the Mitaka UniARM-device is for use in holding medical devices in surgery such as neuro endoscopes, general endoscopes, and hand held instruments. It is a balanced device using pneumatic brakes that can be released from a single switch near the endoscope or hand held instrument. Often referred to as a third arm it provides a stable platform to hold an endoscope or hand held instrument allowing the surgeon the use of his two arms. The system can be released by the push of one button and fixes with the release of that button. A second button is depressed by the palm as a safety device.

AI/ML Overview

The provided document describes the Mitaka UniARM, an endoscope holder. The study details are limited to a performance comparison with predicate devices and a non-clinical test of brake holding power. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific numerical thresholds for performance. Instead, it compares the UniARM's functionalities to predicate devices and describes a non-clinical test.

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Balance	Effectively balances both endoscope and holding arm	"Arm balances both endoscope and holding arm perfectly" (compared to "Adjustable Spring" for Kroner and "Arm is balanced but surgeon holds weight of endoscope system" for Mitaka Point Setter)
Power Source	Uses a power source suitable for its function	"All Pneumatic" (same as Mitaka Point Setter; Kroner is "Electric & Pneumatic")
Attachment Method	Securely positions the device within the OR	"Sits on rollable Base" (compared to "OR table rail" for both Kroner and Mitaka Point Setter)
Holds	Capable of holding endoscopes and hand instruments	"Endoscopes and hand instruments" (same as both predicate devices)
Brake Holding Power (Non-clinical)	Brake holding power is sufficient and comparable to predicate	Tested using a force gauge; "The same force measurement system is used on the Point Setter." (Implies comparable or superior performance, though no specific values are given.)
Clinical Performance (In-patient use)	Safe and effective in actual surgical settings	"The system has been tested in operating rooms with patients for over one year in Japan where it is manufactured." (No specific metrics provided beyond this statement.)
Overall Equivalence	Substantially equivalent to predicate devices with improvements	"Clinical, performance, and non-clinical validation compared to Kroner-Wingman and Mitaka Point Setter show that the devices are substantially equivalent to the UniARM. The UniARM merely offers improvements in reach, holding power, and convenience."

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

Sample Size: The document does not specify a numerical sample size for either the non-clinical or clinical tests.
Data Provenance:
- Non-clinical: Performed by Mitaka Kohki Co., Ltd. (manufacturer) – implied to be in Japan.
- Clinical: Japan, retrospective (implied, as it states "has been tested for over one year").

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

This information is not provided in the document. The clinical testing mentioned ("tested in operating rooms with patients") suggests evaluation by surgeons, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The evaluation focuses on the device's functional equivalence and improvements over predicate devices, not on the improvement of human reader performance with or without AI assistance.

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

This relates to AI/software performance. The Mitaka UniARM is a mechanical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

For the non-clinical brake holding power test: The "ground truth" was established by force gauge measurements against the device's own internal design specifications and comparison to the predicate device's measured performance.
For clinical performance: The "ground truth" was implicitly based on surgeon experience and patient outcomes during the one year of use in Japan, though no specific metrics or 'truth' establishment method is detailed beyond general positive clinical use.

8. The Sample Size for the Training Set

This information is not applicable. The UniARM is a mechanical device, not an AI model that requires a training set.

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

This information is not applicable for the same reason as above (mechanical device, no training set).

Summary

{0}------------------------------------------------

Mitaka Kohki Co., Ltd.

Agent: Mitaka USA, Inc. 2337 Lucky John Drive Park City, Utah 84060

JUL - 6 2009

Telephone: 888-244-6173 Fax: 435-608-6397 Email: maxsturgis@q.com

Section 5. 510(k) Summary

Date Prepared:

March 20, 2009

Contact Person:

Max Sturgis, President Mitaka USA, Inc. 2337 Lucky John Drive Park City, UT 84060 (435) 649-2236 maxsturgis@g.com

Trade Name:

Common Name:

Endoscope Holder

UniARM

Classification Name:

Endoscope and/or Accessories Device Class 2 Regulation Number: 876.1500 & 882.1480 Product Classification GWG Additional Product Classification KOG, & GCJ

1. The legally marketed devices to which Mitaka Kohki is claiming equivalence;

Mitaka Point Setter - K984355 Endoscope holder, K991989 Neuro Dia and clinical use Kroner - Wingman Scope Holder - K000663 General Surgery, K973543 General Surgery

2. Description of the Mitaka UniARM:

Summary: the Mitaka UniARM-device is for use in holding medical devices in surgery such as neuro endoscopes, general endoscopes, and hand held instruments. It is a balanced device using pneumatic brakes that can be released from a single switch near the endoscope or hand held instrument. Often referred to as a third arm it provides a stable platform to hold an endoscope or hand held instrument allowing the surgeon the use of his two arms. The system can be released by the push of one button and fixes with the release of that button. A second button is depressed by the palm as a safety device.

