(57 days)
BD Microtainer® Contact-Activated Lancets, BD Microtainer® Quikheel™ Lancets
There are no reference devices listed in the text.
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No
The device is used to obtain capillary blood specimens for testing, not for therapeutic treatment.
No
The device is a lancing device used to obtain capillary blood specimens for testing, not to perform a diagnosis itself. It is a tool for specimen collection, which can then be used for diagnostic purposes by other devices or tests.
No
The device description clearly details physical components like needles, blades, housing, triggers, and springs, indicating it is a hardware device, not software-only.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. The key is that the device is used for testing the sample.
- Intended Use of the Lancets: The intended use of both the BD Microtainer® Contact-Activated Lancets and the BD Microtainer® Quikheel™ Lancets is to obtain capillary blood specimens. They are the tools used to collect the sample, not to perform the diagnostic test on the sample itself.
- Device Description: The descriptions focus on the mechanism for puncturing the skin and collecting blood, not on any analytical or diagnostic function.
- Lack of Diagnostic Function: There is no mention of the devices analyzing the blood sample or providing any diagnostic information. They are purely for sample collection.
While the blood collected by these lancets is intended for testing (which would be performed by an IVD), the lancets themselves are classified as blood lancets (under 21 CFR 878.4850(a)), which are surgical devices used for obtaining blood samples. They are not the diagnostic instruments.
N/A
Intended Use / Indications for Use
BD Microtainer® Contact-Activated Lancets: The BD Microtaine® Contact-Activated Lancet is a sterile, single-use, permanently retracting, lancing device used to perform fingerstick punctures in in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs}). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood.
BD Microtainer® Quikheel™ Lancets: The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neomates, pre-term (preemie) and full-term infants (non-walking) to obtain capillary blood specimens for testing utilizing small amounts of blood.
Product codes
FMK
Device Description
BD Microtainer® Contact-Activated Lancets: The BD Microtainer® Contact-Activated Lancets are sterile, single-use lancets with a permanently retracting stainless steel needle or blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Contact-Activated Lancet needle/blade is never visible and remains sterile until the protective tab cap is removed. The BD Microtainer® Contact-Activated Lancet is activated by applying pressure against the puncture site upon contact; after skin puncture, the needle/blade returns into the device. Once activated, the device is auto-disabled and cannot be re-used (when used as intended) to minimize the chance of an accidental fingerstick and contamination.
The BD Microtainer® Contact-Activated Lancets are made up of the following key functional components:
- Rear Cap
- Drive Spring
- Lever Element
- Needle Carrier with Protective Tab
- Return Spring
- Shield
- Main Housing
- Tab Cap
- Silicone Lubricant
BD Microtainer® Quikheel™ Lancets: The BD Microtainer® Quikheel™ Lancets are sterile, single-use lancets with a permanently retracting stainless steel blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Quikheel™ Lancets consist of a front and back housing, a trigger, and a spring onto which a stainless-steel blade is mounted. The stainless-steel blade is non-redeployable to minimize the chance of accidental blade stick injury and contamination. The device is designed to produce a very rapid triggering of the blade along a predictable path, for low-trauma sampling.
The BD Microtainer® Quikheel™ Lancets are made up of the following key functional components:
- Front Housing
- Back Housing
- Trigger
- Spring
- Blade
- Silicone Lubricant
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger (for BD Microtainer® Contact-Activated Lancets), Heel (for BD Microtainer® Quikheel™ Lancets)
Indicated Patient Age Range
BD Microtainer® Contact-Activated Lancets: adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs})
BD Microtainer® Quikheel™ Lancets: neonates, pre-term (preemie) and full-term infants (non-walking)
Intended User / Care Setting
Healthcare professional in a clinical 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)
Performance Testing - Bench Summary: Device, biocompatibility, and sterilization testing were conducted on the subject devices to validate that the devices perform as intended over the course of the product shelf life. Results of testing demonstrate acceptable performance for the subject devices.
Performance Testing - Animal Summary: Per the blood lancets classification regulation (21 CFR 878.4850(a)), animal testing is not required for the clearance of the subject devices. Therefore, BD is not submitting any animal performance data in support of this 510(k) submission.
