(59 days)
The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
The provided text describes the Facet Manatee Reusable Lancet Base, a reusable lancing device for obtaining blood samples for diagnostic testing. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information typically requested regarding AI/CAD efficacy studies, such as effects on human readers, ground truth establishment for AI models, and training set details, is not applicable or present in this document.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical bench testing performed to ensure the device meets predetermined criteria and satisfies special controls. While specific numerical acceptance values are not provided, the "Importance" column outlines the intended performance. The conclusion states that the tests demonstrate the candidate device is substantially equivalent to the predicate.
| Property/Characteristic | Test Method | Importance (Acceptance Criteria) | Reported Performance (Implied by Conclusion) |
|---|---|---|---|
| Endcap Removal Force | Tensile strength tester | Ensure cap can be removed easily to insert lancet blade. | Test was performed and criteria met (device is substantially equivalent). |
| Endcap Attachment Force | Tensile strength tester | Ensure cap will remain on lancet base during lancing event. | Test was performed and criteria met (device is substantially equivalent). |
| Depth of Puncture | Calibrated High Speed Video | Ensure depth of puncture is repeatable for various depth settings. | Test was performed and criteria met (device is substantially equivalent). |
| Over-Charging Force | Tensile force gauge | Ensure that device can be charged to engage actuation spring. | Test was performed and criteria met (device is substantially equivalent). |
| Charging Force | Tensile force gauge | Ensure device can be charged to engage actuation spring. | Test was performed and criteria met (device is substantially equivalent). |
| Lancet Insertion Force | Tensile force gauge | Ensure lancet can be easily inserted. | Test was performed and criteria met (device is substantially equivalent). |
| Depth Adjust Torque | Torque gauge | Ensure that depth adjustment can be easily adjusted and that adjustment will not change during use. | Test was performed and criteria met (device is substantially equivalent). |
| Button Activation Force | Tensile force gauge | Ensure activation force is within specification. | Test was performed and criteria met (device is substantially equivalent). |
| Lancet Rotation | Torque gauge | Ensure lancet does not rotate during device actuation. | Test was performed and criteria met (device is substantially equivalent). |
| Drop Test | Simulated Use after drop | Ensure that device can withstand a 1 meter drop to a hard surface and still function. | Test was performed and criteria met (device is substantially equivalent). |
| Life Cycle Test | Simulated use | Ensure device can withstand 3 years of expected use. | Test was performed and criteria met (device is substantially equivalent). |
| Chemical Test | Cleaning and disinfection studies | Ensure device can withstand recommended cleaning and disinfection over useful life. | Test was performed and criteria met (device is substantially equivalent). |
| Storage Temperature Test | Simulated Use | Ensure device can function after exposure to heat and cold cycles. | Test was performed and criteria met (device is substantially equivalent). |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity (materials mediated pyrogen) | Ensure material of construction are biocompatible for their intended use. | Conducted per ISO 10993 at a GLP testing facility; tests were performed and criteria met (device is substantially equivalent). |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical bench testing. It does not specify a "test set" in the context of patient data or clinical trials, nor does it provide details on sample sizes for each bench test beyond the phrase "non-clinical bench testing was performed." The provenance of this data would be laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical device submission not involving expert review of diagnostic images or interpretations.
4. Adjudication method for the test set:
Not applicable. This is a non-clinical device submission.
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:
No MRMC study was done. This device is a mechanical lancing device, not an AI-assisted diagnostic tool. Clinical testing was deemed "not applicable" as per the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical lancing device, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the engineering specifications and performance requirements for the device (e.g., specific force values for button activation, a device functioning after a 1-meter drop). For biocompatibility, the ground truth is established by the relevant ISO 10993 standards and the results from GLP testing, demonstrating the material's biological safety.
8. The sample size for the training set:
Not applicable. This is a non-clinical device submission and does not involve AI/ML training.
9. How the ground truth for the training set was established:
Not applicable. This is a non-clinical device submission and does not involve AI/ML training.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
November 28, 2022
Facet Technologies LLC Mr. James Bonds Director Regulatory Affairs 3900 North. Commerce Drive. Atlanta, Georgia 30344-8149
Re: K223099
Trade/Device Name: Facet Manatee Reusable Lancing Base Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: September 30, 2022 Received: September 30, 2022
Dear Mr. 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) K223099
Device Name
Facet Manatee Reuseable Lancet Base
Indications for Use (Describe)
The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
| 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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K223099
Facet Manatee Reuseable Lancet Base
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. BondsDirector Regulatory AffairsJBonds@facetmed.com |
| Date of Preparation: | November 25, 2022 |
| Device Trade Name: | Facet Manatee Reuseable Lancet Base |
| Common Name: | Lancing Device |
| Classification Name: | Multiple use blood lancet base for single patient use only |
| Regulation: | 878.4850 |
| Product codes: | QRL (Multiple use blood lancet intended for use on a singlepatient use only) |
| Product Classification: | II |
| Panel: | General & Plastic Surgery |
| Predicate Device: | Facet Manatee Reuseable Lancet Base (Product Code MDM,510(k) Exempt) |
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Device Description
The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility.
