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 Description

The Scope Guard Protective Sheath is a polymer tube in various widths and lengths with evenly distributed holes along the length of the shaft. It is designed to snap onto ACMI telescopes for protection during storage and sterilization.

AI/ML Overview

Here's an analysis of the provided text regarding the Scope Guard™ Protective Sheath, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "ACMI Scope Guards have been bench tested for durability, sterile efficacy and material compatibility with several sterilization methods." It then concludes that "The Scope Guard is substantially equivalent to the predicate described for the parameters tested."

To extract conceptual acceptance criteria and reported performance from the provided text, we can infer the following:

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Durability	Bench tested and found to be "substantially equivalent" to predicate device.
Sterile Efficacy	Bench tested and found to be "substantially equivalent" to predicate device.
Material Compatibility	Bench tested and found to be "substantially equivalent" to predicate device for "several sterilization methods."

2. Sample size used for the test set and the data provenance

The document does not provide specific sample sizes for any test sets.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the testing mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for a test set. The testing described appears to be bench testing for physical and sterilization properties, not involving interpretative assessments by human experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for a test set. This is consistent with the type of bench testing described, which typically involves objective measurements rather than expert consensus on subjective interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study. This device is a protective sheath, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone algorithm performance study. As mentioned, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench testing described (durability, sterile efficacy, material compatibility), the "ground truth" would be established by:

Durability: Objective physical measurements against engineering specifications or established industry standards.
Sterile Efficacy: Microbiological testing results (e.g., sterility testing after sterilization cycles) against accepted sterility assurance levels.
Material Compatibility: Visual inspection or material analysis after exposure to sterilization methods to detect degradation or incompatibility issues.

The document does not provide details on the specific methods used to establish these ground truths, but they would be based on objective scientific/engineering principles rather than expert consensus on medical images or pathology.

8. The sample size for the training set

The document does not mention any training set. As this is not an AI/machine learning device, the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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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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Page 2 -

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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 CORPORATION136 Turnpike RdSouthborough, 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 invarious widths and lengths with evenly distributed holesalong the length of the shaft. It is designed to snap ontoACMI telescopes for protection during storage andsterilization.
1. Intended Use	The Scope Guard protective sheath is intended for useduring the transport, storage and sterilization of certainACMI scopes for protection of these delicate instruments. Itis not intended to be used alone for terminal sterilization butcan be used in conjunction with an approved sterilizationwrap to maintain sterility until the device is required for use.The ACMI scopes with Scope Guard can be wrapped, orplaced into an approved sterilization tray for sterilizationprocessing.
2. Technological Characteristics and Substantial Equivalence	The ACMI Scope Guard has been tested and compared tosimilar devices. The Scope Guard is substantially equivalentto 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.

Regulation Number and Section

§ 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.