K092156 · Softscope Medical Technologies, Inc. · FED · Oct 14, 2009 · Gastroenterology, Urology
Device Facts
Record ID
K092156
Device Name
CAD 12, COLONOSCOPY ASSIST DEVICE
Applicant
Softscope Medical Technologies, Inc.
Product Code
FED · Gastroenterology, Urology
Decision Date
Oct 14, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
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.
Device Story
CAD 12 is an endoscopic accessory overtube designed to assist in the insertion and advancement of flexible endoscopes within the lower gastrointestinal tract. The device features a rotating membrane tube driven by two mechanical rotating drive wires. It is intended for use by clinicians during diagnostic and therapeutic procedures. By providing a propulsion assist mechanism, the device facilitates endoscope navigation, potentially reducing procedural difficulty. The device is a mechanical accessory and does not involve electronic processing or software-based analysis.
Clinical Evidence
Bench testing only. Testing included functional performance, safety, biocompatibility, and sterility assessments. No clinical data provided.
Technological Characteristics
Mechanical endoscopic overtube. Features a rotating membrane tube driven by two mechanical rotating drive wires within a catheter sheath. Non-electronic, non-software device. Sterilization and biocompatibility testing performed.
Indications for Use
Indicated for patients undergoing diagnostic or therapeutic lower gastrointestinal endoscopy requiring flexible endoscope insertion and advancement.
Regulatory Classification
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.
Special Controls
*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.
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K092156
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## 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 220<br>Minnetonka, 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
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.
#### 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
б
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K092156
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#### 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
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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
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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
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# 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).
OR
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
5
