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).

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.

AI/ML Overview

The provided text describes the Aquarius™ Stoma Measuring Device, its intended use, and the regulatory review process. However, the document does not contain information about acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in terms of algorithmic performance, as would be common for AI/ML-based medical devices.

This device is a physical medical device and its "acceptance criteria" are related to its physical specifications, material properties, and functionality, as demonstrated through verification testing. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel performance study in the way an AI/ML device would.

Therefore, many of the requested elements (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or not present in this type of document for this type of device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present versus what is not.

Acceptance Criteria and Device Performance (Based on Provided Text)

The document lists "verification tests" performed on the device. These tests implicitly define the "acceptance criteria" by requiring the device to comply with established standards and internal requirements. The "reported device performance" is a statement that the tests were conducted and the device complied.

Acceptance Criteria (Implied by Verification Tests)	Reported Device Performance
Compliance with ISO 14971:2012 (Risk Management)	Confirmed
Dimension verification	Compliant
Surface finish and marking inspection	Compliant
Balloon concentricity and balloon bursting volume	Compliant
Tensile strength of tubing and connections	Compliant
Packaging tests (visual, tensile, dye penetration)	Compliant
Shelf life test	Compliant
Biocompatibility evaluation	Compliant
Risk analysis	Compliant

Specific Study Details:

Sample size used for the test set and the data provenance:
- Test set size: Not explicitly stated for each test. For a physical device, this would typically involve a specific number of units manufactured for testing.
- Data provenance: Not applicable in the context of clinical data for AI. The tests are performed on the manufactured device itself. No country of origin for "data" is relevant here in the AI context. The tests were "conducted on the final sterile device," implying tests performed by the manufacturer, Degania Silicone, Ltd. (Israel).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device, ground truth is established by engineering measurements, adherence to material specifications, and functional testing against predefined standards (e.g., balloon bursting volume). Expert radiologists or similar personnel are not involved in establishing ground truth for these types of tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication is relevant for subjective assessments or disagreements in clinical interpretations, which is not the nature of these engineering and material tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical measuring tool, not an AI algorithm assisting human readers. No MRMC study was performed or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's verification would be based on:
- Engineering specifications and drawings: For dimensions, surface finish, markings.
- Material standards: For tensile strength, biocompatibility.
- Functional requirements: For balloon concentricity and bursting volume.
- Regulatory standards: ISO 14971:2012 for risk management.
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.
How the ground truth for the training set was established: Not applicable. As there's no training set for an AI algorithm, there's no ground truth to establish for it.

In summary: The provided document is for a traditional, physical medical device. It demonstrates substantial equivalence and verification against engineering and material specifications, not algorithmic performance. Therefore, most of the questions pertaining to AI/ML device studies are not applicable. The "study" mentioned is a compilation of non-clinical verification tests confirming compliance with design and safety requirements.

Summary

{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 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

{2}------------------------------------------------

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)

{3}------------------------------------------------

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:
- All Silicone Foley catheter, 510(k) #K063442 >
- Gastrostomy Replacement Tube. 510(k) #K070124 V
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.

Regulation Number and Section

§ 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.