(217 days)
No
The device description and performance studies focus on mechanical aspects of the lancing device and lancets, with no mention of AI or ML.
No
The device is described as being used for the hygienic collection of capillary blood for testing purposes, which is a diagnostic rather than a therapeutic function.
No
This device is intended for the hygienic collection of capillary blood for testing purposes. It is a lancing device, not a diagnostic device itself. The blood collected may then be used with a separate diagnostic device.
No
The device description explicitly details physical components made of plastic and stainless steel, indicating it is a hardware device, not software-only.
Based on the provided information, the Stat Medical Lancing Device Systems are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the collection of capillary blood for testing purposes. It does not perform the testing itself.
- Device Description: The description details the physical components used for obtaining a blood sample (lancing devices and lancets). It does not describe any components that analyze or test the blood sample.
- Lack of Testing Function: The device's function is to create a small puncture to allow blood to be collected. It does not contain reagents, sensors, or any other elements that would perform a diagnostic test on the blood.
- Performance Studies: The performance studies mentioned are related to the physical function and safety of the lancing device (biocompatibility, force testing, etc.), not the accuracy or performance of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Stat Medical Lancing Device Systems are a tool used to obtain the sample for an IVD test, but they are not the IVD test itself.
N/A
Intended Use / Indications for Use
Stat Medical Lancing Device Systems are intended for the hygienic collection of capillary blood for testing purposes from the side of a finger and from alternate site, such as the palm, the upper arm, and the forearm. The Stat Medical Lancing Device Systems are for single patient use in a home setting.
Product codes
QRL, QRK
Device Description
The Stat Medical Lancing Device Systems consist of two types of lancing devices: ULTIMATE Lancing Device and TRIO Lancing Device. These systems also include two types of representative (generic) lancets: COMFORT THIN Twist-Off Lancets and COMFORT THIN Pull-Off Lancets.
The ULTIMATE Lancing Device is a single-person, multiple-use device made of ABS plastic and SUS304 stainless-steel springs, with 8 depth-setting choices. Its intended use 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. It has an optional Alternative Site Test (AST) Cap.
The TRIO Lancing Device is also a single-person, multiple-use device made of ABS plastic and SUS304 stainless-steel springs, with 5 depth-setting choices and a lancet ejector. Its intended use 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. It also has an optional Alternative Site Test (AST) Cap.
The COMFORT THIN Twist-Off Lancets are sterile, single-person, single-use devices made of LDPE plastic with a SUS304 stainless-steel needle tip and an LDPE injection-molded plastic cover over the sterile tip. They come in various needle gauge sizes (28g, 29g, 30g, 33g) and are provided sterile.
The COMFORT THIN Pull-Off Lancets are sterile, single-person, single-use devices made of ABS and PP plastic with a SUS304 stainless-steel needle tip and an ABS and PP plastic cover over the sterile tip. They also come in various needle gauge sizes (21G, 28G, 29G, 30G, 33G) and are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
side of a finger and from alternate site, such as the palm, the upper arm, and the 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 Testing Summary and Conclusions
Biocompatibility Testing: The medical device in its final finished form is identical to the EasyTouch Lancing Device (510(k) K222617) in formulation, processing, sterlization, and geometry and no other chem added (e.g., plasticizers, fillers, addlives, cleaning agents).
Performance Testing: The following tests were performed: Pent testing, cock force testing, insertion force testing, removal force testing, and migration distance testing.
The device complies with the following standards:
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Clinical Testing: Clinical testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable and communicated in the instructions for use (FU) as warnings. There were no special performance or safety concerns identified.
Conclusion: The results of nonclinical testing demonstrate that the same or similar to the predicate devices K214022 and K221072 and should perform as intended in the specified use conditions as well as the predicate device per required standards.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 8, 2023
STAT Medical Devices % Kevin Walls Senior Consultant FDA Compliance Group 33 Golden Eagle Lane Littleton, Colorado 80127
Re: K230310
Trade/Device Name: STAT Medical Device Lancing System Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: August 8. 2023 Received: August 8, 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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-reporting-
combination-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.
