MICROLET NEXT lancing device, MICROLET Lancet

K220633 · Ascensia Diabetes Care U.S., Inc. · QRL · Jun 3, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220633
• Device Name: MICROLET NEXT lancing device, MICROLET Lancet
• Applicant: Ascensia Diabetes Care U.S., Inc.
• Product Code: QRL · General, Plastic Surgery
• Decision Date: Jun 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

Device Story

Manual lancing device used with disposable, sterile 28G stainless steel lancets; coated with medical-grade silicone. Device features adjustable endcap for fingertip sampling (5 depth settings) and clear endcap for alternative site testing (palm). User-operated at home; device is reusable (single-patient use). Mechanism involves spring-loaded puncture to obtain capillary blood droplet. Protective cap on lancet ensures sterility until use; used lancets are discarded. Device aids in blood glucose monitoring; provides patient benefit through controlled, comfortable blood sampling.

Clinical Evidence

Clinical study with 119 lay users (adults with Type 1 or Type 2 diabetes). 119/119 successfully obtained capillary blood from fingertips; 116/119 successfully obtained blood from palms. One non-device-related adverse event (hypoglycemia) reported. Study confirmed system is safe and effective for at-home use.

Technological Characteristics

Materials: Stainless steel needle (siliconized), plastic housing. Sterilization: Gamma radiation (SAL 10^-6). Dimensions: 102.5 x 19 x 20 mm. Sensing/Actuation: Mechanical spring-loaded puncture. Connectivity: None. Software: None.

Indications for Use

Indicated for collecting capillary blood from fingertip or palm for blood glucose or other testing. Fingertip sampling for persons age 2+ years; palm sampling (AST) for adults only. Single-patient use.

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

• MICROLET® Lancet/MICROLET® NEXT lancing device (Class I, 510(k)-exempt)

Submission Summary (Full Text)

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June 3, 2022

Ascensia Diabetes Care U.S., Inc. Sangram Yadav Regulatory Affairs Manager 5 Wood Hollow Road Parsippany, New Jersey 07054

Re: K220633

Trade/Device Name: MICROLET NEXT Lancing Device, MICROLET Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: May 6, 2022 Received: May 9, 2022

Dear Sangram Yadav:

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/cfpm/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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 [phone] or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220633

Device Name The MICROLET® lancet and MICROLET® NEXT lancing device

Indications for Use (Describe)

The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle next to a blue teardrop shape. Above the logo is the text "K220633".

## 510(k) Summary for MICROLET® NEXT lancing device and MICROLET® Lancet

Initial date prepared: March 02, 2022 Revised date: May 25, 2022

According to the requirements of 21 CFR 807.92, the following information is being submitted in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

- 1. Submitter: Ascensia Diabetes Care U.S., Inc 5 Wood Hollow Rd Parsippany, NJ 07054
Contact: Sangram Yadav Regulatory Affairs Manager 5 Wood Hollow Rd Parsippany, NJ 07054 Phone: [phone] E-mail: [e-mail]

Alternate Contact: Brian Truchan Head, Pre-Market Regulatory Affairs 5 Wood Hollow Rd Parsippany, NJ 07054 Phone: [phone] E-mail: [e-mail]

- 2. Device name: MICROLET® Lancet and MICROLET® NEXT lancing device Classification name: Multiple Use Blood Lancet For Single Patient Use Only FDA CDRH review panel: General & Plastic Surgery Product Code: QRL Device Class: Class II Premarket review: Surgical and Infection Control Devices (OHT4) General Surgery Devices (DHT4A)
- 3. Predicate device: MICROLET® Lancet/MICROLET® NEXT lancing device (Class I, 510(k)-exempt blood lancets and lancing device legally offered for sale on or before November 22, 2021).
- 4. Device description:

Ascensia's blood lancets consists of two components. First component is a re-usable base which is referred as MICROLET® NEXT lancing device and the second component is a sterile single use blade which is referred as MICROLET® Lancet. The subject

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Image /page/4/Picture/0 description: The image shows the Ascensia Diabetes Care logo. The logo features a stylized letter 'A' in purple, with a blue teardrop shape to the right. Below the symbol, the word 'ASCENSIA' is written in purple, and below that, 'Diabetes Care' is written in a smaller font. The text 'K220633' is at the top of the image.

