(339 days)
K82270
K82270
No
The device description and performance studies focus on the physical properties and sterility of a textile product (stockinette), with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is described as a sterile stockinette used as a surgical extremity drape or a dressing retainer, primarily for establishing a sterile field or retaining dressings, not for treating a disease or condition.
No
The device is described as a sterile stockinette used as a surgical extremity drape and dressing retainer, with no mention of diagnostic capabilities based on the provided text.
No
The device description and performance studies clearly indicate a physical textile product (stockinette) and not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as a "surgical extremity drape to establish a sterile field" and a "dressing retainer." These are external applications on the body, not tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description of the device (stockinette rolls) aligns with its intended use as a physical barrier or retainer, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition.
- Performance Studies: The performance studies focus on physical properties like blood and viral penetration, strength, flammability, and biocompatibility – all relevant to a surgical drape and dressing retainer, but not to an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Sterile stockinette is used primarily as an surgical extremity drape to establish a sterile field. Bias cut sterile stockinette is used as a dressing retainer where swelling is expected.
Product codes
Not Found
Device Description
Sterile stockinette includes single and double ply rolls, bias cut rolls and impervious stockinette in various widths and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremity (for surgical drape)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were run on Tex-Care Sterile Stockinettes to indicate that they would function in a safe and effective manner:
- ASTM ES 21 - Synthetic Blood Penetration Test: run on 32 samples of impervious stockinettes. All samples passed.
- ASTM ES 22 - Viral Penetration Test: run on 32 samples of impervious stockinettes. All samples passed.
- USP Intracutaneous Test (Biocompatibility testing): No apparent irritation was observed in association with the test article extracts.
- USP Systemic Injection Test (Biocompatibility testing): None of the test animals showed any clinical signs consistent with toxicity.
- Guinea Pig Maximization Test (Sensitization) (Magnusson-Kligman): Showed a 0% sensitization incidence.
- ASTM D 5034-90 Standard Test Method for Breaking Force of Textile Fabric and ASTM D 3787-89 Bursting Strength of Knitted Goods (CRT) Ball Burst Test: Both burst strength and breaking force were shown to be adequate to perform as intended.
- CS-191-53 Part 1610 Flammability of Clothing Textiles tests: Requirements of Classification 1 - Normal Flammability were met by both cotton and impervious stockinettes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K82270
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Nov 22 1996
510 (K) Summary 11-22-96
Trade Name - Tex-Care Sterile Stockinette
Common Name - Sterile Stockinette
Classification Name - Drape, Surgical
Predicate Device : Burlington®Sterile Stockinette also known as Balfour Sterile Stockinette 510 (K) K82270
Description : Sterile stockinette includes single and double ply rolls, bias cut rolls and impervious stockinette in various widths and lengths.
Intended Use : Sterile stockinette is used primarily as an surgical extremity drape to establish a sterile field. Bias cut sterile stockinette is used as a dressing retainer where swelling is expected.
Technical Characteristics : Tex-Care Sterile Stockinette has the same technological characteristics as the predicate device with regard to design, materials, and method of manufacture.
The following tests were run on Tex-Care Sterile Stockinettes to indicate that they would function in a safe and effective manner.
ASTM ES 21 - Synthetic Blood Penetration Test was run on 32 samples of impervious stockinettes to substantiate the claim of being impervious. All samples passed.
ASTM ES 22 - Viral Penetration Test was run on 32 samples of impervious stockinettes to substantiate the claim of being impervious. All samples passed.
Biocompatibility testing :
USP Intracutaneous Test - This test was to determine if any chemicals that may leach or be extracted from the impervious stockinettes were capable of causing local irritation in the dermal tissues of the rabbit. No apparent irritation was observed in association with the test article extracts.
1
P. 03
Re: Tex-Care Sterile Stockinette 510 (k) Summary Biocompatibility Testing Continued:
USP Systemic Injection Test was run to screen the extracts of the impervious stockinette for potential toxic effects as a result of a single dose injection. None of the test animals showed any clinical signs consistent with toxicity at any time during the observation period.
Guinea Pig Maximization Test (Sensitization) (Magnusson-Kligman) was run to evaluate the allergic potential or sensitizing capacity of the impervious stockinettes. The impervious stockinette showed a 0% sensitization incidence.
ASTM D 5034-90 Standard Test Method for Breaking Force of Textile Fabric and ASTM D 3787-89 Bursting Strength of Knitted Goods (CRT) Ball Burst Test were performed on the stockinettes to indicate that the construction had adequate strength to perform as intended. Both burst strength and breaking force were shown to be adequate.
CS-191-53 Part 1610 Flammability of Clothing Textiles tests indicated that requirements of Classification 1 - Normal Flammability were met by both cotton and impervious stockinettes.
John A. Kranaskas Operations Manager Tex-Care Medical 673 Gilmer St. Burlington, NC 27417
910-570-5870