(91 days)
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.
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 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.
Ascensia Diabetes Care's MICROLET® NEXT Lancing Device and MICROLET® Lancet were evaluated through a clinical study and extensive non-clinical performance testing to demonstrate their safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria for the clinical study with specific quantitative targets (e.g., "X% of subjects must obtain sufficient blood volume"). However, the study aims and conclusions implicitly serve as the acceptance criteria for clinical performance related to blood collection, while non-clinical tests have pass/fail criteria.
Here's a summary:
| Acceptance Criteria (Implied from Study Objectives/Results) | Reported Device Performance (Clinical) |
|---|---|
| Ability to obtain sufficient capillary blood from fingertips for blood glucose testing using the adjustable cap. | 119 out of 119 adult subjects (100%) were able to obtain sufficient capillary blood volume from fingertips. |
| Ability to obtain sufficient capillary blood from the palm for blood glucose testing using the AST (Alternative Site Testing) endcap. | 116 out of 119 adult subjects (97.5%) were able to obtain sufficient capillary blood volume from the palm. |
| System is safe and effective for at-home use by people with diabetes, without serious use errors or problems. | Human factors validation testing concluded the system is safe and effective for at-home use by people with diabetes, without serious use errors or problems under expected use conditions. |
| All non-clinical performance and biocompatibility tests passed. | All 24 non-clinical performance tests (e.g., Vibration, Ejector Arm force, Puncture Depth Setting, Corrosion Resistance, Shipping Simulation) and 9 biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous, Pyrogenicity, Systemic Toxicity, Hemolysis) passed. |
| No new questions of safety or effectiveness are raised compared to the predicate device. | The differences between the proposed device and the predicate device do not raise any new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Study): 119 lay persons.
- Data Provenance: The study was conducted at the "Mishawaka site," which generally refers to a clinical study location within the country where the submission is made (USA in this case, given the FDA filing). The document doesn't explicitly state the country for the clinical study, but it is implied to be within the US. The study appears to be prospective as participants were enrolled and tested with the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document refers to "study staff testing the blood on a Contour next family of blood glucose meters" to determine the acceptability of capillary blood volume.
- It does not specify the number or qualifications of these "study staff" experts. It also doesn't mention expert review of images or specific clinical diagnoses by independent experts to establish ground truth in the way one might see for diagnostic AI. In this context, "acceptability" refers to whether enough blood was collected for a meter reading, which is a functional assessment rather than a diagnostic one requiring expert consensus on a disease state.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the clinical study results in the traditional sense of resolving discrepancies between multiple readers or systems. The determination of "sufficient capillary blood volume" was made by "study staff testing the blood on a Contour next family of blood glucose meters." This implies a direct, objective assessment by the meters and observation by staff, rather than a subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not applicable here as the device is a lancing device and lancet, not an AI diagnostic tool. The clinical study focused on the device's ability to collect blood and its safe usage by lay persons.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm-only performance study was not done. The device is a physical medical device (lancing device and lancet), not a software algorithm. Its performance is assessed through mechanical, biological, and user experience testing, not algorithmic accuracy.
7. The Type of Ground Truth Used
- For the clinical study, the "ground truth" for success was defined by the ability to obtain sufficient capillary blood volume as determined by a blood glucose meter ("Contour next family of blood glucose meters"). This is a form of outcomes data pertaining to device functionality (i.e., whether the device successfully facilitates blood collection for testing).
- For non-clinical tests, the ground truth was adherence to predetermined acceptable ranges or conditions (e.g., "no external damage or deterioration," "results were within the acceptance range," "no corrosion," "all devices met min 1.3 mm needle tip distance").
8. The Sample Size for the Training Set
- The document is for a physical medical device (lancing device and lancets), not an AI/ML algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As the device is not an AI/ML algorithm, there is no training set and thus no ground truth established for a training set. The development of the device would have involved engineering specifications, materials science, and usability design, leading to the device submitted for testing.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (1-800-638-2041 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.
-
- 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: 201-936-8856 E-mail: sangram.yadav@ascensia.com
- Submitter: Ascensia Diabetes Care U.S., Inc 5 Wood Hollow Rd Parsippany, NJ 07054
Alternate Contact: Brian Truchan Head, Pre-Market Regulatory Affairs 5 Wood Hollow Rd Parsippany, NJ 07054 Phone: +19142668530 E-mail: brian.truchan@ascensia.com
-
- 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)
-
- 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).
-
- 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.
-
- 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.
