The babyLance™ is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury.

Device Description

The MediPurpose babyLance™ Heel Incision Device is 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 outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. There are three integrated components to the sharps prevention feature: a) a locking mechanism to prevent accidental activation of the device because the user breaks off the trigger locking mechanism from the device, b) once the locking mechanism has been removed, the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision, c) once the blade has been triggered, the device is immediately removed from the infant's foot which retracts the blade. The device is discarded in a sharps container after use.

The babyLance™ comes in two models, preemie and newborn. The preemie model is to be used on pre term neonates, while the newborn model is for full term neonates. The two models are differentiated by color.

AI/ML Overview

The provided text describes the MediPurpose babyLance™ Heel Incision Device and its 510(k) submission (K101417). However, it does not contain a detailed study report with specific acceptance criteria that are quantitatively measured against device performance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed numerical results against predefined acceptance criteria.

Based on the information provided, here's what can be extracted and what is not available:

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

Acceptance Criteria (Implied)	Reported Device Performance
Sharps prevention feature functions as intended (locking mechanism, activation, retraction).	The device has a locking mechanism to prevent accidental activation. Once the locking mechanism is removed and the trigger is depressed, the blade activates. Once triggered, the device is immediately removed from the infant's foot, which retracts the blade. The device is then discarded in a sharps container. (Note: No specific quantitative performance metrics like force required for activation, time for retraction, or failure rates are provided in this summary.)
Device is suitable for heel sticks in newborn and neonatal infants.	Intended for use in heel sticks of newborn and neonatal infants (preemie infants) to obtain a blood sample for newborn screening tests. Two models (preemie and newborn) differentiate by color. (Note: No specific clinical performance metrics like success rate of blood collection, pain scores, or incidence of adverse events are provided in this summary.)
Sharps prevention feature meets FDA guidance.	"Testing was completed for the sharps prevention feature to the FDA's guidance document, which included product drop tests, cut profiles with comparisons to the predicate device, and simulated use." (Note: The specific acceptance criteria within the FDA guidance document are not detailed, nor are the quantitative results of these tests provided. The comparison to the predicate device for "cut profiles" is mentioned but not elaborated.)
Biocompatibility of materials.	"All the materials are known biocompatible materials that have been used in lancets or other similar medical devices." (Note: No specific biocompatibility testing results or acceptance criteria are presented in this summary.)
Safe operation (e.g., no accidental activation).	The locking mechanism prevents accidental activation. (Note: While mentioned as a feature, no specific testing or quantifiable safety metrics are provided.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. General "testing was completed" is mentioned, but details on sample size, data provenance, or study design (retrospective/prospective) are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text. The relevant "testing" involved product drop tests, cut profiles, and simulated use, which are likely engineering/performance tests rather than requiring clinical expert-established ground truth in the way a diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text.

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

An MRMC comparative effectiveness study is not applicable to this device. The babyLance™ is a mechanical incision device, not a diagnostic device that involves human readers or AI assistance in interpreting results.

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

A standalone performance study in the context of an algorithm is not applicable here. This is a mechanical device.

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

The "ground truth" for the performance tests mentioned would likely be established by:

Engineering specifications and standards: For product drop tests and sharps prevention feature functionality.
Comparison to predicate device: For "cut profiles" and overall substantial equivalence.
Simulated use protocols: To evaluate the device's function in a controlled environment.

There isn't a "ground truth" in the clinical diagnostic sense (like pathology or expert consensus) described for this device's performance evaluation in the provided summary.

8. The sample size for the training set

This information is not provided and is not applicable as this is a mechanical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not provided and is not applicable as this is a mechanical device, not an AI or machine learning algorithm.

Summary of missing information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing quantitative acceptance criteria and the comprehensive results of a standalone performance study. Much of the requested information (sample sizes, expert qualifications, adjudication methods, ground truth establishment for clinical endpoints, MRMC studies, training sets) is related to diagnostic devices or AI algorithms and is therefore not present or not applicable to this mechanical medical device based on the provided text. The document refers to "performance testing reports... contained in the 510(k) documentation (Section C)," which would likely contain the detailed information lacking in this summary.

Summary

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MediPurpose Pte. Ltd. Abbreviated 510(k) # K101417- babyLance™ Heel Incision Device

510(k) Summarv

Owner's Information:	MediPurpose Pte. Ltd.3850 Holcomb Bridge Road, Suite 350Norcross, GA 30092Julie Stephens, President/ConsultantRegulatory Resources Group, Inc.K101417September 2010 - RevisedbabyLance™ Heel Incision DeviceInfant Heel LancetLancet, Blood (21 CFR 878.4400)I - Lancet with Sharps Prevention FeatureFMKBD Microtainer® Quikheel™ Lancet, 510(k) # K822209
Contact Person:	OCT 19 2010
510(k) Number:
Date Prepared:
Trade/Proprietary Name:
Common Name:
Classification Name:
Class:
Product Code:
Legally Marketed Predicate Devices:

Device Description:

Intended Use:

The babyLance™ is an incision device to obtain a blood sample from a heel stick in newborn and preemie infants. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury.

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10/417

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MediPurpose Pte. Ltd. Abbreviated 510(k) # K101417- babyLance™ Heel Incision Device

510(k) Summary

Similarities and Differences of the Proposed Devices to the Predicate Devices:

Similarities

The babyLance™ Heel Incision Device has the same basic technology characteristics for an infant heel stick lancet with sharps injury prevention. It is intended for piercing the heel skin of a preemie or newborn, as the predicate devices, and the indications for use are the same. The materials are comparable in that the blades all use medical grade stainless steel and the housings are made of plastics.

Differences

The babyLance™ Heel Incision Device utilizes some of the same materials, specifically the use of medical grade stainless steel for the lancet blades but may use different types or grades of plastics for the housings and triggers. All the materials are known biocompatible materials that have been used in lancets or other similar medical devices.

Conclusion:

The babyLance™ Heel Incision Device has the same principles of operation, intended use, and technological characteristics as the predicate devices. Testing was completed for the sharps prevention feature to the FDA's guidance document, which included product drop tests, cut profiles with comparisons to the predicate device, and simulated use. The performance testing reports are contained in the 510(k) documentation (Section C).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

OCT 1 9 2010

Re: K101417

Trade/Device Name: babyLance™ Heel Incision Device Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: FMK Dated: September 27, 2010 Received: September 29, 2010

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. 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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millan

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101417

Indications for Use

510(k) Number (if known): K101417

OCT 1 9 2010

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)

Nust be Oshen for mxm
(Division Sigh-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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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.