The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Device Description

The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.

AI/ML Overview

This document is a 510(k) Premarket Notification from Trividia Health for their TRUEdraw Lancing Device and Mini Lancing Device. It seeks to demonstrate substantial equivalence to a legally marketed predicate device, the Accu-Chek Softclix Blood Lancing Device (K214022).

The core of the submission revolves around non-clinical bench testing, as clinical testing was deemed not applicable for this device type. Thus, there is no discussion of human-in-the-loop performance, expert ground truth adjudication, or multi-reader multi-case studies typically associated with AI/ML device evaluations.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily based on special controls outlined in 21 CFR 878.4850(c), which focus on design verification and validation testing. The reported performance indicates that the devices passed these tests.

Acceptance Criteria Category	Specific Acceptance Criteria (from 21 CFR 878.4850(c) / Implied)	Reported Device Performance
Mechanical Performance	Materials and mechanical characteristics are suitable for intended use.	Pass for both TRUEdraw and Mini Lancing Device.
	Operation of the lancing device is as intended.	Pass for both TRUEdraw and Mini Lancing Device.
	Device withstands product life and shock conditions.	Pass for both TRUEdraw and Mini Lancing Device.
	Cosmetic attributes are acceptable.	Pass for both TRUEdraw and Mini Lancing Device.
Lancet Compatibility	Critical dimensions (lancet body diameter, exposed needle length, body length) allow for compatibility with commonly available general use lancets.	Pass.
	Proper fit with commonly available general use lancets.	Pass.
Blade Change Mechanism	Lancet blade can be manually changed with every use.	(Implied by overall "Operation of the lancing device" pass)
Structure and Materials	Structure and materials address the risk of sharp object injuries.	(Implied by overall "Materials and mechanical characteristics" pass)
	Structure and materials address the risk of bloodborne pathogen transmission.	(Implied by overall "Materials and mechanical characteristics" pass)
Cleaning and Disinfection Validation	Device maintains functionality and integrity after repeated cleaning and disinfection cycles.	Pass (1,095 cycles using Super Sani-Cloth Wipes, demonstrating 3-year daily use capability for both devices).

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

Given that this is a mechanical safety and performance evaluation of a lancing device, the "test set" refers to the units of the device that underwent the listed mechanical and cleaning/disinfection tests.

Sample Size: The document does not specify an exact number of devices tested for each category (e.g., how many TRUEdraw devices for mechanical performance, how many Mini Lancing Devices for cleaning validation). It generally states "Nonclinical bench testing was performed." For cleaning and disinfection validation, it specifies "1,095 cleaning and disinfecting cycles," implying multiple devices or a single device undergoing repeated cycles to simulate 3 years of daily use.
Data Provenance: The data is generated from bench testing conducted by the manufacturer, Trividia Health. The country of origin for the testing is not explicitly stated, but the company is based in Fort Lauderdale, Florida, United States. The testing is prospective in the sense that it was conducted specifically for this submission.

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

N/A. This is a submission for a mechanical device, not an AI/ML device relying on expert interpretation of medical images. Ground truth is established through engineering and manufacturing specifications, and verification through standard bench testing protocols, rather than expert consensus on retrospective data.

4. Adjudication Method for the Test Set

N/A. As this is not an AI/ML device or a diagnostic device requiring human interpretive ground truth, there is no adjudication method in the context of expert review. Performance is measured against predefined engineering and safety specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A. An MRMC study is not relevant for this type of device (a lancing device). The submission focuses on the mechanical and safety equivalence to a predicate device, not on assessing human reader performance with or without AI assistance.

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

N/A. This is a mechanical lancing device, not an algorithm. There is no software or AI component to evaluate in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this lancing device is based on engineering specifications, design requirements, and established safety and performance standards for lancing devices (e.g., the ability to function mechanically, withstand typical usage, be cleaned effectively, and pose no undue risk of injury or infection). This is verified through objective bench testing.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

N/A. As there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

10/18/2022

Trividia Health Jacqueline Davis Global Regulatory Affairs Specialist IV 2400 N.W. 55th Court Fort Lauderdale, Florida 33309

Re: K221072

Trade/Device Name: TRUEdraw Lancing Device, Mini Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: September 20, 2022 Received: September 21, 2022

Dear Jacqueline Davis:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K221072

Device Name

TRUEdraw Lancing Device; Mini Lancing Device

Indications for Use (Describe)

The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygjenic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is 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)

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K221072 - TRUEdraw Lancing Device; Mini Lancing Device 510(k) Summary

Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Trividia Health
Applicant Address	2400 N.W. 55th CourtFt. Lauderdale, FL 33309 United States
Applicant Contact Telephone	(800) 342-7226
Applicant Contact	Ms. Jacqueline Davis
Applicant Contact Email	jdavis@trividiahealth.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	TRUEdraw Lancing Device; Mini Lancing Device
Common Name	Lancing device
Classification Name	Multiple Use Blood Lancet For Single Patient Use Only
Regulation Number	878.4850(c)
Product Code	QRL
Legally Marketed Predicate Device	21 CFR 807.92(a)(3)
Predicate #	K214022
Predicate Trade Name	Accu-Chek Softclix Blood Lancing Device
Product Code	ORL

Device Description Summary

Intended Use/Indications for Use

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Indications for Use Comparison 21 CFR 807.92(a)(5)

The indications for use of the subject devices are the same as the predicate with the exception that the subject devices are indicated for the forearm as an alternative site and the alternative sites for the predicate devices include the palm, upper arm, and forearm.