Jessica Carr -S
for Mark Trumbore, Ph.D., GWCPM 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)
K230310
Device Name
The STAT Medical Lancing Device Systems
Indications for Use (Describe)
Stat Medical Lancing Device Systems are intended for the hygienic collection of capillary blood for testing purposes from the side of a finger and from alternate site, such as the palm, the upper arm, and the forearm. The Stat Medical Lancing Device Systems are for single patient use in a home setting.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
凶 Over-The-Counter Use (21 CFR 801 Subpart C) _ Prescription Use (Part 21 CFR 801 Subpart D)
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3
STAT Medical Lancing Device Systems 510(k) Summary
Date Prepared
September 5, 2023
Name and Address of Sponsor
STAT Medical Devices 2056 N.E. 153ª 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: STAT Medical Lancing Device Systems
- ULTIMATE Lancing Device
- TRIO Lancing Device
- . Comfort Thins Twist-Off Lancet (K222034)
- . Comfort Thins Pull Off Lancet (K221383)
Common Name: Blood Lancets & Lancing Devices
Regulation Name: Blood Lancets
Regulation Number: 878.4850, Class II
Product Code: QRL, QRK
Device Description
The Stat Medical Lancing Device Systems consist of two types of lancing devices:
ULTIMATE Lancing Device
Single-person, multiple-use device
Made of ABS plastic and SUS304 stainless-steel springs.
8 depth-setting choices
4
TRIO Lancing Device
Single-person, multiple-use device Made of ABS plastic and SUS304 stainless-steel springs. 5 depth-setting choices Lancet Ejector
The Stat Medical Lancing Device Systems consist of two types of representative (generic) . lancets:
COMFORT THIN Twist-Off Lancets
Sterile, single-person, single use device Made of LDPE plastic with a SUS304 stainless-steel needle tip LDPE injection-molded, plastic cover over the sterile tip
COMFORT THIN Pull-Off Lancets
Sterile, single-person, single use device
Made of ABS and PP plastic with a SUS304 stainless-steel needle tip
ABS and PP plastic cover over the sterile tip
ULTIMATE Lancing Device
Device Catalog Number: SM-QLU-L02
AST Cap Catalog Number: SM-QLU-A02
The intended use of the ULTIMATE 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 ULTIMATE Lancing Device is made of ABS plastic and SUS304 stainless-steel springs.
The ULTIMATE 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 ULTIMATE Lancing Device has an Alternative Site Test (AST) Cap, which may be purchased separately. The AST cap allows the user to obtain a blood sample from parts of the body other
5
than the fingers. (The user must refer to their Glucose Meter Instructions for Use for the meter/test strips they are using for identification of alternative test sites.). 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 solution (bleach wipes) and allowed to air dry.
TRIO Lancing Device
Device Catalog Number: SM-TLD-L02
AST Cap Catalog Number: SM-TLD-A02
The intended use of the TRIO 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 TRIO Lancing Device is made of ABS plastic and SUS304 stainless-steel springs.
The TRIO has 5 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 using the lancet ejector. It is then disposed of into an appropriate sharps container. The lancing device end cap and device are cleaned after each use and when they are visibly dirty or show signs of blood and before disinfection but are cleaned at least once per week. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the device and lancing device end cap, followed by wiping dry. Disinfection involves use of a wipe with a bleach solution or bleach wipes. The lancing device end cap is disinfected and allowed to air dry.
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 TRIO Lancing Device has an Alternative Site Test (AST) Cap, which may be purchased separately. The AST cap allows the user to obtain a blood sample from parts of the body other than the fingers. (The user must refer to their Glucose Meter Instructions for Use for the meter/test strips they are using and healthcare professional for identification of alternative test sites.). The AST cap is cleaned and disinfected in the same manner as the lancing device and standard cap.
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 qlucose test strips or meter they are using to determine if AST testing is appropriate.
Comfort Thins Twist-Off Lancets
The Comfort Thins Twist-Off Lancet has 2 parts, the lancet cannula that includes the lancet point (solid stainless-steel needle), and the lancet body that includes the protective cover (or tab) of the device which are molded together and the tab is twisted off for use by the end user.
The Comfort Thins Twist-Off Lancet body and cover are made of LDPE plastic. The needle is
6
made from SUS304 stainless steel. The device is provided sterile and is for single-use only.
Comfort Thins Twist-Off Lancets are offered in a variety of needle gauge sizes. The table below provides a list of the devices available from SMD.
| Product Name | Catalog Number |
|---|---|
| Comfort Thins Twist-Off 28g | SCT-100 (28G) |
| Comfort Thins Twist-Off 29g | STX-100 (29G) |
| Comfort Thins Twist-Off 30g | STM-100 (30G) |
| Comfort Thins Twist-Off 33g | STU-100 (33G) |
The Comfort Thins Twist-Off Lancets do not have any accessories and do not require interaction with other devices in order to function. However, it is recommended that the lancet be loaded into a standard lancing device for use.
Comfort Thins Lancets - Pull Off
The Comfort Thins Lancet has 2 parts, the lancet cannula that includes the lancet point (solid stainless-steel needle), and the lancet body that includes the protective cover (hollow cap) of the device.
