The Facet Lancet is a sterile, disposable single used with a compatible proprietary lancet base (lancing device) to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.

Device Description

The Facet Lancet is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic primarily for blood glucose monitoring in diabetic patients. The lancet is available in two needle sizes, 30 gauge and 33 gauge.

Facet lancets are intended to be used by diabetic patients to obtain a blood sample for assistance in self-monitoring of their blood glucose levels. The lancets consist of a 30G or 33G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Facet Blood Lancets, seeking to demonstrate substantial equivalence to a predicate device. The information focuses on non-clinical bench testing to ensure the device meets predetermined criteria and special controls.

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

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

The document provides a "Summary of Nonclinical Tests Performed" (Table 2) which lists the properties/characteristics tested and their importance. While it doesn't explicitly state quantitative acceptance criteria for each test, it implies that meeting these criteria demonstrates acceptable performance for substantial equivalence. The reported performance is generally stated as "met predetermined criteria" in the text, rather than specific numerical results.

Property/Characteristic	Test Method	Importance	Reported Device Performance
Bond Strength of lancet blade to lancet body	Tensile strength tester	Ensure needle does not detach from lancet body during use	Met predetermined criteria; substantially equivalent to predicate device
Sterility Cap Torque	Torque tester	Ensure that the cap can be easily removed by user when desired	Met predetermined criteria; substantially equivalent to predicate device
Compatibility with lancet bases	Simulated use	Ensure usability with commercially available lancet bases	Met predetermined criteria; substantially equivalent to predicate device
Biocompatibility	Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity (materials mediated pyrogen)	Ensure material of construction are biocompatible for their intended use	Met predetermined criteria; substantially equivalent to predicate device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the non-clinical bench tests (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective), but given it describes a 510(k) submission, the tests were conducted by or for the manufacturer (Facet Technologies LLC) as part of a prospective evaluation for regulatory approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to the non-clinical, bench testing described for this device. Ground truth, in the context of expert consensus, is typically relevant for studies involving human interpretation or diagnosis, which is not the nature of these mechanical and biocompatibility tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods are typically associated with studies involving human interpretation or subjective assessments. For the objective, non-clinical bench tests described here, an adjudication method is not applicable. The results would be based on direct measurements and adherence to specified test procedures.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. These studies are typically used for diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Facet Blood Lancet is a physical medical device for blood sampling, not an AI-powered diagnostic tool.

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

A "standalone" algorithm performance assessment is not applicable here as the Facet Blood Lancet is a physical medical device and does not involve any algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described:

Bond Strength and Cap Torque: The "ground truth" would be established by the engineer's design specifications and defined pass/fail criteria based on mechanical engineering principles and relevant standards.
Compatibility: The "ground truth" would be successful operation with commercially available lancing devices, likely defined by visual inspection and ease of use.
Biocompatibility: The "ground truth" is established by adherence to recognized international standards (ISO 10993 series) which dictate the acceptable biological response to device materials.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI models. The tests performed are physical and biological evaluations of the device itself.

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

As there is no "training set" for this type of device and study, this question is not applicable.

Summary

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11/18/2022

Facet Technologies LLC James Bonds Director Regulatory Affairs 3900 N. Commerce Dr. Atlanta, Georgia 30344

Re: K222539

Trade/Device Name: Facet Blood Lancets Regulation Number: 21 CFR 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: August 19, 2022 Received: August 22, 2022

Dear James Bonds:

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) K222539

Device Name Facet Blood Lancets

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Facet Blood Lancet

510(k) Summary

(Reference 21 CFR 807.92)

Submitted by:	Facet Technologies, LLC3900 North Commerce DriveAtlanta, GA 30344-8149Phone Number: (770) 590-6462Fax Number: (770) 590-6412
Contact:	James R. Bonds
Date of Preparation:	November 18, 2022
Device Trade Name:	Facet Blood Lancet, 30G and 33G
Common Name:	Blood Lancet
Classification Name:	Single use only blood lancet without an integral sharps injuryprevention feature
Regulation:	878.4850
Product code:	QRL (Multiple use blood lancet for single patient use only)
Product Classification:	II
Panel:	General & Plastic Surgery
Predicate Device:	Facet 30G and 33G Lancet (Product Code FMK, 510(k)Exempt)

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Device Description

The predicate device has been in commercial distribution since 2012 in the United States, European, and other worldwide markets. Since commercial distribution of the current lancets began, there have been no design changes.

