of afingertip and from alternative sites,such as the palm, the upper arm, andthe forearm.The sterile, single-use lancets are tobe used with the reusable lancingdevice that is to be cleaned anddisinfected between each use, andthen the lancets are to be disposed of.This system is for use only on asingle patient in a home setting.This system is not suitable for use byhealthcare professionals withmultiple patients in a healthcaresetting.	The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended toobtain capillary blood for testingpurposes from the side of a fingertipand from alternative sites, such as thepalm, the upper arm, and the forearm.The single-use TD-5084 SterileLancets are to be used with thereusable TD- 5010 Lancing Devicethat is to be cleaned and disinfectedbetween each use, and then the TD-5084 Sterile Lancets are to be disposedof.For use only on a single patient in ahome setting.Not suitable for use by healthcareprofessionals with multiple patients ina healthcare setting.	Identical
Characteristic	Predicate Device- K214022Accu-Chek Softclix Blood LancingSystem	Candidate Device- K221419TD-5010 Lancing Device andTD- 5084 Sterile Lancets	Remark
MechanicalLoading	Spring-driven	Spring-driven	Identical
Lancet Sterility	Gamma irradiation	Gamma irradiation	Identical
Number ofUses	Base (lancing device): multiple useLancet: single use	TD-5010 Lancing Device: multiple useTD-5084 Sterile Lancets: single use	Identical
AnatomicalSites	FingertipBall of the hand (palm)Upper armLower arm (forearm)	FingertipBall of the hand (palm)Upper armLower arm (forearm)	Identical
Sharps InjuryPrevention	Lancets are covered by a sterile barriercap until twisted off before use. Untilfiring, the lancet is contained withinthe lancing device housing.Immediately after firing, the lancet isautomatically retracted back intohousing. An ejector sleeve can then bepulled forward for contactless disposalof the lancet.	The TD-5010 Lancing Device can bereset to operate only after the usedlancet has been ejected whichprevents multiple punctures with aused lancet. Ejection of used lancetsis done by sliding the ejector.	Identical
Type of Use	Over the counter use	Over the counter use	Identical

Table 1. Similarities Between the Predicate and Candidate Device

{6}------------------------------------------------

{7}------------------------------------------------

Characteristic	Predicate Device- K214022Accu-Chek Softclix Blood Lancing System	Candidate Device- K221419TD-5010 Lancing Device andTD- 5084 Sterile Lancets	Remark
Appearance	Image: Accu-Chek Softclix Blood Lancing System and lancet	Image: TD-5010 Lancing Device and AST cap and TD-5084 Sterile Lancets	Difference 1
PunctureDepth andExposedNeedleLength	Not publicly available	Segment Puncture depth (mm) Exposed needle length (mm) Segment 1 (Minimum penetration depth) $0.8 \pm 0.1$ $0.8 \pm 0.1$ Segment 2 $1.0 \pm 0.1$ $1.0 \pm 0.1$ Segment 3 $1.2 \pm 0.1$ $1.2 \pm 0.1$ Segment 4 $1.4 \pm 0.1$ $1.4 \pm 0.1$ Segment 5 $1.6 \pm 0.1$ $1.6 \pm 0.1$ Segment 6 $1.8 \pm 0.1$ $1.8 \pm 0.1$ AST Cap (Maximum penetration depth) $2.4 \pm 0.1$ $2.4 \pm 0.1$		Difference 2
Load	Load by pressing priming button when lancet is inserted	The TD-5084 Sterile Lancets can be loaded into TD-5010 lancing device by (1) installing the lancets into lancet holder of lancing device with enough loading force, or (2) inserting the lancets into lancet holder of lancing device then pulling the pulling cap of the TD-5010 lancing device with enough pulling force.	Difference 3
Needle	28G; beveled cut with 3 facets	30G; beveled cut with 3 facets	Difference 4

Table 2. Differences Between the Predicate and Candidate Device

{8}------------------------------------------------

7. Discussion of Differences

7.1 Difference 1 (Appearance)

The user interfaces of candidate device include selector cap, AST cap, release button, pulling cap and ejector, the purposes of design are similar to predicate device. The mechanical performance test was performed to verify the lancets installation, loading, firing and ejection between candidate device and predicate device. All test results met acceptance criteria, which demonstrated that the different appearance design of candidate device could meet the same intended use as predicate device and didn't impact the safety and effectiveness.

The disinfection validation test and biocompatibility tests were performed to verify the housing materials of TD-5010 Lancing Device. The results demonstrated that the housing materials of TD-5010 Lancing Device would not affect the effectiveness of cleaning and disinfection, and biocompatibility.

The biocompatibility tests were performed to verify the materials of TD- 5084 Sterile Lancets. The results demonstrated that the materials of TD- 5084 Sterile Lancets would not affect the biocompatibility.

7.2 Difference 2 (Puncture Depth, Exposed Needle Length and Firmness Force)

The TD-5010 Lancing Device has 6 levels of puncture depth, which are adjustable by rotating the selector cap and installing the AST cap. The predicate device has 11 levels of puncture depth, which are adjustable by rotating the rotatable cap and AST cap.