The Comfort Thins Lancet's body and cover are made of ABS and PP plastics. The needle is made from stainless steel SUS304. The device is provided sterile and is for single-use only.
Comfort Thins Pull Off Lancets are offered in a variety of needle gauge sizes. The table below provides a list of the devices available from SMD.
| Product Name | Catalog Number |
|---|---|
| Comfort Thins MACRO Lancets | SCA-100 (21G) |
| Comfort Thins Lancets | SCR-100 (28G) |
| Comfort Thins XTRA Lancets | SCX-100 (29G) |
| Comfort Thins MICRO Lancets | SCM-100 (30G) |
| Comfort Thins ULTRA Lancets | SCU-100 (33G) |
The Comfort Thins Pull Off Lancets do not have any accessories and do not require interaction with other devices in order to function. However, it is recommended that the lancet be loaded into a standard lancing device for use.
Indications for Use
Stat Medical Lancing Device Systems are intended for the hygienic collection of capillary blood for testing purposes from the side of a finger and from alternate site, such as the palm, the upper arm, and the forearm. The Stat Medical Lancing Device Systems are 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
7
Similarities and Differences between Candidate Device and Predicate Device:
| | Candidate Device - Stat Lancing
Device System | Predicate Device - Accu-Chek Softclix
Blood Lancing System K214022 | Reference Device - TRUEdraw Lancing
Device, Mini Lancing Device K221072 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manu-
facturer | STAT Medical Devices | Roche Diabetes Care, Inc. | Trividia Health |
| Device
Description | Stat Medical Lancing Device Systems
use Stat Medical and representative
lancets to obtain a drop of blood from a
fingertip or alternate sites using the
Stat Medical Alternate Site Testing
(AST) Cap. | Accu-Chek Softclix Blood Lancing
Device uses Accu-Chek Softclix
Lancets to obtain a drop of blood from
a fingertip or alternate sites using the
Accu-Chek Softclix Alternate Site
Testing (AST) Cap. | The TRUEdraw Lancing Device/ Mini
Lancing Device is a reusable blood
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 | The Stat Medical Lancing Device
Systems are intended for the hygienic
collection of capillary blood for testing
purposes from the side of a finger and
from alternate site, such as the palm,
the upper arm, and the forearm. The
Stat Medical Lancing Device Systems
are for single patient use in a home
setting. | 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 | Stat Medical Lancing Device Systems
are intended for the hygienic collection
of capillary blood for testing purposes
from the side of a finger and from
alternate site, such as the palm, the
upper arm, and the forearm. The Stat
Medical Lancing Device Systems are
for single patient use in a home setting. | The Accu-Chek Softclix sterile, single-
use lancets are to be used with the
reusable lancing device that is to be
cleaned and disinfected between each
use, and then the lancets are to be
disposed of.
The 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 | 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
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 |
8
9
Image /page/9/Figure/1 description: This image shows different lancing devices and lancets. There are two different lancing devices with AST caps, one is gray and the other is black. There is also a TRIO device with an AST cap. Finally, there are two different types of lancets: twist-off and pull-off, as well as a picture of a regular lancet.
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| Lancet
| Sterility | Yes, gamma irradiation | Yes, gamma irradiation | |
|---|---|---|---|
| Needle | 0.33mm (28G); beveled cut with 3 facets (both lancets) | 0.4mm (28G); beveled cut with 3 facets | |
| Depth | |||
| Adjustment | TRIO – 5 depth settings | ||
| ULTIMATE – 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) | |
| Range of | |||
| Depth | |||
| (mm) | |||
| *30 | |||
| samples* | Length of Lancet (MM) | Length of Lancet (MM) | N/A |
| Minimum: 26.23 | |||
| Max: 26.63 |
Ultimate Lancing Device
Depth 1 Minimum: 0.095 Max: 0.665
Depth 2 Minimum: 0.285 Max: 0.855
Depth 3 Minimum: 0.38 Max: 0.855
Depth 4 Minimum: 0.475 Max: 0.855
Depth 5 Minimum: 0.475 Max: 0.855
Depth 6 Minimum: 0.57 Max: 0.855
Depth 7 Minimum: 0.57 Max: 0.95
Depth 8 Minimum: 0.665 Max: 0.95
Length of Lancet (MM)
Minimum: 26.23 Max: 26.63
TRIO Lancing Device | Minimum: 25.22
Max: 25.31
Level 1 Minimum: 0 Max: 0.095
