The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® Smith™ Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.

Device Description

The Gyrus ACMI® IPN-2505. Invisio® Smith™ Percutaneous Nephroscope (referred to hereafter as the IPN-2505) is a rigid endoscope that incorporates CMOS (complimentary metal oxide semi-conductor) 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 IDC-1500 Camera Control Unit (CCU).

The IPN-2505 can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The IPN-2505 uses an IDC-1500 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

Here's an analysis of the provided text regarding the Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System:

Based on the provided 510(k) summary, there is no acceptance criteria or study information related to device performance in the traditional sense of metrics like sensitivity, specificity, accuracy, or any comparative effectiveness studies with human readers or standalone AI performance.

This document is a submission for a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on showing similar technological characteristics and intended uses, rather than extensive clinical performance studies that establish quantitative acceptance criteria or human-in-the-loop performance.

Therefore, many of the requested sections regarding acceptance criteria, study details, and AI-related metrics cannot be filled from the given text.

Here's a breakdown of what can be extracted or inferred from the provided text:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices, implying that performance is acceptable if it's similar to the predicates.	The device is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy. This implies functional equivalence in terms of visualization capabilities and procedural utility as the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. No specific test set or clinical study data is detailed in this 510(k) summary for performance evaluation. The submission relies on a comparison of technological characteristics and intended use to predicate devices.

3. 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)

Not applicable / Not provided. No test set requiring expert ground truth is described.

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

Not applicable / Not provided. No test set requiring adjudication is described.

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

No, an MRMC comparative effectiveness study was not done. This device is a percutaneous nephroscope system, which is a physical instrument for direct visualization, not an AI-assisted diagnostic or imaging interpretation tool.

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

No, a standalone performance study was not done. This device is an endoscope, not an AI algorithm.

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

Not applicable / Not provided. The substantial equivalence claim is based on technological characteristics and intended use alignment with predicate devices, not on a ground truth derived from clinical data in a performance study.

8. The sample size for the training set

Not applicable / Not provided. This device is a physical medical instrument, not an AI system that requires a training set.

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

Not applicable / Not provided. As above, this device does not utilize a training set or ground truth in the context of AI.

Summary of Approach in the 510(k) Filing:

The approach taken in this 510(k) filing is to demonstrate substantial equivalence to existing, legally marketed predicate devices. This is achieved by showing:

Similar Intended Use: The IPN-2505 system's intended use for "close visualization of the urinary bladder, renal pelvis and major calyces" and its introduction methods (percutaneous tract, urethra) are compared to the predicates.
Similar Technological Characteristics: The filing highlights that the IPN-2505 incorporates:
- The same basic CMOS video imaging technology as the ACMI® DUR-Digital Ureteroscope and Choledochoscope System (K060269).
- Dimensional similarity (working channel diameter, similar lengths and diameters) to the ACMI® MRO-20 Rigid Percutaneous Nephroscope (K791182).
- Similar construction materials as the MRO-20 (K791182) and the MR-6A/MR-6LA Autoclavable Ureteroscope (K052044).
No New Questions of Safety or Efficacy: The conclusion states that because of these similarities, the device "presents no new questions of safety or efficacy."

This type of submission does not typically include detailed performance data or clinical study results as would be expected for novel devices or those utilizing AI/ML.

Summary

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07259 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System

General Information

DEC 1. 3 2007

Manufacturer:	Gyrus ACMI, Inc.
	136 Turnpike Rd.
	Southborough, MA 01772-2104
Contact Person:	Graham A.L. Baillie
	Senior Regulatory Specialist
	Tel. #: 508-804-2738
	Fax #: 508-804-2624
Date Prepared:	September 10, 2007
Device Description
Classification Name:	Endoscope and accessories
	(21 CFR 876.1500), Class II
	Surgical camera and accessories
	(21 CFR 878.4160), Class I
Trade Name:	Gyrus ACMI® IPN-2505, Invisio®
	Smith™ Percutaneous Nephroscope
	System
Generic/Common Name:	Endoscope, Video Camera and accessories
Predicate Devices
ACMI® DUR-Digital Ureteroscope and Choledochoscope System	K060269
ACMI® MROTM -20 Rigid Percutaneous Nephroscopes	K791182
ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes	K052044

Intended Uses

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Traditional 510(k) Notification 0(k) Summarv

K072594 Pg A22

the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.

Product Description

Technological Characteristics and Substantial Equivalence

The IPN-2505, utilizes features incorporated into the following legally marketed predicate devices:

The IPN-2505 incorporates the same basic CMOS video imaging technology located in the endoscope as the predicate ACMI® DUR-Digital Ureteroscope and Choledochoscope System (K060269).

The IPN-2505 shaft is dimensionally similar to its predicate ACMI® MRO-20 Rigid Percutaneous Nephroscope (K791182), having the same working channel diameter, similar lengths and diameters. The IPN-2505 utilizes similar materials in its construction as the predicate MRO-20 (K791182) and the predicate MR-6A/MR-6LA Autoclavable Ureteroscope (K052044).

Like the predicate MRO-20 the IPN-2505 is indicated to allow close visualization of the renal pelvis and major calyces through a percutaneous tract.

In summary, the Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2007

Mr. Graham A.L. Baillie Sr. Regulatory Specialist Gyrus ACMI, Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772-2104

K072594 Re:

Trade/Device Name: Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System

Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FGA, FEC and FED Dated: September 12, 2007 Received: September 14, 2007

Dear Mr. Baille:

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 (PMA). 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.

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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.

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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

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: Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System

510(k) Number: Ko72594

Intended 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)

Lom Mwhan
(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.