The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.

Device Description

The Unistik® Pro is a sterile single-use safety lancet, a hand-held disposable device intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® Pro sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.q., for blood glucose monitoring in patients with diabetes,

The Unistik® Pro safety lancets are available in 3 different variants, each with a different needle gauge (21G, 25G and 28G with penetration depths of 2.0mm, 1.6mm and 1.2mm respectively) as required by the patient.

The Unistik® Pro sterile single-use safety lancets are designed for prescription and over-thecounter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the finqertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime.

The Unistik® Pro sterile single-use safety lancets feature integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.

AI/ML Overview

The provided text describes the 510(k) summary for the Unistik® Pro, a single-use lancet. While it outlines various performance tests and acceptance criteria for mechanical and material properties, it does not contain information related to an AI/ML-driven medical device, nor does it discuss clinical studies with human readers or image analysis for establishing ground truth. The device is a physical blood lancet, not a diagnostic imaging or AI product.

Therefore, many of the requested criteria for describing an AI/ML device's acceptance criteria and study are not applicable to this document. The document primarily focuses on non-clinical performance data for a physical medical device.

However, based on the non-clinical performance data provided for this physical device, here's an attempt to answer the relevant questions to the best of my ability from the given text:

1. Table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (Requirement)	Reported Device Performance (Results)
Needle Retention Force	Internal test specification	Meets specification
Depth of Penetration	Internal test specification	Meets specification
Sharps Injury Protection	Internal test specification	Meets specification
Button Activation Force	Internal test specification	Meets specification
Cap Removal Torque	Internal test specification	Meets specification
Drop test (as part of sharps injury protection test)	Internal test specification	Meets specification
Biocompatibility	Meets all requirements according to ISO 10993 and FDA guidance	Meets all requirements
Sterilization (Sterility Assurance Level - SAL)	10^-6	Achieved 10^-6

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for each test. It only states that "Design verification testing... has been carried out" and "All additional performance tests met the acceptance criteria." The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned beyond acknowledging that some prior documentation might reference "Artaplast" or other names for the device. These are bench tests, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The ground truth for these physical tests is established through objective measurements against predefined specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies with human readers, not for physical device performance tests.

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
Not applicable. This is a physical medical device (lancet), not an AI-driven diagnostic tool. No human reader studies with AI assistance were conducted or are relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of "ground truth" for these performance tests is based on pre-defined engineering and safety specifications for the physical properties of the lancet (e.g., precise needle penetration depth, force required for activation, effectiveness of sharps protection).

8. The sample size for the training set
Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

10/25/2022

Owen Mumford Ltd % Patty Cronan Quality Manager Owen Mumford USA Inc. 1755 West Oak Commons Ct. Marietta, Georgia 30062

Re: K222303

Trade/Device Name: Unistik® Pro Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 27, 2022 Received: August 1, 2022

Dear Patty Cronan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K222303

Device Name Unistik Pro

Indications for Use (Describe)

The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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."

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SECTION 5.0

510(k) SUMMARY

1. Submitter

Prepared by:	Owen Mumford LtdTel: +44(0)1993 812021Fax: +44(0)1993 813466
Prepared for:	Owner/ OperatorOwen Mumford LtdBrook HillWoodstockOxfordshireOX20 1TUUnited KingdomEstablishment Registration Number: 3003348846
Contact Person:	Darren MansellRegulatory Affairs ManagerOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email: darren.mansell@owenmumford.com
Date Prepared:	27th July 2022
2. Device
510(k) Number:Name of Device:Common Name:Classification Name:Regulatory Class:Product Code:	K222303Unistik® ProBlood lancetsSingle use only blood lancet with an integral sharpsinjury prevention featureFMK

3. Predicate Devices

Predicate Device Name:	SurgiLance® Safety Lancet, under 510k number K101145.
	(Cleared for: Prescription Use and Over-The-Counter Use)

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4. Description of The Device

The purpose of these 510(k) applications is to obtain both prescription-only clearance and overcounter clearance for the Unistik® Pro sterile single-use safety lancets. The intended use for the Unistik® Pro sterile single use safety lancets is similar and substantially equivalent to the predicate device.

Note: The Unistik® Pro was previously produced for Owen Mumford by Artaplast, and as such some of the documentation supplied to support this submission may reference the company "Artaplast". In addition, in Artaplast documentation the device may be referred to as the following previously used names: "Carelance Micro Flow", "Optilance Micro Flow", "Arta Lancet". In some Owen Mumford documentation, Unistik Pro may be referred to as "Unistik Protop". All of the references listed in this note can be considered to refer to the Unistik Pro device produced by Owen Mumford Ltd for the entirety of this submission.

5. Indications for Use

The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.

6. Technological Characteristics

The Unistik® Pro sterile single-use safety lancets are substantially equivalent to the predicate device, the SurgiLance® Safety Lancet, 510(k) number K101145.

