(228 days)
The PLANCET blood lancet is a puncture device to obtain micro-litre capillary whole blood samples from finger tips or palm or alternate body sites. The PLANCET blood lancet is normally loaded in a spring-operated lancing device for rapid puncture of skin.
The PLANCET blood lancet is a needle device to be loaded in a spring operated lancing device for pricking a patient's finger or palm to draw a micro-litre sample of whole blood to perform in-vitro diagnostic (IVD) blood tests. The PLANCET has a needle that is encapsulated by a plastic material that forms a body and a cap. This plastic encapsulation ensures the needle's integrity and sterility till point of use. The needle is made of a high performance and bio-compatible plastic material. The procedure to use PLANCET is to pull off the cap and to load PLANCET into a spring operated lancing device. Once triggered, the PLANCET will be actuated and retracted rapidly to penetrate the skin and create a small wound for getting some capillary whole blood.
Here's an analysis of the PLANCET Blood Lancet's acceptance criteria and studies, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes performance deemed "comparable" to the predicate device.
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance (PLANCET Blood Lancet) |
|---|---|
| Durability and Strength (Needle Integrity) | Able to penetrate a 0.4mm-thick polyurethane (PU) film repeatedly (4 times) without damage to the needle tip or body. This "rules out the possibility that they will break and remain in the skin." |
| Pain Level during Use | Pain level for carrying out a glucose test is comparable to the predicate device. |
| Blood Volume obtained | Sufficient blood for carrying out a glucose test, comparable to the predicate device. |
| Intactness after Use | All PLANCET blood lancets inspected under magnification after actual use remained intact. |
2. Sample Sizes and Data Provenance
-
Test Set (Focus Group Survey):
- Sample Size: 18 people.
- Data Provenance: Not explicitly stated, but it was a "focus group" and "blind study" involving actual use, implying prospective data collection in a controlled environment. The country of origin is not specified, but the manufacturer is based in Singapore, suggesting it might be local data.
-
Test Set (Bench Tests):
- Sample Size: Not explicitly stated for the "series of penetration tests." It mentions "PLANCET blood lancets" in plural, implying multiple devices were tested, but no specific number is given.
- Data Provenance: Retrospective (bench testing/laboratory evaluation). Country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Focus Group Survey: No experts were directly used to establish ground truth in the traditional sense for pain level or blood volume. The participants themselves reported pain levels, and "sufficient blood" was likely determined by whether a glucose test could be successfully performed.
- Bench Tests: No experts were explicitly mentioned for the bench tests. The assessment of needle damage was likely based on objective inspection (e.g., under magnification).
4. Adjudication Method for the Test Set
- Focus Group Survey: Not applicable in the context of expert adjudication. The study was a "blind study" comparing the new device to a predicate device, with participants reporting on their experience.
- Bench Tests: No adjudication method described; assessment was objective inspection.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The focus group study involved human users comparing the device to a predicate, not human readers interpreting data with and without AI assistance. This device is a physical medical instrument (a lancet), not an AI-driven image analysis or diagnostic tool. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable here.
6. Standalone (Algorithm Only) Performance
Not applicable. The PLANCET Blood Lancet is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Focus Group Survey:
- Pain Level: Subjective self-reporting by participants.
- Blood Volume: Functional assessment – whether sufficient blood was obtained for a glucose test (implied clinical utility).
- Needle Intactness: Visual inspection under magnification.
- Bench Tests: Objective physical assessment of needle integrity and penetration capability.
8. Sample Size for the Training Set
Not applicable. This device is a physical lancet, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device like this.
§ 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.