(105 days)
Unistik® Heelstik: The Unistik® Heelstik heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers. Unistik® TinyTouch: The Unistik® TinyTouch heel incision safety lancets are single used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.
The submission devices are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. The devices automatically self-disable after a single use, thus preventing any hazards of re-use. The submission devices are intended for use by healthcare professionals only, for performing heel incisions on newborns, preemies, and toddlers to obtain capillary blood specimens for IVD assays. The product is intended for prescription (Rx) only use.
This document describes the performance testing conducted for the Unistik® TinyTouch and Unistik® Heelstik sterile single-use heel incision safety lancets.
1. Table of Acceptance Criteria and Reported Device Performance
Because this is a 510(k) summary for a medical device that appears to be a blood lancet, the "acceptance criteria" are implied to be established specifications and standards for similar devices, ensuring safety and effectiveness. The reported device performance is consistently listed as "Meets acceptance criteria/ Pass" for all tests. Specific numerical acceptance criteria are not provided in this summary.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Unistik® TinyTouch Specific Tests (from Table 7.1) | ||
| Sterility tab removal force | Defined specification | Meets acceptance criteria/ Pass |
| Button actuation force | Defined specification | Meets acceptance criteria/ Pass |
| Trigger interlock resistance force | Defined specification | Meets acceptance criteria/ Pass |
| Side load function test | Defined specification | Meets acceptance criteria/ Pass |
| Incision profile - depth of cut | Defined specification | Meets acceptance criteria/ Pass |
| Incision profile - length of cut | Defined specification | Meets acceptance criteria/ Pass |
| Simulated storage conditions (8 hr storage at 60°C/0% RH, -20°C/0% RH) | Defined specification | Meets acceptance criteria/ Pass |
| Simulated contact conditions (cleaned/wiped with 70% isopropyl alcohol) | Defined specification | Meets acceptance criteria/ Pass |
| Drop test | Defined specification | Meets acceptance criteria/ Pass |
| Sterile barrier integrity test | Defined specification | Meets acceptance criteria/ Pass |
| Shipping test report | Defined specification | Meets acceptance criteria/ Pass |
| Unistik® Heelstik Specific Tests (from Table 7.2) | ||
| Appearance | Defined specification | Meets acceptance criteria/ Pass |
| Blood collection function | Defined specification | Meets acceptance criteria/ Pass |
| Assembly status | Defined specification | Meets acceptance criteria/ Pass |
| Dimension | Defined specification | Meets acceptance criteria/ Pass |
| Resistance to corrosion | Defined specification | Meets acceptance criteria/ Pass |
| Acidity or Alkalinity | Defined specification | Meets acceptance criteria/ Pass |
| Extractable Metals | Defined specification | Meets acceptance criteria/ Pass |
| Structural integrity | Defined specification | Meets acceptance criteria/ Pass |
| Resistance to re-use | Defined specification | Meets acceptance criteria/ Pass |
| Incision profile - depth and length | Defined specification | Meets acceptance criteria/ Pass |
| Drop test | Defined specification | Meets acceptance criteria/ Pass |
| Packaging test after accelerated aging | Defined specification | Meets acceptance criteria/ Pass |
| Performance test after accelerated aging | Defined specification | Meets acceptance criteria/ Pass |
| Simulated clinical study | Defined specification | Meets acceptance criteria/ Pass |
| General Tests and Standards (for both devices) | ||
| Biocompatibility (per ISO 10993-1) | Compliance with ISO 10993-1 | Met |
| Sterilization (per ISO 11137) to achieve SAL 10^-6 | Compliance with ISO 11137 | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of devices tested for button actuation force). However, it indicates that "Design verification testing... has been carried out to evaluate the performance of the devices against defined acceptance criteria." The tests appear to be laboratory-based bench evaluations.
The data provenance is not explicitly stated in terms of country of origin, but Owen Mumford Ltd is based in the United Kingdom. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For bench testing of a physical medical device like a lancet, the "ground truth" is typically established by engineering specifications, validated test methods, and compliance with recognized standards. This generally does not involve expert consensus in the same way as, for example, image interpretation. The testing would have been performed by qualified technicians and engineers following established protocols. The document does not specify human experts for establishing ground truth for these types of tests.
4. Adjudication Method for the Test Set
Not applicable for this type of bench testing. The results are objective measurements against predefined engineering specifications and pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for a blood lancet, not an AI or imaging device that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The performance data presented refers to the standalone performance of the physical devices themselves through various bench tests (e.g., incision profile, button actuation force, drop test). There is no "algorithm" in the context of an AI device.
7. The Type of Ground Truth Used
The ground truth for the performance tests is based on engineering specifications, predefined acceptance criteria, and compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization). For example, "incision profile - depth of cut" would have a specific numerical range as an acceptance criterion.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.