(218 days)
The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination.
The DIRRA surgical drape device kit is composed of natural or synthetic materials and intended to be used as protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. The DIRRA surgical drape device kit is to be used by medical and dental professionals when performing surgical procedures.
The DIRRA surqical drape device kit consists of the following components: Gown w/ paper towel (2), Mayo stand cover (1), Sterile sheet (1), Patient drape (1), Transparent drape (1), Adhesive strip (4), Tube holder (1), Cord drape (2), Suction tubing w/tip (1), Flat gauze (20), Round gauze sponge (5), Plastic tray (1), Transparent adhesive film (3), Connector for suction tubing (1), Kit wrapping drape (1).
All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label.
The final measurement of the kit (not enveloped) is approximately cm.30x30x10. The kit is then enveloped in sequence and in accordance with the instructions for use. The pack is then inserted in the Sterilization plastic/tyvek pouch and the pouch is sealed. 2 Kits are put into one cardboard box along with instructions for use,. The box is then closed and sterilized by Bioster. A sterilization batch number is applied on the box after the sterilization process has been completed.
The provided document (K041080) is a 510(k) summary for a Surgical Drape Kit. It is a premarket notification for a medical device seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device.
For such a device (Class II, Surgical Drape and Drape Accessories, Product Code: LRO), direct performance studies to establish detailed acceptance criteria and prove performance as one would for a diagnostic or AI-driven device are typically not required in the same manner. The basis of clearance is substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and any differences do not affect safety or effectiveness.
Therefore, the detailed information requested regarding acceptance criteria, study design (sample sizes, experts, adjudication, MRMC, standalone performance), and ground truth establishment is not applicable to this type of 510(k) submission for a surgical drape kit.
Here's how to address each point based on the information provided in this 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance data." (Section: Comparison to predicate devices). Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the format typically seen for a diagnostic device validation. The "acceptance criteria" here relate to demonstrating substantial equivalence to the predicate device in terms of intended use, technological characteristics (materials, sterility, dimensions), and showing that any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Kit for oral implantology, used by dental professionals when performing surgical procedures. Intended as a protective patient covering to isolate a surgical incision site from microbial or other contamination. | Meets: Same indications for use as predicate device (Custom Surgical Pack - distributed by Nobelbiocare and Produced by Maxxim). |
| Technological Characteristics: Materials, sterility, dimensions. | Meets: "almost the same components, with the same technological characteristics (materials, sterility, dimensions)" as the predicate device. |
| Safety and Effectiveness: Differences from predicate device should not affect safety and effectiveness. | Meets: "differences... should not affect the safety and effectiveness." (Note: this is a claim made in the submission, not a conclusion from performance data). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No performance data or test set was used for this 510(k) clearance, as explicitly stated that the determination of substantial equivalence is not based on an assessment of performance data.
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)
Not applicable. No test set or ground truth was established for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used.
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
Not applicable. This device is a surgical drape kit, not an AI-driven diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical drape kit, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was established as performance data was not used for the determination of substantial equivalence. The "ground truth" for this submission would essentially be the predicate device's established safety and effectiveness, to which the new device is compared.
8. The sample size for the training set
Not applicable. This device is a physical product (surgical drape kit), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical surgical drape kit, no ground truth needed to be established for it.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.