(90 days)
The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 year to adults, as a guide for performing intradermal injections.
The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1mL allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique. The Intradermal Adapter has been designed to snap fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.
The provided text describes the 510(k) premarket notification for the "Intradermal Adapter" device. Here's a breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific performance metrics and their corresponding reported values. Instead, it describes a qualitative acceptance based on the device's ability to maintain a controlled injection depth, similar to its predicate device, and the intended expansion of its indications for use.
The "Performance Testing" section states:
"Results of performance testing demonstrated that the Intradermal Adapter, when used as an accessory to the piston syringe, can be indicated for administering intradermal injections to the indicated patient population."
And regarding injection depth:
"...the peer reviewed studies presented in this submission confirm through the acquisition of data from 485 pediatric patients, that the controlled design of the ID Adapter prevents an injection depth to greater than 0.75mm which is well within the epidermis + dermis layer necessary for successful intradermal injection in a pediatric patient age group."
Based on this, we can infer the primary acceptance criterion and reported performance:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Controlled Injection Depth for Intradermal Injections | Prevents an injection depth greater than 0.75mm. This depth is "well within the epidermis + dermis layer necessary for successful intradermal injection." |
| Suitability for Expanded Patient Population (Pediatric) | Acceptable for use in expanded intended use applications for a wider patient age range, including pediatric patients over the age of 2 years. |
| Substantial Equivalence to Predicate Device | Demonstrated to be substantially equivalent to the legally marketed predicate device (K123588) based on technological characteristics and verification testing. |
Study Details:
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Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: 485 pediatric patients.
- Data Provenance: The data was acquired from "peer reviewed journal articles," indicating that the data is retrospective and originates from clinical research studies likely conducted in various countries/institutions depending on the journal articles cited. The document does not specify a single country of origin but refers to "medical literature obtained through peer reviewed journal articles."
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Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth for the test set from the peer-reviewed studies. It references "peer reviewed journal articles" which implies expert validation inherent in the peer-review process, but not specifically for defining ground truth for this device's submission.
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Adjudication Method for the Test Set:
- The document does not mention a specific adjudication method like 2+1 or 3+1. The data was "acquired from medical literature" which would have established its own ground truth and validation methods within those original studies.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. The study described focuses on device performance validation and comparison to Mantoux technique, not on human reader improvement with AI assistance.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This device is a physical medical device (an adapter for a syringe), not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance is not applicable and was not done.
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The Type of Ground Truth Used:
- The ground truth for the injection depth was established through the "controlled design of the ID Adapter" and confirmed by clinical data from peer-reviewed studies demonstrating a consistent injection depth "well within the epidermis + dermis layer necessary for successful intradermal injection." This combines design specifications with clinical outcomes (successful intradermal injection).
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The Sample Size for the Training Set:
- This document describes safety and performance testing for a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" as understood in machine learning is not applicable here. The device's design and engineering principles, informed by prior knowledge and the predicate device, serve a similar function as a "training" phase for an algorithm.
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How the Ground Truth for the Training Set was Established:
- As stated above, the concept of a "training set" is not applicable. The device's design and functionality are based on principles established through prior engineering knowledge, the predicate device (K123588), and understanding of anatomical requirements for intradermal injections. The "ground truth" for its design and desired performance would have been established through biomechanical principles, anatomical knowledge, and validated clinical requirements for successful intradermal delivery.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).