(58 days)
Not Found
No
The description focuses on the mechanical function of the device for blood collection and sharps prevention, with no mention of AI or ML capabilities.
No
This device is for collecting a blood sample for diagnostic purposes (newborn screening tests), not for treating a condition or disease.
No.
The device is an incision device used to obtain a blood sample, which is then used for diagnostic purposes. The device itself does not perform any diagnostic function; it is merely a tool for sample collection.
No
The device description clearly states it is a physical device constructed with a Nylon housing, stainless-steel cutting blade, and deployment mechanism. It is a single-use incision device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
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 safety heelstick is a device used to obtain a blood sample. Its function is to make an incision to allow for blood collection. It does not perform any diagnostic testing on the blood itself.
The description clearly states its purpose is to "obtain a blood sample from the heel of a neonate or infant" and that the blood collected is "for use in newborn screening tests." The babyLance is the tool for collection, not the tool for testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heel
Indicated Patient Age Range
neonate or infant / newborn and neonatal infants (also called preemie infants)
Intended User / Care Setting
trained healthcare professionals
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)
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. Testing results support the determination of substantial equivalence with the results demonstrating that the babyLance Safety Heelstick has equivalent results as the 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.
BabyLance Heel Incision Device, 510K number K130132
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
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
1
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
2
Indications for Use
510(k) Number (if known): K223900
Device Name: babyLance® Heel Incision Device
Indications for Use:
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.
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
3
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. 801-268-8200 |
| Toll Free: 888-268-6222 | |
| https://www.clinicalinnovations.com | |
| 510(k) Number | TBD |
| Contact Person | Alex Garrett |
| Regulatory Affairs Specialist | |
| agarrett@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 Prevention |
| Feature (21 CFR 878.4850, Product Code FMK) | |
| Predicate | BabyLance Heel Incision Device, 510K number K130132 |
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.
| BabyLance | Product Code | Body/Trigger Colors |
|---|---|---|
| Micro preemie | BLM | Yellow/Lime Green |
| Preemie | BLP | Pink/White |
| Newborn | BLN | Blue/Green |
Table 1: Device Variants
4
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:
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.
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 | |||
|---|---|---|---|
| Technological
Characteristics | 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 Fifteen
Singapore, SINGAPORE 089316 | Clinical Innovations, LLC
747 West 4170 South,
Murray, UT 84123,
USA |
| 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. | Intended to be used by
trained healthcare
professionals to draw a blood
sample from the heel of a
neonate or infant. |
| 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. | The babyLance safety
heelstick is a single-use
incision device 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. |
| 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. The
principals involved in the operation of this device are
all principles of mechanical energy. | |
| Labeling | Individual Tyvek label, Secondary box label, Tertiary
shipping box Label. | Same. See Section 13 for
device labeling. |
| Design | ABS housing containing stainless steel blade activated
by a trigger. Blade retracts into housing after incision
is made. | Same |
| Mechanical Specifications | | |
| Overall Size | Length: 1.25 in (3.2 cm)
Height; 1.25 in (3.2 cm) | Same |
| Cut Profile "Micro
Preemie" | N/A | Length: 2.2 mm
Depth: 0.60 mm |
| Cut Profile "Preemie" | Length: 2.89 mm
Depth: 0.86 mm | Length: 3.0 mm
Depth: 0.85 mm |
| Cut Profile
"Newborn" | Length: 3.01 mm
Depth: 1.08 mm | Length: 3.0 mm
Depth: 1.00 mm |
| Material Composition | | |
| Blade (blood contact) | 304 Stainless Steel | Same |
| Housing/Case (heel
contact) | High Density Polyethylene (HDPE) | Same |
| Trigger (no patient
contact) | Acrylonitrile Butadiene Styrene (ABS) | Same |
| 21 CFRLatex content | Latex Free | Same |
| Chemical
Composition | N/A | N/A |
| Energy Source | N/A | N/A |
| Safety Features | | |
| Sharps Injury
Prevention Passive
Feature | 1. Remove trigger lock
2. Blade exits the housing only during use,
spring driven, activated by trigger.
3. Lancet will automatically retract at the end
of incision motion. | Same |
| Prevention of Tip
Exposure | Blade is not exposed except when device is used
against the infant's heel. | Same |
| Automatic Lancet
Retraction After Use | When device is used, the end of the incision motion
retracts and locks the blade back into the housing. | Same |
| Prevention of Lancet
Reuse | The blade retracts back into the housing at the end of
the incision motion; the internal locking mechanism
locks the blade in the housing. | Same |
| Use Condition
Provided | Sterile, Single Patient Use | Same |
| Sterilization Method | Gamma Irradiation | Same |
| SAL | 10-6 | Same |
| Shelf-life | 4 Years | Same |
| Biocompatibility
Profile | "External Communicating Device" with
Tissue/Bone/Dentin contact with limited patient
exposure (