-
- 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;MICROLET® NEXT lancing device (510(k)-exempt), and proposed deviceMICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | ||||
|---|---|---|---|---|
| No | Feature | Predicate DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class I, 510(k)-exempt) | Proposed DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class II) | Similarities/Differences |
| 1 | Classification | Class IProduct Code: FMKRegulation: 21 CFR 878.4850 | Class IIProduct Code: QRLRegulation: 21 CFR 878.4850 | Different |
| 2 | Subtype | Multiple Use BloodLancet For SinglePatient Use Only | Multiple Use BloodLancet For Single PatientUse Only | Same |
| 3 | Type of Use | Over the Counter use | Over the Counter use | Same |
| 4 | Indications for Use | The MICROLET®NEXT lancing device isintended for collectingcapillary blood fromthe fingertip or palmfor blood glucosetesting or other testingutilizing small amountsof blood. The MicroletNext lancing device isfor single-patient use.The Microlet Nextlancing device is usedwith disposable, sterileMICROLET® lancets.The Microlet Nextlancing device with theMicrolet lancet areintended for collectingcapillary blood personsage two years andolder. | The MICROLET®NEXTlancing device is intendedfor collecting capillaryblood from the fingertip orpalm for blood glucosetesting or other testingutilizing small amounts ofblood. The MICROLETNEXT lancing device isfor single-patient use. TheMICROLET NEXTlancing device is usedwith disposable, sterileMICROLET® lancets.The MICROLET NEXTlancing device with theMICROLET lancet areintended for collectingfingertip capillary bloodfrom persons age twoyears and older. Thealternative site testingendcap is intended for | Different.Thealternativesite testingendcap isintended forcollectingcapillaryblood fromthe palm inadults 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 DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class I, 510(k)-exempt) | Proposed DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class II) | Similarities/Differences |
| collecting capillary bloodfrom the palm in adultsonly. | ||||
| 5 | AnatomicalLocationinthe Body | Fingertip or ATS(palm) | Fingertip or ATS (palm) | Same |
| 6 | PatientPopulation | persons age two yearsand older. | persons age two years andolder. The alternative sitetesting endcap is intendedfor collecting capillaryblood from the palm inadults only. | Different |
| 7 | IntendedUser | Persons of differentages diagnosed withDiabetes;can also be used bycaregivers or familymembers who supportan individual withType1 and Type 2diabetes. | Persons of different agesdiagnosed with Diabetes;can also be used bycaregivers or familymembers who support anindividual with Type1 andType 2 diabetes. | Same |
| 8 | Protective coverof thelancet | Protective cap is usedtopush the used lancetinto the center in ordertoavoid injuries. | Protective cap is used topush the used lancet intothe center in order toavoid injuries. | Same |
| 9 | Compatibility ofLancing | Compatible withMicrolet®Next lancing device | Compatible withMicrolet®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 DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class I, 510(k)-exempt) | Proposed DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class II) | Similarities/Differences |
| devicewithLancets | ||||
| 10 | Dimensions/Size | Lancets(Blade):Size 28 G(Gauge)length: 32.3 mmwidth: 9.25 mmdepth: 6.45 mmLancing device(reusable base):102.5 x 19 x 20 mm | Lancets(Blade):Size 28 G(Gauge)length: 32.3 mmwidth: 9.25 mmdepth: 6.45 mmLancing device(reusable base): 102.5 x 19 x 20 mm | Same |
| 11 | Protrusion Length of needle(lancets) | 3.25 ±0.3 mmImage: Diagram of protrusion lengthNote- 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 mmImage: Diagram of protrusion lengthNote- 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;MICROLET® NEXT lancing device (510(k)-exempt), and proposed deviceMICROLET® Lancet MICROLET® NEXT lancing device (up-Classified) | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No | Feature | Predicate DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class I, 510(k)-exempt) | Proposed DeviceMICROLET® LancetMICROLET® NEXTlancing device(Class II) | Similarities/Differences | ||||||||||||||||||||||||
| 13 | Penetration depth | Alternative site testing endcap:3.33 mm.Adjustable cap:Setting Puncture Depth(mm) 1 1.25 2 1.65 3 2.00 4 2.38 5 2.75The difference between each depth level is 0.4 mm or less. | Alternative site testing endcap:3.33 mm.Adjustable cap:Setting Puncture Depth(mm) 1 1.25 2 1.65 3 2.00 4 2.38 5 2.75The 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 DeviceMICROLET® Lancet MICROLET® NEXT lancing device(Class I, 510(k)-exempt) | Proposed DeviceMICROLET® Lancet MICROLET® NEXT lancing device(Class II) | Similarities/Differences |
| 18 | Shelf life | Lancets- 5 years | Lancets- 5 years | Same |
| 19 | Use life | Lancing device 3 years | Lancing device 2 years | Different |
| 20 | disinfectionfrequency | Once a week | After each use | Different |
-
- 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.
