The babyLance safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.

Device Description

The babyLance™ safety heelstick is a sterile, single-use device designed to be a one-handed, automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests.

The babyLance™ is constructed with a Nylon housing which holds the stainless-steel cutting blade and deployment mechanism. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury. It is supplied in a sterile polypropylene tray with a Tyvek™ lid.

The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. The user breaks off the trigger lock from the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision. Once the blade has been triggered, the blade is automatically retracted within the housing. The device is discarded in a sharps container after use.

AI/ML Overview

I am sorry, but the provided text, while being an FDA 510(k) clearance letter and summary for a medical device (babyLance Safety Heelstick), does not contain any information about acceptance criteria or a study proving the device meets such criteria in terms of algorithmic performance, AI assistance, human reader improvement, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

Indications for Use: The device is a single-use incision device for obtaining blood samples from the heel of neonates or infants, with a sharps prevention feature.
Technological Characteristics: Comparison of various design elements, materials, mechanical specifications (e.g., cut profile), safety features (sharps injury prevention, automatic retraction, reuse prevention), sterilization, and biocompatibility with the predicate device.
Physical Characterization: Mention of tests conducted like biocompatibility, shelf-life, shipping, usability, simulated use, and user validation, but no specific performance metrics or acceptance criteria for an AI/algorithm component are presented.

The device described is a mechanical blood lancet, not an AI-powered diagnostic or imaging device. Therefore, the questions related to AI performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 24, 2023

Alex Garrett Regulatory Affairs Specialist 747 West 4170 South Murray, Utah 84123

Re: K223900

Trade/Device Name: babyLance Safety Heelstick (BLM, BLN, BLP) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: December 15, 2022 Received: December 28, 2022

Dear Alex Garrett:

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

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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 medical devices and radiation-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): K223900

Device Name: babyLance® Heel Incision Device

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _______________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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Image /page/3/Picture/0 description: The image shows the logo for Clinical Innovations. The logo features a stylized, abstract shape composed of interconnected segments in shades of blue and green. To the right of the shape, the words "CLINICAL INNOVATIONS" are written in a clear, sans-serif font. Below the company name, the tagline "for MOM. for BABY. for LIFE." is displayed in a smaller font size.

(5) 510(k) Summary

Manufacturer Name	Clinical Innovations, LLC
Manufacturer Address	747 West 4170 South, Murray, UT 84123, USA
Manufacturer contact information	P. 801-268-8200Toll Free: 888-268-6222https://www.clinicalinnovations.com
510(k) Number	TBD
Contact Person	Alex GarrettRegulatory Affairs Specialistagarrett@laborie.com
Preparation Date	16-DEC-2022
Trade Name	babyLance Safety Heelstick Device
Common Name	Disposable Safety Lancet
Classification Name	Single Use Only Blood Lancet With An Integrated Sharps Injury PreventionFeature (21 CFR 878.4850, Product Code FMK)
Predicate	BabyLance Heel Incision Device, 510K number K130132

Device Description

BabyLance	Product Code	Body/Trigger Colors
Micro preemie	BLM	Yellow/Lime Green
Preemie	BLP	Pink/White
Newborn	BLN	Blue/Green

Table 1: Device Variants

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Image /page/4/Picture/1 description: The image shows the logo for Clinical Innovations. The logo features a stylized, abstract shape composed of four curved segments in shades of gray and green. To the right of the shape, the words "CLINICAL INNOVATIONS" are written in a sans-serif font, with "CLINICAL" stacked above "INNOVATIONS". Below the company name is the tagline "forMOM. forBABY. forLIFE." in a smaller, lighter font.

Indications for Use

As provided in the Instructions for Use (IFU) (See Appendix I), for babyLance Safety Heelstick Device:

Contraindications

As provided in the IFU (See Appendix I), for babyLance Safety Heelstick Device, the device is not to be used in the following conditions:

Presence of local edema
Puncturing previously traumatized skin in the same location
Presence of cyanosis or impaired perfusion
Puncturing the calcaneus
. Infection at the site

Patient Population

babyLance Safety Heelstick Devices are to be used on newborns and premature infants.

Predicate Comparison

Materials, Principals of Operation, Indications for Use Contraindications and Patient Population for babyLance are the same as the predicate device.

