(167 days)
Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.
Heel Incision Safety Lancet is comprised of top upper cover, bottom cover, button, safety plug, slider, rod, holder, spring, blade. The spring provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired when the spring is under pressure. The safety plug is to protect the blade from triggering before use. Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals. Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.
The provided document is a 510(k) Premarket Notification for a medical device (Heel Incision Safety Lancet) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study proving a device meets acceptance criteria for an AI/ML-based medical device.
Therefore, many of the requested details regarding acceptance criteria, AI/ML study design, sample sizes, expert involvement, and ground truth establishment (especially for AI/ML models) are not applicable and not present in this document. This document describes a traditional medical device (a lancet) and its non-clinical performance testing.
However, I can extract the closest analogous information available from the document regarding acceptance criteria and performance for this non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document provides a "Summary of non-clinical testing" with "Items" (which can be interpreted as the performance characteristics for which acceptance was sought) and "Results" (the performance shown). While explicit "acceptance criteria" values (e.g., "must be > X N Force") are not always stated, the "Results" implicitly demonstrate acceptance where they state "No failures observed", "Meet the requirement", or "Compared with equivalent devices, there was no statistical difference."
| Items (Performance Characteristic) | Stated Results (Performance/Acceptance) | Implied Acceptance Criteria (Based on Results) |
|---|---|---|
| Material of blade | F type stainless steel materials | Blade material is F type stainless steel. |
| Appearance | The surface has no burr and scratch | Absence of burr and scratch on the surface. |
| Dimensions of product (Height) | The height of product(mm): 32±1.5 | Height within 32±1.5 mm. |
| Dimensions of product (Width) | The width of product(mm): 35±1.5 | Width within 35±1.5 mm. |
| Blade corrosion resistance | No blemishes | No blemishes due to corrosion. |
| Force to activate Safety Screw button | Compared with equivalent devices, there was no statistical difference | Performance of safety screw button activation force is statistically similar to equivalent devices. |
| Trigger force | Compared with equivalent devices, there was no statistical difference | Performance of trigger force is statistically similar to equivalent devices. |
| Safety overriding and unlocking force after activation | Compared with equivalent devices, there was no statistical difference | Performance of safety overriding and unlocking force is statistically similar to equivalent devices. |
| Sterility | Sterile | Device is sterile. |
| Limits acidity and alkalinity | Meet the requirement | Acidity and alkalinity limits are met. |
| Total heavy metal | Meet the requirement | Total heavy metal requirements are met. |
| Incision depth and length | All models have been tested within tolerances | Incision depth and length for all models are within specified tolerances. |
| Safety self-locking | There were no failures observed in a test run of 500 devices | No failures in safety self-locking in 500 tests. |
| Safety plug pullout | There were no failures observed in a test run of 500 devices | No failures in safety plug pullout in 500 tests. |
| Shooting performance | There were no failures observed in a test run of 500 devices | No failures in shooting performance in 500 tests. |
| Accidental access to sharp once in safe mode | There were no failures observed in a test run of 500 devices | No accidental access to sharp in safe mode in 500 tests. |
Biocompatibility Testing:
| Item (Biocompatibility Test) | Test Results (Performance/Acceptance) | Implied Acceptance Criteria (Based on Results) |
|---|---|---|
| In Vitro Cytotoxicity | No Cytotoxicity | Absence of cytotoxicity. |
| Skin Sensitization | No Skin sensitization | Absence of skin sensitization. |
| Intracutaneous reactivity | No irritation | Absence of irritation. |
| Acute Systemic Toxicity Test | No Acute Systemic Toxicity | Absence of acute systemic toxicity. |
| Material mediated pyrogenicity | Absence of pyrogens | Absence of pyrogens. |
| In vitro Hemolytic | No Hemolytic | Absence of hemolytic properties. |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Sizes: For key functional tests like "Safety self-locking," "Safety plug pullout," "Shooting performance," and "Accidental access to sharp once in safe mode," a test run of 500 devices was used, with "no failures observed." For other physical property and material tests, specific sample sizes are not explicitly stated, but are implied to be sufficient for meeting the standard/requirement (e.g., "All models have been tested within tolerances").
- Data Provenance: The tests are "bench testing" and "biocompatibility evaluations" conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., based in Suzhou, Jiangsu, P.R.China. The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance is established by direct measurement of physical properties (e.g., dimensions, forces) and standard laboratory tests (e.g., material analysis, sterility, biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML ground truth establishment where human readers might disagree. For bench testing of a physical device, results are typically objective measurements or pass/fail outcomes against defined specifications.
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 is not applicable as this is a physical medical device, not an AI/ML-based diagnostic or assistive technology. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained, for this physical device, the "ground truth" for performance is established by:
- Direct physical measurements (e.g., dimensions, force values).
- Standardized analytical tests (e.g., material composition, sterility).
- Biocompatibility tests according to ISO standards.
- Pass/fail criteria based on safety and functional requirements.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.
§ 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.