(116 days)
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
The Tasso+ device is a sterile, disposable blood lancet. After attachment of a compatible third-party collection tube, the backing is removed from the medical adhesive that is located on the skin side of the device is adhered, in position, to the skin by this adhesive backing.
The device is actuated by pressing the button, causing an energized spring to release and swing the lancet assembly containing a single stainless-steel lancet in an arching motion to create an incision. The lancet contacts the patient momentarily, less than one second, to create a single incision. The mechanism automatically positions the lancet in an inactive position after it has made the incision to prevent sharps injury or re-actuation.
In addition to deploying the lancet, the push of the button generates a slight vacuum to facilitate blood flow under gravity into the blood collection tube. The blood flows from the incision via an open channel in the base and into the compatible tube. The blood flow is one-way, from the skin to the tube, preventing blood re-exposure.
The user is instructed to stop blood collection after a maximum of five minutes of draw time or when the blood reaches the maximum volume fill indicator on the attached tube. The device is then peeled off the skin, and the compatible third-party tube is removed and capped for transport.
The document describes the acceptance criteria and the study that proves the device (Tasso+) meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance (Regulatory Compliance, Safety, and Design Specifications) | Compliance with various FDA-recognized consensus standards for sterilization, packaging, biological evaluation, labeling, performance testing of packages, accelerated aging, leak detection, hemolytic properties, sharps injury protection, and usability engineering. Compliance with special controls described in 21 CFR 878.4850(a)(2). | All verification and validation testing for Tasso+ confirms that product specifications are met and are equivalent in design and technological and performance characteristics as the predicate device. Tasso+ is also in compliance with the special controls described in 21 CFR 878.4850(a)(2). |
| Clinical Performance (Ability to collect blood samples) | The device must demonstrate its ability to collect blood samples from the upper arm of human subjects according to device labeling. The minimum acceptable volume collected must be within the lower limit of the 90% confidence interval. Performance as intended with a compatible tube. | The Tasso+ successfully demonstrated its ability to collect blood samples from the upper arm of human subjects according to the device labeling. The devices demonstrated that the minimum acceptable volume collected was within the lower limit of the 90% confidence interval. The devices had a total success rate of 94.2% and demonstrated that they performed as intended with a compatible tube. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but derived from the success rate, it would be the total number of attempts made by subjects in the clinical performance study. The 94.2% success rate indicates a significant number of samples were taken.
- Data Provenance: The study involved "human subjects" who "self-collected their blood samples." This indicates a prospective clinical study where data was collected specifically for the purpose of evaluating the Tasso+ device. The document does not specify the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This information is not provided in the document. The clinical study focuses on the device's ability to physically collect blood samples, rather than a diagnostic interpretation where expert ground truth would typically be established. The "ground truth" here is the successful collection of blood and achieving a minimum volume, which can be objectively measured.
4. Adjudication Method for the Test Set
- This information is not applicable/provided as the clinical study appears to focus on objective physical measurements (blood collection success, volume) rather than subjective assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The study described is a performance study of the Tasso+ device itself, not a comparison of human readers with and without AI assistance.
6. If a Standalone Performance Study Was Done
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done for the non-clinical performance data, where the device's physical and technical specifications were tested against established standards. From the clinical performance perspective, users operated the device directly (self-collection), so the "algorithm" is the device's mechanical function, and its performance was assessed in a standalone manner (without another human intervening in the blood collection process once initiated by the user).
7. The Type of Ground Truth Used
- Clinical Performance: The ground truth for the clinical performance study was objective measurement of successful blood collection and minimum acceptable volume achievement. The document states that the "devices demonstrated that the minimum acceptable volume collected was within the lower limit of the 90% confidence interval" and had a "total success rate of 94.2%."
- Non-Clinical Performance: For non-clinical performance, the ground truth was compliance with recognized consensus standards (e.g., ISO, ASTM standards) and meeting established product specifications.
8. The Sample Size for the Training Set
- This information is not provided in the document. The Tasso+ is a physical blood lancing device, not an AI/ML algorithm that typically requires a training set. The development of such a device involves engineering design, prototyping, and testing, but not "training sets" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the device is not an AI/ML algorithm. The "ground truth" during the device's development would be established through engineering design specifications, material science testing, and regulatory standards for blood lancing devices.
§ 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.