(69 days)
Convertors® Drape Materials
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No
The device description and performance studies focus on the physical properties and biocompatibility of the materials, with no mention of AI or ML.
No
The device is described as a protective patient covering to isolate a surgical site from contamination, which is a barrier function rather than a therapeutic one. It does not actively treat or diagnose a disease or condition.
No
The device is described as a protective patient covering to isolate a surgical incision site and prevent contamination, which is a protective and barrier function, not a diagnostic one.
No
The device description explicitly states it is composed of nonwoven fabric and synthetic polymer film, indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used during a medical procedure on a patient's body.
- Device Description: The description details the materials used to create a physical drape and leggings.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the materials, not on the accuracy or performance of a diagnostic test.
The device described is a surgical drape/covering, which is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Convertors® Drapes and Leggings are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Product codes
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Device Description
These drapes and leggings will be composed o a nonwoven fabric adhesively laminated to a synthetic polymer film. The nonwoven contains adhesively bonded polyester fibers. The film is a 1.25 mil finely embossed blended polyethylene construction.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
All materials used in the fabrication of this Convertors® drapes and leggings were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/intracutaneous reactivity. These materials also met the requirements of hydrostatic head, impact penetration, synthetic blood penetration (ASTM 1670-1995), Phi X174 (ASTM 1671-1995) Trapazoid Tear, Grab Tensile, Mullen Burst, Basis Weight, and flammability, Class 2. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.
Key Metrics
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Predicate Device(s)
Convertors® Drape Materials
Reference Device(s)
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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
DEC 2 3 1996
of
Image /page/0/Picture/3 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be the logo of a company or organization. To the left of the word is a graphic of small squares.
Allegiance Healthcare Corporation 1500 Waukagan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
XII. SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Drapes and Leggings
| Manufacturer: | Allegiance Healthcare Corporation
Convertors® Operations
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
Allegiance Healthcare Corporation
1500 Waukegan Road MPK
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | September, 1996 |
| Common Name: | Convertors® Drapes and Leggings |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Convertors® Drape Materials |
| Description: | These drapes and leggings will be composed o
a nonwoven fabric adhesively laminated to a
synthetic polymer film. The nonwoven
contains adhesively bonded polyester fibers.
The film is a 1.25 mil finely embossed blended
polyethylene construction. |
1
Image /page/1/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic element composed of small dots arranged in a pattern resembling a stylized star or burst. The word itself appears to be slightly italicized, giving it a sense of motion or emphasis.
Allegiance Healthcare Corporation 1500 Waukagan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.786.2460
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Drapes and Leggings
| Intended Use: | The Convertors® Drapes and Leggings are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. |
|---|---|
| Substantial Equivalence: | The Convertors® Drapes and Leggings are substantially equivalent to the Convertors® legging drape materials in that: the intended use is the samethe performance attributes are similar |
| Summary of testing: | All materials used in the fabrication of this Convertors® drapes and leggings were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/intracutaneous reactivity. These materials also met the requirements of hydrostatic head, impact penetration, synthetic blood penetration (ASTM 1670-1995), Phi X174 (ASTM 1671-1995) Trapazoid Tear, Grab Tensile, Mullen Burst, Basis Weight, and flammability, Class 2. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use. |