The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.

AI/ML Overview

The provided document is a 510(k) summary for the Medipoint Blood Lancets. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria in the same way a new device with novel claims would. The "acceptance criteria" here implicitly refer to the performance and safety characteristics established by the predicate devices and relevant standards.

However, I can extract the information related to the device's performance based on the non-clinical testing sections to address your questions as best as possible within the context of this document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary, the "acceptance criteria" are implied by the performance of the predicate devices and relevant standards (e.g., ISO 10993 for biocompatibility, and expectations for a blood lancet's physical integrity). The study aims to show the subject device performs equivalently.

Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Subject Device)
Mechanical Integrity (during use)	Withstands forces encountered during use without bending or damage.
Biocompatibility:	Passed Cytotoxicity
- Cytotoxicity	Passed Sensitization
- Sensitization	Passed Irritation or Intracutaneous Reactivity
- Irritation / Intracutaneous Reactivity	Passed Acute Systemic Toxicity (Material-Mediated Pyrogenicity)
- Acute Systemic Toxicity	Individual packages are sterile. Sterilization validated via moist heat.
Sterility

Study Proving Device Meets Acceptance Criteria

The study described is a series of non-clinical tests performed to demonstrate that the Medipoint Blood Lancets perform equivalently to their predicate devices and meet relevant safety standards.

2. Sample Size for the Test Set and Data Provenance:

Performance Testing (Mechanical Integrity): Not explicitly stated, but typically involves a representative sample of devices.
Biocompatibility Testing: Not explicitly stated, but typically involves a sufficient number of samples as per ISO 10993 guidelines to perform the required tests.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. These are typically bench and lab tests conducted by the manufacturer or contracted labs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This is not applicable as the studies described are non-clinical bench tests and biocompatibility assessments, not diagnostic performance studies requiring expert interpretation or ground truth establishment in the traditional sense (e.g., imaging interpretation). The "ground truth" for these tests are objective measurements and standardized biological responses.

4. Adjudication Method for the Test Set:

Not applicable, as these are objective non-clinical tests, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI or diagnostic tools on human reader performance, which is not relevant for a blood lancet device.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

Not applicable. This device is a physical blood lancet, not an algorithm or AI. The "standalone performance" here refers to the device's physical and biological performance characteristics as a medical device.

7. Type of Ground Truth Used:

Performance Testing (Mechanical Integrity): The "ground truth" is adherence to predefined engineering specifications and the ability to withstand forces without damage, often compared against predicate device performance.
Biocompatibility Testing: The "ground truth" is established by standard biological assays (e.g., cell viability for cytotoxicity, immune response for sensitization) and regulatory thresholds for acceptable biological reactions as defined in ISO 10993.
Sterility: The "ground truth" is a Sterility Assurance Level (SAL) validated through a microbial challenge and sterility testing as per ISO 11135 or similar standards.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product and does not involve AI or machine learning models that require a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

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January 13, 2023

Medipoint Holdings, LLC Rochelle Stern Managing Partner 72 East 2nd St. Mineola, New York 11501

Re: K223480

Trade/Device Name: Medipoint Blood Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: November 18, 2022 Received: November 18, 2022

Dear Rochelle Stern:

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. 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.

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

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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 (OS) 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 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,

Jessica Carr -S

for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices 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) K223480

Device Name Medipoint Blood Lancets

Indications for Use (Describe)

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K223480 – 510(k) Summary

Date Prepared:

01/13/2023

Submitted By:

Medipoint Holdings, LLC 72 East 2nd Street Mineola, NY 11501

Contact:

Name:	Rochelle Stern
Title:	Managing Partner
Telephone:	516-294-8822
Email:	rochelle@medipoint.com

Device:

Trade Name:	Medipoint Blood Lancets
Common Name:	Blood Lancet
FDA Product Code:	QRK
Classification Name:	Single Use Only Blood Lancet Without An Integral Sharps InjuryPrevention Feature
510(k) Number:	K223480

Predicate Devices:

The device is substantially equivalent to the following predicate devices:

Primary Predicate:	Medipoint Blood Lancets (510(k)-Exempt prior to reclassification
Secondary Predicate:	Facet Technologies LLC Facet 28G Universal Lancet (K221433)

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Device Description:

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use.

Indications for Use:

Th Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Technological Characteristics and Performance Data (Predicate Comparison):

The device has equivalent design, intended use, material performance, and biocompatibility compared to the predicate devices.

The device has equivalent non-clinical performance as the primary predicate device.

A comparison of technological characteristics and performance data to the predicate devices is provided in Table 1, below.

