The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

Device Description

The TAP Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The TAP Lancet comprises a lancing module and a vacuum creation module which operate in an entirely mechanical fashion. The device uses a lancet and vacuum to initiate blood flow from the capillary bed in the upper arm. To use the device, the user removes that TAP Lancet from a sterile barrier package. Next, the user removes a protective liner from the bottom of the device to expose a layer of medical adhesive and places the device onto the

AI/ML Overview

Let's break down the information regarding the acceptance criteria and the study proving the device meets them for the TAP Lancet.

The provided text is a 510(k) Summary for the TAP Lancet, a blood lancing device. The summary focuses on demonstrating substantial equivalence to a predicate device and includes details about non-clinical and clinical performance testing.

Here's the breakdown of the acceptance criteria and study as presented in the document:

1. Acceptance Criteria and Reported Device Performance

The document describes the performance of the device in a clinical study primarily under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section. The key metric reported related to the device's functional performance in producing blood samples.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to successfully produce blood samples	Total success rate of 95.0%
Device performs as intended	"demonstrated that they performed as intended"
Compliance with functional requirements	"met all functional requirements evaluated"
Safety and effectiveness for intended use	"found to be safe and effective for the intended use"
Residual risks deemed acceptable	"all residual risks were deemed acceptable"

Note: The document doesn't explicitly state quantitative 'acceptance criteria' in a table format for the clinical study results, but rather presents the study outcome as meeting the overall performance goals.

2. Sample Size and Data Provenance

Test Set (Clinical Study):
- Sample Size: Not explicitly stated as a number of subjects. The text mentions "human subjects" and "The devices had a total success rate of 95.0%". From the information on the training set (380 samples), this seems to be a separate smaller study for usability.
- Data Provenance: Not specified regarding country of origin. The study was an "actual-use study" where "Subjects produced their blood samples following the TAP Lancet instructions for use," indicating a prospective study design.
Training Set (Usability Study, from context of "clinical testing" section related to usability):
- Sample Size: 380 samples (This is the only specific number of "samples" mentioned in relation to a study that isn't device/material testing).
- Data Provenance: Not specified regarding country of origin. The study was a "human use study" that also seems prospective, as subjects were producing blood samples using the device.

3. Number of Experts and Qualifications for Ground Truth

The document does not indicate the use of experts to establish ground truth for the clinical performance. The "ground truth" for the clinical study appears to be the successful production of microliter capillary whole blood samples by the device itself when used by human subjects according to instructions. This implies a direct observational assessment of the device's primary function rather than interpretation by human experts.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The success of blood sample production is likely a direct, measurable outcome, not requiring interpretation or adjudication by multiple reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or described. The study focused on the performance of the device itself (ability to produce blood samples) and its usability, not on comparing human readers with and without AI assistance. This device is a physical lancing device, not an AI/imaging diagnostic tool.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a physical medical device (lancet), not an algorithm or software. Its performance is inherent to its mechanical function.

7. Type of Ground Truth Used

The ground truth for the clinical performance assessment was outcomes data related to the device's primary function: the successful production of microliter capillary whole blood samples. This was a direct, observable outcome of the device's use.

8. Sample Size for the Training Set

As mentioned above, if we interpret "training set" as the data used for the usability study which informed product improvements or finalized the design:

Sample Size: 380 samples.

9. How Ground Truth for the Training Set Was Established

The "training set" (presumably the samples from the usability study) ground truth was established by direct observation and assessment of the device's ability to produce blood samples and its usability when used by human subjects. The phrase "Subjects produced their blood samples following the TAP Lancet instructions for use" and "The devices had a total success rate of 95.0% and demonstrated that they performed as intended" suggests that success was a direct observation of whether a sample was obtained as specified. The usability portion would have involved feedback or evaluation based on the instructions for use.

Summary

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April 19, 2023

YourBio Health, Inc. Sean McCarthy Director of Clinical and Regulatory Affairs 200 Boston Avenue Suite 3700 Medford, Massachusetts 02155

Re: K223201

Trade/Device Name: TAP Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: FMK Dated: October 13, 2022 Received: October 14, 2022

Dear Sean McCarthy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

The OHT4: Office of Surgical and Infection Control Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitations must appear in the Precautions/Warnings/Contraindications section of the device's labeling in addition to being placed prominently immediately after any images or references to a collection tube:

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1. This device is only for use with compatible collection tubes that are cleared for use with this device;
1. This device is not intended for use as a blood collection kit; and
1. This device is not intended for at-home collection or collection by lay-users.

