The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are intended for the examination/operation of the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Description

Like the predicate ACMI® MR-Series Ureteroscopes, the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are semi-rigid endoscopes with two working channels. Flexible accessories such as stone baskets, retrievers, forceps, electrohydraulic lithotripter probes and laser fibers may be used through either working channel. The main component parts of each device include: The metal shaft, Two working channels, An eyepiece, Optical imaging fibers, Light guide connector post, A distal lens, Light carrier fibers. This Special 510(k) proposes the addition of autoclaving processes as a sterilization method, a change in shaft material from stainless steel to MP35N alloy, as well as a change in the manufacturing process to allow the shaft to be hermetically sealed using a micro-TIG and laser welding process in place of epoxy seals.

AI/ML Overview

The provided text describes a Special 510(k) Notification for the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes, focusing on modifications to an existing predicate device. This submission primarily addresses changes in sterilization method and material, not performance studies as typically seen with AI/ML devices. Therefore, a direct response to many of your questions regarding acceptance criteria and performance studies in the context of AI/ML evaluation cannot be fully provided by the given text.

However, I can extract information related to the device and the nature of this 510(k) submission, and explain why certain aspects of your request are not applicable based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document is a 510(k) Summary of Safety and Effectiveness for modifications to an existing device, not a new device requiring extensive performance studies with specific acceptance criteria in the way an AI/ML diagnostic device would. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device despite the proposed changes.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as per submission)
Material Compatibility/Safety: Ensuring the new shaft material (MP35N alloy) is safe and performs comparably to stainless steel.	Substantially equivalent to predicate device. Implies that the safety and performance of the new material for the intended use are acceptable and do not raise new questions of safety or effectiveness.
Sterilization Efficacy: Validating that autoclaving effectively sterilizes the device without compromising its integrity or function.	The proposed addition of autoclaving as a recommended sterilization process is stated as "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies validation of the autoclaving process for the device.
Mechanical Integrity/Durability: Confirming that the new hermetic sealing process (micro-TIG and laser welding) is robust and durable.	The change in manufacturing process to hermetically seal the shaft in place of epoxy seals is similarly categorized as "not significant changes or modifications" to safety or efficacy.
Functional Equivalence: Maintaining the same or essentially the same indications for use, principles of operation, overall length, working channel length, and working channel inner diameters.	"The indications for use, principles of operation, overall length, working channel length and working channel inner diameters of the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes remain the same or essentially the same as the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The submission focuses on modifications to an existing device (sterilization method and material change), rather than clinical performance testing in a "test set" as would be done for a diagnostic or prognostic AI/ML device. The "data provenance" would likely refer to engineering and biocompatibility testing, but specific details are not outlined here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. There is no mention of a "ground truth" derived from expert consensus for clinical image interpretation, as this is a physical medical device modification.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above.

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

This information is not applicable and not provided as this is a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided as this is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" in this context would implicitly be engineering specifications, material science data, and sterilization validation results demonstrating that the modified device meets design requirements and remains safe and effective for its intended use, comparable to the predicate device. This is not explicitly detailed in the provided 510(k) summary, as the summary focuses on the conclusion of substantial equivalence rather than the raw data.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train AI/ML models, which is not relevant to this type of device modification submission.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided for the same reasons as #8.

Summary

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ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes ACMI Corporation Turnpike Road AUG 1 6 2005 uthborough, MA 01772

Special 510(k) Notification Summary of Safety and July 26, 2005

510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes

General Information

Manufacturer:

K052044
pg 1 of 2

ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104

Establishment Registration Number:

Contact Person:

Director, Regulatory Affairs

Endoscope and accessories

(21 CFR 876.1500), Class II Gastroenterology/Urology Panel

Endoscope and accessories

ACMI® MR-6A/MR-6LA Autoclavable

Terrence E. Sullivan

2020483

July 26, 2005

Date Prepared:

Device Description

Classification Name:

Trade Name:

Generic/Common Name:

Predicate Device

ACMI® MR-Series Ureteroscopes

K011849

Ureteroscopes

Intended Uses

The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes (MR-6A) are intended for The examination/operation of the urinary tract, and using additional accessories, to the claimmation operation of the exapentic procedures. These devices are marketed as perform various diagnostic and mering, disinfecting and sterilization are included in reusable devices, member for creaming, excition 7.0, "Cleaning, Disinfection, and Sterilization".

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Special 510(k) Notification Summary of Safety and Effectiveness July 26, 2005

Product Description

K052044
py r of 2

The main component parts of each device include:

The metal shaft 1.
1. Two working channels
An evepiece 3.
1. Optical imaging fibers
Light guide connector post 5.
A distal lens 6.
1. Light carrier fibers

This Special 510(k) proposes the addition of autoclaving processes as a sterilization method, a change in shaft material from stainless steel to MP35N alloy, as well as a change in the manufacturing process to allow the shaft to be hermetically sealed using a micro-TIG and laser welding process in place of epoxy seals. The indications for use, principles of operation, overall length, working channel length and working channel inner diameters of the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes remain the same or essentially the same as the predicate device.

Summary of Safety and Effectiveness

The proposed modifications for the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes, as described in this submission, are substantially equivalent to the predicate device. The proposed addition of autoclaving as a recommended sterilization process and change in shaft modification in design specifications, performance specifications, and dimensional specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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Image /page/2/Picture/2 description: The image shows a black and white logo. The logo features a stylized bird with three lines representing its wings or feathers. The bird is facing to the right. There is some text in a circular arrangement to the left of the bird, but the text is not legible.

AUG 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terrence E. Sullivan Director, Regulatory Affairs ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772

Re: K052044

Trade/Device Name: ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: July 26, 2005 Received: July 28, 2005

Dear Mr. Sullivan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes

510(k) Number: K 052044

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: __ X ___

OR Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

. 1

Nancy C brogdon
(Division Sign-Off)

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

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.