Table 2: Substantial Equivalence Comparison Table

TechnologicalCharacteristics	babyLance (predicate)	babyLance(device under review)
Clearance Date	February 11, 2013	TBD
510(k) number	K130132	TBD
510(k) submitter	MediPurpose Pte. Ltd.15 Hoe Chiang Road#12-02 Tower FifteenSingapore, SINGAPORE 089316	Clinical Innovations, LLC747 West 4170 South,Murray, UT 84123,USA
Intended Use	The babyLance is an incision device to obtain a bloodsample from the heel of newborn and preemieinfants. The babyLance has a sharps preventionfeature to protect the user from a sharps injury.	Intended to be used bytrained healthcareprofessionals to draw a bloodsample from the heel of aneonate or infant.
Indications for Use	The babyLance is an incision device to obtain a bloodsample from the heel of newborn and preemieinfants. The babyLance has a sharps preventionfeature to protect the user from a sharps injury.	The babyLance safetyheelstick is a single-useincision device to obtain ablood sample from the heel ofa neonate or infant.babyLance has a sharpsprevention feature to protectthe user from a needlestickinjury.
Product Code	FMK	Same
Panel	General & Plastic Surgery	Same
Classification	Class I	Class II
Regulation	21 CFR 878.4400	21 CFR 878.4850
Patient Population	Newborn, Premature Infants	Same
Principals of	The stainless-steel blade is deployed by removing the	Same
Operation	trigger lock and pressing a spring-loaded trigger. Theprincipals involved in the operation of this device areall principles of mechanical energy.
Labeling	Individual Tyvek label, Secondary box label, Tertiaryshipping box Label.	Same. See Section 13 fordevice labeling.
Design	ABS housing containing stainless steel blade activatedby a trigger. Blade retracts into housing after incisionis made.	Same
Mechanical Specifications
Overall Size	Length: 1.25 in (3.2 cm)Height; 1.25 in (3.2 cm)	Same
Cut Profile "MicroPreemie"	N/A	Length: 2.2 mmDepth: 0.60 mm
Cut Profile "Preemie"	Length: 2.89 mmDepth: 0.86 mm	Length: 3.0 mmDepth: 0.85 mm
Cut Profile"Newborn"	Length: 3.01 mmDepth: 1.08 mm	Length: 3.0 mmDepth: 1.00 mm
Material Composition
Blade (blood contact)	304 Stainless Steel	Same
Housing/Case (heelcontact)	High Density Polyethylene (HDPE)	Same
Trigger (no patientcontact)	Acrylonitrile Butadiene Styrene (ABS)	Same
21 CFRLatex content	Latex Free	Same
ChemicalComposition	N/A	N/A
Energy Source	N/A	N/A
Safety Features
Sharps InjuryPrevention PassiveFeature	1. Remove trigger lock2. Blade exits the housing only during use,spring driven, activated by trigger.3. Lancet will automatically retract at the endof incision motion.	Same
Prevention of TipExposure	Blade is not exposed except when device is usedagainst the infant's heel.	Same
Automatic LancetRetraction After Use	When device is used, the end of the incision motionretracts and locks the blade back into the housing.	Same
Prevention of LancetReuse	The blade retracts back into the housing at the end ofthe incision motion; the internal locking mechanismlocks the blade in the housing.	Same
Use ConditionProvided	Sterile, Single Patient Use	Same
Sterilization Method	Gamma Irradiation	Same
SAL	10-6	Same
Shelf-life	4 Years	Same
BiocompatibilityProfile	"External Communicating Device" withTissue/Bone/Dentin contact with limited patientexposure (<24 hour)	Same
Biocompatibility(ISO 10993-1)	Cytotoxicity - not cytotoxicSensitization – no evidence of causing sensitizationIrritation – no evidence of causing irritation

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Image /page/5/Picture/0 description: The image shows the logo for Clinical Innovations. The logo features a stylized, abstract shape in shades of gray and green, resembling interconnected segments. To the right of the shape, the words "CLINICAL INNOVATIONS" are written in a simple, sans-serif font, with "CLINICAL" in a lighter gray and "INNOVATIONS" in a darker gray. Below the company name is the tagline "forMOM. forBABY. forLIFE." in a smaller, lighter font.

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Image /page/6/Picture/0 description: The image shows the logo for Clinical Innovations. The logo features a circular design with three overlapping shapes in gray and green. To the right of the circular design, the words "CLINICAL INNOVATIONS" are written in gray. Below that, the words "forMOM. forBABY. forLIFE." are written in a smaller font.

Biocompatibility

According to ISO 10993-1:2018 Biocompatibility compliance assessment, the device was assessed to be "External Communicating Device" with Tissue/Bone/Dentin contact with limited patient exposure (<24 hour).

Biocompatibility testing has been performed on finished product materials, which are in contact with the human body, in accordance with ISO 10993 Part 1: Biological Evaluation of Medical Device. The results of this pre-clinical testing indicate that the materials met the test requirements as specified and that based on the results of the testing performed, the device is considered appropriate from a biological and toxicological perspective for its intended use in all patient populations.

Physical Characterization

babyLance Safety Heelstick Device has completed the applicable physical characterization and verification. This testing included: Biocompatibility, Shelf-Life, Shipping, Usability, Simulated Use and User Validation.

Substantial Equivalence

The babyLance Safety Heelstick device has the same principles of operation, intended use, and technological characteristics as the predicate device. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the babyLance Safety Heelstick has equivalent results as the predicate device.

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.