The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liguid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.

Device Description

The hygh-tec drainage is sold as a kit to include a main catheter component, collection bag, inflation syringe, and closure strap. The catheter component consists of a retaining and sealing balloon element, a trans-anal segment, drainage shaft, an elastically deformable tip, a colored positioning ring, a stool irrigation tube, an irrigation line, and an air filling line.

AI/ML Overview

I am sorry, but the provided text does not contain information regarding acceptance criteria and a study that proves the device meets the acceptance criteria for an AI/ML powered device. The document is a 510(k) premarket notification for a medical device called "hygh-tec drainage," which is a fecal management system, not an AI/ML powered device.

Therefore, I cannot provide the requested information, which includes:

A table of acceptance criteria and reported device performance.
Sample size for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance.
Type of ground truth.
Sample size for the training set.
How the ground truth for the training set was established.

Summary

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February 9, 2023

Creative Balloons GmbH Michael Nilo President and Principal Consultant Nilo Medical Consulting Group 3491 Denny St. Pittsburgh, PA 15201

Re: K221400

Trade/Device Name: hygh-tec drainage Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: January 10, 2023 Received: January 11, 2023

Dear Michael Nilo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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Je Hi An, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K221400

Device Name hygh-tec drainage

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Prepared: January 10, 2023

I. SUBMITTER

Creative Balloons GmbH Bruchsaler Straße 22 68753 Waghäusel Germany Phone: +49 (0)7254.40397-0

Contact: Michael Nilo Nilo Medical Consulting Group 3491 Denny St. Pittsburgh, PA 15201 Phone: (717) 421-4396 e-mail: michael.nilo@nilomedicalconsulting.com

II. DEVICE

Name of Device:	hygh-tec drainage
Common/Usual Name:	Fecal Management System
Regulation Numbers:	21 CFR 876.5980
Regulation Name:	Gastrointestinal tubes and accessories
Regulatory Class:	II
Product Codes:	KNT, Tubes, Gastrointestinal (And Accessories)
III. PREDICATE DEVICE
Primary Predicate	Flexi-Seal® SIGNAL™ Fecal Management System
	K150350

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The hygh-tec drainage is a fecal management system that is intended for continuous, transanal drainage and collection of liquid or semi-liquid stools and to provide access for the administration of medications. The device is not intended for use on pediatric patients

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following table identifies technological characteristics shared between the predicate and subject device:

Parameter	Subject Device	Predicate
	hygh-tec drainage(K221400)	FlexiSealFecal Management System(K150350)
FDA Product Code	KNT	KNT
FDA ClassificationRegulation	21 CFR 876.5980	21 CFR 876.5980

Table 1: Comparison of Technological Characteristics with Predicate Device

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Classification	Class II	Class II
Intended use	The hygh-tec drainage is a fecalmanagement system that isintended for continuous, trans-analdrainage and collection of liquid orsemi-liquid stools and to provideaccess for the administration ofmedications. The device is notintended for use on pediatricpatients.	To manage fecal incontinencethrough the collection of liquid tosemi liquid stool to provide accessto administer medications
FunctionalConfiguration	A head unit with collapsible wave-shaped hose section envelopedwith a sealed balloon segment onthe distal end secured in therectum and proximal endconnected to a collection bag	Collapsible catheter with distal endsecured in the rectum andproximal end connected to acollection bag
Retention Feature	Low pressure contoured cuff forpatients anatomy and facilitatingsealing.	Soft annular Balloon
Balloon material	Thermoplastic Polyurethane (TPU)	Silicone rubber (Elastomere)
Inflation management	Sealed air-filled balloon(low-pressure Cuff)	Sealed water filled balloon
Retention ballooninflation medium	Air (85ml)	Water/saline (45ml)
Catheter tube length	1730 mm	1550mm - 1670mm
Length oftrans-anal area	~ 49 mm (length of the trans-analballoon segment)	~ 7 cm (from Balloon to blackPosition marking)
Position marking	Yes(Yellow ring)	Yes(Black marking on catheter tube)
Inflation andirrigation portconnections	Luer	Luer
Inflation lines	1	2
Irrigation lines	1	1
Sampling port	Closable snap seal for cathetersyringe access – natural color	Closeable snap seal for cathetersyringe access - natural color
Collection bagconfiguration	Disposable with vent andconnector	Disposable with integrated cap andvent
Collection bag size	2 litre	1 litre
Method of bedconnection	Hanging strap and a hook-on bagconnector	Hanging Strap on bag connector
Flow stopmechanism	External Strap	External Tube Strap
Sterility status	Non-sterile	Non-sterile
Max Usage of Device	29 days	29 days
Medication Delivery	Yes	Yes
Packaging	Thermoformed plasticclamshell	Thermoformed plasticclamshell

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The following differences between the subject and predicate device were evaluated to support a substantial equivalence determination:

The filling medium of the retention balloons is different (air vs. water) ●

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The materials utilized in the subject and predicate device are different. ●

VII. PERFORMANCE TESTING

The following performance testing was conducted to support substantial equivalence:

Performance Testing

The following design verification activities have been performed to ensure the appropriate functionality of the system:

Shelf-Life Testing .
Simulation of Transport Loads ●
Leak Tightness Testing ●
Retention Testing ●
Overfilling Testing ●
Flow Rate Measurement Testing

Biocompatibility

Biocompatibility testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'."

VIII. CONCLUSIONS

The differences that exist between the hygh-tec drainage and its predicate do not raise different questions of safety or effectiveness. The results of performance and biocompatibility testing demonstrate that the hygh-tec drainage will perform safely as intended and support a determination of substantial equivalence to the predicate device which is marketed for the same intended use.

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K221400 Page 6 of 6

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.