(203 days)
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI or ML.
No.
The device is used to collect capillary blood for testing purposes. It does not treat or cure any condition.
No
The device is described as a lancing device used to collect capillary blood samples, not to perform a diagnosis. It is a tool for blood collection, which may then be used for diagnostic testing through other devices like a glucometer.
No
The device description explicitly states it is made of ABS plastic and SUS304 stainless-steel springs and describes its mechanical function, indicating it is a physical hardware device.
Based on the provided text, the EasyTouch™ Lancing Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases, conditions, or infections. The testing is done in vitro (in a test tube or other artificial environment).
- Function of the EasyTouch Lancing Device: The EasyTouch Lancing Device's primary function is to collect the blood sample by puncturing the skin. It does not perform any analysis or testing on the blood itself.
- Intended Use: The intended use clearly states it is "to collect capillary blood for testing purposes." The testing itself is done by a separate device (like a blood glucose meter and test strips), which would be considered an IVD.
- Device Description: The description focuses on the mechanical aspects of the device for skin puncture and lancet handling.
Therefore, the EasyTouch™ Lancing Device is a medical device used in conjunction with IVDs (like blood glucose meters and test strips) to obtain the necessary sample, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.
Product codes (comma separated list FDA assigned to the subject device)
QRK, QRL
Device Description
The EasyTouch Lancing Device is used with the FreeStyle Lancet, which was cleared under 510(k) K221433 under the device name Facet 28GUniversal Lancet
The intended use of the EasyTouch Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites.
The EasyTouch Lancing Device is made of ABS plastic and SUS304 stainless-steel springs.
The EasyTouch Lancing Device has 8 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is removed. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with soap and warm water and allowed to air dry after each use and disinfected per the IFU, as needed.
If the patient is testing from a site other than the finger an optional AST Cap may be put onto the device instead of the "standard" lancing device end cap.
The EasyTouch Lancing Device has an Alternative Site Test (AST) Cap, which is not sold separately. The AST Cap id only provided with the meter kit alongside the lancing device. The AST Cap allows the user to obtain a blood sample from parts of the body other than the fingers. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the lancing device end cap, followed by wiping dry. The device is disinfected via wiping down with a cloth dampened in a bleach wipes) and allowed to air dry.
The Alternate Site Testing (AST) Cap is a single-person multi-use optional plastic accessory for the lancing device. It may be used in place of the original lancing device end cap when a patient is taking a blood sample from a site on the body other than the finger. Proper use of the device requires that the user first verify with their physician and the Instructions for Use of the blood glucose test strips or meter they are using to determine if AST testing is appropriate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, upper arm, forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single patient use in a 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. Physical testing included dimensional measurements, function reliability drop test, piercing depth test, and cock force test. Biocompatibility was evaluated through a battery of tests to meet ISO 10993-1 requirements:
- MEM Elution Cytotoxicity .
- Kligman Maximization
- . Intracutaneous Injection
Compatibility between the FreeStyle Lancets and the EasyTouch Lancing Device was tested previously under 510(k) K221433 under the device name Facet 28GUniversal Lancet, which is the same device as the FreeStyle Lancets.
Clinical testing was not required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2023
STAT Medical Devices % Kevin Walls Principal Consultant FDA Compliance Group 33 Golden Eagle Lane Littleton, Colorado 80127
Re: K222617
Trade/Device Name: EasyTouch Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK, QRL Dated: March 2, 2023 Received: March 2, 2023
Dear Kevin Walls:
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,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2013.03.21
15:45:58 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
EasyTouch Lancing Device
Indications for Use (Describe)
The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
3
EasyTouch Lancing Device 510(k) Summary
Date of Preparation
March 17, 2023
Name and Address of Sponsor
STAT Medical Devices 2056 N.E. 153rd Street North Miami Beach, FL 33162 Hemel Mariano (Quality Manager) 305-945-0011 Ext. 312 hmariano@statdevices.com
Establishment Registration Number: 1058955
Name and Address of Official Correspondent
FDA Compliance Group 33 Golden Eagle Lane Littleton, Colorado 80127 Contact: Mr. Kevin Walls. MBA Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
Device Information
Trade Name: EasyTouch Lancing Device Common Name: Blood Lancets & Lancing Devices Classification Name: Blood Lancets Regulation Number: 878.4850, Class II Product Code: QRL, QRK
Device Description
The EasyTouch Lancing Device is used with the FreeStyle Lancet, which was cleared under 510(k) K221433 under the device name Facet 28GUniversal Lancet
The intended use of the EasyTouch Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites.
