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510(k) Data Aggregation
(152 days)
BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
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 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.
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.
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