(316 days)
No
The device description and performance studies focus on physical characteristics and mechanical testing, with no mention of AI/ML terms or data processing.
No
The device is solely used for measuring the depth of a stoma tract to aid in selecting the correct size of another device (the Gastrostomy Button); it does not provide any therapeutic effect itself.
No
Explanation: The device is used to measure the depth (length) of a stoma tract to assist in selecting the proper length of a gastrostomy button. While measurement is a form of assessment, it primarily provides information for treatment planning (selecting the correct device size) rather than diagnosing a disease, condition, or abnormal state. It acts as an aid for device selection, not a diagnostic tool for medical conditions.
No
The device description explicitly states it is comprised of physical components (12 Fr with graduated scale, funnel, tubular shaft retaining balloon) made of silicone, indicating it is a hardware device, not software-only.
Based on the provided information, the Aquarius™ Stoma Measuring 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.
- Aquarius™ Stoma Measuring Device Function: The intended use of this device is to physically measure the depth of a gastrostomy stoma tract. It is a physical measuring tool used directly on the patient's body, not a test performed on a sample taken from the body.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. The device is used to obtain a physical measurement.
Therefore, the Aquarius™ Stoma Measuring Device falls under the category of a medical device used for measurement and assistance in selecting another medical device (the G-Button), but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aquarius™ Stoma Measuring Device is designed to determine the depth (length) of a well-established gastrostomy stoma tract in order to assist in proper length selection of the Aquarius™ Gastrostomy Button (G-Button). Intended for transient use (less than 60 minutes).
Product codes
KNT
Device Description
The Aquarius™ Stoma Measuring Device comprises a 12 Fr with graduated scale, a funnel with an inflation valve and a tubular shaft retaining balloon. The Aquarius™ Stoma Measuring Device is made of 100% silicone, EtO sterilized and for single use. Intended to be use in hospital environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrostomy stoma tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital environment.
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
Non- clinical verification of Aquarius™ Stoma Measuring Device was conducted through the risk management process according to ISO 14971:2012 and verification testing. The following verification tests were conducted on the final sterile device.
- Dimension verification
- Surface finish and marking inspection
- Balloon concentricity and balloon bursting volume tests
- Tensile strength of the tubing part and the connections of the device
- Packaging tests: visual, tensile strength and dye penetration
- Shelf life test
- Biocompatibility evaluation
- Risk analysis
The test results confirm the compliance of the Aquarius™ Stoma Measuring Device with the requirements established by standards.
Key Metrics
Not Found
Predicate Device(s)
AMT Balloon Stoma measuring devices, K973893
Reference Device(s)
All Silicone Foley catheter, 510(k) #K063442, Gastrostomy Replacement Tube. 510(k) #K070124
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.
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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 stylized graphic of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are black and are positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2016
Degania Silicone, Ltd. Zoya Lee RA CO Degania Bet Emek Hayarden Israel 15130
Re: K152246
Trade/Device Name: Aquarius™ Stoma Measuring Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 10, 2016 Received: May 12, 2016
Dear Zoya Lee:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. Indications for Use
510(k) Number: K152246
Device Name: Aquarius™ Stoma Measuring Device
Indication of Use: The Aquarius™ Stoma Measuring Device is designed to determine the depth (length) of a well-established gastrostomy stoma tract in order to assist in proper length selection of the Aquarius™ Gastrostomy Button (G-Button). Intended for transient use (less than 60 minutes).
X_ONLY_ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) # K152246
Date: June 19, 2016
510(k) Summary
- a) Type of 510(k) submission: Traditional
- b) Common name: Stoma Measuring Device
- c) Device trade name: Aquarius™ Stoma Measuring Device
- d) Classification Panel: 21 CFR 876.5980
- e) Classification Name: Gastrointestinal tube and accessories.
- Class: II f)
- g) Product code: 78KNT
- h) Predicate Device: AMT Balloon Stoma measuring devices, K973893
- i) Reference Devices:
- j) 510(k) Owner name : Degania Silicone Ltd, Degania Bet, Emek Hayarden, Israel, 1513000, tel: +97146755100, fax: +97246709182
- k) FDA Registration Number: 8030107
- Contact person: Zoya Lee, Regulatory Affairs, e-mail: zoya@ds-il.com, fax: 1) +972 4 675 5155, tel: +972 4 6755122
- m) Device Description: The Aquarius™ Stoma Measuring Device comprises a 12 Fr with graduated scale, a funnel with an inflation valve and a tubular shaft retaining balloon. The Aquarius™ Stoma Measuring Device is made of 100% silicone, EtO sterilized and for single use. Intended to be use in hospital environment.
- n) Indication for Use. The Aquarius™ Stoma Measuring Device is designed to determine the depth (length) of a well-established gastrostomy stoma tract in order to assist in proper length selection of the Aquarius™ Gastrostomy Button (G-Button). Intended for transient use (less than 60 minutes).
- o) Technological and non-clinical summary. The Aquarius™ Stoma Measuring Device is substantially equivalent to the predicate AMT Balloon Stoma measuring device, K973893. There are no significant differences in the design, materials, performance and safe characteristics between subject device and predicate device:
-
The subject and the predicate devices have the similar design. They both are comprised of a funnel, a tubular shaft and a distal retaining balloon.
- √ The constructive material is the same: silicone rubber
-
The performance characteristics are the same: inserting of the device via stoma site, anchoring and holding the device by inflated balloon, and reading the measurement of the scale on the shaft.
4
The indication of use is the same: to determine the depth (length) of a wellestablished gastrostomy stoma tract in order to assist in proper length selection of the gastrostomy-feeding device.
Non- clinical verification of Aquarius™ Stoma Measuring Device was conducted through the risk management process according to ISO 14971:2012 and verification testing. The following verification tests were conducted on the final sterile device.
- √ Dimension verification
- Surface finish and marking inspection >
-
Balloon concentricity and balloon bursting volume tests
-
Tensile strength of the tubing part and the connections of the device
-
Packaging tests: visual, tensile strength and dye penetration
-
Shelf life test
-
Biocompatibility evaluation
-
Risk analysis
The test results confirm the compliance of the Aquarius™ Stoma Measuring Device with the requirements established by standards.
o) Conclusion:
The Aquarius™ Stoma Measuring Device is substantially equivalent to AMT Balloon Stoma measuring device cleared under K973893. There are no new questions of safety and effectiveness for Aquarius™ Stoma Measuring Device as compared to the predicate devices.