K232912 · Facet Technologies, LLC · QRL · Jan 25, 2024 · General, Plastic Surgery
Device Facts
Record ID
K232912
Device Name
Facet Aurora Reusable Lancet Base
Applicant
Facet Technologies, LLC
Product Code
QRL · General, Plastic Surgery
Decision Date
Jan 25, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Facet Aurora 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 lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
Device Story
The Facet Aurora Reusable Lancet Base is a non-sterile, spring-loaded mechanical lancing device used to obtain capillary blood samples. It operates by manually charging a spring mechanism, which, upon button activation, quickly ejects and retracts a proprietary lancet blade to puncture the skin. The device features 7 adjustable penetration depth settings (0.5mm–2.75mm). It is intended for single-patient use in home settings and must be cleaned and disinfected between uses. The device is operated by the patient or a caregiver. By providing a controlled lancing event, it facilitates blood collection for diagnostic monitoring, such as blood glucose testing, benefiting patients requiring frequent blood sampling.
Clinical Evidence
No clinical data. Bench testing only. Testing included mechanical verification (endcap forces, activation force, depth accuracy, lancet rotation), durability (drop test, 3-year life cycle), environmental stress (temperature cycling), and biocompatibility (ISO 10993-1, -5, -10, -11).
Technological Characteristics
Materials: Polycarbonate and ABS (acrylonitrile-butadiene-styrene). Mechanism: Spring-loaded manual actuation. Dimensions: 7 depth settings (0.5mm–2.75mm, ~0.3mm increments). Connectivity: None (mechanical). Sterilization: Non-sterile; designed for cleaning/disinfection between uses.
Indications for Use
Indicated for children, adolescents, and adults requiring capillary blood sampling for diagnostic testing (e.g., blood glucose monitoring) in a home setting.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*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.
Predicate Devices
Facet Aurora Reuseable Lancet Base (Product Code MDM, 510(k) Exempt)
Submission Summary (Full Text)
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January 25, 2024
Facet Technologies, LLC James Bonds Director Regulatory Affairs 3900 North Commerce Drive Atlanta, Georgia 30344
Re: K232912
Trade/Device Name: Facet Aurora Reusable Lancet Base Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: January 5, 2024 Received: January 5, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.01.25 13:59:29 -05'00' Mark Trumbore, 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) K232912
Device Name Facet Aurora Reusable Lancet Base
Indications for Use (Describe)
The Facet Aurora 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 lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and 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) | |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;">☐ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="white-space: nowrap;">❌ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# K232912
# Facet Aurora Reuseable Lancet Base
# 510(k) Summary (Reference 21 CFR 807.92)
| Submitted by: | Facet Technologies, LLC<br>3900 North Commerce Drive<br>Atlanta, GA 30344-8149<br>Phone Number: (770) 590-6462<br>Fax Number: (770) 590-6412 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | James R. Bonds<br>Director Regulatory Affairs<br>JBonds@facetmed.com |
| Date of Preparation: | January 5, 2024 |
| Device Trade Name: | Facet Aurora 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 single<br>patient use only) |
| Product Classification: | II |
| Panel: | General & Plastic Surgery |
| Predicate Device: | Facet Aurora Reuseable Lancet Base (Product Code MDM,<br>510(k) Exempt) |
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## Device Description
The Facet Aurora Reuseable Lancet Base is a blood sampling device used in conjunction with a lancet blade of proprietary design to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
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 Aurora Reusable Lancet Base (commonly referred to as a lancing device) is a nonsterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and adults in a home setting.
The device is designed to be cleaned and disinfected between uses on a single patient.
## Technological Characteristics
The primary technological characteristics and intended use of the Facet Aurora Reuseable Lancet Base are substantially equivalent to the predicate device.
As indicated in, the Facet Aurora Reuseable Lancet Base is substantially equivalent to characteristics of the identified predicate device, the Facet Aurora Reuseable Lancet Base previously marketed as a 510(k) exempt device.