A comparison of the intended uses and technological characteristics of the Unistik® Pro sterile single-use safety lancets to the predicate SurgiLance® devices is summarized in table 5.1 below.

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Table 5.1 A comparison of the device characteristics between the predicate and submission devices

Device Characteristic	Predicate Device:SurgiLance® SafetyLancets - K101145.	Submission Device -Unistik® Pro sterile single-usesafety lancets
Intended Use	The SurgiLance® SafetyLancet is a skin puncturedevice to obtain micro bloodsamples.The SurgiLance® SafetyLancet has a sharpsprevention feature to protectthe user from needlestickinjuries.	The intended user is any patientthat needs to obtain capillarysamples at home/clinicalenvironment. Unistik Pro is asingle-use lancet used to obtain acapillary blood sample.Therefore, substantially equivalentto the predicate device
Use environment	Home and clinical	Home and clinical
Operating principle	Contact-activated spring-powered automatic lancingand needle retraction.	Manually activated (rear fire button)spring-powered automatic lancingand needle retraction.
Design/ construction	Stainless steel lancet needlemoulded into a plastic lancetholder component, which inturn is assembled into amoulded plastic outerhousing with a pre-loadedsteel spring	Similar to the predicate device,consisting of stainless steel lancetneedle moulded into plastic lancetholder component, assembled intoa moulded plastic outer housingwith a steel spring, additionally witha plastic rear firing button
Integral sharps injury preventionfeature?	Yes	Unchanged from the predicatedevice
Single-use?	Yes	Unchanged from the predicatedevice
Sterility	Sterile	Unchanged from the predicatedevice
Components and Materials	Plastic external and internalcomponents, stainless steelneedle and steel spring	Unchanged from the predicatedevice, but likely that plastic andsteel specifications used differ frompredicate.
Package	Laminate pulp board cartons	Unchanged from the predicatedevice.
Device Characteristic		Predicate Device:SurgiLance® SafetyLancets – K101145.	Submission Device -Unistik® Pro sterile single-usesafety lancets
NeedleSpecifications	NeedleGauges(SWG)	18G, 21G	21G, 25G and 28GThe predicate device is available in18G and 21G variants only,therefore the Unistik® Pro sterilesingle-use safety lancets representan extended range of highergauges (smaller needle diameters)compared to the predicate.
	LancingDepths (mm)	1.8 mm & 2.3 mm (18G)1.0 mm, 1.8 mm, 2.2 mm &2.8 mm (21G)	2.0mm (21G), 1.6mm (25G) and1.2mm (28G)The Unistik® Pro sterile single-usesafety lancets lancing depth rangefalls within the range offered by thepredicate device, i.e. 1.2mm –2.0mm (Unistik Pro) compared tothe predicate range of 1.0mm – 2.
	Sterilisationmethod	Not known.	25-60 kGy electron beam irradiationvalidated to achieve a sterilityassurance level (SAL) of 10-6.

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7. Performance Data

Non-clinical performance data:

Design verification testing of the Unistik® Pro sterile single-use safety lancets has been carried out to evaluate the performance of the devices against defined acceptance criteria.

The following table provides a summary of the relevant design verification testing.

Bench Testing:

Test	Requirement	Results
Needle Retention Force	Internal test specification	Meets specification
Depth of Penetration	Internal test specification	Meets specification
Sharps Injury Protection	Internal test specification	Meets specification
Button Activation Force	Internal test specification	Meets specification
Cap Removal Torque	Internal test specification	Meets specification
Drop test (as part of sharps injuryprotection test)	Internal test specification	Meets specification

Table 5.1: Summary of the performance tests performed on Unistik Pro

The devices comply with the acceptance criteria established based on the specifications of the devices. All additional performance tests met the acceptance criteria.

The results from these tests demonstrate that the Unistik® Pro sterile single-use safety lancets are safe and effective when used as intended.

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Biocompatibility:

Based on available information and biocompatibility reports available for the device and its components, Owen Mumford concludes that the device meets all requirements according to ISO 10993 and FDA guidance when used as intended.

Please see Section 15 - Biocompatibility for more information.

Sterilisation:

The sterility of the devices is assured using a sterilisation method validated in accordance with ISO 11137 "Medical Devices – Validation and Routine Control of Radiation Sterilisation". Through the sterilisation methods used, all devices are sterilised to provide a Sterility Assurance Level (SAL) of 10-6.

Sterilization Method: Electron beam irradiation Radiation dose range: 25-60 kGy Sterility assurance level (SAL): 10-6

Shelf life

The Unistik® Pro sterile barrier has been qualified for 5 years, but Owen Mumford is currently submitting Unistik Pro with a 2.5-year shelf life, with a plan to supplement this submission with accelerated-aged functional testing data in the near future. For more information see Section 18 – Performance Testing.

8. Conclusion

In summary, the differences between the Unistik® Pro sterile single-use safety lancets and the predicate device have no impact on safety and effectiveness and the products are therefore substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4850 Blood lancets.

(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.