The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Device Description

The ACMI® DUR®- Digital Ureteroscope and Choledochoscope (DUR®-D) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semiconductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.

The DUR®-Digital Ureteroscope and Choledochoscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The DUR®- Digital Ureteroscope and Choledochoscope may also be used to manage biliary calculi in a choledochoscope indication. The DUR®-D System uses a Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

AI/ML Overview

The provided text describes the ACMI® DUR-Digital Ureteroscope and Choledochoscope System. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes, expert qualifications, or quantitative performance metrics typically found in a clinical study or even a rigorous design verification and validation report for a complex medical device.

The information primarily focuses on demonstrating substantial equivalence to predicate devices for 510(k) clearance, rather than a standalone performance study with defined acceptance criteria and statistical proof.

Here's an analysis based on the provided text, highlighting what is and is not available:

Acceptance Criteria and Device Performance (Based on Provided Text)

The document states that the new device met performance requirements by demonstrating comparable performance to predicate devices. It does not define explicit, quantitative acceptance criteria in this summary.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Performance comparable to ACMI® DUR®-8E (physical characteristics)	"Testing demonstrated that the performance requirements were met, and that the DUR®-D exhibited comparable performance characteristics to... the predicate DUR®-8E."
Performance comparable to Invisio™ ICN (digital visualization)	"Testing demonstrated that the performance requirements were met, and that the DUR®-D exhibited comparable performance characteristics to... the predicate Invisio™ ICN."

Study Details and Missing Information:

Here's a breakdown of the requested information, indicating what is present and what is absent from the summary:

A table of acceptance criteria and the reported device performance
- Availability: Partially available (implied criteria, general statement of performance). No specific quantitative criteria are provided.
- Details: The "acceptance criteria" are implied to be "performance characteristics comparable to predicate devices." The "reported device performance" is a general statement that these characteristics were met or exhibited.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Availability: Not available.
- Details: The document refers to "design verification" and "testing" but does not specify the sample size of devices tested or the data provenance. It's likely these were internal engineering tests rather than a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Availability: Not available.
- Details: No information is provided about experts, ground truth establishment, or any form of expert review for testing. This type of submission focuses on technical equivalence rather than clinical performance evaluated by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Availability: Not available.
- Details: No adjudication method is mentioned, as there's no reported expert-based evaluation.
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
- Availability: Not available.
- Details: No MRMC study was mentioned. This device is an endoscope system (a direct visualization tool), not an AI-powered diagnostic or assistive tool, so such a study would not be applicable or expected for this type of 510(k) submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Availability: Not applicable/Not available.
- Details: This device is a manual medical imaging instrument (endoscope) used by a medical professional, not an algorithm, so a standalone algorithm performance study is irrelevant. The comparison focused on the technical performance of the device itself (e.g., image quality, physical dimensions) against predicate devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Availability: Not available.
- Details: Since the "testing" focused on comparing physical and visualization characteristics against predicate devices, the "ground truth" would likely be the established performance specifications or measured characteristics of those predicate devices, rather than clinical ground truth (like pathology or outcomes) for this type of submission. The summary does not elaborate on how this was established.
The sample size for the training set
- Availability: Not applicable/Not available.
- Details: This device is a hardware system, not a machine learning algorithm. Therefore, there is no "training set" in the AI sense.
How the ground truth for the training set was established
- Availability: Not applicable/Not available.
- Details: As there is no training set, this question is not relevant.

Summary of the Study:

The "study" described is a design verification and validation process conducted internally by the manufacturer (ACMI Corporation). Its purpose was to demonstrate substantial equivalence to already legally marketed predicate devices, the ACMI® DUR®-8E (for flexible endoscope technology, physical characteristics, and indications for use) and the ACMI® Invisio™ ICN System (for basic video imaging technology).

The core of the study involved:

Comparing the physical performance characteristics of the ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) against the predicate DUR®-8E.
Comparing the digital visualization characteristics of the DUR®-D against the predicate Invisio™ ICN.

The conclusion was that the new device met its performance requirements and exhibited comparable performance characteristics to both predicate devices, thus presenting "no new questions of safety or efficacy." This type of demonstration is standard for a Traditional 510(k) submission, where the focus is on showing similarity to existing products rather than proving novel clinical effectiveness through large-scale trials.

Summary

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ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road MAR 3 1 2006 Southborough, MA 01772

Traditional 510(k) Notification 510(k) Summary January 30, 2006

510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® DUR-Digital Ureteroscope and Choledochoscope S

General Information

Manufacturer:	ACMI Corporation136 Turnpike Rd.Southborough, MA 01772-2104
Contact Person:	Terrence E. SullivanDirector, Regulatory AffairsTel. #: 508-804-2739Fax #: 508-804-2624
Date Prepared:	January 30, 2006
Device Description
Classification Name:	Endoscope and accessories(21 CFR 876.1500), Class IISurgical camera and accessories(21 CFR 878.4160), Class I
Trade Name:	ACMI® DUR-Digital Ureteroscope andCholedochoscope System (DUR®-D)
Generic/Common Name:	Endoscope, Video Camera and accessories
Predicate Devices
ACMI® Invisio™ ICNACMI DUR®-8E	K042225 K012925 and K023358

Intended Uses

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-1)) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

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ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Traditional 510(k) Notification 510(k) Summary January 30, 2006

K ci.0269 pg 2 of 3

The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Product Description

Technological Characteristics and Substantial Equivalence

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System, utilizes features incorporated into the following legally marketed predicate devices:

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System utilizes the same flexible endoscope technology design as those used in the predicate DUR®-8E device (K012925 and K023358).

The DUR®- Digital Ureteroscope and Choledochoscope is dimensionally similar to the predicate DUR®-8E, having the same working channel diameter and length, and utilizes the same materials in its construction as the predicate DUR®-8E.

The DUR®-Digital Ureteroscope and Choledochoscope incorporates the same basic video imaging technology located in the endoscope as the predicate ACMI® Invisio™ ICN System (K042225).

Like the predicate DUR®-8E, the ACMI® DUR®-Digital Ureteroscope and Choledochoscope (DUR®-D) System is indicated for use in therapeutic and diagnostic procedures in the entire intrarenal collecting system, and may also be used to manage biliary calculi.

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ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Traditional 510(k) Notification 510(k) Summary January 30, 2006

K060269 Pg 3 of 3

During design verification, the performance of the DUR®-D was compared against the physical performance characteristics of the predicate DUR®-8E and the digital visualization characteristics of the predicate Invisio™ ICN. Testing demonstrated that the performance requirements were met, and that the DUR®-D exhibited comparable performance characteristics to both the predicate DUR®-8E and predicate Invisio™ ICN.

In summary, the ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird is depicted with three curved lines representing its body and wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

MAR 3 1 2006

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: K060269

Trade/Device Name: ACMI® DUR-Digital Ureteroscope and Choledochoscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FBN and FGB Dated: January 30, 2006 Received: February 1, 2006

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 (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.

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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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Traditional 510(k) Notification Statement of Intended Use January 30, 2006

Device Name: ACMI® DUR-Digital Ureteroscope and Choledochoscope System

510(k) Number: K

Indications for use:

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System Flexible Ureteroscope includes the DUR-Digital Invisio™ and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

(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:

(Per 21 CFR 801.109)

David A. Lygum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 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.