Technological Comparison 21 CFR 807.92(a)(6)

The subject devices have the same technological characteristics as the predicate device in terms of design and general type of materials used, principle of operation, usage, features, and function.

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	Subject Devices	Predicate Device
	TRUEdraw Lancing Device;Mini Lancing Device	Accu-Chek Softclix Lancing Device(cleared as part of the Accu-ChekSoftclix BloodLancing System under K214022)
Description	The TRUEdraw/ Mini LancingDevice is a reusable lancet basethat uses compatible single-use,sterile lancets to obtain a drop ofblood from a fingertip oralternative site (forearm) using theclear end cap.	The Accu-Chek Softclix LancingDevice uses compatible Accu-ChekSoftclix Lancets to obtain a drop ofblood from a fingertip oralternative sites using the Accu-ChekSoftclix Alternative Site Testing(AST) Cap.
Intended Use/ Indicationsfor Use	For use with a disposable sterilelancet for the hygienic collectionof capillary blood for testingpurposes from the side of afingertip and from the forearm.For use only on a single patientin a home setting.Not suitable for use byhealthcare professionals withmultiple patients in a healthcaresetting.	For the hygienic collection ofcapillary blood for testing purposesfrom the side of a fingertip and fromalternative sites, such as the palm,the upper arm, and the forearm.For use only on a single patient in ahome setting.Not suitable for use by healthcareprofessionals with multiple patients ina healthcare setting.
Prescription/over-the-counter use	Over-the-counter	Over-the-counter
Where Device Used	Home	Home
Number of uses	Multiple uses by a single patient	Lancing device: multiple uses by asingle patient
Anatomicalsites	FingertipForearm	FingertipBall of the hand (palm)Upper armLower arm (forearm)
Principle of operation	Mechanical, spring-driven	Mechanical, spring-driven
Materials	Plastics (body, internalcomponents), metal (internalsprings)	Plastics (body, internal components),metal (internal springs)
Depthadjustment	5 levels by twisting nozzle/endcap (finer adjustments can bemade by setting the indicatorarrow between the numbers)	11 levels by twisting cap
Load andfiring	Load lancet by pulling back onthe lance body when the lancet isinserted. Fire by pressing thetrigger button.	Load lancet by pressing primingbutton when lancet is inserted. Fireby pressing the release button.
Lancet retracted after use	Yes	Yes

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Alternative site cap	Yes
	Yes

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Nonclinical bench testing was performed per the special controls in 21 CFR 878.4850(c). This included design verification & validation testing to ensure that the lancet blade can be manually changed with every use, that the structure and materials are consistent with the intended use and address the risk of sharp object injuries and blood borne pathogen transmission, and mechanical performance testing to demonstrate that the device will withstand the forces encountered during use.

Description	Tests Performed	Results
Mechanical performanceverification for TRUEdrawlancing device	- Materials and mechanicalcharacteristics- Operation of the lancing device- Product life and shock conditions- Cosmetic attributes	- Pass- Pass- Pass- Pass- Pass
Mechanical performanceverification for mini lancingdevice	- Materials and mechanicalcharacteristics- Operation of the lancing device- Product life and shock conditions- Cosmetic attributes	- Pass- Pass- Pass- Pass- Pass
Compatibility with commonlyavailable general use lancets	- Critical dimensions (lancet bodydiameter, exposed needle length,body length)- Fit	- Pass- Pass
Cleaning and disinfectionvalidation - TRUEdraw lancingdevice and alternate site cap	1,095 cleaning and disinfecting cycles usingSuper Sani-Cloth Wipes.	Pass. The TRUEdraw lancingdevice and alternate site capmay be cleaned and disinfectedwith Super Sani-Cloth Wipesonce-daily for 3-years.
Cleaning and disinfectionvalidation - mini lancingdevice and alternate site cap	1,095 cleaning and disinfecting cycles usingSuper Sani-Cloth Wipes.	Pass. The mini lancing deviceand alternate site cap may becleaned and disinfected withSuper Sani-Cloth Wipes once-daily for 3-years.

Clinical testing is not applicable.

Conclusion

The results of nonclinical testing demonstrate that the subject devices are as safe, as effective, and perform as well as or better than the predicate device identified above.

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.