The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.

Device Description

The CAD 12 is an endoscopic accessory device configured as an overtube to aid insertion and advancement of an endoscope. The CAD 12 utilizes a rotating membrane tube to advance the endoscope in the lower GI tract. The rotating membrane tube is driven by two mechanical rotating drive wires.

AI/ML Overview

The provided document does not contain details about specific acceptance criteria, study design, or performance metrics in a structured way that would allow for the filling of the requested table and detailed description. The document states:

"An extensive collection of tests has been conducted and successfully completed, including functional performance, safety, biocompatibility and sterility testing. All testing indicates that CAD 12 meets its specification requirements."

However, it does not elaborate on what those "specification requirements" or "acceptance criteria" are, nor does it provide performance data, sample sizes, ground truth establishment methods, or details about expert involvement in a study. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study report against pre-defined acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not specified in the document.
Reported Device Performance: Not specified in terms of quantitative metrics or individual test results. The document only states "All testing indicates that CAD 12 meets its specification requirements."

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
Not specified	Not specified
Not specified	Not specified

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
The document only mentions "extensive collection of tests" including "functional performance, safety, biocompatibility and sterility testing," but no details on study participants, data sources, or cohorts.

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

Not specified. The document does not describe any study involving experts to establish a "ground truth" for colonoscopy assistance device performance.

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

Not specified. Without a study involving ground truth establishment by multiple experts, an adjudication method is not applicable or mentioned.

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 MRMC or comparative effectiveness study involving human readers with/without AI assistance is mentioned. The device is a mechanical "Colonoscopy Assist Device" (overtube with rotating membrane), not an AI diagnostic tool.

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

The device is a physical, mechanical endoscopic accessory, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable.

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

Not applicable as no specific "ground truth" for a performance study is described. The "testing" mentioned refers to functional, safety, biocompatibility, and sterility tests against internal specifications, not clinical outcomes or expert consensus for diagnostic accuracy.

8. The sample size for the training set:

Not applicable. The device is a mechanical overtube, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. (See #8)

Summary

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

K092156

Pg 1 of 2

SECTION 3. 510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for CAD 12.

SUBMITTER'S NAME:	SoftScope Medical Technologies, Inc.
ADDRESS:	6110 Blue Circle Drive, Suite 220Minnetonka, MN 55343
CONTACT PERSON:	Bernard (Bud) Horwath
TELEPHONE NUMBER:	651-481-9734
FAX NUMBER:	952-564-3914
DATE OF SUBMISSION:	July 15, 2009

OCT 1 4 2009

Identification of device 1.

Proprietary Name: CAD 12, Colonoscopy Assist Device Common Name: Overtube, Endoscopy Assist Device Classification Status: Class II per regulations 876.1500 Product Codes: KOG

2. Equivalent devices

SoftScope Medical believes that CAD 12 is substantially equivalent to the following predicate devices:

Intended Use and Device Design:

Spirus Medical Endo-Ease Overtube, K052084 �
Fujinon EC-450 Double Balloon Overtube, K090116 g

Rotating Drive Mechanism:

Boston Scientific Sonicath Ultrasonic Catheter, K970049/K060947 ♥
Olympus Ultrasonic Transducer, K982610/K063683 .

3. Description of the Device

4. Intended use

The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.

SoftScope Medical Technologies, Inc. CAD 12 510k

Confidential

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

K092156
pg 2 of 2

Technological characteristics, comparison to predicate device. ડ.

Like the Overtube predicate devices, CAD 12 has the same intended use and basic design intent. The CAD 12 is an overtube design, which is placed over the endoscope to aid in its insertion and advancement via a propulsion assist mechanism.

The CAD 12 propulsion drive cable is similar to the shaft of the Ultrasonic transducer predicates, using a mechanical rotating drive wire within a catheter sheath.

Discussion of performance testing. 6.

An extensive collection of tests has been conducted and successfully completed, including functional performance, safety, biocompatibility and sterility testing. All testing indicates that CAD 12 meets its specification requirements.

7. Conclusion

Based on extensive performance testing and a comparison to the predicate devices, it is the conclusion of SoftScope Medical that CAD 12 is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

SoftScope Medical Technologies, Inc. CAD 12 510k

Confidential

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

Image /page/2/Picture/0 description: The image shows the logo and text for the Department of Health & Human Services. The logo is on the left side of the text. The text is in all caps and is black.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SoftScope Medical Technologies, Inc. % Mr. Bernard Horwath Consultant Horwath Resource Group 4486 Timberline Court VADNAIS MN 55127

OCT 1 4 2009

Re: K092156

Trade/Device Name: CAD 12 Colonoscopy Assist Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: July 15, 2009 Received: July 16, 2009

Dear Mr. Horwath:

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. Iisting 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

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

Page 2 -

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 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/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,

Janine M. Morris

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

Enclosure

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

SECTION 2. INDICATIONS for USE STATEMENT

510(k) Number_K092156

Device Name: CAD 12

Indications for Use:

The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109).

Over the Counter Use (Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number,

SoftScope Medical Technologies, Inc. CAD 12 510k

Confidential

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.