COLONOSCOPE/SIGMOIDOSCOPE SHEATHES

K100966 · Sheathing Technologies, Inc. · FDF · Aug 3, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100966
• Device Name: COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
• Applicant: Sheathing Technologies, Inc.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Aug 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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.

Device Story

Polyurethane sheath provides conformal covering for colonoscopes and sigmoidoscopes; open at proximal end for channel access and distal end for insertion. Used in clinical settings during non-sterile endoscopic procedures. Acts as physical barrier to reduce gross contamination of endoscope surface; minimizes staff exposure to contaminants during post-procedure cleaning. Single-patient, disposable device.

Clinical Evidence

No clinical data. Bench testing only: stretch testing, imperforate seam testing, and biocompatibility (cytotoxicity, intracutaneous toxicity, sensitization) per ISO 10993-1:2003 for limited contact duration.

Technological Characteristics

Polyether-blend polyurethane material. Conformal sheath design with proximal and distal openings. Available in rigid and flexible configurations for colonoscopes and sigmoidoscopes. Single-use, disposable. Biocompatible per ISO 10993-1:2003. Sterilized or non-sterile options.

Indications for Use

Indicated for use in non-sterile colonoscopy or sigmoidoscopy procedures to reduce gross endoscope contamination and staff exposure during cleaning.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ProtectiScope CS, Stryker GI (K081004)
• Colonosight Model 510B, Sightline Technologies (K032688)

Submission Summary (Full Text)

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## 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

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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
- 4. Sterile/NS (if applicable)
- 5. Expiration date
- 6. Lot number
- 7. Size of sheath
- 8. Instructions for use
- Indications for use 9.
- 10. Caution statements
- 11. 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.

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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)
- 3. 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:

- 1. Bench Testing:
- a. Stretch testing
- b. Imperforate seams
- 2. 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

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K100966
pg444

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according to the ISO 10993-1:2003 biocompatibility standard for contact with skin and mucous membranes for a limited (<24 hour) contact duration.

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Image /page/4/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Jennifer Downing Manager of Quality & Research Sheathing Technologies, Inc. 18431 Technology Drive MORGAN HILL CA 95037

AUG 3 - 2010

Re: K100966

Trade/Device Name: Colonoscope/Sigmoidoscope Sheath Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, ODB Dated: July 14, 2010 Received: July 19, 2010

Dear Ms. Downing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Hubert Lehman ind

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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K100966

## Indications for Use Statement

AUG 3 - 2010

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510(k) Number (if known):

510(k) Number_

Device Name: Colonoscope/Sigmoidoscope Sheath

Indication For Use: 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|---|--------|------------------------------------------------|
|-------------------------------------------------|---|--------|------------------------------------------------|

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices,

X 1007 (000)