The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.

Device Description

The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet. The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.

AI/ML Overview

The provided documentation describes the One Drop Lancing Device, which is intended for collecting capillary blood from the fingertip for testing purposes in a home setting. The document confirms that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document explicitly states that "Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied." It also mentions "mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the device continued to meet the specified requirements."

While the document indicates that these criteria were met, it does not provide a specific table detailing the acceptance criteria values and the device's measured performance against each. It only lists the types of tests conducted.

Acceptance Criteria Category	Reported Device Performance
Mechanical Design Verification and Validation	Ensured risks were appropriately managed and specified requirements were met.
Dimensional Measurements	Performed (specific results not provided).
Function Reliability Drop Test	Performed (specific results not provided).
Piercing Depth Test	Performed (specific results not provided).
Cock Force Test	Performed (specific results not provided).
Biocompatibility (ISO 10993-1)	Evaluated through a battery of tests to meet requirements. (specific results not provided).
Compatibility with One Drop branded Lancets	Tested and confirmed as compatible (references K221383).
Special Controls (21 CFR 878.4850)	Satisfied.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for the non-clinical bench tests. It also does not provide information on data provenance (e.g., country of origin of the data, retrospective or prospective) as the testing described is non-clinical bench testing, not clinical human studies.

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

Since the testing described is non-clinical bench testing of a mechanical device, the concept of "experts used to establish the ground truth" in the context of clinical interpretation (like radiologists for imaging) is not applicable. The "ground truth" would be the engineering specifications and regulatory requirements, and the tests were performed by engineers/technicians in a lab setting.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical bench testing against engineering specifications, not a clinical study requiring adjudicated interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to the One Drop Lancing Device. This device is a mechanical lancing device, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

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

This is not applicable to the One Drop Lancing Device, as it is a mechanical device without an algorithm.

7. The type of ground truth used:

The ground truth for the non-clinical testing of the One Drop Lancing Device can be inferred as:

Engineering specifications and design requirements: For dimensional measurements, function reliability, piercing depth, and cock force.
International standards (ISO 10993-1): For biocompatibility.
Regulatory Special Controls (21 CFR 878.4850): For overall regulatory compliance.

8. The sample size for the training set:

Not applicable, as there is no "training set" for a mechanical lancing device; it does not involve machine learning or AI.

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

Not applicable, as there is no "training set."

Summary of the Study:

The study was a series of non-clinical bench tests conducted to evaluate the mechanical performance, safety, and compatibility of the One Drop Lancing Device. These tests aimed to ensure the device met predetermined engineering specifications, international standards (ISO 10993-1 for biocompatibility), and regulatory special controls (21 CFR 878.4850). The tests included:

Dimensional measurements
Function reliability drop test
Piercing depth test
Cock force test
Biocompatibility testing
Compatibility with One Drop branded Lancets (by reference to K221383)

The document concludes that "The intended use, technology, non-clinical testing, and functionality of the One Drop Lancing Device demonstrate a substantially equivalent safety and effectiveness profile to the predicate device."

Summary

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February 15, 2023

STAT Medical Devices % Mr. Kevin Walls, MBA Principal Consultant FDA Compliance Group 33 Golden Eagle Lane Littleton. Colorado 80127

Re: K223815

Trade/Device Name: ONE DROP Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: QRL,QRK Dated: December 20, 2022 Received: December 20, 2022

Dear Mr. Walls:

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

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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

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Indications for Use

510(k) Number (if known)

K223815

Device Name

ONE DROP Lancing Device

Indications for Use (Describe)

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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One Drop Lancing Device 510(k) Summary

Name and Address of Sponsor

STAT Medical Devices 2056 N.E. 153rd Street North Miami Beach, FL 33162 Hemel Mariano (Quality Manager) 305-945-0011 Ext. 312 hmariano@statdevices.com

Establishment Registration Number: 1058955

Document Date: 02/01/2023

Name and Address of Official Correspondent

FDA Compliance Group 33 Golden Eagle Lane Littleton, Colorado 80127 Contact: Mr. Kevin Walls, MBA Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com

Device Information

Trade Name: One DropLancing Device Common Name: Blood Lancets & Lancing Devices Classification Name: Blood lancets Requlation Number: 878.4850, Class II Product Code: QRL, QRK

Device Description

The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet

The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites.

