(161 days)
KNT
Not Found
No
The device description details a purely mechanical system based on pressure and fluid dynamics, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is described as an "accessory" that provides a "visual monitor of proper functioning of the tube" and "indicates proper functioning of the dual lumen tube", rather than directly treating or diagnosing a medical condition in a patient.
No
The device is described as an "Operation Indicator" that visually monitors the "proper functioning of the tube during medical use" by indicating air flow. It does not diagnose a medical condition or disease in a patient, but rather the performance of another medical device.
No
The device description clearly describes a physical chamber filled with sterile water and a capillary vent, indicating it is a hardware device, not software-only.
Based on the provided information, the SightSure® Operation Indicator 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.
- SightSure® Function: The SightSure® Operation Indicator works by visually monitoring the proper functioning of a medical tube (a dual lumen gastrointestinal sump tube) by observing air bubbles in a water-filled chamber. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to monitor the mechanical function of a medical device, not to diagnose or detect a condition in the patient.
Therefore, the SightSure® Operation Indicator falls under the category of a medical device accessory that aids in the proper operation of another medical device, rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The SightSure® Operation Indicator is indicated for use as an accessory to a dual lumen gastrointestinal sump tube with an air vent lumen which allows for a visual monitor of proper functioning of the tube during medical use.
Product codes
KNT
Device Description
The device is characterized by a chamber that is filled with sterile water prior to use. Negative pressure provided by a functioning dual lumen medical tube vent lumen is applied to the chamber through a tube linking the vent (sump) lumen to the sealed chamber. Atmospheric equilibration of the chamber is provided through a capillary vent that has its distal end in the liquid media. Equilibration of the chamber results in flow of atmospheric air into the capillary tube and subsequent egress of bubbles in the liquid media of the device indicates proper functioning of the dual lumen tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nasal Flowmeter, Thrope Tube Flowmeter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Summary of Safety and Effectiveness 11.0
MAR 1 5 2000
| Submitter Name and Address: | MEDevices, Inc.
1840 Industrial Drive, Suite 210
Libertyville, Illinois 60048 |
|--------------------------------------|-------------------------------------------------------------------------------------|
| Contact Person:
Telephone Number: | Michele H. Vovolka
847-856-0355 |
| Date Summary Prepared: | October 3, 1999 |
| Proprietary Name: | SightSure Operation Indicator |
| Common Name: | Dual Lumen Tube Operation Indicator |
| Classification Name: | Gastrointestinal Tube and Accessories |
| Device Classification: | Class II per 21 CFR 876.5980 |
| Panel Code: | 78 |
| Procodes: | KNT |
| Predicate Devices: | Nasal Flowmeter
Thrope Tube Flowmeter |
Product Design:
The device is characterized by a chamber that is filled with sterile water prior to use. Negative pressure provided by a functioning dual lumen medical tube vent lumen is applied to the chamber through a tube linking the vent (sump) lumen to the sealed chamber. Atmospheric equilibration of the chamber is provided through a capillary vent that has its distal end in the liquid media. Equilibration of the chamber results in flow of atmospheric air into the capillary tube and subsequent egress of bubbles in the liquid media of the device indicates proper functioning of the dual lumen tube.
Intended Uses/Indications:
The SightSure® Operation Indicator is indicated for use as an accessory to a dual lumen gastrointestinal sump tube with an air vent lumen which allows for a visual monitor of proper functioning of the tube during medical use.
1
Physical/ Mechanical Specifications:
The device is characterized by a chamber that is filled with sterile water prior to use. Negative pressure provided by a functioning dual lumen medical tube vent lumen is applied to the chamber through a tube linking the vent (sump) lumen to the sealed chamber. Atmospheric equilibration of the chamber is provided through a capillary vent that has its distal end in the liquid media. Equilibration of the chamber results in flow of atmospheric air into the capillary tube and subsequent egress of bubbles in the liquid media of the device indicates proper functioning of the dual lumen tube.
Biological Specifications:
This SightSure Operation Indicator is non-patient contact and does not require testing per ISO 10993.
Materials:
The product is manufactured with components primarily made of styrene and vinyl.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, facing left. The eagle is enclosed in a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2000
MEDevices, Inc. c/o Ms. Michele H. Vovolka President Vantage Consulting International, Ltd. P.O. Box 848 Grayslake, IL 60030
Re: K993358 SightSure Operation Indicator - for use with a dual lumen gastrointestinal sump tube Dated: January 21, 2000 Received: January 24, 2000 Requlatory Class: II 21 CFR §876.5980/Procode: 78 KNT
Dear Ms. Vovolka:
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 reclassfied 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (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 substantially equivalion 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 requlation may result in requlatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication 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 viteg diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel C. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
510(k) Number (if known): K993358
SightSure Operation Indicator Device Name:
Indications For Use:
The SightSure® Operation Indicator is indicated for use as an accessory to a dual lumen gastrointestinal sump tube with an air vent lumen which allows for a visual monitor of proper functioning of the tube during medical use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE !F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over -The-Counter Use | ||
|---|---|---|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K993358 |
|---|---|
| --------------- | --------- |