(15 days)
The intended use of the iLook™ 25 Needle Guide Attachment and Bracket Assembly when used in conjunction with the Ultrasound System and attached to the Ultrasound System's transducer is to facilitate proper needle placement to various depths in vascular or other anatomical structures from the transducer surface.
The iLook™ 25 Needle Guide Attachment and Bracket Assembly is an accessory to the iLook™ 25 Diagnostic Ultrasound System. The accessory is made up of a bracket designed in such a way to facilitate easy and secure attachment to the iLook™ 25 transducer. There are features on the bracket that prevent the bracket from being attached incorrectly to the transducer. The needle guide is a separate polymeric part that attaches to the bracket through a sterile sheath. Multiple needle guides are available corresponding to different depths that the clinician may need for accurate guided needle placement into vascular or other anatomical structures. The needle guides are designed to accept and retain various sized needles. The kit is shipped separately with a sterile sheath, ultrasound transmission gel, and contains multiple needle guides, sterile sheath, ultrasound transmission gel, and bands.
The provided text describes a 510(k) submission for the "iLook™ 25 Needle Guide Attachment and Bracket Assembly." This is a premarket notification for a Class II medical device, and as such, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and precise performance metrics in the way a pivotal clinical trial for a novel device would.
Based on the information provided, here's a breakdown of the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are not explicitly stated in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through various types of testing to ensure safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Security: Bracket securely attaches to the iLook™ transducer and prevents disengagement. | "The bracket is designed in such a way to facilitate easy and secure attachment to the iLook™ transducer. There are features on the bracket that prevent the bracket from being disengaged from the transducer." "The needle guides are designed to accept and retain the needle guides in a mechanically secure way." |
| Needle Guide Retention: Needle guides are securely retained by the bracket. | "The needle guides are designed to accept and retain the needle guides in a mechanically secure way." |
| Biocompatibility: Device materials meet relevant standards for patient contact. | "The iLook™ 25 Needle Guide Attachment and Bracket Assembly met biocompatibility requirements specified by ISO 10993-01 and FDA Memorandum #G95-1 for their classification." |
| Sterilization: Sterilization method is validated and effective. | "Sterilization requirements were met through validations performed by the contract manufacturer." |
| Environmental, Packaging, Shipping, Shelf Life: Device withstands typical handling and storage conditions. | "Environmental, packaging, shipping, shelf life... requirements were met through validations performed by the contract manufacturer." |
| Substantial Equivalence: Similarities in technological characteristics and intended use to predicate devices. | The conclusion states: "The testing described above supports the conclusion that the iLook™ 25 Needle Guide Attachment and Bracket Assembly should be substantially equivalent to the safety and effectiveness demonstrated by the predicate devices." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify sample sizes for the various tests performed. The testing described appears to be primarily non-clinical (bench testing and validation studies), rather than a clinical trial with a "test set" in the sense of patient data.
- Test Set Sample Size: Not specified.
- Data Provenance: The document implies in-house testing and third-party validation by the contract manufacturer. No country of origin for clinical data is applicable as no clinical data is reported. The tests are prospective validations for manufacturing and material compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided document. The device is an accessory (needle guide), and its performance is assessed through mechanical, biocompatibility, and sterilization validations, not typically through expert-adjudicated "ground truth" on a test set of medical outcomes or interpretations.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done and is not mentioned. This type of study is for image interpretation or diagnostic tools, not for a mechanical accessory like a needle guide.
6. If a Standalone (i.e. algorithm only without human-in-the-loop) Performance Was Done
This is not applicable. This device is a physical accessory designed for human use with an ultrasound system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed would be established by:
- Engineering specifications and test standards: For mechanical and functional performance (e.g., proper fit, retention force).
- ISO 10993-01 and FDA Memorandum #G95-1: For biocompatibility.
- Validated sterilization protocols: For sterility.
- Established environmental and packaging standards: For shelf-life, shipping.
There is no "expert consensus, pathology, or outcomes data" as ground truth in the context of this device's testing for 510(k) clearance.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/ML algorithm or a diagnostic imaging device that requires training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.