STAT Medical Device Lancing System

K230310 · Stat Medical Devices · QRK · Sep 8, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230310
• Device Name: STAT Medical Device Lancing System
• Applicant: Stat Medical Devices
• Product Code: QRK · General, Plastic Surgery
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended 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.

Device Story

STAT Medical Lancing Device Systems (ULTIMATE and TRIO models) are manual, spring-driven, reusable devices for capillary blood sampling. User inserts a sterile, single-use lancet into the device; selects penetration depth (8 settings for ULTIMATE; 5 for TRIO); cocks the spring mechanism; and presses a button to fire. The lancet pierces the skin and automatically retracts into the housing. An optional Alternative Site Testing (AST) cap allows sampling from non-fingertip sites. Devices are intended for single-patient home use; not for healthcare settings. Users clean and disinfect the device and end cap between uses per instructions. Output is a blood drop for glucose testing. Benefits include hygienic, controlled-depth skin puncture for patient self-monitoring.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-5, -10, -11, -12, -23) and mechanical performance testing (penetration depth, cock force, insertion/removal force, migration distance).

Technological Characteristics

Materials: ABS plastic, SUS304 stainless steel. Mechanism: Spring-driven, manual loading/firing. Depth adjustment: 5 or 8 settings via dial/lever. Connectivity: None (standalone). Sterilization: Gamma irradiation (lancets). Form factor: Handheld, reusable lancing device with disposable lancets.

Indications for Use

Indicated for single-patient home use for the hygienic collection of capillary blood from the fingertip or alternate sites (palm, upper arm, forearm) for blood glucose testing.

Regulatory Classification

Identification

The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Special Controls

*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.

Predicate Devices

• Accu-Chek Softclix Blood Lancing System (K214022)

Reference Devices

• TRUEdraw Lancing Device (K221072)
• Mini Lancing Device (K221072)
• EasyTouch Lancing Device (K222617)
• Comfort Thins Twist-Off Lancet (K222034)
• Comfort Thins Pull Off Lancet (K221383)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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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## 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 [e-mail]

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: [phone] Fax: [phone] Email: [e-mail]

#### 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

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## 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

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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

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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

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# Similarities and Differences between Candidate Device and Predicate Device:

| | Candidate Device - Stat Lancing<br>Device System | Predicate Device - Accu-Chek Softclix<br>Blood Lancing System K214022 | Reference Device - TRUEdraw Lancing<br>Device, Mini Lancing Device K221072 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manu-<br>facturer | STAT Medical Devices | Roche Diabetes Care, Inc. | Trividia Health |
| Device<br>Description | Stat Medical Lancing Device Systems<br>use Stat Medical and representative<br>lancets to obtain a drop of blood from a<br>fingertip or alternate sites using the<br>Stat Medical Alternate Site Testing<br>(AST) Cap. | Accu-Chek Softclix Blood Lancing<br>Device uses Accu-Chek Softclix<br>Lancets to obtain a drop of blood from<br>a fingertip or alternate sites using the<br>Accu-Chek Softclix Alternate Site<br>Testing (AST) Cap. | The TRUEdraw Lancing Device/ Mini<br>Lancing Device is a reusable blood<br>lancet holder intended to be used in<br>conjunction with a sterile, single-use<br>blood lancet for obtaining a capillary<br>blood sample for testing purposes from<br>the fingertip and from alternative sites,<br>such as the forearm. |
| Intended<br>Use | The Stat Medical Lancing Device<br>Systems are intended for the hygienic<br>collection of capillary blood for testing<br>purposes from the side of a finger and<br>from alternate site, such as the palm,<br>the upper arm, and the forearm. The<br>Stat Medical Lancing Device Systems<br>are for single patient use in a home<br>setting. | Accu-Chek Softclix Blood Lancing<br>Device System is intended for the<br>hygienic collection of capillary blood for<br>testing purposed from the side of a<br>finger and from alternate site, such as<br>the palm, the upper arm, and the<br>forearm. | TRUEdraw Lancing Device/ Mini<br>Lancing Device is intended for multiple<br>use by a single patient. |
| Indications<br>for Use | Stat Medical Lancing Device Systems<br>are intended for the hygienic collection<br>of capillary blood for testing purposes<br>from the side of a finger and from<br>alternate site, such as the palm, the<br>upper arm, and the forearm. The Stat<br>Medical Lancing Device Systems are<br>for single patient use in a home setting. | The Accu-Chek Softclix sterile, single-<br>use lancets are to be used with the<br>reusable lancing device that is to be<br>cleaned and disinfected between each<br>use, and then the lancets are to be<br>disposed of.<br>The system is for use only on a single<br>patient in a home setting<br>This system is not suitable for use by<br>healthcare professionals with multiple<br>patients in a healthcare setting | The TRUEdraw Lancing Device is for<br>use with a disposable sterile lancet for<br>the hygienic collection of capillary blood<br>for testing purposes from the side of a<br>fingertip and from alternative sites,<br>such as the forearm.<br>The Mini Lancing Device is for use with<br>a disposable sterile lancet for the<br>hygienic collection of capillary blood for<br>testing purposes from the side of a<br>fingertip and from alternative sites,<br>such as the forearm. |
| | | | The TRUEdraw Lancing Device/ Mini<br>Lancing Device is for use only on a<br>single patient in a home setting.<br><br>The TRUEdraw Lancing Device/ Mini<br>Lancing Device is not suitable for use<br>by healthcare professionals with<br>multiple patients in a healthcare setting. |
| Number of<br>Uses | Base (lancing device) – multiple use<br>Lancet - single use | Base (lancing device) – multiple use<br>Lancet - single use | Base (lancing device) – multiple use<br>Lancet - single use |