MICROLET® NEXT lancing device and MICROLET® Lancet falls under multiple Use Blood Lancet For Single Patient Use Only category. The subject MICROLET® NEXT Lancing Device is a pen-like instruments to be used with the compatible subject MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing. The MICROLET® NEXT Lancing Device is available with two endcaps: the Black/White cap for fingertip sampling and the Clear Alternative Site Testing (AST) for palm sampling. The Black/White cap has a dial control that allows the user to adjust the blade penetration depth for comfort when obtaining the blood droplet. The subject MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is intended to be used with compatible lancing devices. The lancets are sterile, single-use devices. They must be discarded after each use. The lancet comprises the following elements: a steel needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. They are available with 28G (0.36mm) diameter lancets. Together, they are intended for obtaining a capillary blood sample for blood glucose testing or other testing utilizing small amounts of blood. The lancet needle consists of stainless steel which is coated with medical grade silicone for smooth penetration of the skin. The lancet needle is siliconized. This is encased in a plastic cover. The proposed MICROLET® Lancets are offered in a variety of colors. Figure-2 shows different colored lancets (seven colors-Yellow. Orange, Red, Green, Blue, Purple and Pink). The needle tip is hidden by a protective cap, which has to be removed before usage and creates the sterile barrier. After usage the lancet can be placed back into the protective cap for disposal. thereby protecting users from unintended injuries. The proposed MICROLET® Lancet can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is Intended to be used with compatible lancing device. The lancet comprises the following elements: a steel needle, needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. The product can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® NEXT lancing device is used for obtaining capillary blood samples from the fingertip. Capillary samples can be obtained from the palm as well The lancing device is for use only on a single patient.

- 5. Indications for Use: The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.
- 6. Substantial Equivalence:

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Image /page/5/Picture/0 description: The image shows the text 'K220633' in a clear, sans-serif font. The text is presented in a single line, with each character distinctly visible. The number is likely an identification or serial number.

Image /page/5/Picture/1 description: The image shows the Ascensia Diabetes Care logo. The logo features a stylized letter "A" in purple, next to a light blue water droplet. Below the graphic is the text "ASCENSIA" in purple, with the words "Diabetes Care" in a smaller font size underneath.

Technological similarities and differences are as follows:

