(99 days)
Surgical Procedure Packs are kits for oral implantology, used by dental professionals when performing surgical procedures.
Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.
Omnia Surgical Procedure Packs are composed of disposable devices, drapes, and surgical garb intended for professional use in preparing the operating environment with protective coverings that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. The contents of these kits may include:
- Surgical Gowns (various models) with or without hand towels ●
- Sterile Surgical Drapes (various models) .
- Face mask .
- Protective caps .
- Sheath/Tubing Sleeve .
- Surgical aspirator with adaptor .
- Surgical Gauze .
- Sterile disinfection sponge and/or basin .
- Adhesive Film .
- Syringe (s) .
- Needle(s) .
- . Single-use scalpel
- Small dental mirror/dental explorer/tweezer .
- Bone collector ●
- . Saliva ejector
- . Irrigation/Infusion line
- Stopcock and ramp for infusion .
- Waste bag for contaminated material .
The provided document, K110724, describes Omnia Surgical Procedure Packs and their substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device's performance. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and reader studies are not applicable or cannot be extracted from this specific 510(k) summary. The summary focuses on comparative data for substantial equivalence, not de novo performance validation against acceptance criteria for a new type of device.
However, I can extract the parts that relate to performance characteristics and the supporting data provided for substantial equivalence.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
The acceptance criteria for the Omnia Surgical Procedure Packs are implicitly derived from demonstrating substantial equivalence to the predicate device (Surgical Drape Kit, K041080) and conformance to applicable industry standards for its components. The "performance" here is demonstrating that the new device meets or exceeds the predicate's performance and relevant industry benchmarks for its individual components.
| Acceptance Criterion (Implicit) | Reported Device Performance by Omnia |
|---|---|
| Intended Use Equivalence: Prepare operating environment with protective coverings to maintain cleanliness and limit contamination during medical/dental surgeries. | Substantially Equivalent to Predicate: "Omnia believes that the Omnia Surgical Procedure Packs are substantially equivalent to the Surgical Drape Kit manufactured by D.I.R.R.A. srl and cleared via 510(k) # K041080. Both devices consist 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. Both devices also include other surgical devices of general utility during various types of medical and/or dental surgeries." (Page 3) |
| Biocompatibility: Materials used are safe for patient contact. | Nonclinical Testing: Biocompatibility was assured via nonclinical testing in accordance with ISO 10993. (Page 4) |
| Sterilization Efficacy & Shelf-Life: Device is sterile and maintains sterility over time. | Validation & Data: Device sterilization is obtained using ethylene oxide. Sterilization processes were validated in accordance with EN 556 and ISO 11135. Shelf-life has been demonstrated to be a minimum of 5 years after sterilization. (Page 4) |
| Performance of Gowns, Masks, Drapes: Conformance to relevant material and barrier standards. | Non-clinical Performance Data: Non-clinical performance data for the gowns, masks, and drapes demonstrated conformance to applicable standards (ISO 13795 - ASTM 2407-06 - ASTM 1670-08 - ASTM 1671-07). The characteristics of these items have been previously described in K012186 and K020393 (gowns and drapes) and K911334 (masks). (Page 4) |
| Packaging & Sterilization Method Equivalence: Similar to predicate device. | Substantially Equivalent to Predicate: "the Omnia Procedure Pack and the predicate device are packaged similarly (single pack in medical envelope) and sterilized via the same sterilization method (ETO)." (Page 3) |
| Kit Contents Equivalence: Generally similar utility and composition as predicate. | Comparison Chart: A table comparing the kit contents confirms general similarity and intended utility. (Page 3) |
1. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This summary does not describe a clinical "test set" in the context of diagnostic accuracy or a specific performance study involving patient data beyond demonstrating material and sterilization properties. The "testing" involved non-clinical evaluations of materials and sterilization processes.
- Data Provenance: The non-clinical testing for biocompatibility, sterilization, and individual component performance (gowns, masks, drapes) would have been conducted in a laboratory setting, likely in Italy (the submitter's country). The specific details on where these tests were conducted are not provided. The data is "retrospective" in the sense that it's laboratory test results rather than prospective clinical trials.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical procedure pack, not a diagnostic or AI device requiring expert ground truth for a test set. The validation relies on technical standards (ISO, EN, ASTM) and manufacturing controls.
3. Adjudication method for the test set:
- Not applicable for the reasons stated above.
4. 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 not an AI-powered diagnostic tool, nor does it involve human readers in this context. It's a collection of sterile disposable items.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
6. The type of ground truth used:
- Biocompatibility, Sterilization, Component Performance: The "ground truth" for these aspects comes from established international and industry standards (e.g., ISO 10993 for biocompatibility, EN 556 and ISO 11135 for sterilization, ISO 13795, ASTM 2407-06, ASTM 1670-08, ASTM 1671-07 for gowns/masks/drapes). The "truth" is whether the device components meet these predefined performance specifications.
7. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established:
- Not applicable.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.