The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.

Device Description

The SurgiLance® Safety Lancet is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be ergonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types. The SurgiLance® Safety Lancet comes in seven (7) models: two low flow, two medium flow, and three high flows. The seven models are differentiated by their casing color. SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down against the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.

AI/ML Overview

This document is a 510(k) summary for the SurgiLance® Safety Lancet. It does not describe an AI/ML device, therefore, the requested information elements related to AI/ML device testing are not applicable.

The document indicates that the device is a puncture device used to obtain micro blood samples and has a sharps prevention feature. The 510(k) submission establishes substantial equivalence to a primary predicate device (MediPurpose SurgiLance® Safety Lancet, K101145) and an additional predicate device (BD Autolancet [Microtainer® Lancet], K822209), stating that the proposed device did not change technological characteristics or material specifications from the primary predicate.

Here's the information that can be extracted relevant to acceptance criteria and device performance:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that the device was tested to meet performance and safety requirements. However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it states that testing was "completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization" and lists the types of tests performed.

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	Demonstrated compliance through manufacturing and sterilization for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemolysis testing as per ISO 10993-1.
Performance and Safety	Tests for drop, trigger force and reverse safety, penetration and depth force measurements, and simulated use were completed. The sharps prevention feature was fully tested to FDA's guidance document.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for performance and safety testing. It also does not mention data provenance (e.g., country of origin, retrospective/prospective). This is common for this type of device where performance is typically evaluated through laboratory testing rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical medical device, and its performance and safety are assessed through engineering and laboratory testing against established standards and predicate devices, not by expert interpretation of patient data to establish "ground truth."

4. Adjudication method for the test set:

Not applicable. This is not an AI/ML device or a device requiring expert adjudication of results.

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:

Not applicable. This is not an AI/ML device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of typical AI/ML ground truth. For this device, "ground truth" would be defined by engineering specifications, material properties, and functionality benchmarks established in industry standards and by predicate device performance. For instance, penetration depth would be measured directly, or sharps retraction would be visually confirmed as per design.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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September 22, 2022

MediPurpose Pte. Ltd. % Ms. Julie Stephens President Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K222224

Trade/Device Name: SurgiLance® Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 25, 2022 Received: July 25, 2022

Dear Ms. Stephens:

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,

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) K222224

Device Name SurgiLance® Safety Lancet

Indications for Use (Describe)

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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MediPurpose Pte. Ltd. Traditional 510(k) - SurgiLance® Safety Lancet

510(k) Summary - 510(k) # K222224

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

Submitted By:	MediPurpose Pte. Ltd.10 Anson Road, No. 12-08 International PlazaSingapore, Central Singapore 079903 SINGAPORE	US Agent:
		MediPurpose, Inc.
		3883 Rogers Bridge Rd NW-Suite 501
		Duluth, GA 30097 USA
		Phone: (404) 855-3655
MediPurpose Contact:	Adeline Yi - adelineyi@medipurpose.com
Consultant Contact:	Julie Stephens - jstephens@regresourcesgroup.comRegulatory Resources Group, Inc. - Phone: (678) 513-0693111 Laurel Ridge Dr, Alpharetta, GA 30004 USA
Date Submitted:	September 21, 2022

Device Name and Classification:

Trade/Proprietary Name:	SurgiLance® Safety Lancet
Common Name:	Blood Lancet with Sharps Prevention Feature
Classification Name:	Blood Lancets - Single use only blood lancet with an integral sharps injury prevention feature
Regulation Number:	21 CFR 878.4850
Class:	II
Product Code:	FMK

Legally Marketed Predicate Device:

Primary Predicate: MediPurpose SurgiLance® Safety Lancet, 510(k) # K101145 Additional Predicate: BD Autolancet [Microtainer® Lancet], 510(k) # K822209

Device Description:

SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down aqainst the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.

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MediPurpose Pte. Ltd. Traditional 510(k) - SurgiLance® Safety Lancet

510(k) Summary - 510(k) # K222224

Indications for Use:

The SurgilLance® Safety Lancet is a puncture device to obtain micro blood samples. The Surgil.ance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.

The Indications for Use statement for the SurgiLance® Safety Lancet did not change from the cleared 510(k) # K101145. SurgiLance Safety Lancets [Proposed Device and Primary Predicate Device].

Technological Characteristics:

SurgiLance® Safety Lancets [Proposed Device] did not change technological characteristics or material specifications from the cleared 510(k) # K101145 [Primary Predicate Device]. The SurgiLance Safety Lancets are substantially equivalent to the BD Microtainer lancets [Additional Predicate Device] as they have the same basic technology characteristics for piercing the skin with a needle or blade to draw a micro-sample of blood and include a sharps injury prevention feature. The materials are comparable in that the needles and blades all use medical grade stainless steel and the housings are made of medical grade plastics.

		Comparison of Technological Characteristics to the Predicate Devices
--	--	----------------------------------------------------------------------	--	--	--

Proposed Device510(k) #: Pending	Primary Predicate Device510(k) #: K101145	Additional Predicate Device510(k) #: K822209
SurgiLance® Safety Lancet	SurgiLance® Safety Lancet	BD Microtainer® Contact-Activated Lancet
FMK; 21 CFR 878.4850; Class II[New Classification]	FMK; 21 CFR 878.4400;Class I	FMK; 21 CFR 878.4400; Class I
Materials
Needles -Stainless steelsBlades - Stainless steelsHousing/Case, Holder, Cap -Plastics	Same - No changes	Needles - Surgical steelsBlades - Surgical steelsHousing/Case, Holder, Cap -Plastics
Mechanical Specifications
Low Flow - Needle - G28 & G21Medium Flow - Needle - G21High Flow - Blade - G21 & G18	Same - No changes	Low Flow - Needle - G30Medium Flow - Needle - G21High Flow - Blade 1.5mm/G16.5
Labeled Cut Profiles: Cut Depths (mm) and Blood Flow
Low Flow - 1.7& 1.0 depthsMedium Flow - 1.8 & 2.2 depthsHigh Flow - 2.8, 1.8 & 2.3depths	Same - No changes	Low Flow - 1.5 depth (singledrop)Medium Flow - 1.8 depthHigh Flow - 2.0 depth

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MediPurpose Pte. Ltd. Traditional 510(k) - SurgiLance® Safety Lancet

Proposed Device510(k) #: Pending	Primary Predicate Device510(k) #: K101145	Additional Predicate Device510(k) #: K822209
Safety Features
• Single use only with an integralsharps injury preventionfeature.• Needle/blade is not exposedexcept when lancet isactivated.• The needle/blade retracts backinto the housing at the end ofthe incision motion; the triggermechanism is disabled andlocks the needle/blade in thehousing.	Same - No changes	• Single use only with anintegral sharps injuryprevention feature.• Needle/blade is not exposedexcept when lancet isactivated.• The needle/blade retracts backinto the housing at the end ofthe incision motion; the triggermechanism is disabled andlocks the needle/blade in thehousing.

510(k) Summary - 510(k) # K222224

Summary of Testing:

The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 biocompatibility requirements. Cytotoxicity, Sensitization, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, and Hemolysis testing was completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization. Performance and safety testing completed for the Surgil.ance® Safety Lancet included tests for drop testing, trigger force and reverse safety, penetration and depth force measurements, and simulated use testing.

Substantial Equivalence Conclusions:

SurgiLance® Safety Lancets have the same principles of operation, intended use, and technological characteristics including the materials used, mechanical specifications, cutting profiles, and sharps injury prevention features as the predicate devices. The sharps prevention feature was fully tested to the FDA's guidance document as demonstrated in the performance testing.

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.