(58 days)
HVO surgical drapes are made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. They are designed to be repackaged and/or sterilized before use. This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.
The proposed HVO, Inc. Various Disposable Non-Sterile Surgical Drapes function in the same manner as predicate devices in that they are intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination. Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are SMS, Micro-embossed LDPE, Clear LDPE, Nonwoven (wetlaid cellulose), Airtex, Sontara, Krayton, Medical Grade Single and Double Coated Tapes, Bridging, Polyfoam, Velcro, Polyester Mesh, Hot Melt, Cold Glue and Coated Medical Grade Liners. Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.
The provided text describes a 510(k) submission for "Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes." This document primarily focuses on establishing substantial equivalence to existing predicate devices based on material composition, intended use, and general characteristics rather than presenting a performance study with specific acceptance criteria and detailed statistical analysis for a novel device.
Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment from a study is not present in the provided text.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific numerical acceptance criteria or performance metrics in the format of a table you'd typically see for an AI algorithm or a device requiring specific functional performance targets. Instead, the "performance" is implicitly demonstrated through a comparison of characteristics to predicate devices.
| Characteristics | Acceptance Criteria (Implicit - Same or Similar to Predicate) | Reported Device Performance (HVO, Inc. Devices) |
|---|---|---|
| Materials | Must be same or similar to predicate devices | SMS, Micro-Embossed LDPE, Clear LDPE, Sontara, Nonwoven, Krayton, Airtex, Polyfoam, Medical Grade Single And Double Coated Tapes, Velcro, Cold Glue, Hot Melt, Bridging, Polyester Mesh Coated Medical Grade Liners |
| Absorbency | Same as predicate devices | Absorbent and Non-Absorbent |
| Packaging | Same as predicate devices | Bulk and Single Use |
| Disposable | Same as predicate devices | Yes |
| Sterility | Non-Sterile or Sterile (predicate allows both, HVO is Non-Sterile) | Non-Sterile |
| Function | Isolate a site of surgical incision from microbial and other contamination (intended use) | Intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination. |
Study that proves the device meets the acceptance criteria:
The "study" presented is a comparison to legally marketed predicate devices. The sponsor argues that their devices are substantially equivalent to these predicates due to similar design, materials, and intended use. The FDA concurred with this assessment, indicating that the device meets the regulatory requirements for market entry based on this comparison. The FDA's 510(k) clearance letter (K050508) serves as the "proof" that the device met the criteria for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. This submission is for surgical drapes and relies on a comparison to existing devices, not a performance study with a test set of data. There are no "data" in the sense of patient cases or images.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable.
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:
- MRMC Study: No, this is not an AI-assisted device.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the legally marketed predicate devices. The HVO drapes are deemed "substantially equivalent" if they share similar technological characteristics and intended use with these predicates, implying they would also share similar safety and effectiveness.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
§ 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.