Performance Testing - Clinical Summary: Per the blood lancets classification regulation (21 CFR 878.4850(a)), clinical testing is not required for the clearance of the subject devices. Therefore, BD is not submitting any clinical performance data in support of this 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BD Microtainer® Contact-Activated Lancets, BD Microtainer® Quikheel™ Lancets (previously Class I exempt, reclassified to Class II devices requiring a 510(k) under Docket No. FDA-2016-N-0040 on November 22, 2021)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 16, 2022
Becton, Dickinson and Company Alexandra Kirby Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K223243
Trade/Device Name: BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: October 19, 2022 Received: October 20, 2022
Dear Alexandra Kirby:
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) K223243
Device Name
BD Microtainer® Contact-Activated Lancets and BD Microtainer® Quikheel™ Lancets
Indications for Use (Describe)
BD Microtainer® Contact-Activated Lancets
The BD Microtaine® Contact-Activated Lancet is a sterile, single-use, permanently retracting, lancing device used to perform fingerstick punctures in in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs}). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood.
BD Microtainer® Quikheel™ Lancets
The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neomates, pre-term (preemie) and full-term infants (non-walking) to obtain capillary blood specimens for testing utilizing small amounts of blood.
| Type of Use (Select one or both, as applicable) |
|---|
| Research Use Only (RUO) / For Further Manufacturing |
| For In-Vitro Diagnostic Use (IVD) / Intended Use |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K223243
510(K) SUMMARY 5
BD Microtainer® Contact-Activated Lancets and BD Microtainer® Ouikheel™ Lancets
Summary Preparation Date: December 16, 2022
Submitted by:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885 Phone: (201) 847-6800
Contact:
Alexandra Kirby Staff Regulatory Affairs Specialist Email: Alexandra.Kirby@bd.com Phone: (862) 774-2318
Proprietary Names: BD Microtainer® Contact-Activated Lancets, BD Microtainer® Quikheel™ Lancets
Common or Usual Names: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Regulatory Information
Classification Name: Blood Lancets Classification Regulation: 21 CFR 878.4850(a) Regulatory Class: Class II Product Code: FMK Classification Panel: General & Plastic Surgery
Predicate Device: BD Microtainer® Contact-Activated Lancets, BD Microtainer® Quikheel™ Lancets (previously Class I exempt, reclassified to Class II devices requiring a 510(k) under Docket No. FDA-2016-N-0040 on November 22, 2021)
Device Establishment: Becton, Dickinson and Company
Registration Number: 2243072
Performance Standards:
-
- EN ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
-
- EN ISO 14971:2019 Medical Devices Application of risk management to medical devices
4
-
- EN ISO 23908:2013 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
-
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems*
-
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes*
-
- EN ISO 15223-1:2021 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
-
- EN ISO 20417:2021 Medical devices Information to be supplied by the manufacturer
-
- EN 556-1:2001/AC:2006 Sterilization Of Medical Devices Requirements For Medical Devices To Be Designated "Sterile" - Part 1: Requirements For Terminally Sterilized Medical Devices
-
- EN ISO 11137-1:2015/A2:2019 Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
-
- EN ISO 11137-2:2015 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
-
- EN ISO 11137-3:2017 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
-
- EN ISO 11737-1:2018/A1:2021 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on products
-
- EN ISO 11737-2:2020 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
-
- ISO/TS 13004:2013 Sterilization of health care products Radiation Substantiation of selected sterilization dose: Method VDmax D
-
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- EN ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
-
- ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
5
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
-
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
-
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-
- ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
-
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
-
- ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of materials
-
- ISO 10993-23:2021, Biological Evaluation of Medical Devices Part 23: Tests for irritation.
-
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
-
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Svstems
-
- ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
-
- ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
- EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
-
- EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
-
- EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
-
- CLSI GP42-A7: Collection of Capillary Blood Specimens. 7th Edition
For the BD Microtainer® Contact-Activated Lancets, only partial compliance is claimed for standards marked with an asterisk (*).
Indications for Use
6
BD Microtainer® Contact-Activated Lancets
The BD Microtainer® Contact-Activated Lancet is a sterile, single-use, permanently retracting. lancing device used to perform fingerstick punctures in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs]). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood.
BD Microtainer® Quikheel™ Lancets
The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neonates, pre-term (preemie) and full-term infants (nonwalking) to obtain capillary blood specimens for testing utilizing small amounts of blood.
Device Description
BD Microtainer® Contact-Activated Lancets
The BD Microtainer® Contact-Activated Lancets are sterile, single-use lancets with a permanently retracting stainless steel needle or blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Contact-Activated Lancet needle/blade is never visible and remains sterile until the protective tab cap is removed. The BD Microtainer® Contact-Activated Lancet is activated by applying pressure against the puncture site upon contact; after skin puncture, the needle/blade returns into the device. Once activated, the device is auto-disabled and cannot be re-used (when used as intended) to minimize the chance of an accidental fingerstick and contamination.
