(428 days)
The NanoDrop Lancet is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.
The Drawbridge Health NanoDrop Lancet Device is a sterile, single-use, disposable lancet for capillary blood sampling. The device incorporates two (2) stainless steel needles with blade tips to make two (2) small incisions in the skin. The device is made of a gray plastic housing base that has a molded outer rim and a bowl-shaped cavity. The outer rim is covered by a hydrogeladhesive to better attach the device to the skin, with a cover over the hydrogel adhesive pad for its protection. The bowl shape provides space for the skin to be drawn up as slight controlled vacuum pressure is applied, and for the needle blades to access the skin after piercing through a septum and vacuum chamber foil. There are two (2) clearly marked gray push buttons on the device:
- The gray button marked "I" is for activation of the vacuum; and
- The gray button marked "II" is for deployment of the needle blades.
There is a yellow removable plastic locking feature to prevent accidental activation of the button that deploys the needle blades(gray button marked "II"). There is also a white vacuum chamber lid securely attached on top of the base, over the gray lancet enclosure, where the two needle blades are held in a clear plastic needle holder, along with the main spring and retraction spring, and into which they automatically retract after use, with no access to this gray lancet enclosure possible. This prevents the lancet from being used more than once, and it keeps the blades retracted for sharps injury prevention safety and for disposal. A permanent plug obstructs the port and mitigates unintended connection of a collection container.
The single model number is FD004.
Here's a breakdown of the acceptance criteria and study information for the NanoDrop Lancet device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The following performance testing met all acceptance criteria" but does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and a general statement of meeting criteria. Thus, I will list the tests and the general performance statement where specific metrics are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-clinical Performance | Met all acceptance criteria |
| Pain levels and preferred method of obtaining blood (User Study) | Met all acceptance criteria |
| Lancet Cut (Penetration) Depth | Met all acceptance criteria |
| Applied Vacuum Lower Bound Test | Met all acceptance criteria |
| Lancet Needle Blade Diameter | Met all acceptance criteria |
| Device Length and Width | Met all acceptance criteria |
| Device Redeployment Testing | Met all acceptance criteria |
| Lancet Retraction Distance | Met all acceptance criteria |
| Pull Force Testing of Needle from Holder | Met all acceptance criteria |
| Sharps Injury Prevention Feature Drop Testing | Met all acceptance criteria |
| Pull Force and Mechanical Testing of Permanent Plug | Met all acceptance criteria |
| Permanent Plug Leak Test | Met all acceptance criteria |
| Hydrogel Ring and Bloodborne Pathogen Barrier | Met all acceptance criteria |
| USP-NF: 2020 Chapter Testing for Particulates in Solutions or Medical Devices | Met all acceptance criteria |
| Biocompatibility | Successfully completed |
| ISO 10993-1: Biological Evaluation of Medical Devices-Part 1: Evaluation and testing within a risk management process | Successfully completed |
| ISO 10993-3: Biological Evaluation of Medical Devices- Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Successfully completed |
| ISO 10993-4: Biological Evaluation of Medical Devices-Part 4: Selection of tests for interaction with blood | Successfully completed |
| ISO 10993-5: Biological Evaluation of Medical Devices-Part 5: Test for in vitro cytotoxicity | Successfully completed |
| ISO 10993-10: Biological Evaluation of Medical Devices-Part 10: Test for irritation and skin sensitization | Successfully completed |
| ISO 10993-11: Biological Evaluation of Medical Devices-Part 11: Test for systemic toxicity; Material-mediated Pyrogenicity | Successfully completed |
| USP-NF 2018 USP : USP Limulus Amebocyte Lysate (LAL) Test - Kinetic-Turbidimetric Method | Successfully completed |
| Sterilization/Shelf-life/Shipping Testing | Passed |
| Sterilization Method | Radiation (electron beam) |
| Sterility Assurance Level | SAL 10-6 |
| ANSI/AAMI/ISO 11137-1, -2, -3 | Passed |
| ASTM F1980-16 (Accelerated Aging) | Passed |
| ASTM 4169-16 (Shipping Containers) | Passed |
| ASTM F2096-11 (Gross Leaks) | Passed |
| ASTM F88/F88M-15 (Seal Strength) | Passed |
| Clinical Performance | Met all acceptance criteria |
| Safety and Use of NanoDrop Lancet Device | Met all acceptance criteria |
| User's opinion regarding handling characteristics | Met all acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 30 subjects (each with two samples for the NanoDrop Lancet and two samples for the predicate device, totaling four samples per subject).
- Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the study was retrospective or prospective, though a "clinical study was performed" generally implies a prospective design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The clinical study was focused on "safety and use" and "user's opinion," suggesting direct participant feedback rather than expert-adjudicated ground truth in the traditional sense of medical image analysis or diagnosis.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the study (safety, use, user opinion for a blood lancet), a formal adjudication method like "2+1" or "3+1" is unlikely to be applicable in the same way it would be for diagnostic device performance studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Was an MRMC study done? A clinical study was performed comparing the NanoDrop Lancet Device to a comparable cleared OTC FMK fingerstick lancet (Acti-Lance K220643) to evaluate "safety and use" and "user's opinion with regards to handling characteristics." While it involved comparison, it doesn't explicitly fit the typical definition of an MRMC study focused on diagnostic accuracy with multiple human readers interpreting cases. It's more of a comparative user experience and safety study.
- Effect Size: The document does not provide specific quantitative effect sizes for how much human readers (or users, in this context) improve with the AI (device) vs. without the AI (predicate device). It only states that "All acceptance criteria were met, supporting safe and effective use of the NanoDrop Device unsupervised and self-administered by adults on the upper arm."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a medical lancet, not an AI or algorithm-driven device. Therefore, the concept of "standalone performance" for an algorithm does not apply to this product. The non-clinical performance tests (like cut depth, vacuum, redeployment, etc.) are essentially evaluating the device's standalone mechanical and functional performance, but not in the context of an "algorithm."
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was essentially:
- Device safety: Observed absence of adverse events or complications.
- Device effectiveness/use: Successful acquisition of capillary blood samples.
- User opinion: Subjective feedback from participants regarding handling characteristics.
This isn't ground truth established by pathology or expert consensus in a diagnostic sense, but rather direct observational and subjective feedback from participants in a usability and safety context.
8. The Sample Size for the Training Set
The document describes a clinical study as a performance evaluation for market clearance, not a study to train an algorithm. As this is not an AI/ML device, there is no training set in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this information is not applicable.
§ 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.