| Table 1.1 Comparison between predicate MICROLET® Lancet;<br>MICROLET® NEXT lancing device (510(k)-exempt), and proposed device<br>MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| No | Feature | Predicate Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences |
| 1 | Classification | Class I<br>Product Code: FMK<br>Regulation: 21 CFR 878.4850 | Class II<br>Product Code: QRL<br>Regulation: 21 CFR 878.4850 | Different |
| 2 | Subtype | Multiple Use Blood<br>Lancet For Single<br>Patient Use Only | Multiple Use Blood<br>Lancet For Single Patient<br>Use Only | Same |
| 3 | Type of Use | Over the Counter use | Over the Counter use | Same |
| 4 | Indications for Use | The MICROLET®<br>NEXT lancing device is<br>intended for collecting<br>capillary blood from<br>the fingertip or palm<br>for blood glucose<br>testing or other testing<br>utilizing small amounts<br>of blood. The Microlet<br>Next lancing device is<br>for single-patient use.<br>The Microlet Next<br>lancing device is used<br>with disposable, sterile<br>MICROLET® lancets.<br>The Microlet Next<br>lancing device with the<br>Microlet lancet are<br>intended for collecting<br>capillary blood persons<br>age two years and<br>older. | The MICROLET®NEXT<br>lancing device is intended<br>for collecting capillary<br>blood from the fingertip or<br>palm for blood glucose<br>testing or other testing<br>utilizing small amounts of<br>blood. The MICROLET<br>NEXT lancing device is<br>for single-patient use. The<br>MICROLET NEXT<br>lancing device is used<br>with disposable, sterile<br>MICROLET® lancets.<br>The MICROLET NEXT<br>lancing device with the<br>MICROLET lancet are<br>intended for collecting<br>fingertip capillary blood<br>from persons age two<br>years and older. The<br>alternative site testing<br>endcap is intended for | Different.<br>The<br>alternative<br>site testing<br>endcap is<br>intended for<br>collecting<br>capillary<br>blood from<br>the palm in<br>adults only. |
| Table 1.1 Comparison between predicate MICROLET® Lancet; | | | | |
| MICROLET® NEXT lancing device (510(k)-exempt), and proposed device | | | | |
| | | | MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | |
| No | Feature | Predicate Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences |
| | | | collecting capillary blood<br>from the palm in adults<br>only. | |
| 5 | Anatomi<br>cal<br>Location<br>in<br>the Body | Fingertip or ATS<br>(palm) | Fingertip or ATS (palm) | Same |
| 6 | Patient<br>Populati<br>on | persons age two years<br>and older. | persons age two years and<br>older. The alternative site<br>testing endcap is intended<br>for collecting capillary<br>blood from the palm in<br>adults only. | Different |
| 7 | Intended<br>User | Persons of different<br>ages diagnosed with<br>Diabetes;<br>can also be used by<br>caregivers or family<br>members who support<br>an individual with<br>Type1 and Type 2<br>diabetes. | Persons of different ages<br>diagnosed with Diabetes;<br>can also be used by<br>caregivers or family<br>members who support an<br>individual with Type1 and<br>Type 2 diabetes. | Same |
| 8 | Protectiv<br>e cover<br>of the<br>lancet | Protective cap is used<br>to<br>push the used lancet<br>into the center in order<br>to<br>avoid injuries. | Protective cap is used to<br>push the used lancet into<br>the center in order to<br>avoid injuries. | Same |
| 9 | Compati<br>bility of<br>Lancing | Compatible with<br>Microlet®<br>Next lancing device | Compatible with<br>Microlet®<br>Next lancing device | Same |
| Table 1.1 Comparison between predicate MICROLET® Lancet; | | | | |
| MICROLET® NEXT lancing device (510(k)-exempt), and proposed device | | | | |
| MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | | | | |
| No | Feature | Predicate Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences |
| | device<br>with<br>Lancets | | | |
| 10 | Dimensions/Size | Lancets(Blade):<br>Size 28 G(Gauge)<br>length: 32.3 mm<br>width: 9.25 mm<br>depth: 6.45 mm<br>Lancing device(reusable base):<br>102.5 x 19 x 20 mm | Lancets(Blade):<br>Size 28 G(Gauge)<br>length: 32.3 mm<br>width: 9.25 mm<br>depth: 6.45 mm<br>Lancing device(reusable base): 102.5 x 19 x 20 mm | Same |
| 11 | Protrusion Length of needle(lancets) | 3.25 ±0.3 mm<br><br>Image: Diagram of protrusion length<br><br>Note- Protrusion Length of needle is the length of the exposed needle from the lancet body, after the protective cap is removed. | 3.25 ±0.3 mm<br><br>Image: Diagram of protrusion length<br><br>Note- Protrusion Length of needle is the length of the exposed needle from the lancet body, after the protective cap is removed. | Same |
| 12 | Depth settings | 5 depth settings | 5 depth settings | Same |

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Image /page/6/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized purple triangle next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, with the words "Diabetes Care" written in a smaller font below it. The text "K220633" is at the top of the image.

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Image /page/7/Picture/0 description: The image shows the text 'K220633' in a simple, sans-serif font. The text is presented in a clear and legible manner. The characters are evenly spaced and well-defined against the plain background. The text appears to be a code or identifier.

Image /page/7/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo consists of a purple triangle and a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, and below that, the words "Diabetes Care" are written in a smaller font.

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Image /page/8/Picture/0 description: The image shows the text 'K220633' in a clear, sans-serif font. The text is presented in a single line, with each character distinctly visible. The number '2' is repeated multiple times within the string of text.