The BD Microtainer® Contact-Activated Lancets are made up of the following key functional components:
-
- Rear Cap
-
- Drive Spring
-
- Lever Element
-
- Needle Carrier with Protective Tab
-
- Return Spring
-
- Shield
-
- Main Housing
-
- Tab Cap
-
- Silicone Lubricant
BD Microtainer® Quikheel™ Lancets
The BD Microtainer® Quikheel™ Lancets are sterile, single-use lancets with a permanently retracting stainless steel blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Quikheel™ Lancets consist of a front and back housing, a trigger, and a spring onto which a stainless-steel blade is mounted. The stainless-steel blade is non-redeployable to minimize the chance of accidental blade stick injury
7
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
and contamination. The device is designed to produce a very rapid triggering of the blade along a predictable path, for low-trauma sampling.
The BD Microtainer® Quikheel™ Lancets are made up of the following key functional components:
-
- Front Housing
-
- Back Housing
-
- Trigger
-
- Spring
-
- Blade
-
- Silicone Lubricant
Substantial Equivalence1
The subject and predicate device are substantially equivalent as described in Table 1 and Table 2.
| Table 1 | BD Microtainer® Contact-Activated Lancet Substantial Equivalence
Comparison | | |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Subject Device
BD Microtainer®
Contact-Activated
Lancets | Predicate Device
BD Microtainer®
Contact-Activated
Lancets² | Comparison |
| Device
Classification | Class II requiring a 510(k) | Class I 510(k) exempt | The subject BD Microtainer®
Contact-Activated Lancets
devices were reclassified from
Class I exempt devices not
requiring a 510(k) to Class II
devices requiring a 510(k)
under Docket No. FDA-2016-
N-0040, effective November
22, 2021. |
| Characteristic | Subject Device
BD Microtainer®
Contact-Activated
Lancets | Predicate Device
BD Microtainer®
Contact-Activated
Lancets2 | Comparison |
| Intended Use /
Indications for Use | The BD Microtainer®
Contact-Activated Lancet
is a sterile, single-use,
permanently retracting,
lancing device used to
perform fingerstick
punctures in in adults,
adolescents, children, and
infants (greater than 6
months of age and 10 kg
(22 lbs)). The device is
intended to be used by a
healthcare professional in
a clinical setting to obtain
capillary blood specimens
for testing utilizing small
amounts of blood. | The BD Microtainer®
Contact-Activated Lancet
is a sterile, single-use,
permanently retracting,
lancing device used to
perform fingerstick
punctures in in adults,
adolescents, children, and
infants. The device is
intended to be used by a
healthcare professional in a
clinical setting to collect
capillary blood specimens
for diagnostic testing. | The current intended use
statement has been converted
to an indications for use
statement for this initial
510(k) submission. The
subject devices' intended
use/indications for use also
incorporates a minimum age
and weight indication
consistent with
recommendations outlined for
fingerpricks in CLSI GP42-
A7: Collection of Capillary
Blood Specimens, 7th Edition
(FDA Recognition Number 7-
301) and WHO Guidelines On
Drawing Blood: Best Practices
In Phlebotomy. The proposed
indications for use only add
specificity and clarity about
what minimum age/weight
criteria are appropriate for the
fingerstick; the changes do not
result in a new intended use. |
| Target Population | Adults, adolescents,
children, and infants
(greater than 6 months of
age and 10 kg (22 lbs)) | Adults, adolescents,
children, and infants | This proposed modification
incorporates a minimum age
and weight indication
consistent with
recommendations outlined for
fingerpricks in CLSI GP42-
A7: Collection of Capillary
Blood Specimens, 7th Edition
(FDA Recognition Number 7-
301) and WHO Guidelines On
Drawing Blood: Best Practices
In Phlebotomy. The proposed
indications for use only add
specificity and clarity about
what minimum age/weight
criteria are appropriate for the
fingerstick; the changes do not
result in a new target
population. |
| Device Design | | | |
| Models | 366592
366593
366594
366599 | 366592
366593
366594
366599 | Same |
| Colors | Purple, Pink, Blue | Purple, Pink, Blue | Same |
| Types of Lancing
Device | Needle, Blade | Needle, Blade | Same |
| Characteristic | Subject Device
BD Microtainer®
Contact-Activated
Lancets | Predicate Device
BD Microtainer®
Contact-Activated
Lancets2 | Comparison |
| Needle/Blade
Depths | 1.5 mm, 1.8 mm, 2.0 mm | 1.5 mm, 1.8 mm, 2.0 mm | Same |
| Needle/Blade
Gauges/Widths | 30G (0.31 mm), 21G
(0.81 mm), 1.5 mm | 30G (0.31 mm), 21G (0.81
mm), 1.5 mm | Same |
| Blood Flows | Low, Medium, High | Low, Medium, High | Same |
| Device Materials | | | |
| Needle Carrier with
Protective Tab | Polystyrene | Polystyrene | Same |
| Main Housing/Tab
Cap/Rear Cap | Polypropylene | Polypropylene | Same |
