(90 days)
Not Found
No
The device description and lack of mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms indicate a purely mechanical device.
No.
The device acts as an aid for endoscope insertion and advancement, which is a procedural aid rather than a direct therapeutic intervention on the patient's condition.
No
The device description states it is an "endoscopic accessory device configured as an overtube to aid insertion and advancement of an endoscope" during diagnostic and therapeutic procedures. Its function is mechanical assistance for scope advancement, not diagnostic assessment itself.
No
The device description explicitly states it is an "endoscopic accessory device configured as an overtube" and utilizes "mechanical rotating drive wires," indicating it is a hardware device with mechanical components, not software-only.
Based on the provided information, the CAD 12 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used with a flexible endoscope to aid in insertion and advancement during lower gastrointestinal endoscopy. This is a procedural aid, not a device that performs tests on biological samples in vitro (outside the body).
- Device Description: The description details a mechanical device (overtube with a rotating membrane) designed to facilitate the physical movement of an endoscope within the body. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, urine, or any other biological sample. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
Therefore, the CAD 12 is a medical device used in vivo (within the body) to assist in an endoscopic procedure, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KOG, FED
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052084, K090116, K970049, K060947, K982610, K063683
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 |
| 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:
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
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
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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
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).
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