(57 days)
Not Found
No
The description focuses on a mechanical lancing device for blood sampling and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is described as a lancing device for capillary blood sampling, which is a diagnostic tool, not a therapeutic one. It's used for obtaining samples, not for treating a condition.
No
Explanation: The device is described as a "lancing device" designed for "capillary blood sampling" which is a step in collecting a sample, not performing a diagnosis. The text explicitly states it's for "blood sampling," not for analyzing or interpreting the sample, which are functions of a diagnostic device.
No
The device description clearly states it is a "lancing device," which is a physical, disposable hardware product used for capillary blood sampling. The performance studies also describe "mechanical functions" and "bench testing," further indicating a hardware device.
Based on the provided information, the Accu-Chek Safe-T-Pro Plus lancing device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Function of the Device: The Accu-Chek Safe-T-Pro Plus lancing device is used to obtain a blood sample. It is the tool for collecting the sample, not for performing a diagnostic test on the sample.
- Intended Use: The intended use clearly states it is for "capillary blood sampling." It doesn't mention any diagnostic testing or analysis of the blood sample itself.
- Lack of Diagnostic Metrics: The "Key Metrics" section is "Not Found," and the performance studies focus on mechanical function, safety features, and comparison to a predicate lancing device, not on diagnostic accuracy (like sensitivity, specificity, etc.).
The device is a tool for sample collection, which is a step that precedes an in vitro diagnostic test, but it is not the IVD itself.
N/A
Intended Use / Indications for Use
The Accu-Chek Safe-T-Pro Plus 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.
Product codes
FMK
Device Description
The Accu-Chek Safe-T-Pro Plus 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, heel
Indicated Patient Age Range
adults and children 1 year and older or, if the patient is a child under 1 year
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechication & validation testing in order to to ensure the risks were appropriately managed, in addition to verliying that the device's mechanical functions are suitable for use over the device. See more in attached Verification Summary.
Clinical Testing is not applicable; risk analysis confirmed 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. See Risk documents provided in Biocompatability section.
The Accu-Chek Safe-T-Pro Plus Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger font size and enclosed in a blue square.
May 19, 2022
Roche Diabetes Care, Inc. Jason Lee Senior Quality Lead 9115 Hague Road Indianapolis, Indiana 46256
Re: K220849
Trade/Device Name: Accu-Chek Safe-T-Pro Plus Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: March 22, 2022 Received: March 23, 2022
Dear Jason Lee:
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.
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
1
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 (OS) 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 provisions (Sections (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
2
Indications for Use
Submission Number (if known)
Device Name
Accu-Chek Safe-T-Pro Plus Lancing Device
Indications for Use (Describe)
The Accu-Chek Safe-T-Pro Plus 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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Page 1/2
510(k) Summary
Prepared on: 2022-03-22
| Contact Details | 21 CFR 807.92(a)(1) | ||||
|---|---|---|---|---|---|
| Applicant Name | Roche Diabetes Care, Inc. | ||||
| Applicant Address | 9115 Hague Road Indianapolis IN 46256 United States | ||||
| Applicant Contact Telephone | 1-317-435-4782 | ||||
| Applicant Contact | Mr. Jason Lee | ||||
| Applicant Contact Email | jason.lee.jl1@roche.com | ||||
| Correspondent Name | Roche Diabetes Care, Inc. | ||||
| Correspondent Address | 9115 Hague Road Indianapolis IN 46256 United States | ||||
| Correspondent Contact Telephone | 1-317-840-9231 | ||||
| Correspondent Contact | Mrs. Ginger Emrich | ||||
| Correspondent Contact Email | ginger.emrich@roche.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Accu-Chek Safe-T-Pro Plus Lancing Device | ||||
| Common Name | Blood lancets | ||||
| Classification Name | Blood lancets | ||||
| Regulation Number | 878.4850 | ||||
| Product Code | FMK | ||||
| Legally Marketed Predicate Devices | |||||
| 21 CFR 807.92(a)(3) | |||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K101145 | SurgiLance Safety Lancets | FMK | |||
| Device Description Summary | 21 CFR 807.92(a)(4) | ||||
| The Accu-Chek Safe-T-Pro Plus 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 Plus 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. | |||||
| Indications for Use Comparison | |||||
| 21 CFR 807.92(a)(5) |
4
K220849
The indications for use of the candidate device are the same as the predicate.
Technological Comparison
The technological characteristics of the candidate device are the same as the predicate.
Non-Clinical and/or Clinical Tests Summary & 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 (mechication & validation testing in order to to ensure the risks were appropriately managed, in addition to verliying that the device's mechanical functions are suitable for use over the device. See more in attached Verification Summary.
Clinical Testing is not applicable; risk analysis confirmed 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. See Risk documents provided in Biocompatability section.
The Accu-Chek Safe-T-Pro Plus Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device.
21 CFR 807.92(a)(6)