(24 days)
Not Found
No
The description focuses on the mechanical function of a heel incision device and does not mention any AI or ML components or capabilities.
No
The device is described as an "incision device to obtain a blood sample" for diagnostic purposes, not for treating a disease or condition.
No.
The device is described as an "incision device to obtain a blood sample" and is used for "blood collection for use in newborn screening tests," indicating it's a tool for sample acquisition, not for diagnosing a condition itself.
No
The device description clearly describes a physical, mechanical device with a plastic casing, trigger, and blade, designed for making incisions. It is not software-only.
No, the babyLance® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the body.
- The babyLance® is a device used to obtain a blood sample. Its function is to create an incision to allow for blood collection. It does not perform any diagnostic testing or analysis on the blood itself.
The babyLance® is a medical device used in the process of collecting a sample that will be used for IVD testing (newborn screening tests), but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMK
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. The user breaks off the trigger lock from the device, 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heel
Indicated Patient Age Range
newborn and preemie infants
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Testing results support the determination of substantial equivalence with the results demonstrating that the babyLance® Heel Incision Device (Version 2, proposed device) has equivalent or in some cases improved results than the first version of the babyLance Heel Incision Device (predicate device).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MediPurpose Pte. Ltd. Special 510(k) - babyLance® Heel Incision Device
510(k) Summary - Revised
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| 510(k) Number: | K130132 |
|---|---|
| Submitted By: | MediPurpose Pte. Ltd. |
| 15 Hoe Chiang Road | |
| #12-02 Tower Fifteen | |
| Singapore, SINGAPORE 089316 | |
| Contact Person: | Julie Stephens, President/Consultant |
| Regulatory Resources Group, Inc. | |
| Date Submitted: | February 8, 2013 |
| Trade/Proprietary Name: | babyLance® Heel Incision Device |
| Common Name: | Infant Heel Lancet |
| Classification Name: | Manual surgical instrument for general use (21 CFR 878.4800) |
| Class: | 1 and Sharps Prevention Feature |
| Product Code: | FMK |
| Legally Marketed | |
| Predicate Devices: | babyLance™ Heel Incision Device, 510(k) # K101417 |
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. The user breaks off the trigger lock from the device, 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.
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.
Intended Use:
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.
1
MediPurpose Pte. Ltd. Special 510(k) - babyLance® Heel Incision Device
510(k) Summary - Revised
Similarities and Differences of the Proposed Devices to the Predicate Devices:
Similarities
The modified babyLance® Heel Incision Device (Version 2) has the same basic technology characteristics for an infant heel stick lancet and retains the sharps injury prevention features. It is intended for piercing the heel skin of a preemie or newborn, as the predicate device, and the indications for use are the same. The materials are the same except as noted under differences with the blades using the same medical grade stainless steel and the housings made of the same plastics.
Differences
The modified babyLance® Heel Incision Device (Version 2) outside housing was redesigned with a flat surface against the heel for better stability during the heel stick procedure (i.e., the overall design is now square). The trigger activation was modified with the addition of a spring to prevent the possibility of variable incisions. The added non patient contacting spring is medical grade stainless steel and the trigger plastic was changed to Nylon. All the materials are known biocompatible materials that have been used in lancets or other similar medical devices.
Summary of Testing:
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.
Substantial Equivalence Conclusions:
The babyLance® Heel Incision Device has the same principles of operation, intended use, and technological characteristics as the predicate devices. 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® Heel Incision Device (Version 2, proposed device) has equivalent or in some cases improved results than the first version of the babyLance Heel Incision Device (predicate device).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medipurpose PTE, Limited % Regulatory Resources Group, Incorporated Ms. Julie Stephens Consultant 111 Laurel Ridge Drive Alpharetta, Georgia 30004
February 11, 2013
Re: K130132
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: January 17, 2013 Received: January 22, 2013
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Julie Stephens
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/Safetv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter Di Romm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130132
Device Name: babyLance® Heel Incision Device
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
igitally signed by Long H. Che DN: