(117 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a disposable sheath, with no mention of AI or ML technologies.
No
The device is described as an accessory to reduce contamination of endoscopes and exposure of staff during cleaning, not to treat a medical condition or provide therapy to a patient.
No
The device is described as an "accessory for use in nonsterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope." Its function is to provide a physical barrier for the endoscope, not to diagnose medical conditions or analyze patient data.
No
The device is a physical sheath made of polyurethane, intended to cover endoscopes. The description details material composition, physical forms (rigid/flexible, sterile/non-sterile), and packaging, all indicative of a hardware device. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce gross contamination of endoscopes during procedures and reduce staff exposure to contamination during cleaning. This is a device used during a medical procedure on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical sheath that covers an endoscope. It does not involve any reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is clearly described as an accessory for a medical procedure (colonoscopy/sigmoidoscopy) and its function is related to hygiene and contamination control, not diagnosis.
N/A
Intended Use / Indications for Use
The Sheathing Technologies, Inc. Polyurethane Colonoscope/Sigmoidoscope Sheath provides a conformal covering to fit various lengths and widths of colonoscopes and sigmoidoscopes (hereafter referred to as 'endoscopes'). The cover is open at the proximal end to allow free use of the endoscope's channels, and open at the distal end for insertion of the endoscope. Various sizes and shapes of Sheaths are offered to address the variations in size of the endoscopes.
This device is an accessory for use in nonsterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.
Colonoscope/Sigmoidoscope Sheaths are meant for use in non-sterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.
Product codes
FDF, ODB
Device Description
The Sheathing Technologies, Inc. Polyurethane Colonoscope/Sigmoidoscope Sheath provides a conformal covering to fit various lengths and widths of colonoscopes and sigmoidoscopes (hereafter referred to as 'endoscopes'). The cover is open at the proximal end to allow free use of the endoscope's channels, and open at the distal end for insertion of the endoscope. Various sizes and shapes of Sheaths are offered to address the variations in size of the endoscopes.
This device is an accessory for use in nonsterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.
The cover material is a polyether-blend polyurethane, which is the same blend currently used for Sheathing Technologies probe covers (510(K) K963831 for Sheathes Non-Latex, Non-Sterile and 510(K) K990175 for Sheathes Non-Latex, Sterile).
Product categories/models include
- Rigid sigmoidoscope Sheaths (sterile and non-sterile)
- Flexible sigmoidoscope Sheaths (sterile and non-sterile)
- Colonoscope Sheaths (sterile and nonsterile)
Sheaths are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities. All are intended for non-sterile procedures, and all are for single patient/procedure, disposable use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Tests:
-
- Bench Testing:
- a. Stretch testing
- b. Imperforate seams
-
- Biocompatibility
- a. Cytotoxicity
- b. Intracutaneous Toxicity
- c. Sensitization
Conclusions from Non-Clinical Tests: Sheathing Technologies's Polyurethane sigmoidoscope/colonoscope Sheath has sufficient strength and elasticity for the intended application. It is biocompatible according to the ISO 10993-1:2003 biocompatibility standard for contact with skin and mucous membranes for a limited (
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Section 5: 510(K) Summary
2.100966.
pg. 1084
(As required by 21 CFR 807.92)
Polyurethane Colonoscope/Sigmoidoscope Sheath
July 14, 2010
AUG 3 - 2010
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
To Whom it may Concern:
This letter, along with the attached materials is to notify your office of the intention of Sheathing Technologies to market the following device starting on or after (90) days from this date.
Device/Specification Developer: Sheathing Technologies, Inc. 18431 Technology Drive Morgan Hill, CA 95037
Establishment Registration No.: 2950776
Contact Persons:
Jennifer Downing Manager of Quality & Research 1-408-782-2720
Richard Stevens Director of Product Development 1-408-782-2720
Trade Name:
Colonoscope/Sigmoidoscope Sheathes™
Common Name:
Colonoscope/Sigmoidoscope Sheath
5-1
1
K100966
Pg 2 of 4
Classification Name:
Equivalence:
Colonoscope/Sigmoidoscope Accessory
510(K) K081004, ProtectiScope CS, Stryker Gl (disposable sheath only) 510(K) K032688, Colonosight Model 510B, Sightline Technologies (disposable sheath only)
Labeling and Usage:
The following information will be found on each box/bag . (See Section 13, Proposed Labeling):
- Proprietary name 1.
- Quantity of sheathes packed 2.
- Name and Location of Manufacturer ന്
-
- Sterile/NS (if applicable)
-
- Expiration date
-
- Lot number
-
- Size of sheath
-
- Instructions for use
- Indications for use 9.
-
- Caution statements
-
- Prescription Statement
Device Description:
The Sheathing Technologies, Inc. Polyurethane Colonoscope/Sigmoidoscope Sheath provides a conformal covering to fit various lengths and widths of colonoscopes and sigmoidoscopes (hereafter referred to as 'endoscopes'). The cover is open at the proximal end to allow free use of the endoscope's channels, and open at the distal end for insertion of the endoscope. Various sizes and shapes of Sheaths are offered to address the variations in size of the endoscopes.
This device is an accessory for use in nonsterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.
5-2
2
K.100966
Pg 3 of 4
The cover material is a polyether-blend polyurethane, which is the same blend currently used for Sheathing Technologies probe covers (510(K) K963831 for Sheathes Non-Latex, Non-Sterile and 510(K) K990175 for Sheathes Non-Latex, Sterile).
Product categories/models include
- Rigid sigmoidoscope Sheaths (sterile 1. and non-sterile)
- Flexible sigmoidoscope Sheaths (sterile 2. and non-sterile)
-
- Colonoscope Sheaths (sterile and nonsterile)
Sheaths are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities. All are intended for non-sterile procedures, and all are for single patient/procedure, disposable use.
Substantial Equivalence:
The Sheathing Technologies, Inc. Polyurethane Colonoscope/Sigmoidoscope Sheath is identified as substantially equivalent to Stryker GI's current, legally marketed ProtectiScope ™ colonoscope Sheath and to Sightline Technologies's current, legally marketed ColonoSight™ colonoscopy Sheath.
Non-Clinical Tests:
-
- Bench Testing:
- a. Stretch testing
- b. Imperforate seams
-
- Biocompatibility
- a. Cytotoxicity
- b. Intracutaneous Toxicity
- c. Sensitization
Conclusions from Non-Clinical Tests: Sheathing Technologies's Polyurethane sigmoidoscope/colonoscope Sheath has sufficient strength and elasticity for the intended application. It is biocompatible
5-3
3
K100966
pg444
5-4
according to the ISO 10993-1:2003 biocompatibility standard for contact with skin and mucous membranes for a limited (