A. Design configuration:

Brakes Uses fail safe clutches which when activated by Nitrogen pressure from operating a. room source allow the clutches to turn freely. When the nitrogen pressure is released by surgeon controlled button the pressure escapes and the clutches hold tight.
ت Mechanics - The UniARM uses a system of counterweights that allow the surgeon to balance the weight of an endoscope or instrument. This gounter balancing allows greater ease and precision in repositioning the endoscope or instrument.

5-1

{1}------------------------------------------------

Base The system is mounted to a base with four wheels so it can be positioned at the side of ﻦ patient. Base brakes hold the base securely. The base has mounted an elevating unit to allow arm to be raised and lowered for optimal positioning.
K090792

Image /page/1/Figure/1 description: The image shows a UniARM device with labels pointing to different parts. The labels include: 1. Hand grip, 2. Endoscope Holder, 3. Elevating column handle, 4. Base, 5. Base brakes, and 6. Counterweight. The UniARM device has a long arm extending from a central column, which is mounted on a wheeled base.

Intended use: The UniARM is for use in holding medical devices in surgery such as neuro endoscopes, general endoscopes, and hand held instruments.
Technological characteristics compared to the Mitaka Point Setter – K984355 and the Kroner Scope Holder - K000663 (Distributed by Stryker under "Wingman" name).

Both the Mitaka Point Setter (manufactured by Mitaka Kohki Co.) and the Kroner scope holder are used to hold endoscopes and other hand held instrumentation. Both perform the same third hand function. Below see table with device comparison and below that see photos of Mitaka Point Setter and Kroner - Wingman scope holder.

Function	Kroner - Wingman	Mitaka Point Setter	Mitaka UniARM
Balance	Adjustable Spring	Arm is balanced butsurgeon holds weight ofendoscope system.	Arm balances bothendoscope and holdingarm perfectly
Power source	Electric & Pneumatic	All pneumatic	All Pneumatic
Attaches to:	OR table rail	OR table rail	Sits on roll able Base
Holds	Endoscopes and handinstruments	Endoscopes and handinstruments	Endoscopes and handinstruments

{2}------------------------------------------------

p. 3 of 4 16090792

and the comments of the comments of

Kroner Wingman distributed by Stryker

Image /page/2/Picture/2 description: The image shows a medical device, possibly a surgical tool holder, against a dark background. The device features a series of adjustable arms and clamps, with a prominent "Stryker" logo visible on one of the components. The device appears to be made of metal and plastic, with a combination of cylindrical and rectangular shapes. The overall impression is of a precision instrument designed for use in a medical setting.

Mitaka Point Setter

Image /page/2/Picture/4 description: The image shows a piece of machinery with the word "Mitaka" on the side. The machine has a black base with a white top. There are various metal components attached to the top of the machine. A cord is plugged into the machine on the left side.

{3}------------------------------------------------

Non-clinical performance data: The system goes through a test procedure using a force gauge to test all 5. brake holding power. The same force measurement system is used on the Point Setter. See section 18.
Clinical Performance: The system has been tested in operating rooms with patients for over one Q: year in Japan where it is manufactured.
Conclusion: Clinical, performance, and non-clinical validation compared to Kroner-Wingman and Mitaka 7. Point Setter show that the devices are substantially equivalent to the UniARM . The UniARM merely offers . improvements in reach, holding power, and convenience.

5-4

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2009

Mitaka Kohki Co., Ltd. % Mitaka USA, Inc. Mr. Maxwell Sturgis President 2337 Lucky John Drive Park City, Utah 84060

Re: K090792

Trade/Device Name: UniARM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, GWG Dated: June 2, 2009 Received: June 3, 2009

Dear Mr. Sturgis:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{5}------------------------------------------------

Page 2 - Mr. Maxwell Sturgis

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ely yours,

N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Revised Indications for Use

510(k) Number (if known):

Device Name: UniARM

Indications for Use: The UniARM is for use in holding medical devices such as endoscopes and retractors in surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

nike

Page 1 of

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090792

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.