- Summary of Non-Clinical Performance Data
| Table 1.2 Biocompatibility testing standards and results for the proposedMICROLET® Lancet and MICROLET® lancing device | |||
|---|---|---|---|
| No | Test | Standard | Results |
| 1 | CytotoxicityStudy - ISOElution Method | ISO 10993-5:2009Biological evaluation of medicaldevices — Part 5: Tests for in vitrocytotoxicity | Non-cytotoxic |
| 2 | ISO Guinea PigMaximizationSensitizationTest | ISO 10993-10:2010Biological evaluation of medicaldevices — Part 10: Tests for irritationand skin sensitization | Non-sensitizer |
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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 proposedMICROLET® Lancet and MICROLET® lancing device | |||
|---|---|---|---|
| No | Test | Standard | Results |
| 3 | ISOIntracutaneousStudy in Rabbits | ISO 10993-10:2010Biological evaluation of medicaldevices - Part 10: Tests for irritationand skin sensitization | Non-irritant |
| 4 | MaterialMediatedPyrogenicity inRabbits | ISO 10993-11:2017Biological evaluation of medicaldevices - Part 11: Tests for systemictoxicity | Non-pyrogenic |
| 5 | ISO AcuteSystemicToxicity | ISO 10993-11:2017Biological evaluation of medicaldevices - Part 11: Tests for systemictoxicity | Non-toxic |
| 6 | ASTMHemolysis Study | ISO 10993-4:2017Biological evaluation of medicaldevices - Part 4: Selection of tests forinteractions with blood | Non-hemolytic |
| Biocompatibility testing for MICROLET® lancing device | |||
| 7 | CytotoxicityStudy - ISOElution Method | ISO 10993-5:2009Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicity | Non-cytotoxic |
| 8 | ISO Guinea PigMaximizationSensitizationTest | ISO 10993-10:2010Biological evaluation of medicaldevices - Part 10: Tests for irritationand skin sensitization | Non-sensitizer |
| 9 | ISOIntracutaneousStudy in Rabbits | ISO 10993-10:2010Biological evaluation of medicaldevices - Part 10: Tests for irritationand 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 andMICROLET® NEXT lancing device | ||
|---|---|---|
| No | Test | Results |
| 1 | Vibration Testing | PassThere was no external damage or deterioration noted to any of the devices tested. |
| 2 | Ejector Arm remove force | PassThe Ejector arm force results for all devices were within the acceptance range. |
| 3 | Endcap Assembly removal and installtorque verification | PassBoth the install and removal torque mean values were well within acceptable criteria. |
| 4 | Lancet Ejection force | PassAll device results were within the acceptance range. |
| 5 | Lancet insertion force | PassAll device results were within the acceptance range. |
| 6 | Priming forceverification | PassAll device results were within the acceptance range. |
| 7 | Puncture DepthSetting verification | PassAll device results were within the acceptance range. |
| 8 | Trigger buttonactuation force | PassAll device results were within the acceptance range. |
| 9 | Device Sizeverification | PassAll device results were within the acceptance range. |
| 10 | Lancet Anti Rotation torque | PassAll device results were within the acceptance range. |
| 11 | Puncture settingtorque | PassAll device results were within the acceptance range. |
| 12 | SolutionCompatibility reliability testing | PassAll device results were within the acceptance range. |
| 13 | Reliability TestingMechanical vibrationfree fall drop | PassAll devices meet the visual , functional andperformance acceptance criteria relevant to testrequirements. |
| 14 | High speed CameraAnalysis | PassAll device data results were within acceptance criteria. |
| 15 | Corrosion Resistancetesting | PassAfter the test no corrosion was noticed on any of theproduct parts. |
| 16 | Dry heat storage test- | Pass |
| Table 1.3 Performance testing for the proposed MICROLET® Lancet andMICROLET® NEXT lancing device | ||
| No | Test | Results |
| 17 | Dry heat Storage test | After the test no damage to the functionality of thedevice was noticed.PassAfter the test no damage to the functionality of thedevice was noticed. |
| 18 | Mechanical vibration test | PassAll device data results were within acceptance criteria. |
| 19 | Thermal Shock | PassAll device data results were within acceptance criteria |
| 20 | AST needle tip flushverification test | PassAll devices met the min 1.3 mm needle tip distance. |
| 21 | Reliability RetailCarton Free FallDrop Report | PassAll devices met tested in the retail carton kit meet theacceptance criteria. |
| 22 | Bulk Device shippingtest | PassNo damages were observed to the content after thetest. |
| 23 | Shipping Simulationtesting | PassAll device packaging passed the shipping simulationstesting. |
| 24 | Human factor | PassThe MICROLET® Lancet and MICROLET® NEXTlancing device human factors validation testing wasconducted to demonstrate the device can be used bypeople with diabetes without serious use errors orproblems under the expected use conditions. Thesummative evaluation concluded the system is safeand effective for at-home use by people with diabetes. |
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Image /page/12/Picture/0 description: The image shows the text 'K220633' in a clear, sans-serif font. The text is presented in a straightforward manner, with each character distinctly visible. The numbers and letters are evenly spaced, contributing to the overall readability of the text.