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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<br>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<br>Adjustment | TRIO – 5 depth settings<br>ULTIMATE – 8 depth settings<br>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<br>Depth<br>(mm)<br>*30<br>samples* | Length of Lancet (MM) | Length of Lancet (MM) | N/A |
| | Minimum: 26.23<br>Max: 26.63<br><br>Ultimate Lancing Device<br>Depth 1 Minimum: 0.095 Max: 0.665<br>Depth 2 Minimum: 0.285 Max: 0.855<br>Depth 3 Minimum: 0.38 Max: 0.855<br>Depth 4 Minimum: 0.475 Max: 0.855<br>Depth 5 Minimum: 0.475 Max: 0.855<br>Depth 6 Minimum: 0.57 Max: 0.855<br>Depth 7 Minimum: 0.57 Max: 0.95<br>Depth 8 Minimum: 0.665 Max: 0.95<br>Length of Lancet (MM)<br>Minimum: 26.23 Max: 26.63<br>TRIO Lancing Device | Minimum: 25.22<br>Max: 25.31<br><br>Level 1 Minimum: 0 Max: 0.095<br>Level 2 Minimum: 0.095 Max: 0.38<br>Level 3 Minimum: 0.19 Max: 0.475<br>Level 4 Minimum: 0.38 Max: 0.665<br>Level 5 Minimum: 0.475 Max: 0.665<br>Level 6 Minimum: 0.475 Max: 0.76<br>Level 7 Minimum: 0.57 Max: 0.855<br>Level 8 Minimum: 0.57 Max: 0.855<br>Level 9 Minimum: 0.665 Max: 0.855<br>Level 10 Minimum: 0.665 Max: 0.95<br>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<br>Depth +<br>AST Cap<br>*30<br>samples* | <b>Ultimate Lancing Device + AST Cap</b> | | <b>Length of Lancet (MM)</b> | | 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 | |
| | <b>TRIO Lancing Device + AST Cap</b> | | 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<br>Loading | Spring-driven | Spring-driven | Spring-driven |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Load and<br>Firing | Load by advancing lancet into holding<br>section and pushing down,<br>Fire by pressing release button | Load by pressing priming button when<br>lancet is inserted,<br>Fire by pressing release button | Load lancet by pulling back on<br>the lance body when the lancet is<br>inserted. Fire by pressing the •<br>trigger button. |
| Anatomical<br>Sites | Fingertip<br>Ball of hand (palm)<br>Upper arm<br>Lower arm | Fingertip<br>Ball of hand (palm)<br>Upper arm<br>Lower arm | Fingertip<br>Forearm |
| Sharps<br>Injury<br>Prevention | Lancets are covered by a sterile barrier<br>cap until twisted or pulled off before<br>use. Until firing, the lancet is contained<br>within the lancing device housing.<br>Immediately after firing, the lancet is<br>automatically retracted back into the<br>housing. An ejector sleeve can then be<br>advanced forward for contactless<br>disposal of the lancet. | Lancets are covered by a sterile barrier<br>cap until twisted off before use. Until<br>firing, the lancet is contained within the<br>lancing device housing. Immediately<br>after firing, the lancet is automatically<br>retracted back into the housing. An<br>ejector sleeve can then be pulled<br>forward for contactless disposal of the<br>lancet. | Lancets are covered by a sterile barrier<br>cap until twisted off before use. Until<br>firing, the lancet is contained within the<br>lancing device housing. Immediately<br>after firing, the lancet is automatically<br>retracted back into the housing. An<br>ejector sleeve can then be pulled<br>forward for contactless disposal of the<br>lancet. |
| Ejector<br>sleeve | Ultimate Lancing Device: No<br>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.