The EasyTouch Lancing Device is made of ABS plastic and SUS304 stainless-steel springs.
The EasyTouch Lancing Device has 8 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing
4
device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is removed. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with soap and warm water and allowed to air dry after each use and disinfected per the IFU, as needed.
If the patient is testing from a site other than the finger an optional AST Cap may be put onto the device instead of the "standard" lancing device end cap.
The EasyTouch Lancing Device has an Alternative Site Test (AST) Cap, which is not sold separately. The AST Cap id only provided with the meter kit alongside the lancing device. The AST Cap allows the user to obtain a blood sample from parts of the body other than the fingers. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the lancing device end cap, followed by wiping dry. The device is disinfected via wiping down with a cloth dampened in a bleach wipes) and allowed to air dry.
The Alternate Site Testing (AST) Cap is a single-person multi-use optional plastic accessory for the lancing device. It may be used in place of the original lancing device end cap when a patient is taking a blood sample from a site on the body other than the finger. Proper use of the device requires that the user first verify with their physician and the Instructions for Use of the blood glucose test strips or meter they are using to determine if AST testing is appropriate.
Indications for Use
The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.
Legally Marketed Predicate Device
Predicate #: K214022
Predicate Trade Name: Accu-Chek Softclix Blood Lancing System
Manufacturer: Roche Diabetes Care, Inc.
Product Code: QRL, QRK
Reference Device
TRUEdraw Lancing Device, Mini Lancing Device (K221072) is a reference device regarding the absence of an ejector sleeve.
5
Similarities and Differences between Candidate Device and Predicate Device:
| | Candidate Device - EasyTouch Lancing
Device | Predicate Device – Accu-Chek Softclix
Blood Lancing System K214022 | Reference Device - TRUEdraw Lancing
Device, Mini Lancing Device K221072 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Device
Description | EasyTouch Lancing Device uses the
Abbott FreeStyle Lancets to obtain a | Accu-Chek Softclix Blood Lancing
Device uses Accu-Chek Softclix Lancets | The TRUEdraw Lancing Device/ Mini
Lancing Device is a reusable blood |
| | drop of blood from a fingertip or
alternate sites using the Stat Medical
Alternate Site Testing (AST) Cap. | to obtain a drop of blood from a
fingertip or alternate sites using the
Accu-Chek Softclix Alternate Site
Testing (AST) Cap. | lancet holder intended to be used in
conjunction with a sterile, single-use
blood lancet for obtaining a capillary
blood sample for testing purposes from
the fingertip and from alternative sites,
such as the forearm. |
| Intended
Use | EasyTouch Lancing Device is intended
for the hygienic collection of capillary
blood for testing purposed from the
side of a finger and from alternate site,
such as the palm, the upper arm, and
the forearm. | Accu-Chek Softclix Blood Lancing
Device System is intended for the
hygienic collection of capillary blood
for testing purposed from the side of a
finger and from alternate site, such as
the palm, the upper arm, and the
forearm. | TRUEdraw
Lancing Device/ Mini Lancing Device is
intended for multiple use by a single
patient. |
| Indications
for Use | The EasyTouch™ Lancing Device is for
use with FreeStyle Lancets to collect
capillary blood for testing purposes
from the fingertip and from alternate
sites, such as the palm, the upper arm,
or the forearm. The EasyTouch Lancing
Device is for single patient use in a
home setting. | The Accu-Chek Softclix Blood Lancing
System is intended for the hygienic
collection of capillary blood for testing
purposes from the side of a fingertip
and from alternative sites, such as the
palm, the upper arm, and the forearm.
The sterile, single-use lancets are to be
used with the reusable lancing device
that is to be cleaned and disinfected | The TRUEdraw Lancing Device is for use
with a disposable sterile lancet for the
hygienic collection of capillary blood
for testing purposes from the side of a
fingertip and from alternative sites,
such as the forearm.