The mechanical performance test was performed between candidate device and predicate device to verify the percussion of lancets for each puncture depth. The firmness force test was also performed in the accelerated and real-time aging tests of TD-5084 Sterile Lancets. According to the test results, puncture depths and exposed needle length of candidate device and predicate device both met its specifications, and the firmness force was within acceptance criteria in the accelerated and real-time aging tests. The puncture depth range and exposed needle length range of candidate device were similar to predicate device, and the needle of TD-5084 Sterile Lancets was verified to be firmly fixed in lancet housing at each time point of accelerated and real-time aging tests, which demonstrated that the safety and effectiveness of candidate device were substantially equivalent to predicate device.

7.3 Difference 3 (Load)

The TD-5084 Sterile Lancets can be loaded into TD-5010 Lancing Device by (1) installing the lancets into lancet holder of lancing device with enough loading force, or (2) inserting the lancets into lancet holder of lancing device then pulling the pulling cap of the TD-5010 lancing device with enough pulling force.

For predicate device, the lancets can be loaded into lancing device only by pressing the priming button.

The effectiveness of loading the lancets on lancing device was verified by measuring loading force and pulling force of TD-5010 Lancing Device. For predicate device, effectiveness of lancet loading was verified by measuring the pressing force of priming button.

All test results of lancets loading force on candidate device and predicate device met the acceptance criteria, which demonstrated that the safety and effectiveness of lancets loading (loading force and pulling force) of candidate device was substantially equivalent to predicate device.

7.4 Difference 4 (Needle)

The specification of TD-5084 Sterile Lancets (30G) is different from the lancets of predicate device (28G). In order to confirm the performance between the different lancet specifications, percussion of TD-5084 Sterile Lancets and predicate device was verified by measuring the puncture depth. The firmness force was also verified in the accelerated and real-time aging tests of TD-5084 Sterile Lancets.

{9}------------------------------------------------

All test results met the acceptance criteria, which demonstrated that puncture depths of both the TD-5084 Sterile Lancets (30G) and predicate device (28G) met the specifications, and the needle of TD-5084 Sterile Lancets (30G) was firmly fixed in lancet housing at each time point of accelerated and real-time aging tests. The safety and effectiveness of candidate device were substantially equivalent to predicate device.

8. Non-Clinical Testing Summary and Conclusions

8.1 Mechanical performance test
Mechanical functions were verified between candidate device and predicate device by bench tests.
8.1.1. Lancet Cap Twist Force and Pulling Force Test
To ensure the lancet cap of TD-5084 Sterile Lancets can be easily and safely removed by end user. the study verified the twist force and pulling force of removing the lancet cap between predicate device and candidate device. All test results met acceptance criteria which demonstrated that lancet cap of candidate device can be removed by end user smoothly and safely.
8.1.2. Firmness Force Test
The firmness force was measured by pulling up the needle from the lancet housing of candidate device to verify the needle was firmly fixed in lancet housing at each time point of accelerated and real-time aging tests. All test results met acceptance criteria, which demonstrated that the lancet needle of candidate device was firmly fixed in lancet housing during its claimed shelf life.

8.1.3. Drop testing

The appearance and performance of candidate device were verified after performing drop forces in order to ensure the candidate device met its intended use while conducting drop forces during operations. All test results met acceptance criteria, which demonstrated that lancing devices installed with lancets met its intended use after undergoing drop forces during operations.

8.1.4. Measure Penetration Depth
The different gap dimensions of lancing device will allow the needle on the lancet exposure in different lengths to reach different penetration depths for obtaining blood drops. The penetration depths were verified and compared between candidate device and predicate device. All results met acceptance criteria which demonstrated that the candidate device met its intended use and its claimed specifications.
8.1.5. Loading force and pulling force
The TD-5084 Sterile Lancets can be loaded into TD-5010 Lancing Device by: (1) installing the lancets into lancet holder of lancing device with enough loading force, or (2) pulling the pulling cap of the lancing device with enough pulling force.

This study measured the loading force and pulling force of the candidate device, and the pressing force of priming button for the predicate device.

All results met acceptance criteria, which demonstrated that the lancets can be effectively and smoothly loaded into lancing device by end users.

8.2 Storage stability test
Storage stability test of candidate device was performed to ensure the safety and effectiveness were suitable for use over the shelf life of device.
8.3 Robustness test
Robustness test demonstrated that the TD-5010 Lancing Device was robust against cleaning

{10}------------------------------------------------

and disinfection procedures after multiple cleaning and disinfection cycles using EPAregistered disinfecting wipes.

Nonclinical tests were performed in accordance with 21 CFR 878.4850. Clinical Testing is not applicable. Risks are analyzed to confirm that all identified risks were effectively mitigated. There were no special concerns of safety and effectiveness identified.

9. Conclusions

According to results of nonclinical tests, the TD-5010 Lancing Device and TD-5084 Sterile Lancets have a substantially equivalent safety and effectiveness profile to the predicate device (K214022).

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.