(57 days)
The Accu-Chek Softclix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
This system is for use only on a single patient in a home setting.
This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
The Accu-Chek Softclix Lancing Device uses compatible Accu-Chek Softclix Lancets to obtain a drop of blood from a fingertip or alternative sites. The Accu-Chek Softclix Blood Lancing System consists of three components:
- Accu-Chek Softclix Lancing Device
- Accu-Chek Softclix Lancets
- Accu-Chek Softclix Alternative Site Testing (AST) Cap
The provided text describes the regulatory clearance of a blood lancing system and focuses on the substantial equivalence to a predicate device, rather than detailed acceptance criteria and a study proving those criteria.
Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted as they are not present in this regulatory document. This document emphasizes non-clinical (bench) testing to ensure functional equivalence and risk mitigation for a medical device.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. It states that "Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device." This implies that the device met certain mechanical and safety standards but doesn't list specific quantitative criteria or their outcomes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text only mentions "nonclinical bench testing" and "design verification testing" without specifying sample sizes for these tests or the origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. As this is a mechanical blood lancing device, "ground truth" in the context of expert review for diagnostic accuracy is not relevant. The testing focuses on mechanical function, safety, and performance as a lancing device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically associated with qualitative or diagnostic assessments, which are not the focus of this device's testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging or AI-assisted diagnostic devices. This device is a blood lancing system, which does not involve human readers interpreting AI results.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The device described, a blood lancing system, does not involve an algorithm for standalone performance assessment in the way AI systems do. Its performance is mechanical and safety-related.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document explicitly states: "Clinical Testing is not applicable: risk analysis confirmed that all identified risks were addressed and mitigated appropriately." Therefore, ground truth, as often defined for diagnostic accuracy, was not established through clinical data, pathology, or expert consensus on patient outcomes. Instead, the "ground truth" for this device's performance would be adherence to engineering specifications, safety standards (e.g., sharps injury prevention), and mechanical functionality confirmed through bench testing.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set mentioned for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 17, 2022
Roche Diabetes Care, Inc. Mr. Cameron Smith Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250
Re: K214022
Trade/Device Name: Accu-Chek Softclix Blood Lancing System Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL, ORK
Dated: December 21, 2021 Received: December 22, 2021
Dear Mr. Cameron Smith:
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 (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) K214022
Device Name Accu-Chek Softclix Blood Lancing System
Indications for Use (Describe)
The Accu-Chek Softclix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
This system is for use only on a single patient in a home setting.
This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Type of Use (Select one or both, as applicable):
| ☐ Prescription Use (Part 21 CFR 201.5): |
|---|
| ☑ Over-The-Counter Use (21 CFR 201.6): |
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Contact Details [21 CFR 807.92(a)(1)]
Applicant Name: Roche Diabetes Care, Inc. Applicant Address: 9115 Hague Road Indianapolis, IN 46250-0457; United States of America Applicant Contact Telephone: (317) 696-1965 Applicant Contact: Mr. Cameron Smith Applicant Contact Email: cameron.smith.cs1 @roche.com
Device Name [21 CFR 807.92(a)(2)]
Device Trade Name: Accu-Chek Softclix Blood Lancing System Common Name: Blood Lancets Classification Names: Blood Lancets Regulation Number: 878.4850, Class II Product Code: QRL, QRK
Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]
Predicate #: K810075 Predicate Trade Name: Autoclix Lancet Product Code: FMK
Device Description Summary [21 CFR 807.92(a)(4)]
The Accu-Chek Softclix Lancing Device uses compatible Accu-Chek Softclix Lancets to obtain a drop of blood from a fingertip or alternative sites. The Accu-Chek Softclix Blood Lancing System consists of three components:
-
- Accu-Chek Softclix Lancing Device
-
- Accu-Chek Softclix Lancets
- Accu-Chek Softclix Alternative Site Testing (AST) Cap 3.
Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
The Accu-Chek Softclix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
This system is for use only on a single patient in a home setting.
This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Indications for Use Comparison [21 CFR 807.92(a)(5)]
The indications for use of the candidate device are the same as the predicate with the predicate device has people with diabetes as clients, and the candidate device is for general use.