As indicated in Table 1, the Facet Aurora Reuseable Lancet Base is substantially equivalent to characteristics of the identified predicate device, the Facet Aurora Reuseable Lancet Base previously marketed as a 510(k) exempt device.
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| Characteristic | Predicate Device | Subject Device |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Indication for Use | The Facet Aurora<br>Reusable Lancet Base<br>(commonly referred to<br>as a lancing device) is<br>a non-sterile reusable<br>device which provides<br>a spring-loaded<br>mechanism to quickly<br>eject and retract a<br>lancet of proprietary<br>design to effect a<br>lancing event for the<br>purpose of obtaining a<br>droplet of capillary<br>blood for diagnostic<br>testing in children,<br>adolescents, and adults<br>in a home setting.<br>The device is designed<br>to be cleaned and<br>disinfected between<br>uses on a single<br>patient. | Same |
| Manufacturer | Facet Technologies,<br>LLC | Same |
| 510(k) Number | N/A | K232912 |
| Product Code | MDM | QRL |
| Sterility | Non-sterile, can be<br>cleaned and low-level<br>disinfected between<br>uses | Same |
| Penetration<br>Adjustment Depths | 7 depth settings<br>0.5mm-2.75mm, with<br>each change of the<br>depth setting being<br>approximately 0.3 mm | Same |
| Materials | Polycarbonate, ABS<br>(acrylonitrile-butadiene-<br>styrene), present<br>separately and as<br>copolymers | 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.
| Property/Characteristic | Test Method | Importance | Reference |
|----------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------|
| Endcap Removal Force | Tensile strength<br>tester | Ensure cap can be<br>removed easily to<br>insert lancet blade | N/A |
| Endcap Attachment<br>Force | Tensile strength<br>tester | Ensure cap will<br>remain on lancet<br>base during lancing<br>event | N/A |
| Depth of Puncture | Calibrated High<br>Speed Video | Ensure depth of<br>puncture is<br>repeatable for<br>various depth<br>settings | N/A |
| Over-Charging Force | Tensile force gauge | Ensure that device<br>can be charged to<br>engage actuation<br>spring | N/A |
| Charging Force | Tensile force gauge | Ensure device can<br>be charged to<br>engage actuation<br>spring | N/A |
| Lancet Insertion Force | Tensile force gauge | Ensure lancet can be<br>easily inserted | N/A |
| Depth Adjust Torque | Torque gauge | Ensure that depth<br>adjustment can be<br>easily adjusted and<br>that adjustment will<br>not change during<br>use | N/A |
| Button Activation Force | Tensile force gauge | Ensure activation<br>force is within<br>specification | N/A |
| Lancet Rotation | Torque gauge | Ensure lancet does<br>not rotate during<br>device actuation | N/A |
#### Summary of Nonclinical Tests Performed Table 2:
{7}------------------------------------------------
| Property/Characteristic | Test Method | Importance | Reference |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Drop Test | Simulated Use after<br>drop | Ensure that device<br>can withstand a 1<br>meter drop to a hard<br>surface and still<br>function | N/A |
| Life Cycle Test | Simulated use | Ensure device can<br>withstand 3 years of<br>expected use | N/A |
| Chemical Test | Cleaning and<br>disinfection studies | Ensure device can<br>withstand<br>recommended<br>cleaning and<br>disinfection over<br>useful life | N/A |
| Storage Temperature<br>Test | Simulated Use | Ensure device can<br>function after<br>exposure to heat and<br>cold cycles | N/A |
| Biocompatibility | Cytotoxicity,<br>Sensitization,<br>Irritation or<br>Intracutaneous<br>reactivity, Acute<br>Systemic toxicity<br>(materials mediated<br>pyrogen) | Ensure material of<br>construction are<br>biocompatible for<br>their intended use | FDA Guidance Use<br>of International<br>Standard 10993-1,<br>"Biological evaluation<br>of medical devices -<br>Part 1: Evaluation<br>and testing within a<br>risk management<br>process", Sept.<br>2020,<br>ISO 10993-1, ISO<br>10993-5, ISO 0993-<br>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 Aurora 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.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
