(136 days)
Cardinal Health Tiburon® surgical drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.
This drape is classified as Level 4 per AAM Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.
The Cardinal Health Tiburon® surgical drapes described in this submission are single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of absorbent nonwoven fabric backed with a protective film that stops fluid strikethrough. The drapes are provided in various sizes and shapes to meet the surgical procedure. The sterile product will be sold as an individually ethylene oxide sterilized wrapped drape that is placed in a polyolefin - based vented pouch and heat sealed prior to sterilization and are intended for external use only.
These drapes are comprised of a fabric that is an blue absorbent polyolefin spun melt nonwoven fabric adhesively bonded to a polyolefin blue film.
Cardinal Health Tiburon® surgical drapes meet the Level 4 requirements of the AAM Liquid Barrier Classifications.
This submission covers ten different models of Cardinal Health surgical drapes in Table 1. The catalog numbers listed in this submission are representative of all drape models. All models utilize the same material technology.
The information provided describes the Cardinal Health Tiburon® surgical drape, a medical device, and its acceptance criteria as demonstrated through performance testing.
Here's an analysis based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Indication: Provide an absorbent sterile barrier during surgical procedures. | "Completion of the performance tests demonstrated that the surgical drape provides an adequate sterile barrier after sterilization." |
| Material Composition: Absorbent nonwoven fabric backed with a protective film that stops fluid strikethrough. | "These drapes are comprised of a fabric that is an blue absorbent polyolefin spun melt nonwoven fabric adhesively bonded to a polyolefin blue film." |
| Sterility: Sterilized using ethylene oxide. | "The sterile product will be sold as an individually ethylene oxide sterilized wrapped drape..." and "The drape is sterilized using ethylene oxide..." |
| Barrier Performance (AAMI Standard PB70): Meet Level 4 liquid barrier classification. | "Cardinal Health Tiburon® surgical drapes meet the Level 4 requirements of the AAM Liquid Barrier Classifications." and "This drape is classified as Level 4 per AAMI Standard PB70 Liquid Barrier Performance..." |
| Biocompatibility: Safe for intended use. | "Cardinal Health Tiburon® surgical drapes were tested in compliance with the requirements of Level 4 liquid barrier performance of AAMI Standard PB70... In addition... these drapes were evaluated according to ISO 10993 and are considered toxicologically acceptable for its intended use." (Specifically, "Non-cytotoxic, Non-sensitizing, Non-irritating" as per Table #2). |
| Substantial Equivalence: Equivalent to predicate device (3M Health Care Steri-Drape™ Fabric Surgical Drape K031287). | The document explicitly states "The Cardinal Health Tiburon® surgical drapes are substantially equivalent to the predicate device." and details comparisons in Table #2 concluding "Substantially Equivalent" for most comparable aspects. |
Study Information
-
Sample size used for the test set and the data provenance:
- Sample Size: The document states that "Extensive performance testing has been completed on the Cardinal Health Tiburon® surgical drape," and "This submission covers ten different models of Cardinal Health surgical drapes in Table 1. The catalog numbers listed in this submission are representative of all drape models. All models utilize the same material technology." However, it does not specify the exact number of drape samples tested for each performance criterion.
- Data Provenance: The data appears to be prospective as it involves performance testing conducted specifically for this submission. The country of origin is not explicitly stated for the testing, but the manufacturer is Cardinal Health 200, LLC, based in McGaw Park, IL, USA.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a physical product (surgical drape), not an AI/diagnostic device that relies on expert interpretation of data. Therefore, the concept of "ground truth established by experts" in the context of medical image analysis or disease diagnosis does not directly apply here. The "ground truth" for this device's performance is objective measurements according to established industry standards (AAMI Standard PB70, ISO 10993).
-
Adjudication method for the test set:
- Not applicable as this is a physical product performance study, not a study involving human interpretation or clinical adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and its relevance is not applicable to a surgical drape's physical performance evaluation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device submission, not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that the drape's physical properties are tested directly, without human interpretation as part of the core performance metric.
-
The type of ground truth used:
- The "ground truth" for the performance claims (e.g., Level 4 barrier, biocompatibility) is based on objective measurements and adherence to established industry standards (e.g., AAMI Standard PB70 for liquid barrier performance, ISO 10993 for biocompatibility). These standards define metrics and test methods.
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of developing this surgical drape.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.