Technological Comparison [21 CFR 807.92(a)(6)]
The candidate and predicate devices share technological characteristics including their design, mechanical mechanism, principle of operation, energy source and usage, features, form, fit, and function.
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| Predicate Device - Autoclix K810075 | Candidate Device - Accu-Chek Softclix BloodLancing System K214022 | |
|---|---|---|
| Devicedescription | Autoclix is an automatic device used toobtain a drop of blood from the fingertip, earlobe or heel. It operates in conjunction withthe Autoclix Lancet, a sterile, disposableblood lancet. | The Accu-Chek Softclix Lancing Device usescompatible Accu-Chek Softclix Lancets toobtain a drop of blood from a fingertip oralternative sites using the Accu-Chek SoftclixAlternative Site Testing (AST) Cap. |
| Intendeduse | The Autoclix Lancet is intended for thepainless, safe and hygienic collection ofcapillary blood, preferably from the side ofthe finger tip for diagnostic purposes. | The Accu-Chek Softclix Blood Lancing System isintended for the hygienic collection of capillaryblood for testing purposes from the side of afingertip and from alternative sites, such as thepalm, the upper arm, and the forearm. |
| Indicationsfor use | The Autoclix Lancet, as an aid forpatients to prick themselves in order toperform self-controls, shall only beused by a single patient. It is notsuitable for professional (“multi-user”)application. People with diabetes are considered asclients, although the use of the productin the neonatal field is not admissible. | The sterile, single-use lancets are to be usedwith the reusable lancing device that is to becleaned and disinfected between each use,and then the lancets are to be disposed of. This system is for use only on a single patientin a home setting. This system is not suitable for use byhealthcare professionals with multiplepatients in a healthcare setting. |
| Number ofUses | Base (lancing device): multiple use Lancet: single use | Base (lancing device): multiple use Lancet: single use |
| Predicate Device – Autoclix K810075 | Candidate Device - Accu-Chek Softclix BloodLancing System K214022 | |
| Deviceimages | Lancing Device (and pressure platforms):Image: Autoclix lancing device and pressure platforms | Lancing Device (and AST Cap):Image: Accu-Chek Softclix lancing device and AST cap |
| Lancet:Image: Autoclix lancet | Lancet:Image: Accu-Chek Softclix lancet | |
| LancetSterility | Yes, gamma irradiation | Yes, gamma irradiation |
| Needle | 0.4mm (28G); 3-facet cut | 0.4mm (28G); beveled cut with 3 facets |
| Depthadjustment | 3 levels by using different pressure platforms | 11 levels by twisting cap |
| Mechanicalloading | Spring-driven | Spring-driven |
| Load andfiring | Load with pressing the plunger when lancet is inserted, Fire with pressing the pressure platform. | Load by pressing priming button when lancet is inserted, Fire by pressing the release button. |
| Anatomicalsites | Fingertip Ear lobe Heel | Fingertip Ball of the hand (palm) Upper arm Lower arm (forearm) |
| Predicate Device – Autoclix K810075 | Candidate Device – Accu-Chek Softclix BloodLancing System K214022 | |
| Sharpsinjuryprevention | The Autoclix is designed so that it can bereset to operate only after the used lancet hasbeen ejected. In this way, multiple punctureswith a used lancet are prevented. Automaticejection of used lancets is done by pressingthe plunger. | Lancets are covered by a sterile barrier cap untiltwisted off before use. Until firing, the lancet iscontained within the lancing device housing.Immediately after firing, the lancet is automaticallyretracted back into housing. An ejector sleeve canthen be pulled forward for contactless disposal ofthe lancet. |
Similarities / Differences from Candidate Device to Predicate Device
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Non-Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]
Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device.
Clinical Testing is not applicable: risk analysis confirmed that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified.
Conclusions
The results of nonclinical testing demonstrate that the candidate device has a substantially equivalent safety and effectiveness profile to the predicate device and should perform as intended in the specified use conditions as well as the predicate device per required standards.
§ 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.