The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.
Indication for Use
The Facet Manatee Reuseable Lancet Base (commonly referred to as a lancing device) is a nonsterile reuseable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
Intended Use
The Facet Manatee Reuseable Lancet Base is intended to be used with a standard or universal lancet blade to perform a skin puncture of a finger or alternate site (palm of the hand, upper arm, lower arm, thigh) for collection of a droplet of capillary blood for subsequent diagnostic testing. This system is not suitable for use by healthcare professionals with multiple patients.
Technological Characteristics
The primary technological characteristics and intended use of the Facet Manatee Reuseable Lancet Base are substantially equivalent to other legally marketed universal lancets.
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As indicated in Table 1, the Facet Manatee Reuseable Lancet Base is substantially equivalent to characteristics of the identified predicate device, the Facet Manatee Reuseable Lancet Base previously marketed as a 510(k) exempt device.
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Indication for Use | The Facet ManateeReuseable Lancet Base(commonly referred to asa lancing device) is a non-sterile reuseable devicewhich provides a spring-loaded mechanism toquickly eject and retract asingle or regular versionlancet to effect a lancingevent for the purpose ofobtaining a blood samplefor diagnostic testing inchildren, adolescents (useon children andadolescents should be byor under supervision of anadult), and adults in ahome setting. The deviceis designed to be cleanedand disinfected betweenuses on a single patient. | Same |
| Intended Use | The Facet ManateeReuseable Lancet Base isThe Facet ManateeReuseable Lancet Base isintended to be used witha standard or universallancet blade to perform askin puncture of a fingeror alternate site (palm ofthe hand, upper arm,lower arm, thigh) forcollection of a droplet ofcapillary blood forsubsequent diagnostictesting. This system isnot suitable for use byhealthcare professionalswith multiple patients. | Same |
| Characteristic | Predicate Device | Subject Device |
| Manufacturer | Facet Technologies, LLC | Same |
| 510(k) Number | N/A | K223099 |
| Product Code | MDM | QRL |
| Sterility | Non-sterile, can be cleanedand low-level disinfectedbetween uses | Same |
Comparison of Subject Device and Predicate Device Table 1:
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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 mechanical functions of the device are suitable for use over the shelf life of the device.
Clinical testing is not applicable as the risk analysis confirmed that all identified risks were addressed and mitigated appropriately. Residual risks after mitigation were acceptable. There were no special performance of safety concerns identified.
| Property/Characteristic | Test Method | Importance | Reference |
|---|---|---|---|
| Endcap Removal Force | Tensile strengthtester | Ensure cap can beremoved easily toinsert lancet blade | N/A |
| Endcap AttachmentForce | Tensile strengthtester | Ensure cap willremain on lancetbase during lancingevent | N/A |
| Depth of Puncture | Calibrated HighSpeed Video | Ensure depth ofpuncture isrepeatable forvarious depthsettings | N/A |
| Over-Charging Force | Tensile force gauge | Ensure that devicecan be charged toengage actuationspring | N/A |
| Property/Characteristic | Test Method | Importance | Reference |
| Charging Force | Tensile force gauge | Ensure device canbe charged toengage actuationspring | N/A |
| Lancet Insertion Force | Tensile force gauge | Ensure lancet can beeasily inserted | N/A |
| Depth Adjust Torque | Torque gauge | Ensure that depthadjustment can beeasily adjusted andthat adjustment willnot change duringuse | N/A |
| Button Activation Force | Tensile force gauge | Ensure activationforce is withinspecification | N/A |
| Lancet Rotation | Torque gauge | Ensure lancet doesnot rotate duringdevice actuation | N/A |
| Drop Test | Simulated Use afterdrop | Ensure that devicecan withstand a 1meter drop to a hardsurface and stillfunction | N/A |
| Life Cycle Test | Simulated use | Ensure device canwithstand 3 years ofexpected use | N/A |
| Chemical Test | Cleaning anddisinfection studies | Ensure device canwithstandrecommendedcleaning anddisinfection overuseful life | N/A |
| Storage TemperatureTest | Simulated Use | Ensure device canfunction afterexposure to heat andcold cycles | N/A |
Table 2: Summary of Nonclinical Tests Performed
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| Property/Characteristic | Test Method | Importance | Reference |
|---|---|---|---|
| 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 |
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 Manatee Reuseable Lancet Base 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.
§ 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.