(88 days)
FMK
Not Found
No
The device description and performance studies focus on mechanical and material properties of a simple lancet, with no mention of AI or ML capabilities.
No
The device is used to obtain a blood sample for diagnostic testing, specifically blood glucose monitoring. It does not treat or prevent a disease or condition.
No
The device, a lancet, is used to obtain a blood sample for subsequent diagnostic testing. It is not the diagnostic device itself, but rather a tool used in the blood collection process for diagnostic purposes.
No
The device is a physical lancet, a hardware component used for blood sampling. The description explicitly details its physical construction (stainless steel needle, LDPE overmolding) and sterilization method.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the lancet is used "to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing." This clearly indicates the blood sample is intended for analysis outside of the body to aid in diagnosis or monitoring.
- Device Description: The description mentions the lancets are used "to obtain a sample of capillary blood for diagnostic primarily for blood glucose monitoring in diabetic patients." Blood glucose monitoring is a common IVD application.
- Regulatory Classification: The predicate device is listed as "Facet 30G and 33G Lancet (Product Code FMK, 510(k) Exempt)". Product Code FMK is the FDA product code for "Lancet, Blood". Devices under this product code are classified as Class II and are typically considered IVDs because they are used to collect samples for in vitro diagnostic tests. While this specific predicate is 510(k) exempt, the product code itself is associated with IVDs.
Therefore, the Facet Lancet, as described, fits the definition of an In Vitro Diagnostic device because it is used to collect a biological sample (blood) for subsequent diagnostic testing performed outside of the body.
N/A
Intended Use / 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.
Product codes
QRL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
child, adolescent, or adult patient
Intended User / Care Setting
home setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Facet 30G and 33G Lancet (Product Code FMK, 510(k) Exempt)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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
1
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
2
Indications for Use
510(k) Number (if known) K222539
Device Name Facet Blood Lancets
Indications for Use (Describe)
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.
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, LLC
3900 North Commerce Drive
Atlanta, GA 30344-8149
Phone Number: (770) 590-6462
Fax 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 injury
prevention 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) | |
4
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.
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.
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.
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.
5
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Indication 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. | Same | |
| Intended Use | The Facet Lancet is | |
| intended to perform a skin | ||
| puncture of a finger for | ||
| collection of a droplet of | ||
| capillary blood for | ||
| subsequent diagnostic | ||
| testing. The Lancet is | ||
| used with compatible | ||
| reusable lancet bases | ||
| (lancing devices) that | ||
| accept a proprietary | ||
| version lancet to perform | ||
| a lancing event. The | ||
| Facet Lancet is for single | ||
| use only on an individual | ||
| patient. | 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 (PMS | ||
| 283C) | Same | |
| Needle Material | 304 Stainless steel | Same |
| Body Material | Low density polyethylene | |
| (LDPE) | Same | |
| Body/needle bond | ||
| strength | $\geq 8.2$ N | Same |
| Cap Twist-off torque | $\leq 4.9$ N-cm | Same |
| Characteristic | Predicate Device | Subject Device |
| Sterility | Sterilized by Gamma | |
| Radiation | ||
| SAL = $10^{-6}$ | Same |
Table 1: Comparison of Subject Device and Predicate Device
6
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 lancet | |||
| blade (needle) to lancet | |||
| body | Tensile strength | ||
| tester | Ensure needle does | ||
| not detach from | |||
| lancet body during | |||
| use | N/A | ||
| Sterility Cap Torque | Torque tester | Ensure that the cap | |
| can be easily | |||
| removed by user | |||
| when desired | N/A | ||
| Compatibility with lancet | |||
| bases (lancing devices) | Simulated use | Ensure usability with | |
| commercially | |||
| available lancet | |||
| bases | N/A | ||
| Biocompatibility | Cytotoxicity, | ||
| Sensitization, | |||
| Irritation or | |||
| Intracutaneous | |||
| reactivity, Acute | |||
| Systemic toxicity | |||
| (materials mediated | |||
| pyrogen) | Ensure material of | ||
| construction are | |||
| biocompatible for | |||
| their intended use | FDA Guidance Use | ||
| of International | |||
| Standard 10993-1, | |||
| "Biological evaluation | |||
| of medical devices - | |||
| Part 1: Evaluation | |||
| and testing within a | |||
| risk management | |||
| process", Sept. | |||
| 2020, | |||
| ISO 10993-1, ISO | |||
| 10993-5, ISO 0993- | |||
| 10, ISO 10993-11 |
7
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.