The Mini Lancing Device is for use with
a disposable sterile lancet for the
hygienic collection of capillary blood
for testing purposes from the side of a |
| | | between each use, and then the
lancets are to be disposed of.
This system is for use only on a single
patient in a home setting.
This system is not suitable for use by
healthcare professionals with multiple
patients in a healthcare setting. | fingertip and from alternative sites,
such as the forearm.
The TRUEdraw Lancing Device/ Mini
Lancing Device is for use only on a
single patient in a home setting.
The TRUEdraw Lancing Device/ Mini
Lancing Device is not suitable for use
by healthcare professionals with
multiple patients in a healthcare
setting. |
| Number of
Uses | Base (lancing device) – multiple use
Lancet - single use | Base (lancing device) – multiple use
Lancet - single use | Base (lancing device) – multiple use
Lancet - single use |
| Device
Images | Lancing Device & AST Cap:
Image: Lancing Device & AST Cap | Lancing Device & AST Cap:
Image: Lancing Device & AST Cap | Not available |
6
7
| Freestyle Lancet (K221433): | Lancet: | ||
|---|---|---|---|
| Image: Freestyle Lancet | Image: Lancet | ||
| Lancet | |||
| Sterility | Yes, gamma irradiation | Yes, gamma irradiation | Not available |
| Needle | 0.33mm (28G); beveled cut with 3 | ||
| facets (both lancets) | 0.4mm (28G); beveled cut with 3 facets | Not available | |
| Depth | |||
| Adjustment | 8 depth settings by sliding lever or | ||
| rotating dial | 11 levels by twisting cap | 5 levels by twisting nozzle/end | |
| cap (finer adjustments can be | |||
| made by setting the indicator | |||
| arrow between the numbers) | |||
| Mechanical | |||
| Loading | Spring-driven | Spring-driven | Spring-driven |
| Load and | |||
| Firing | Load by advancing lancet into holding | ||
| section and pushing down. | Load by pressing priming button when | ||
| lancet is inserted. | Load lancet by pulling back on | ||
| the lance body when the lancet is | |||
| Fire by pressing release button | Fire by pressing release button | inserted. Fire by pressing the | |
| trigger button. | |||
| Anatomical | |||
| Sites | Fingertip | ||
| Ball of hand (palm) | |||
| Upper arm | |||
| Lower arm | Fingertip | ||
| Ball of hand (palm) | |||
| Upper arm | |||
| Lower arm | Fingertip | ||
| Forearm | |||
| Sharps | |||
| Injury | |||
| Prevention | Lancets are covered by a sterile barrier | ||
| cap until twisted or pulled off before | |||
| use. Until firing, the lancet is contained | |||
| within the lancing device housing. | |||
| Immediately after firing, the lancet is | |||
| automatically retracted back into the | |||
| housing. | |||
| Additionally, the users are also | |||
| instructed to save the lancet cap in | |||
| order to reseal the lancets after use for | |||
| the safe removal of the lancet from the | |||
| lancing device. | Lancets are covered by a sterile barrier | ||
| cap until twisted off before use. Until | |||
| firing, the lancet is contained within | |||
| the lancing device housing. | |||
| Immediately after firing, the lancet is | |||
| automatically retracted back into the | |||
| housing. An ejector sleeve can then be | |||
| pulled forward for contactless disposal | |||
| of the lancet. | The users are also instructed to save | ||
| the lancet cap in order to reseal the | |||
| lancets after use for the safe removal | |||
| of the lancet from the lancing device. | |||
| Ejector | |||
| sleeve | No | No | No |
8
9
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. Physical testing included dimensional measurements, function reliability drop test, piercing depth test, and cock force test. Biocompatibility was evaluated through a battery of tests to meet ISO 10993-1 requirements:
- MEM Elution Cytotoxicity .
- Kligman Maximization
- . Intracutaneous Injection
Compatibility between the FreeStyle Lancets and the EasyTouch Lancing Device was tested previously under 510(k) K221433 under the device name Facet 28GUniversal Lancet, which is the same device as the FreeStyle Lancets.
Clinical Testing
Clinical testing was not required to demonstrate substantial equivalence.
Conclusion
The intended use, technology, non-clinical testing, and functionality of the EasyTouch Lancing Device demonstrate a substantially equivalent safety and effectiveness profile to the predicate device.