(24 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on mechanical and software control for visualization and therapeutic access.
Yes
The device description states that it is designed for both diagnostic and therapeutic colonoscopy procedures, and the insertion tube is designed to accommodate biopsy tools and equipment to remove intestinal polyps and other therapeutic uses.
Yes
The "Device Description" explicitly states, "The ProtectiScope CS, Non-intrapull colonoscope is designed for use in both diagnostic and therapeutic colonoscopy procedures" and mentions "visualization of the colon."
No
The device description explicitly lists hardware components such as a system control unit, flexible insertion tube, control body, and umbilicus, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a colonoscope used for visualization and therapeutic access to the lower gastrointestinal tract. It is introduced rectally and provides video visualization of the colon.
- Lack of Sample Analysis: There is no mention of the device analyzing any samples taken from the patient's body. Its function is direct visualization and intervention within the body.
Therefore, the ProtectiScope CS, Non-intrapull colonoscope falls under the category of a medical device used for direct examination and intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
Product codes
78 FDF, 87 KOG
Device Description
The ProtectiScope CS, Non-intrapull colonoscope is a software controlled device intended for use to visualize the colon to the level of the cecum. The ProtectiScope CS, Non-intrapull colonoscope includes a system control unit, flexible insertion tube, control body, and umbilicus. The insertion tube features a disposable sleeve that is discarded after the colonoscopy procedure is completed.
The ProtectiScope CS, Non-intrapull colonoscope is designed for use in both diagnostic and therapeutic colonoscopy procedures. The insertion tube is designed to accommodate biopsy tools and equipment to remove intestinal polyps and other therapeutic uses.
The design change included in this submission is removal of the air assisted push technology feature of the device. The modified Protectiscope CS, Non-Intrapull device is manually advanced through the large bowel for visualization of the colon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The colon.
Indicated Patient Age Range
adult patient populations
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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MAY - 2 2008
K081004
Page 1 of 2
510(k) Summary of Safety and Effectiveness for the ProtectiScope CS, Non-intrapull Colonoscope
Proprietary Name:
Common Name:
Classification Name and Reference
Regulatory Class:
Device Product Code:
For Information contact:
ProtectiScope CS, Non-intrapull colonoscope
Colonoscope and accessories, flexible/rigid
Endoscope and accessories, 21 CFR §876.1500
Class II
78 FDF - colonoscope and accessories, flexible/rigid
87 KOG - endoscope and/or accessories
Tiffani Rogers Sr. Regulatory Affairs Specialist Stryker GI 1420 Lakeside Parkway #110 Flower Mound, Texas 75028 Phone: (972) 410-7313 Fax: (972) 410-7150 E-Mail: Tiffani.Rogers(@stryker.com
Date Summary Prepared:
April 3, 2008
Device Description
The ProtectiScope CS, Non-intrapull colonoscope is a software controlled device intended for use to visualize the colon to the level of the cecum. The ProtectiScope CS, Non-intrapull colonoscope includes a system control unit, flexible insertion tube, control body, and umbilicus. The insertion tube features a disposable sleeve that is discarded after the colonoscopy procedure is completed.
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K081004
Page 2 of 2
The ProtectiScope CS, Non-intrapull colonoscope is designed for use in both diagnostic and therapeutic colonoscopy procedures. The insertion tube is designed to accommodate biopsy tools and equipment to remove intestinal polyps and other therapeutic uses.
The design change included in this submission is removal of the air assisted push technology feature of the device. The modified Protectiscope CS, Non-Intrapull device is manually advanced through the large bowel for visualization of the colon.
Intended Use and Indications for Use:
Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
Substantial Equivalence:
The Protectiscope CS, non-intrapull device included in this submission is a modification to the to the ColonoSight 520B device cleared in K032688. The sole modification is the removal of the air assisted push technology feature of the device. The current design of the Protectiscope CS, non-intrapull device is manually advanced through the colon by the physician like standard colonoscopes. The determination of substantial equivalence is based on the similarities in intended use, design, and general performance to the predicate ColonoSight 520B cleared in K032688.
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2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 AMH
Ms. Tiffani D. Rogers Sr. Regulatory Affairs Specialist Stryker GI 1420 Lakeside Parkway #110 FLOWER MOUND TX 75028
Re: K081004
Trade/Device Name: Protectiscope CS Colonoscope, Non-Intrapull Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: April 3, 2008 Received: April 8, 2008
Dear Ms. Rogers:
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 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 vour 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/cdrh/industry/support/index.html.
Sincerely vours.
Nancy 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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Indications for Use
510(k) Number (if known): K081004
Device Name: Protectiscope CS Colonoscope, Non-intrapull
Indications
Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
Prescription Use
OR (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene Lewin
Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K0811