(59 days)
FMK
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
This device is used to obtain a blood sample for diagnostic testing, specifically for blood glucose monitoring, not for treating a condition.
No
Explanation: The device is a lancet used to obtain a blood sample for subsequent diagnostic testing, but it does not perform the diagnostic testing itself.
No
The device is a physical lancet with a needle and plastic components, designed for obtaining blood samples. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used "to obtain a droplet of capillary blood for subsequent diagnostic testing". This is a key characteristic of an IVD device – it's used to collect a sample for diagnostic purposes.
- Device Description: The description reinforces this by stating it's a "blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients." Blood glucose monitoring is a common diagnostic test.
- Predicate Device: The predicate device is also a "Facet 28G Universal Lancet (Product Code FMK, 510(k) Exempt)". While the exemption status doesn't automatically make it an IVD, the product code "FMK" is associated with "Blood Specimen Collection Devices" which are often used in conjunction with IVD tests.
While the device itself doesn't perform the diagnostic test, it is an essential component in the process of obtaining the sample needed for the diagnostic test. Therefore, it falls under the scope of IVD devices.
N/A
Intended Use / Indications for Use
The Facet 28G Universal Lancet is a sterile, disposable single used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. 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
QRK, QRL
Device Description
The Facet 28G Universal Lancet is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
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 28G 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 or an alternative site, such as the palm, upper arm, or forearm.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Facet 28G Universal 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 logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
July 15, 2022
Facet Technologies LLC James Bonds Director Regulatory Affairs 3900 N. Commerce Dr. Atlanta, Georgia 30344
Re: K221433
Trade/Device Name: Facet 28G Universal Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK, QRL Dated: May 16, 2022 Received: May 17, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
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) K221433
Device Name Facet 28G Universal Lancet
Indications for Use (Describe)
The Facet 28G Universal Lancet is a sterile, disposable single used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.
| 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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3
Facet 28G Universal 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: | July 13, 2022 |
| Device Trade Name: | Facet 28G Universal Lancet |
| Common Name: | Blood Lancet |
| Classification Name: | Single use only blood lancet without an integral sharps injury
prevention feature |
| Regulation: | 878.4850 |
| Product codes: | QRK (Single use only blood lancet without an integral sharps
injury prevention feature)
QRL (Multiple use blood lancet for single patient use only) |
| Product Classification: | II |
| Panel: | General & Plastic Surgery |
| Predicate Device: | Facet 28G Universal Lancet (Product Code FMK, 510(k)
Exempt) |
4
Device Description
The Facet 28G Universal Lancet) is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
The predicate device has been in commercial distribution since 2006.
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 28G 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.
The predicate device is currently in commercial distribution 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 28G Universal Lancet is a sterile, disposable, single use device used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.
Technoloqical Characteristics
The primary technological characteristics and intended use of the Facet 28G Universal Lancet are substantially equivalent to the predicate device.
As indicated in Table 1, the Facet 28G Universal Lancet is substantially equivalent to characteristics of the identified predicate device, the Facet 28 G Universal Lancet previously marketed as a 510(k) exempt device.
5
Subject Device
Predicate Device
| Indication for Use | The Facet 28G Universal
Lancet is a sterile,
disposable single use
device used to obtain a
droplet of capillary blood
for subsequent diagnostic
testing from the finger or
an alternative site, such
as the palm, upper arm,
or forearm. 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 28G Universal
Lancet is intended to
perform a skin puncture of
a finger or alternate site
(palm of the hand, upper
arm, or forearm) for
collection of a droplet of
capillary blood for
subsequent diagnostic
testing. The Lancet may
be used in combination
with a reusable lancet
base (lancing device) that
accepts a universal-type
lancet to perform a
lancing event. The Facet
28G Universal Lancet is
for single use only on an
individual patient. | Same |
| Manufacturer | Facet Technologies, LLC | Same |
| 510(k) Number | N/A | K221433 |
| Product Code | FMK | QRK, QRL |
| Tip configuration | Bevel | Bevel |
| Needle Length | 3.1±0.45 mm | Same |
| Needle Gauge | 28G | Same |
| Body Color | Light blue | Same |
Table 1: Comparison of Subject Device and Predicate Device
Characteristic
6
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Needle Material | 304 Stainless steel | Same |
| Body Material | Low density polyethylene | |
| (LDPE) | Same | |
| Body/needle bond | ||
| strength | $\geq$ 13.23 N | Same |
| Cap Twist-off torque | $\leq$ 4.9 N-cm | Same |
| Sterility | Sterilized by Gamma Radiation | |
| SAL = $10^{-6}$ | Same |
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 |
7
| Property/Characteristic | Test Method | Importance | Reference |
|---|---|---|---|
| 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 |
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 28G Universal Lancet demonstrate a substantially equivalent safety and effectiveness profile to the predicate device and should perform as well as the predicate in the intended use conditions.