Image /page/8/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized "A" shape in purple next to a blue teardrop shape. Below the shapes, the text "ASCENSIA" is written in a bold font, with "Diabetes Care" written in a smaller font underneath.

| Table 1.1 Comparison between predicate MICROLET® Lancet;<br>MICROLET® NEXT lancing device (510(k)-exempt), and proposed device<br>MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|------|
| No | Feature | Predicate Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class I, 510(k)-<br>exempt) | Proposed Device<br>MICROLET® Lancet<br>MICROLET® NEXT<br>lancing device<br>(Class II) | Similarities/<br>Differences | | | | | | | | | | | | | | | | | | | | | | | | |
| 13 | Penetration depth | Alternative site testing endcap:<br>3.33 mm.<br>Adjustable cap:<br><br>Setting Puncture Depth(mm) 1 1.25 2 1.65 3 2.00 4 2.38 5 2.75<br>The difference between each depth level is 0.4 mm or less. | | | | | | | | | | | | | Alternative site testing endcap:<br>3.33 mm.<br>Adjustable cap:<br><br>Setting Puncture Depth(mm) 1 1.25 2 1.65 3 2.00 4 2.38 5 2.75<br>The difference between each depth level is 0.4 mm or less. | | | | | | | | | | | | | Same |
| 14 | Duration of Body Contact | Transient, less than 1 minute | Transient, less than 1 minute | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| 15 | Use(Single patient) | Single use Sterile lancets | Single use Sterile lancets | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| 16 | Use(lancing devices) | Reusable. The lancing device is for use only on a single patient. | Reusable. The lancing device is for use only on a single patient | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| 17 | Sterilization method and SAL | Sterilized by Radiation SAL=10-6 | Sterilized by Radiation SAL=10-6 | Same | | | | | | | | | | | | | | | | | | | | | | | | |

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Image /page/9/Picture/1 description: The image is a logo for Ascensia Diabetes Care. The logo features a purple triangle next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, with the words "Diabetes Care" written in a smaller font below it.

| Table 1.1 Comparison between predicate MICROLET® Lancet; | | | | |
|--------------------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------|
| MICROLET® NEXT lancing device (510(k)-exempt), and proposed device | | | | |
| MICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | | | | |
| No | Feature | Predicate Device<br>MICROLET® Lancet MICROLET® NEXT lancing device<br>(Class I, 510(k)-exempt) | Proposed Device<br>MICROLET® Lancet MICROLET® NEXT lancing device<br>(Class II) | Similarities/<br>Differences |
| 18 | Shelf life | Lancets- 5 years | Lancets- 5 years | Same |
| 19 | Use life | Lancing device 3 years | Lancing device 2 years | Different |
| 20 | disinfecti<br>on<br>frequency | Once a week | After each use | Different |

- 7. Summary of Non-Clinical Performance Data
Biocompatibility: Cytotoxicity,Inctracutaneous, Systemic Toxicity, Hemolysis, Sensitization and Pyrogen testing was performed on all patient contacting materials lancet and lancing device in accordance with FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process (summarized in below table). All patient contact components demonstrated biocompatibility.

| Table 1.2 Biocompatibility testing standards and results for the proposed<br>MICROLET® Lancet and MICROLET® lancing device | | | |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------|
| No | Test | Standard | Results |
| 1 | Cytotoxicity<br>Study - ISO<br>Elution Method | ISO 10993-5:2009<br>Biological evaluation of medical<br>devices — Part 5: Tests for in vitro<br>cytotoxicity | Non-cytotoxic |
| 2 | ISO Guinea Pig<br>Maximization<br>Sensitization<br>Test | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices — Part 10: Tests for irritation<br>and skin sensitization | Non-sensitizer |

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below these shapes, the word "ASCENSIA" is written in a bold, sans-serif font, with the words "Diabetes Care" written in a smaller font below it.

