SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH

K030684 · Acmi Corporation · OCU · Jun 3, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030684
• Device Name: SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
• Applicant: Acmi Corporation
• Product Code: OCU · Gastroenterology, Urology
• Decision Date: Jun 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.

Device Story

Scope Guard Protective Sheath is a polymer tube with distributed holes along its shaft; designed to snap onto ACMI telescopes. Device provides physical protection for delicate instruments during transport, storage, and sterilization. It is not a standalone terminal sterilization device; must be used with approved sterilization wraps or trays. Used in clinical settings where endoscopes are processed. Benefits include reduced risk of damage to delicate scope components during handling and sterilization cycles.

Clinical Evidence

Bench testing only. Testing included durability, sterile efficacy, and material compatibility with various sterilization methods.

Technological Characteristics

Polymer tube with distributed holes; various widths and lengths; snap-on design for ACMI telescopes. Compatible with standard sterilization methods.

Indications for Use

Indicated for the protection of ACMI endoscopes during transport, storage, and sterilization processing.

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

• Polyvac Surgical Instrument Delivery System (K012105)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

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

ACMI Corporation Ms. Christine Nichols, RAC 136 Turnpike Road Southborough, MA 01772-2104

JUL 2 7 2015

Re: K030684 Trade/Device Name: Scope Guard™ Protective Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCU, KCT Dated (Date on orig SE ltr): March 4, 2003 Received (Date on orig SE Itr): March 5, 2003

Dear Ms. Nichols,

This letter corrects our substantially equivalent letter of June 3, 2003.

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

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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 (reporting of medical device-related 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 contact 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/ResourcesforYou/Industry/default.htm. 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,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### V. Statement of Intended Use.

510(k) Number (if Known):

Device Name:

Scope Guard™ Protective Sheath

Indications For Use:

The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**

OR

Over-The-Counter Use (Optional Format 1-2-96)

David R. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Confidential and Proprietary to ACMI Corporation

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Image /page/3/Picture/0 description: The image shows the logo for ACMI in black and white. The logo consists of three diagonal lines on the left, followed by the letters "ACMI" in a bold, sans-serif font. The diagonal lines are thicker at the top and taper towards the bottom, creating a sense of movement. The letters are evenly spaced and aligned with the diagonal lines, forming a cohesive and recognizable brand identity.

Scope Guard ™Protective Sheath 510(k) Premarket Notification

JUN - 3 2003

K030684

### IV. Summary of Safety and Effectiveness

# 510(k) Summary for Scope Guard™ Protective Sheath

| A. Sponsor | ACMI CORPORATION<br>136 Turnpike Rd<br>Southborough, MA 01772 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Device Name | Scope Guard™ |
| C. Predicate Device | Polyvac Surgical Instrument Delivery System (K012105) |
| D. Device Description | The Scope Guard Protective Sheath is a polymer tube in<br>various widths and lengths with evenly distributed holes<br>along the length of the shaft. It is designed to snap onto<br>ACMI telescopes for protection during storage and<br>sterilization. |
| 1. Intended Use | The Scope Guard protective sheath is intended for use<br>during the transport, storage and sterilization of certain<br>ACMI scopes for protection of these delicate instruments. It<br>is not intended to be used alone for terminal sterilization but<br>can be used in conjunction with an approved sterilization<br>wrap to maintain sterility until the device is required for use.<br>The ACMI scopes with Scope Guard can be wrapped, or<br>placed into an approved sterilization tray for sterilization<br>processing. |
| 2. Technological Characteristics and Substantial Equivalence | The ACMI Scope Guard has been tested and compared to<br>similar devices. The Scope Guard is substantially equivalent<br>to the predicate described for the parameters tested. |

# 3. Performance Testing

ACMI Scope Guards have been bench tested for durability, sterile efficacy and material compatibility with several sterilization methods.