| Shield | Polyethylene | Polyethylene | Same |
| Lever Element | Acrylonitrile butadiene
styrene (ABS) | Acrylonitrile butadiene
styrene (ABS) | Same |
| Drive Spring | Steel tinned wire | Steel tinned wire | Same |
| Return Spring | Steel tinned wire | Steel tinned wire | Same |
| Needle/Blade | Stainless steel | Stainless steel | Same |
| Needle/Blade
Lubricant | Silicone fluid | Silicone fluid | Same |
| Materials | Compliant with ISO
10993 series | Compliant with ISO 10993
series | Same |
| Packaging and Sterility | | | |
| Sterile Needle
Carrier and
Needle/Blade | Yes | Yes | Same |
| Sterility Assurance
Level (SAL) 10-6 | Yes | Yes | Same |
| Sterilization Method | Gamma irradiation | Gamma irradiation | Same |
| Shelf Life | 5 years | 5 years | Same |
| Contains Packaging
Support Insert | No | Yes | To accommodate the new,
standalone IFU created for the
subject BD Microtainer®
Contact-Activated Lancets,
the shelf carton height and the
shelf box material density will
be increased. The increased
shelf carton height and density
will also result in the removal
of a support insert previously
used to hold the box together.
Ship testing was conducted to
support this packaging change. |
1 The term "substantial equivalence" as used in this 510(k) Notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. 2 Per Docket No. FDA-2016-N-0040, " . . any 510(k)-exempt blood lances legally offered for sale on or before November 22, 2021, can serve as
predicates for substantial equivalence purposes.'
8
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management Becton, Dickinson and Company
9
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management Becton, Dickinson and Company
10
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management
Becton, Dickinson and Company
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Characteristic | BD Microtainer® | ||
| Quikheel™ Lancets | BD Microtainer® | ||
| Quikheel™ Lancets3 | Comparison | ||
| Device | |||
| Classification | Class II requiring a 510(k) | Class I 510(k) exempt | The subject BD |
| Microtainer® | |||
| Quikheel™ Lancets | |||
| devices were | |||
| reclassified from Class | |||
| I exempt devices not | |||
| requiring a 510(k) to | |||
| Class II devices | |||
| requiring a 510(k) | |||
| under Docket No. | |||
| FDA-2016-N-0040, | |||
| effective November | |||
| 22, 2021. | |||
| Intended Use / | |||
| Indications for Use | The BD Microtainer® | ||
| Quikheel™ Lancet is a sterile, | |||
| single-use medical device with | |||
| a push-button activated, | |||
| permanently retracting blade. | |||
| The device is intended to be | |||
| used by healthcare | |||
| professionals to perform heel | |||
| sticks in neonates, pre-term | |||
| (preemie) and full-term infants | |||
| (non-walking) to obtain | |||
| capillary blood specimens for | |||
| testing utilizing small amounts | |||
| of blood. | The BD Microtainer® | ||
| Quikheel™ Lancet is a sterile, | |||
| single-use medical device with | |||
| a push-button activated, | |||
| permanently retracting blade. | |||
| The device is intended to be | |||
| used by healthcare | |||
| professionals to perform heel | |||
| sticks in neonates, pre-term | |||
| (preemie) and full-term infants | |||
| (non-walking) to obtain | |||
| capillary blood specimens for | |||
| testing utilizing small amounts | |||
| of blood. | The current intended | ||
| use statement has been | |||
| converted to an | |||
| indications for use | |||
| statement for this | |||
| initial 510(k) | |||
| submission. | |||
| Target Population | Neonates, Premature And Full | ||
| Term Infants | Neonates, Premature And Full | ||
| Term Infants | Same | ||
| Device Design | |||
| Models | 368100 | ||
| 368101 | 368100 | ||
| 368101 | Same | ||
| Colors | Pink, Teal | Pink, Teal | Same |
| Incision Depths | 0.85 mm, 1.00 mm | 0.85 mm, 1.00 mm | Same |
| Incision Lengths | 1.75 mm, 2.50 mm | 1.75 mm, 2.50 mm | Same |
| Blood Flows | Low, High | Low, High | Same |
| Device Materials | |||
| Blade (infant) and | |||
| Blade (preemie) | Stainless steel | Stainless steel | Same |
| Spring | Polycarbonate | Polycarbonate | Same |
| Trigger | Polycarbonate | Polycarbonate | Same |
| Internal Trigger/ | |||
| Spring Lubricant | Silicone Fluid | Silicone Fluid | Same |
| Housing (front/back) | Polystyrene | Polystyrene | Same |
| Materials | Compliant with ISO 10993 | Compliant with ISO 10993 | Same |
| BD Microtainer® Ouikheel™ Lancet Substantial Equivalence Comparison
| Table 2 | ||||
|---|---|---|---|---|
| -------------------------------------------------------------------------------- | -- | -- | -- | -- |
3 Per Docket No. FDA-2016-N-0040, " ...ary 510(k)-exempt blood lancets legally offered for sale on or before November 22, 2021, can serve as predicates for substantial equivalence purposes."
