(30 days)
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No
The summary describes a standard video sigmoidoscope with channels for procedures, and there is no mention of AI, ML, image processing, or any related concepts.
Yes
The device explicitly states its intended use is to provide "therapeutic access" for "surgical procedures," indicating it has a therapeutic function beyond just visualization.
Yes
The device is described as providing "optical visualization" of the rectal cavity, which is a method of observation and examination used for diagnostic purposes. While it also offers therapeutic access, visualization is a key component of diagnosis.
No
The intended use and device description clearly describe a physical instrument (video sigmoidoscope) with channels for insufflation, irrigation, and surgical procedures, indicating it is a hardware device.
Based on the provided information, the RectoSight® RS300-04 and ProctoSight® PS310-04 devices are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that the devices are for optical visualization of, and therapeutic access to the rectal cavity. This involves directly examining a part of the body and performing procedures within it.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Function: The description of the devices as video sigmoidoscopes with channels for insufflation, irrigation, and surgical procedures aligns with a device used for direct examination and intervention within the body, not for analyzing samples.
Therefore, these devices fall under the category of medical devices used for direct examination and procedures within the body, not IVDs.
N/A
Intended Use / Indications for Use
The RectoSight® RS300-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures. The ProctoSight® PS310-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
Product codes
78 FER, 78 GCF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
rectal cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle with three lines extending from its head, resembling feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2001
Ms. Simcha Edell Clinical Trials Manager SightLine Technologies Ltd. Advanced Technology Center MATAM, Haifa, 31905 ISRAEL
Re: K011825 RectoSight® RS300-04 and ProctoSight® PS310-04 Dated: May 9, 2001 Received: June 11, 2001 Regulatory Class: II 21 CFR §876.1500/Procodes: 78 FER and GCF
Dear Ms. Edell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
i f your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantialin assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmadsmamain.html".
Sincerely yours.
Nancy C Brogdon
rogdon Nancy C. Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
1
Image /page/1/Picture/0 description: The image shows the word "sightline" in a stylized font. The letters are black and bold, with the "l" in "line" being taller and more curved than the other letters. The word appears to be a logo or brand name.
Advanced Technology Center, MATAM, Haifa 31905, Israel Tel. +972-4-855-0447, Fax. +972-4-855-0164 E-mail: trials(asightline.co.il Internet: www.sightline.co.il
Indications for Use Statement
K o ii 825
Page 1 of 1
510(k) Number (if known):
Device Name: RectoSight® RS300-04 and
ProctoSight® PS310-04
Indications for use: The RectoSight® RS300-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
The ProctoSight® PS310-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Yancey Brogdon
Sign-Off
Division of Reproductive, Abdominal, ENT
and Radiological Devices
510(k) Number K011825
.