(56 days)
The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
The Accu-Chek Safe-T-Pro Uno lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Uno lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only.
The provided text describes a 510(k) summary for the Accu-Chek Safe-T-Pro Uno Lancing Device. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study that proves the device meets those criteria, such as sample size, data provenance, expert qualifications, or adjudication methods.
The document outlines the device's indications for use, its description, and compares it to a predicate device (SurgiLance Safety Lancets) to establish substantial equivalence. 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 & validation 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." A "Verification Summary" is mentioned as an attachment, which presumably contains the detailed test results, but this summary is not provided in the given text.
Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than detailing a specific performance study with acceptance criteria and results.
Disclaimer: Without the "Verification Summary" mentioned in the document, it is impossible to provide the requested details about acceptance criteria and reported performance. The information below is based solely on what is explicitly stated or can be inferred from the provided text, which is limited regarding specific performance metrics.
Based on the provided text, the following information can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific acceptance criteria or reported device performance metrics in a quantifiable manner. It mentions "nonclinical bench testing" and "design verification & validation testing" were performed to ensure risks were appropriately managed and verify mechanical functions are suitable for use over the lifetime of the device. The conclusion states the device "performs as well or better than the legally marketed predicate device," which is a general statement rather than specific performance data with corresponding acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text does not provide any information about the sample size used for the test set, data provenance, or whether the study was retrospective or prospective. It only refers to "nonclinical bench testing" and "design verification & validation testing."
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 as the provided text describes non-clinical bench testing for a lancing device, not a study evaluating human interpretation or a diagnostic algorithm requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the provided text describes non-clinical bench testing for a lancing device and does not involve adjudication of results from multiple reviewers.
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 as the device is a lancing device and does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a lancing device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the traditional sense of medical image analysis or diagnostic algorithms. For a lancing device, "ground truth" would refer to established engineering and mechanical standards, as implied by "design verification & validation testing" and compliance with "FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)."
8. The sample size for the training set
This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 5. 2022
Roche Diabetes Care, Inc. Julia Best Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Illinois 46055
Re: K220364
Trade/Device Name: Accu-Chek Safe-T-Pro Uno Lancing Device Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class II Product Code: FMK Dated: February 3, 2022 Received: February 8, 2022
Dear Julia Best:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-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
Submission Number (if known)
Device Name
Accu-Chek Safe-T-Pro Uno Lancing Device
Indications for Use (Describe)
The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K220364 K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
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: +49 173 3198175 Applicant Contact: Mrs. Julia Best Applicant Contact Email: julia.best@roche.com
Device Name [21 CFR 807.92(a)(2)]
Device Trade Name: Accu-Chek Safe-T-Pro Uno Lancing Device Common Name: Blood Lancets Classification Names: Single use only blood lancet with an integral sharps injury prevention feature Regulation Number: 878.4850, Class II Product Code: FMK
Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]
Predicate #: K101145 Predicate Trade Name: SurgiLance Safety Lancets Product Code: FMK
Device Description Summary [21 CFR 807.92(a)(4)]
The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals.
It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
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K220364
K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
| Predicate Device - SurgiLance K101145 | Candidate Device - Accu-Chek Safe-T-Pro UnoLancing Device K220364 | |
|---|---|---|
| Devicedescription | The SurgiLance Safety Lancet is a needle or bladedevice used to prick a test site to draw a micro-sample of blood which can then be tested for anarray of diagnostic assays.The SurgiLance Safety Lancet is safely retractedand concealed before and after use. Once the lancetis used, it is rendered inoperative, providing addedsafety for patient and clinician. The device isdiscarded after use. | The Accu-Chek Safe-T-Pro Uno lancing device is aneedle used for capillary blood sampling for use indiagnostic testing.The Accu-Chek Safe-T-Pro Uno lancing device contains asharps injury prevention feature where the lancet isretracted and concealed before and after use. Once thelancet is used, it is rendered inoperative. The device isdesigned for single use only. |
| Intended use | The SurgiLance Safety Lancet is a puncture deviceto obtain micro blood samples. The SurgiLanceSafety Lancet has a sharps prevention feature toprotect the user from a needlestick injury. | The Accu-Chek Safe-T-Pro Uno lancing device is asterile, single-use, disposable lancing device intended tobe used by healthcare professionals.It is designed for capillary blood sampling from thefingertip of adults and children 1 year and older or, if thepatient is a child under 1 year, from the heel. |
| Intended Users | Healthcare professionals and consumers | Healthcare professionals only |
| Number ofUses | Single use only with integral sharps injuryprevention feature | Same |
| Predicate Device - SurgiLance K101145 | Candidate Device - Accu-Chek Safe-T-Pro UnoLancing Device K220364 | |
| Device images | Image: SurgiLance K101145 | Image: Accu-Chek Safe-T-Pro Uno Lancing Device K220364 |
| LancetSterility | Yes, gamma irradiation | Same |
| Needle Gaugeand Depthlevels | Six models for different depth settings,differentiated by casing color:Yellow: 21 Gauge – 1.0 mm depthGray: 21 Gauge – 1.8 mm depthOrange: 21 Gauge – 2.2 mm depthPink: 21 Gauge – 2.8 mm depthLime: 18 Gauge – 1.8 mm depthBlue: 18 Gauge – 2.3 mm depth | Only one model:28 Gauge needle – 1.5 mm depth |
| Mechanicalloading | Spring-driven | Same |
| Predicate Device - SurgiLance K101145 | Candidate Device - Accu-Chek Safe-T-Pro UnoLancing Device K220364 | |
| Load andfiring | Loading / priming the device is not required.Press red end of lancet down against test site toactivate lancet mechanism. | Loading / priming the device is not required.Press release button to activate lancet mechanism. |
| Anatomicalsites | Test site Fingertip | Fingertip (adults and children 1 year and older) Heel (child under 1 year) |
| Sharps injuryprevention | The SurgiLance Safety Lancet has a passive safetymechanism that automatically activates after userequiring no action by the user. The lancet is safelyretracted and concealed before and after use. Oncethe lancet is used, it is rendered inoperative. | Same |
Similarities / Differences from Candidate Device to Predicate Device
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K220364 K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
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K220364
K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
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 & validation 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. See more in attached Verification Summary.
Conclusions
The predicate and the candidate device are both used to obtain a blood sample for diagnostic testing. Furthermore, both are sterile, single-use lancets with a sharps injury prevention feature, following the same mechanical load mechanism. In conclusion, the Accu-Chek Safe-T-Pro Uno Lancing Device is substantially equivalent to the SurgiLance Safety Lancets. The Accu-Chek Safe-T-Pro Uno Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device.
§ 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.