The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level

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by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed.

The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.

Indications for Use

Legally Marketed Predicate Device

Predicate #: K214022

Predicate Trade Name: Accu-Chek Softclix Blood Lancing System

Product Code: QRL, QRK

Similarities and Differences between Candidate Device and Predicate Device:

	Predicate Device - Accu-Chek SoftclixBlood Lancing System K214022	Candidate Device – One DropLancing Device
DeviceDescription	Accu-Chek Softclix Blood LancingDevice uses Accu-Chek SoftclixLancets to obtain a drop of blood froma fingertip or alternate sites using theAccu-Chek Softclix Alternate SiteTesting (AST) Cap.	One Drop Lancing Device uses theOne Drop branded Lancets to obtaina drop of blood from a fingertip.
IntendedUse	Accu-Chek Softclix Blood LancingDevice System is intended for thehygienic collection of capillary blood fortesting purposed from the side of afinger and from alternate site, such asthe palm, the upper arm, and theforearm.	One Drop Lancing Device is intendedfor the hygienic collection of capillaryblood for testing purposed from theside of a finger.

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Indicationsfor Use	The Accu-Chek Softclix Blood LancingSystem is intended for the hygieniccollection of capillary blood for testingpurposes from the side of a fingertipand from alternative sites, such as thepalm, the upper arm, and the forearm.The sterile, single-use lancets are to beused with the reusable lancing devicethat is to be cleaned and disinfectedbetween each use, and then thelancets are to be disposed of.This system is for use only on a singlepatient in a home setting.This system is not suitable for use byhealthcare professionals with multiplepatients in a healthcare setting.	The One Drop Lancing Device is for usewith One Drop branded Lancets tocollect capillary blood for testingpurposes from the fingertip. The OneDrop Lancing Device is for single patientuse in a home setting.
Number ofUses	Base (lancing device) – multiple use	Base (lancing device) – multiple use
	Lancet - single use	Lancet - single use
DeviceImages	Lancing Device & AST Cap:	Lancing Device:

	ONE DROP

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	Image: Lancet and lancet cap	One Drop branded Lancet (K221383):Image: One Drop branded Lancet
LancetSterility	Yes, gamma irradiation	Yes, gamma irradiation
Needle	0.4mm (28G); beveled cut with 3 facets	0.21mm (33G); beveled cut with 3 facets
DepthAdjustment	11 levels by twisting cap	5 depth settings by sliding lever
MechanicalLoading	Spring-driven	Spring-driven
Load andFiring	Load by pressing priming button whenlancet is inserted,Fire by pressing release button	Load by advancing lancet into holdingsection and pushing down,Fire by pressing release button
AnatomicalSites	FingertipBall of hand (palm)Upper armLower arm	Fingertip
SharpsInjuryPrevention	Lancets are covered by a sterile barriercap until twisted off before use. Untilfiring, the lancet is contained within thelancing device housing. Immediatelyafter firing, the lancet is automaticallyretracted back into the housing. Anejector sleeve can then be pulledforward for contactless disposal of thelancet.	Lancets are covered by a sterile barriercap until twisted or pulled off beforeuse. Until firing, the lancet is containedwithin the lancing device housing.Immediately after firing, the lancet isautomatically retracted back into thehousing. An ejector sleeve can then bepulled forward for contactless disposalof the lancet.

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Non-Clinical Testing Summary and Conclusions

Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied. This includes mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the device continued to meet the specified requirements. Physical testing included dimensional measurements, function reliability drop test, piercing depth test, and cock force test. Biocompatibility was evaluated through a battery of tests to meet ISO 10993-1 requirements.

Compatibility between the One Drop branded Lancets and the One Drop Lancing Device was tested previously under 510(k) K221383 under the device name MedtFine Blood Lancet, which is the same device as the One Drop branded Lancets.

Conclusion

The intended use, technology, non-clinical testing, and functionality of the One Drop Lancing Device demonstrate a substantially equivalent safety and effectiveness profile 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.