(75 days)
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Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a surgical drape, with no mention of AI or ML.
No
The device is described as a "protective patient covering," specifically an "incise drape" to create a sterile barrier during surgery, which prevents contamination rather than treating a medical condition.
No
The device is described as a protective patient covering during surgical procedures, specifically to isolate a surgical incision site. Its function is to provide a microbial barrier, not to diagnose a condition.
No
The device description clearly outlines a physical, sterile incise drape made of polyurethane film with adhesive, supplied in various sizes and sterilized by gamma irradiation. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used on the patient's body during surgery.
- Device Description: The description details a sterile incise drape made of polyurethane film with adhesive. This is a physical product applied externally.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility and microbial barrier performance, which are relevant to a physical barrier device, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is applied to the body as a protective measure.
N/A
Intended Use / Indications for Use
As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination.
Product codes
79KKX
Device Description
The Volmed Operation Drape is a sterile incise drape composed of a transparent mat polyurethane film coated on one side with an acrylic medical grade adhesive, supported by peelable white, silicon coated, double sided polyethylene protected release paper. The other side of the polyurethane film is protected by a polyethylene film which is removed after application of the drape to the surqical site.
Volmed Operations Drapes are supplied in 10 cm x 10 cm x 20 cm, 20 cm x 20 cm, 20 cm x 40 cm and 30 cm x 60 cm sizes in individual packages sterilized by gamma irradiation.
The biocompatibility of the device has been established by in vitro cytotoxicity, subcutaneous implantation (guinea pig), and dermal irritation (rabbit) tests. A repeat insult patch test in human volunteers showed that the material does not induce irritation or allergic contact dermatitis. In addition, a microbial permeability study with S. aureus was performed to demonstrate the effective performance of the drape as a bacterial barrier.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The biocompatibility of the device has been established by in vitro cytotoxicity, subcutaneous implantation (guinea pig), and dermal irritation (rabbit) tests. A repeat insult patch test in human volunteers showed that the material does not induce irritation or allergic contact dermatitis. In addition, a microbial permeability study with S. aureus was performed to demonstrate the effective performance of the drape as a bacterial barrier.
Key Metrics
Not Found
Predicate Device(s)
Steri-Drape® Surgical Incise Drapes
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
K 955872
510 (k) SUMMARY
MAR 1 2 1996
ADMINISTRATIVE
Medal International Sales Company, LLC Submitter: Route 17 Box 283-P Fort Worth, Texas 76126 (817) 244-8977
Contact Person: S. Douglas Pritchett
December 26, 1995 Date of Preparation:
DEVICE NAME 11.
| Proprietary Name: | Volmed™ Operation Drape |
|---|---|
| Common Name: | Sterile Surgical Incise Drape |
| Classification Name: | Sterile Surgical Drape |
| Regulatory Class: | Class II Device |
| Product Code: | 79KKX |
III. PREDICATE DEVICE
Steri-Drape® Surgical Incise Drapes, legally marketed prior to May 28, 1976 by 3M Company.
IV. DEVICE DESCRIPTION
The Volmed Operation Drape is a sterile incise drape composed of a transparent mat polyurethane film coated on one side with an acrylic medical grade adhesive, supported by peelable white, silicon coated, double sided polyethylene protected release paper. The other side of the polyurethane film is protected by a polyethylene film which is removed after application of the drape to the surqical site.
Volmed Operations Drapes are supplied in 10 cm x 10 cm x 20 cm, 20 cm x 20 cm, 20 cm x 40 cm and 30 cm x 60 cm sizes in individual packages sterilized by gamma irradiation.
The biocompatibility of the device has been established by in vitro cytotoxicity, subcutaneous implantation (guinea pig), and dermal irritation (rabbit) tests. A repeat insult patch test in human volunteers showed that the material does not induce irritation or allergic contact dermatitis. In addition, a microbial permeability study with S. aureus was performed to demonstrate the effective performance of the drape as a bacterial barrier.
1
INTENDED USE V.
As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination.
vi. CONCLUSION
The technological characteristics of the Volmed Operation Drape are the same as those of predicate devices, such as the Steri-Drape® Surgical Incise Drape (3M Company). Biocompatibility and performance testing of the Volmed Operation Drape have demonstrated topical safety as well as effective microbial barrier performance. Accordingly, Medal International Sales Company has concluded that the Volmed Operation Drape is safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the Steri-Drape® Surgical Incise Drape (3M Company).