(163 days)
The hygh-tec drainage II is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.
The hygh-tec drainage II is a fecal drainage system that is comprised of a stool collection bag, and an inflating syringe. The device is used by healthcare professional heatthcare environment for continuous trans-anal drainage and collection of stools. The stool drainage tool is the patient while a liquid is infused within a specialized port to irigate the rectum. The organic matter then progresses through the drainage tube where it is eventually stored in the collection bag for evaluation or disposal. Along with stool drainage, the hygh-tec drainage II system can be used for the administration that would be prescribed by physicians.
This is a device for fecal management and thus does not include performance studies that would require the information requested for AI/ML devices. As such, most of the fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 10993-5:2009 | Pass | Passed |
| ISO 10993-10:2021 | Pass | Passed |
| ISO 10993-23:2021 | Pass | Passed |
| Tensile Strength Testing | Pass | Passed |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable, as this device does not contain algorithm/AI.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as this device does not contain algorithm/AI.
4. Adjudication Method for the Test Set
Not applicable, as this device does not contain algorithm/AI.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this device does not contain algorithm/AI.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this device does not contain algorithm/AI.
7. Type of Ground Truth Used
Not applicable, as this device does not contain algorithm/AI.
8. Sample Size for the Training Set
Not applicable, as this device does not contain algorithm/AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not contain algorithm/AI.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The device, hygh-tec drainage II, underwent non-clinical testing to demonstrate substantial equivalence to its predicate device. The following tests were performed and all passed:
- ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2021: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
- ISO 10993-23:2021: Biological evaluation of medical devices – Part 23: Tests for irritation.
- Tensile Strength Testing: This test assessed the material strength of the device.
These tests indicate that the device is biocompatible and structurally sound for its intended use. The 510(k) summary explicitly states that "all tests passed," leading to the conclusion that the device is substantially equivalent and meets the necessary performance and safety requirements. The primary difference between the subject device and the predicate is the material of the drainage tube, changing from PVC to a three-layer extruded tube made of TPU-EVOH-TPU, which was presumably evaluated through these tests.
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January 17, 2025
AMB Medtec % Michael Nilo President and Principal Consultant Nilo Medical Consulting Group LLC 3706 Butler St. Suite #313 Pittsburgh, Pennsylvania 15201
Re: K242336
Trade/Device Name: hygh-tec drainage II Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT Dated: December 18, 2024 Received: December 18, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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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-device-advice-comprehensive-regulatoryassistance/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,
Anthony Lee -S
Anthony Lee, Ph.D., M.B.A. 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) K242336
Device Name hygh-tec drainage II
Indications for Use (Describe)
The hygh-tec drainage II is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) #: K242336
510(k) Summary
Prepared on: 2024-12-18
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5)
| Applicant Name | AMB Medtec |
|---|---|
| Applicant Address | Bruchsaler Straße 22 Waghäusel 68753 Germany |
| Applicant Contact Telephone | 725440397-20 |
| Applicant Contact | Mr. Frank Gehres |
| Applicant Contact Email | frank.gehres@amb-medtec.com |
| Correspondent Name | Nilo Medical Consulting Group LLC |
| Correspondent Address | 3706 Butler St, Suite #313 Pittsburgh PA 15201 United States |
| Correspondent Contact Telephone | 717-421-4396 |
| Correspondent Contact | Michael Nilo, President and Principal Consultant |
| Correspondent Contact Email | michael.nilo@nilomedicalconsulting.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | hygh-tec drainage II |
|---|---|
| Common Name | Gastrointestinal tube and accessories |
| Classification Name | Gastrointestinal Tube And Accessories |
| Regulation Number | 876.5980 |
| Product Code(s) | KNT |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | K221400 |
|---|---|
| Predicate Trade Name (Primary Predicate is listed first) | hygh-tec® drainage |
| Product Code | KNT |
Device Description Summary
21 CFR 807.92(a)(4)The hygh-tec drainage II is a fecal drainage system that is comprised of a stool collection bag, and an inflating syringe. The device is used by healthcare professional heatthcare environment for continuous trans-anal drainage and collection of stools. The stool drainage tool is the patient while a liquid is infused within a specialized port to irigate the rectum. The organic matter then progresses through the drainage tube where it is eventually stored in the collection bag for evaluation or disposal. Along with stool drainage, the hygh-tec drainage II system can be used for the administration that would be prescribed by physicians.
Intended Use/Indications for Use
The hygh-tec drainage II is a fecal management system that is intended for continuous, trans-anal 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
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Indications for Use Comparison
The indications for use for both the Hygh-Tec drainage II and the predicate device are identical.
Technological Comparison
The design and the principle of operation are the same between the Hygh-Tec drainage II and the Hygh-Tec® Basic-Plus. The only difference is in the material used for the drainage tube. The subject device uses a three-layer extruded tube made of TPU-EVOH-TPU while the predicate drainage tube is made of PVC.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following tests were performed to test the device for substantial equivalence and all tests passed: ISO 10993-5:2009 ISO 10993-10:2021 ISO 10993-23:2021 Tensile Strength Testing
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
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§ 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.