(215 days)
The ConMed" DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.
The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
CAT. NO. DESCRIPTION
2-1003 METZENBAUM, 33CM LENGTH
2-1004 MINI-METZENBAUM, 33CM LENGTH
2-1005 5MM BABCOCK GRASPER, 33CM LENGTH
2-1008 FENESTRATED GRASPER, 33CM LENGTH
2-1009 CURVED DISSECTOR, 33CM LENGTH
1-1010 STANDARD HANDLE
2-1013 HOOK, 33CM LENGTH
2-1014 10MM BABCOCK, 33CM LENGTH
1-1015 COMPACT HANDLE
2-1017 RIGHT ANGLE MEEKER DISSECTOR 33CM
2-1018 TAPERED DISSECTOR, 33CM LENGTH
2-1019 ALLIS GRASPER, 33CM LENGTH
1-1024 IN-LINE HANDLE
1-1028 ENDOWEAVE GRASPER, 33 CM LENGTH
The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with ConMed's 43cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
Cat. No. Description
2-4301 Metzenbaum, 43cm length
2-4304 Mini- Metzenbaum, 43cm length
2-4305 5mm Babcock Grasper, 43cm
2-4308 Curved Dissector, 43cm length
2-4307 Fenestrated Grasper, 43cm length
2-4314 10mm Babcock, 43cm
2-4317 Right Angle Meeker dissector 43cm
2-4318 Tapered Dissector, 43cm
2-4319 Allis Grasper, 43cm
2-4328 Endoweave Grasper, 43cm
Sterilize the 33cm DetachaTip Instrument Tray (1-1027) and the 43cm DetachaTip Instrument Tray (1-4327) using the following parameters:
Method: Steam (wrapped)
Cycle: Pre-vacuum
Temperature: 270°F(132°C)
Exposure Time: 4 minutes
Dry Cycle Time: 20 minutes
The ConMed™ DETACHATIP® INSTRUMENT TRAYS consist of a Radel R Polyphenylsulfone base, a Radel R Polyphenylsulfone tray, a silicone rubber mat, a Radel R Polyphenylsulfone lid with tray lid clips with perforations to facilitate steam penetration, and stainless steel carrying handles. The tray holds the ConMed™ DETACHATIP® surgical instruments before, during, and after the sterilization process. The tray set has a locking lid to contain the instruments.
The provided document describes the ConMed™ DetachaTip® Instrument Trays, which are perforated containment devices for medical device sterilization. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Sterilant Penetration (Pre-vacuum Steam Sterilization) | Effective during pre-vacuum steam sterilization. |
| Minimum Sterilization Temperature | 132°C |
| Minimum Exposure Time | 4 minutes |
| Minimum Dry Time | 20 minutes (required to prevent wet packs when using the prevacuum cycle) |
| Compatibility with Instrument Sizes | 33cm DetachaTip Instrument Tray (1-1027) with 33cm instruments; 43cm DetachaTip Instrument Tray (1-4327) with 43cm instruments. Specifically listed CAT. NO. and DESCRIPTION provided for both tray types. |
| Material Compatibility | Constructed from Radel R Polyphenylsulfone (base, tray, lid, lid clips), silicone rubber mat, and stainless steel carrying handles. |
| Containment | Locking lid to contain instruments. |
| Reusability | Reusable. |
| Non-Servicable/Non-Repairable | Will not be serviced or repaired. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Validation was conducted using wrapped trays." It does not specify:
- The exact sample size (number of trays or test cycles) used for the validation.
- The country of origin of the data.
- Whether the study was retrospective or prospective.
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 document. For instrument sterilization trays, ground truth would typically be established through standardized microbiological and physical testing protocols, rather than expert interpretation of results in the way a diagnostic AI might be. The document mentions "biological indicators and thermocouples," which suggests objective measurement, not subjective expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads where there's disagreement), to arrive at a consensus "ground truth." For device performance validation related to sterilization, the outcomes are objective (e.g., presence/absence of microbial growth, temperature readings, wet pack detection).
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
This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic imaging devices or software where human readers interpret medical images. The ConMed™ DetachaTip® Instrument Trays are physical sterilization containers, not diagnostic devices, and thus do not involve human "readers" or AI assistance in their primary function or validation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. Standalone performance studies typically refer to the performance of an AI algorithm operating independently. The ConMed™ DetachaTip® Instrument Trays are passive medical devices (trays) and do not contain algorithms or AI. Their performance is assessed through physical and microbiological validation tests directly on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the sterilization performance was established using objective measurements:
- Biological Indicators (BIs): Used to confirm sterility by detecting the killing of a highly resistant microorganism.
- Thermocouples: Used to measure and confirm that the required temperature was reached and maintained throughout the sterilization cycle.
- Wet Pack Detection: Implicitly part of the drying cycle validation, aiming to ensure no residual moisture.
8. The sample size for the training set
This information is not applicable and not provided. The ConMed™ DetachaTip® Instrument Trays are not an AI/ML device, so there is no "training set." The validation performed is for the physical device itself.
9. How the ground truth for the training set was established
This information is not applicable and not provided as there is no training set for this type of device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).