| Table 1.2 Biocompatibility testing standards and results for the proposed<br>MICROLET® Lancet and MICROLET® lancing device | | | |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------|
| No | Test | Standard | Results |
| 3 | ISO<br>Intracutaneous<br>Study in Rabbits | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>and skin sensitization | Non-irritant |
| 4 | Material<br>Mediated<br>Pyrogenicity in<br>Rabbits | ISO 10993-11:2017<br>Biological evaluation of medical<br>devices - Part 11: Tests for systemic<br>toxicity | Non-pyrogenic |
| 5 | ISO Acute<br>Systemic<br>Toxicity | ISO 10993-11:2017<br>Biological evaluation of medical<br>devices - Part 11: Tests for systemic<br>toxicity | Non-toxic |
| 6 | ASTM<br>Hemolysis Study | ISO 10993-4:2017<br>Biological evaluation of medical<br>devices - Part 4: Selection of tests for<br>interactions with blood | Non-hemolytic |
| Biocompatibility testing for MICROLET® lancing device | | | |
| 7 | Cytotoxicity<br>Study - ISO<br>Elution Method | ISO 10993-5:2009<br>Biological evaluation of medical<br>devices - Part 5: Tests for in vitro<br>cytotoxicity | Non-cytotoxic |
| 8 | ISO Guinea Pig<br>Maximization<br>Sensitization<br>Test | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>and skin sensitization | Non-sensitizer |
| 9 | ISO<br>Intracutaneous<br>Study in Rabbits | ISO 10993-10:2010<br>Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>and skin sensitization | Non-irritant |

Note- MICROLET® NEXT lancing device, including adjustable (ABS) and Alternate Site Testing (AST) (Polycarbonate) caps; subject to this premarket notification is identical to the previously legally US-marketed (510k exempt) device in formulation, processing, sterilization, and geometry, and no other chemicals have been added.

### 8. Performance Testing

The following Performance testing were conducted to demonstrate the basic performance of MICROLET® Lancet and lancing device and confirmed that the MICROLET® Lancet and lancing device performs as intended.

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Image /page/11/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo consists of a stylized letter "A" in purple, next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, with the words "Diabetes Care" written in a smaller font below it.

| Table 1.3 Performance testing for the proposed MICROLET® Lancet and<br>MICROLET® NEXT lancing device | | |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No | Test | Results |
| 1 | Vibration Testing | Pass<br>There was no external damage or deterioration noted to any of the devices tested. |
| 2 | Ejector Arm remove force | Pass<br>The Ejector arm force results for all devices were within the acceptance range. |
| 3 | Endcap Assembly removal and install<br>torque verification | Pass<br>Both the install and removal torque mean values were well within acceptable criteria. |
| 4 | Lancet Ejection force | Pass<br>All device results were within the acceptance range. |
| 5 | Lancet insertion force | Pass<br>All device results were within the acceptance range. |
| 6 | Priming force<br>verification | Pass<br>All device results were within the acceptance range. |
| 7 | Puncture Depth<br>Setting verification | Pass<br>All device results were within the acceptance range. |
| 8 | Trigger button<br>actuation force | Pass<br>All device results were within the acceptance range. |
| 9 | Device Size<br>verification | Pass<br>All device results were within the acceptance range. |
| 10 | Lancet Anti Rotation torque | Pass<br>All device results were within the acceptance range. |
| 11 | Puncture setting<br>torque | Pass<br>All device results were within the acceptance range. |
| 12 | Solution<br>Compatibility reliability testing | Pass<br>All device results were within the acceptance range. |
| 13 | Reliability Testing<br>Mechanical vibration<br>free fall drop | Pass<br>All devices meet the visual , functional and<br>performance acceptance criteria relevant to test<br>requirements. |
| 14 | High speed Camera<br>Analysis | Pass<br>All device data results were within acceptance criteria. |
| 15 | Corrosion Resistance<br>testing | Pass<br>After the test no corrosion was noticed on any of the<br>product parts. |
| 16 | Dry heat storage test- | Pass |
| Table 1.3 Performance testing for the proposed MICROLET® Lancet and<br>MICROLET® NEXT lancing device | |…