Furthermore, the indication for use "The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples." must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita Ashar, M.D., M.B.A., F.A.C.S.

Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223201

Device Name TAP Lancet

Indications for Use (Describe)

The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

Type of Use (Select one or both, as applicable)

	☒ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary TAP Lancet® K223201

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Owner/Applicant:	YourBio Health, Inc.200 Boston AvenueSuite 3700Medford, MA 02155Telephone: (617) 547-7246Establishment registration number: 3012853700
OfficialCorrespondent	Sean T. McCarthyDirector of Clinical and Regulatory AffairsYourBio Health, Inc.200 Boston Avenue, Suite 3700Medford, MA 02155Telephone: (617) 435-6023smccarthy@yourbiohealth.com
Date of Summary:	April 19, 2023
Device Trade Name:	TAP Lancet®
Common or UsualName:	Blood lancet/Single Use Only Blood Lancet With An Integral Sharps InjuryPrevention Feature
Regulation Number:	21 CFR 878.4850
Device Class:	II
Product Code:	FMK
Panel:	General Surgery OHT4
Predicate Device:	Tasso+ (K221131)
Device Description:	The TAP Lancet is a single-use blood lancing device with an integralsharps injury prevention feature intended for producing microlitercapillary whole blood samples. The TAP Lancet comprises a lancingmodule and a vacuum creation module which operate in an entirelymechanical fashion. The device uses a lancet and vacuum to initiateblood flow from the capillary bed in the upper arm. To use the device,the user removes that TAP Lancet from a sterile barrier package. Next,the user removes a protective liner from the bottom of the device toexpose a layer of medical adhesive and places the device onto the
Intended Use/Indications for Use:	The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
Indications for Use Comparison	The indications for use of the candidate device are the same as the indications for use of the predicate device.
Technological Comparison	The technological characteristics of the candidate device are the same as the technological characteristics of the predicate device. The TAP Lancet blade length (1 mm) ensures that insertion risk has been mitigated. The blade length is shorter than the skin thickness (epidermal and dermal layers), which averages approximately 1-2 mm thick at the target collection site. Furthermore, the base of the blade bottoms out on the surface, preventing the blade tip from inserting any farther than its total length. The blade length was specifically designed to target capillary blood vessels such as arterioles and venules within the dermis layer of the skin, while minimizing invasiveness and preventing penetration beyond the subcutaneous layer. TAP Lancet incision size is 0.175 mm x 0.050 mm x 30 (maximum depth: 1mm). Predicate device incision size is Max Length: 5 mm and Max Depth: 2 mm.
Non-Clinical and/or Clinical Tests Summary & Conclusions	Non-clinical performance studies were conducted to confirm the overall functional specification testing of the device against its design specifications and intended use and to support substantial equivalence. The following testing was conducted:Package Integrity Testing:Package integrity testing was conducted to verify that the package formed a sealed sterile barrier. Package integrity testing included seal strength integrity evaluation via bubble leak testing (ASTM F2096), and seal peel strength evaluation (ASTM F88). Ship testing was conducted according to ISTA 2A with environmental conditioning.Shelf-life and Ship Testing:Shelf-life testing was conducted according to ASTM F1980.Biocompatibility Testing:The biocompatibility of the device materials was demonstrated via testing conducted in accordance with ISO 10993-1.Pyrogenicity Testing:The device was evaluated for pyrogenicity. The results demonstrated that the device is considered non-pyrogenic and meets the requirements of the Pyrogen Test, ISO 10993-11 guidelines.Usability Testing:The usability of the TAP Lancet with the instructions for use was

evaluated in an actual-use study and is discussed in the clinical testing
section of this submission. The device, in conjunction with the
instructions for use, was found to be safe and effective for the intended
use, and all residual risks were deemed acceptable for this type of
device. An assessment of clinical performance data for the TAP Lancet
successfully demonstrated its ability to produce blood samples from the
upper arm of human subjects according to the device labeling. Subjects
produced their blood samples following the TAP Lancet instructions for
use. The devices had a total success rate of 95.0% and demonstrated that
they performed as intended. The TAP Lancet met all functional
requirements evaluated in non-clinical and clinical performance testing
to demonstrate that the product is safe and effective for the intended use.

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K223201

Regulation Number and Section

§ 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.