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Traditional 510(k): Medipoint Holdings, LLC 72 East 2nd Street Mineola, NY 11501 510(k) Number: K223480

Table 1: Comparison to Predicate Devices

ProductCharacteristic	Subject Device	Primary Predicate	Secondary Predicate	Substantial Equivalence
Applicant	Medipoint Holdings, LLC	Medipoint Holdings, LLC	Facet Technologies LLC	N/A
Product/TradeName	Medipoint Blood Lancets	Medipoint Blood Lancets	Facet 28G UniversalLancet	N/A
Common Name	Blood Lancet	Blood Lancet	Blood Lancet	Same Common Name
DeviceClassificationName	Single Use Only BloodLancet Without An IntegralSharps Injury PreventionFeature	Manual surgicalinstrument for general use	Single Use Only BloodLancet Without An IntegralSharps Injury PreventionFeature	Different device classification namecompared to primary predicate due toreclassification order. However, thedevice is identical. Sameclassification name as secondarypredicate.
510(k) Number	K223480	N/A, 510(k)-exempt	K221433	N/A
ClassificationRegulation	21 CFR 878.4850	21 CFR 878.4800	21 CFR 878.4850	Different classification regulationcompared to primary predicate due toreclassification order. However, thedevice is identical. Sameclassification regulation as secondarypredicate.
Product Code	QRK	FMK	QRK	Different product code compared toprimary predicate due toreclassification order. However, thedevice is identical. Same productcode as secondary predicate.
Intended Use	Medipoint Blood Lancetsare indicated to obtain acapillary blood samplefrom the fingertip for	Medipoint Blood Lancetsare intended for use topuncture the skin to obtain	The Facet 28G UniversalLancet is intended toperform a skin puncture ofa finger or alternate site	The subject device is intended for thesame use as the primary predicatedevice and similar intended use
ProductCharacteristic	Subject Device	Primary Predicate	Secondary Predicate	Substantial Equivalence
	testing utilizing smallamounts of blood.Medipoint Blood Lancetsare single-use only.	a drop of blood fordiagnostic purposes.Medipoint Blood Lancetsare single-use only.	(palm of the hand, upperarm, or forearm) forcollection of a droplet ofcapillary blood forsubsequent diagnostictesting. The Lancet maybe used in combinationwith a reusable lancetbase (lancing device) thataccepts a universal-typelancet to perform a lancingevent. The Facet28G Universal Lancet isfor single use only on anindividual patient.	compared to the secondary predicatedevice.
Indications forUse	Medipoint Blood Lancetsare indicated to obtain acapillary blood samplefrom the fingertip fortesting utilizing smallamounts of blood.	Medipoint Blood Lancetsare indicated for fingertipblood sampling fordiagnostic purposes.	The Facet 28G UniversalLancet is a sterile,disposable single usedevice used to obtain adroplet of capillary bloodforsubsequent diagnostictesting from the finger oran alternative site, such asthe palm, upper arm, orforearm. The Lancet isto be properly disposed ofafter a single use on an	There are minor differences in theindications for use statement betweenthe subject device the predicatedevices but the indications for use aresubstantially equivalent.
Sterility	Sterile (Moist Heat)	Sterile (Moist Heat)	Sterile (GammaIrradiation)	Identical sterilization process andparameters compared to the primarypredicate. While the sterilization
ProductCharacteristic	Subject Device	Primary Predicate	Secondary Predicate	Substantial Equivalence
				method is difference from thesecondary predicate, both areprovided sterile.
Type of Use	Over-The-Counter	Over-The-Counter	Over-The-Counter	Identical.
DeviceDimensions	1 5/8" Long, 15/64" Wide,0.007" Thick (0.025 –0.032" Thick with knurls)	1 5/8" Long, 15/64" Wide,0.007" Thick (0.025 –0.032" Thick with knurls)	Needle: 3.1±0.45 mmBody: length not disclosedin 510(k) summary	Device dimensions are identical to theprimary predicate.
MaximumPenetrationDepth	7/64 inch (2.78 mm) ±1/64 inch (0.40 mm)	7/64 inch (2.78 mm) ±1/64 inch (0.40 mm)	3.1±0.45 mm	Similar, the Medipoint Blood Lancetmaximum penetration is less than thesecondary predicate.
Materials ofConstruction	430 Stainless Steel	430 Stainless Steel	304 Stainless Steel needlewith low densitypolyethylene body	Materials of construction are identicalto the primary predicate. The subjectdevice material and needle portion ofthe secondary predicate are bothconstructed of stainless steel.
TipConfiguration	Bevel	Bevel	Bevel	Substantially equivalent, all deviceshave a beveled point.
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Substantially equivalent, the subjectdevice has undergonebiocompatibility testing in accordancewith ISO 10993-1 based on theintended nature and duration ofcontact.

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Non-Clinical Testing:

Non-clinical testing performed for the Medipoint Blood Lancets includes testing performed to ensure that predetermined performance criteria and conformance to special controls (21 CFR 878.4850) were met.

Performance Testing

The Medipoint Blood Lancets are constructed from a single piece of stainless steel and have no moving parts, joints, or caps which require mechanical testing. Performance testing completed for the Medipoint Blood Lancets demonstrates that the device withstands the forces encountered during use without bending or damage.

Biocompatibility Testing

Biocompatibility testing was selected based on ISO 10993 and the nature of device contact. The following biocompatibility tests were performed with passing results:

Cytotoxicity ●
Sensitization
Irritation or Intracutaneous Reactivity .
. Acute Systemic Toxicity (Material-Mediated Pyrogenicity)

All biocompatibility testing passed and demonstrates an acceptable biocompatibility profile for the intended nature and duration of contact of this device.

Conclusions:

The subject device and the predicate devices underwent evaluation for equivalence in the intended use of each device, biocompatibility, performance, environment of use, and the principles of operation. This evaluation demonstrates that the subject device is substantially equivalent to the predicate devices.

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.