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510(k) Data Aggregation
(77 days)
KOALA CLAMP, KOALA CLAMP AND CUTTER
The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbilical cord.
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This is a medical device 510(k) premarket notification for the Koala Clamp & Cutter, an umbilical cord clamp and cutter device. The submission aims to demonstrate substantial equivalence to a predicate device, the ClampCut by PriceInvena APS (510(k) No. 982464).
Given the nature of this submission, which is for a physical medical device (an umbilical cord clamp and cutter) and not an AI/ML-driven diagnostic or prognostic device, the concepts of "acceptance criteria," "device performance" in the context of AI metrics (like sensitivity, specificity), "sample size for test/training sets," "ground truth establishment by experts/pathology," "MRMC studies," or "standalone algorithm performance" are not applicable.
The document focuses on comparing the physical characteristics, materials, intended use, and general performance attributes (like sterility) of the Koala Clamp & Cutter to its predicate device. This is a common approach for 510(k) submissions for non-software/AI devices, where substantial equivalence is demonstrated through engineering and material comparisons, and potentially performance testing related to its mechanical function.
Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device evaluation. The document does not contain data or studies related to AI/ML performance.
However, I can extract the comparison chart provided, which highlights the device's technical specifications:
1. Table of Acceptance Criteria and Reported Device Performance
(Note: "Acceptance Criteria" here refers to the comparison points for substantial equivalence, not AI performance metrics. "Device Performance" refers to the characteristics of the Koala Clamp.)
| Comparison Characteristic | Koala Clamp | Predicate Device (ClampCut SCC-23) |
|---|---|---|
| Indications for Use | Simultaneously clamp and cut the umbilical cord. | Simultaneously clamp and cut the umbilical cord. Reduces risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases. |
| Target Population | All births | All births |
| Materials: Plastic | Lexan 144R (alternate: Lexan 124R) | Polyamid 6.6. |
| Biocompatible | Yes | Yes |
| Materials: Blade | Stainless Steel Surgical Blade | Stainless Steel Knife |
| Shield (for Blade) | Yes | No |
| Dimensions: Open Unit | 74mm x 50.6mm x 32.9mm | 120mm x 70mm x 20mm |
| Dimensions: Closed Unit | 46.8mm x 50.6mm x 32.9mm | 85mm x 60mm x 20mm |
| Dimensions: Infant Clamp | 43.5mm x 23.9mm x 6.5mm | 50mm x 9mm x 7mm |
| Weight of Total Unit | 1.316 oz | 0.811 oz (23 grammes) |
| Weight of Cutter Unit alone | 0.53 oz | 0.713 oz (20.2 grammes) |
| Weight of Infant Clamp alone | 0.086 oz | 0.099 oz (2.8 grammes) |
| Sterility | Gamma-Sterilized (alternate: Ethylene Oxide Gas) | Ethylene Oxide Gas |
| Anatomical Sites | Umbilical Cord | Umbilical Cord |
The remaining requested information (2-9) is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML-driven diagnostic/prognostic tool. There are no AI algorithms, test sets, training sets, ground truth derived from expert consensus, or MRMC studies described in this document. The "study" proving the device meets criteria is implicitly the declaration of substantial equivalence based on the comparison of physical and performance characteristics to a legally marketed predicate device.
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(56 days)
KOALA CLAMP
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