Indications for Use

The Facet Lancet is a sterile, disposable, single use device used with a compatible proprietary lancet base (lancing device) to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.

Technological Characteristics

The primary technological characteristics and intended use of the Facet Lancet are substantially equivalent to other legally marketed universal lancets.

As indicated in Table 1, the Facet Lancet is substantially equivalent to characteristics of the identified predicate device, the Facet Lancet previously marketed as a 510(k) exempt device.

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Characteristic	Predicate Device	Subject Device
Indication for Use	The Facet Lancet is asterile, disposable, singleuse device used with acompatible proprietarylancet base (lancingdevice) to obtain a dropletof capillary blood from thefinger for subsequentdiagnostic testing. TheLancet is to be properlydisposed of after a singleuse on an individual child,adolescent, or adultpatient in a home setting.	Same
Intended Use	The Facet Lancet isintended to perform a skinpuncture of a finger forcollection of a droplet ofcapillary blood forsubsequent diagnostictesting. The Lancet isused with compatiblereusable lancet bases(lancing devices) thataccept a proprietaryversion lancet to performa lancing event. TheFacet Lancet is for singleuse only on an individualpatient.	Same
Manufacturer	Facet Technologies, LLC	Same
510(k) Number	N/A	Same
Product Code	FMK	QRL
Tip configuration	Bevel	Bevel
Needle Length	$3.5\pm0.30$ mm	Same
Needle Gauge	30G and 33G	Same
Body Color	30G: Gray (PMS 10C)33G: Light blue (PMS283C)	Same
Needle Material	304 Stainless steel	Same
Body Material	Low density polyethylene(LDPE)	Same
Body/needle bondstrength	$\geq 8.2$ N	Same
Cap Twist-off torque	$\leq 4.9$ N-cm	Same
Characteristic	Predicate Device	Subject Device
Sterility	Sterilized by GammaRadiationSAL = $10^{-6}$	Same

Table 1: Comparison of Subject Device and Predicate Device

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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 over the shelf life of the device. Physical testing included lancet body to needle bond strength, sterility cap twist-off torque, and compatibility with commercially available reusable lancet bases (lancing devices). Biocompatibility was evaluated through a battery of tests to meet ISO 10993-1 requirements.

Table 2: Summary of Nonclinical Tests Performed

Property/Characteristic	Test Method	Importance	Reference
Bond Strength of lancetblade (needle) to lancetbody	Tensile strengthtester	Ensure needle doesnot detach fromlancet body duringuse	N/A
Sterility Cap Torque	Torque tester	Ensure that the capcan be easilyremoved by userwhen desired	N/A
Compatibility with lancetbases (lancing devices)	Simulated use	Ensure usability withcommerciallyavailable lancetbases	N/A
Biocompatibility	Cytotoxicity,Sensitization,Irritation orIntracutaneousreactivity, AcuteSystemic toxicity(materials mediatedpyrogen)	Ensure material ofconstruction arebiocompatible fortheir intended use	FDA Guidance Useof InternationalStandard 10993-1,"Biological evaluationof medical devices -Part 1: Evaluationand testing within arisk managementprocess", Sept.2020,ISO 10993-1, ISO10993-5, ISO 0993-10, ISO 10993-11

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In summary, the results of nonclinical testing demonstrate that the candidate device is substantially equivalent to the predicate device.

Conclusion

The intended use, technology, non-clinical testing, and functionality of the Facet 30G and 33G Lancet demonstrate a substantially equivalent safety and effectiveness profile to the predicate device and should perform as well as the predicate in the specified use conditions.

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.