Image /page/12/Picture/1 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" formed by a purple triangle on the left and a blue teardrop shape on the right. Below the symbol, the word "ASCENSIA" is written in a bold, sans-serif font, with the words "Diabetes Care" in a smaller font underneath.
8. Clinical Testing:
A total of 119 lay persons who had never used the proposed MICROLET® Lancet and MICROLET® NEXT lancing device previously were enrolled into the study at the Mishawaka site, and 119 completed the study.
- 119 adult subjects were able to obtain sufficient capillary blood volume from ● fingertips to conduct blood glucose testing, by using the adjustable cap.
- . 116 adult subjects were able to obtain sufficient capillary blood volume from the palm to conduct blood glucose testing, by using the AST(Alternative site testing endcap.
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Image /page/13/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter 'A' formed by a purple triangle and a blue teardrop shape. Below the symbol, the word 'ASCENSIA' is written in bold, followed by 'Diabetes Care' in a smaller font.
The demographics and diabetes history information for all subjects enrolled in the study (n=119) included the following:
- 22% (26) reported they had type 1 diabetes; 76% (90) had type 2 diabetes and 3% ● (3) had diabetes but did not know their diabetes type
- The average (mean) age was 55.1 years (with a range of 23 to 84 years). ●
- . 80.7% (96) of subjects were less than age 65 years
Below is the demographic information for subjects:
Gender: Female 61(51.3%); Male 58(48.7%)
Ethnicity: Hispanic/Latino 3(2.5%); Non-Hispanic 110(92.4%); not reported 6(5.0%)
Race: Asian 1(0.8%), African American 14(11.8%), Caucasian 99(83.2%), American Indian/Alaskan Native 3(2.5%), Wish to not report 3(2.5%).
Following was the inclusion/exclusion criteria for the clinical study:
Inclusion Criteria:
- Males and females, 18 years of age and older ●
- People with type 1 or type 2 diabetes
- People who regularly perform self-tests (at least once/day) with their own lancing device
- Able to speak, read and understand English (subjects must demonstrate ability to read a paragraph from the first page of the Informed Consent document to qualify for the study)
- . Willing to complete all study procedures
Exclusion Criteria:
- Those with missing tips of the fingers indicated numerically or are physically unable to lance the palm areas and all 6 of the fingers
- Hemophilia or any other bleeding disorder ●
- Pregnancy
- Physical, visual or neurological impairments that would make the person unable to perform, testing. Subjects who have used the proposed lancing device in a previous clinical evaluation
Adverse Events: One (1) adverse event of hypoglycemia was reported. This was a nonserious, mild, anticipated, non-device related Adverse Event (AE). The event was resolved prior to the subject leaving the clinical site.
Conclusion- The acceptability of capillary blood volume obtained using the adjustable fingerstick and alternative site testing endcap by lay users with diabetes, was determined by study staff testing the blood on a Contour next family of blood glucose meters. Performance was analyzed using the percentage of numeric vs non-numeric meter readings obtained. All primary and secondary objectives of the clinical study were met.
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Image /page/14/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 alphanumeric code K220633.
-
- Conclusion Regarding Substantial Equivalence
The proposed 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 single-patient 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 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.
- Conclusion Regarding Substantial Equivalence
The proposed MICROLET® Lancet/ MICROLET® NEXT lancing device has the similar intended use, incorporate the same fundamental technology as the predicate MICROLET® Lancet/ MICROLET® NEXT lancing device which were previously 510 (k) exempt. The differences between 510(k)-exempt MICROLET® Lancet/ MICROLET® NEXT lancing device (legally offered for sale on or before November 22, 2021) and up classified MICROLET® Lancet lancing device do not raise any new questions of safety, or effectiveness. Test data to verify the performance of the up classified MICROLET® Lancet/lancing device has been provided including: biocompatibility, Sterility, clinical and non-clinical performance testing and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.
§ 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.