11
BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management Becton, Dickinson and Company
| Characteristic | Subject Device
BD Microtainer®
QuikheelTM Lancets | Predicate Device
BD Microtainer®
QuikheelTM Lancets3 | Comparison |
|-----------------------------------------|---------------------------------------------------------|------------------------------------------------------------|------------|
| Packaging and Sterility | | | |
| Sterile | Yes | Yes | Same |
| Sterility Assurance
Level (SAL) 10-6 | Yes | Yes | Same |
| Sterilization Method | Gamma irradiation | Gamma irradiation | Same |
| Shelf Life | 5 years | 5 years | Same |
As provided in Table 1 and Table 2, the subject devices and their respective predicates use the same operating principles, incorporate the same detailed designs, are manufactured from the same materials, are sterilized using the same method (gamma irradiation) with the same SAL of 10°, use the same technological characteristics, have identical shelf lives (5 years), are packaged using similar sterile barrier and case materials, and have the same intended use. The new indications for use established as part of this 510(k) submission align with the respective predicates' intended uses.
The subject BD Microtainer® Contact-Activated Lancets' intended use incorporates a minimum age and weight indication consistent with recommendations outlined for fingerpricks in CLSI GP42-A7: Collection of Capillary Blood Specimens, 7th Edition (FDA Recognition Number 7-301) and WHO Guidelines On Drawing Blood: Best Practices In Phlebotomy. The proposed indications for use only add specificity and clarity about what minimum age/weight criteria are appropriate for the fingerstick; the changes do not result in a new intended use.
The subject and predicate BD Microtainer® Quiltheel™ Lancets have the same intended use. The current intended use statement has been converted to an indications for use statement for this initial 510(k) submission.
Performance Testing - Bench Summary
Device, biocompatibility, and sterilization testing were conducted on the subject devices to validate that the devices perform as intended over the course of the product shelf life. Results of testing demonstrate acceptable performance for the subject devices.
Performance Testing - Animal Summary
Per the blood lancets classification regulation (21 CFR 878.4850(a)), animal testing is not required for the clearance of the subject devices. Therefore, BD is not submitting any animal performance data in support of this 510(k) submission.
Performance Testing - Clinical Summarv
Per the blood lancets classification regulation (21 CFR 878.4850(a)), clinical testing is not required for the clearance of the subject devices. Therefore, BD is not submitting any clinical performance data in support of this 510(k) submission.
Conclusion
12
In summary, the BD Microtainer® Contact-Activated Lancets have the same intended use as their predicate device, and a new indication for use statement which aligns to this intended use. The BD Microtainer® Quikheel™ Lancets have the same intended use as their predicate device, and the indications for use statement is identical to the predicate's intended use statement. In addition, the BD Microtainer® Contact-Activated Lancets and BD Microtainer® Quikheel™ Lancets have the same technological characteristics and principles of operation as their respective predicates. Performance testing confirms that the subject devices perform as intended and are as safe and effective as their respective predicate devices.
The subject devices were reclassified from Class I exempt devices not requiring a 510(k) to Class II devices requiring a 510(k) under Docket No. FDA-2016-N-0040, effective November 22, 2021. This 510(k) serves as BD's initial 510(k) submission for these devices in response to the reclassification and 510(k) requirement.
Based on information provided, the proposed devices are substantially equivalent to their respective predicate devices.