Level 2 Minimum: 0.095 Max: 0.38
Level 3 Minimum: 0.19 Max: 0.475
Level 4 Minimum: 0.38 Max: 0.665
Level 5 Minimum: 0.475 Max: 0.665
Level 6 Minimum: 0.475 Max: 0.76
Level 7 Minimum: 0.57 Max: 0.855
Level 8 Minimum: 0.57 Max: 0.855
Level 9 Minimum: 0.665 Max: 0.855
Level 10 Minimum: 0.665 Max: 0.95
Level 11 Minimum: 0.76 Max: 0.95 | |
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| Depth 1 Minimum: 0.095 | Max: 0.38 | ||||
|---|---|---|---|---|---|
| Depth 2 Minimum: 0.38 | Max: 0.76 | ||||
| Depth 3 Minimum: 0.475 | Max: 0.855 | ||||
| Depth 4 Minimum: 0.475 | Max: 0.855 | ||||
| Depth 5 Minimum: 0.57 | Max: 0.95 | ||||
| Range of | |||||
| Depth + | |||||
| AST Cap | |||||
| *30 | |||||
| samples* | Ultimate Lancing Device + AST Cap | Length of Lancet (MM) | N/A | ||
| Depth 1 Minimum: 0 | Max: 0 | Minimum: 25.22 | Max: 25.31 | ||
| (mm) | Depth 2 Minimum: 0 | Max: 0.095 | |||
| Depth 3 Minimum: 0 | Max: 0.095 | Level 1 Minimum: 0 | Max: 0 | ||
| Depth 4 Minimum: 0 | Max: 0.19 | Level 2 Minimum: 0 | Max: 0 | ||
| Depth 5 Minimum: 0 | Max: 0.38 | Level 3 Minimum: 0 | Max: 0 | ||
| Depth 6 Minimum: 0.19 | Max: 0.475 | Level 4 Minimum: 0 | Max: 0 | ||
| Depth 7 Minimum: 0.38 | Max: 0.57 | Level 5 Minimum: 0 | Max: 0 | ||
| Depth 8 Minimum: 0.38 | Max: 0.665 | Level 6 Minimum: 0 | Max: 0 | ||
| TRIO Lancing Device + AST Cap | Level 7 Minimum: 0 | Max: 0 | |||
| Level 8 Minimum: 0 | Max: 0 | ||||
| Depth 1 Minimum: 0 | Max: 0 | Level 9 Minimum: 0 | Max: 0 | ||
| Depth 2 Minimum: 0 | Max: 0 | Level 10 Minimum: 0 | Max: 0.19 | ||
| Depth 3 Minimum: 0 | Max: 0.38 | Level 11 Minimum: 0.095 | Max: 0.38 | ||
| Depth 4 Minimum: 0.19 | Max: 0.475 | ||||
| Depth 5 Minimum: 0.285 | Max: 0.57 | ||||
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| Mechanical
| Loading | Spring-driven | Spring-driven | Spring-driven |
|---|---|---|---|
| Load and | |||
| Firing | Load by advancing lancet into holding | ||
| section and pushing down, | |||
| Fire by pressing release button | Load by pressing priming button when | ||
| lancet is inserted, | |||
| Fire by pressing release button | Load lancet by pulling back on | ||
| the lance body when the lancet is | |||
| 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. An ejector sleeve can then be | |||
| advanced forward for contactless | |||
| disposal of the lancet. | 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. | 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. | |||
| Ejector | |||
| sleeve | Ultimate Lancing Device: No | ||
| Trio Lancing Device: Yes | Yes | No |
Indication for Use Comparison
The indications for use of the candidate device system are the predicate with the predicate device has a dedicated lancet and the candidate lancing device can be used with "standard" lancets.
Technological Comparison
The candidate and predicate devices share characteristics including their design, mechanical mechanism, principle of operation, energy source and usage, features, form, fit and function.
Non-clinical Testing Summary and Conclusions
Biocompatibility Testing
The medical device in its final finished form is identical to the EasyTouch Lancing Device (510(k) K222617) in formulation, processing, sterlization, and geometry and no other chem added (e.g., plasticizers, fillers, addlives, cleaning agents).
Performance Testing
The following tests were performed: Pent testing, cock force testing, insertion force testing, removal force testing, and
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migration distance testing.
The device complies with the following standards:
| ISO 10993-5 Third edition 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
|---|---|
| ISO 10993-23 First edition 2021-01 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| ISO 10993-11 Third edition 2017-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| ISO 10993-12 Fifth edition 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| ISO 10993-10 Fourth edition 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
Clinical Testing
Clinical testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable and communicated in the instructions for use (FU) as warnings. There were no special performance or safety concerns identified.
Conclusion
The results of nonclinical testing demonstrate that the same or similar to the predicate devices K214022 and K221072 and should perform as intended in the specified use conditions as well as the predicate device per required standards.