The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction or urethral obstruction or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.

Device Description

The Applied Medical Technology, Inc. (AMT) Low-Profile Suprapubic Catheter & Drainage Set (LPSPC) consists of two primary assemblies. The LPSPC is identical in materials and manufacturing processes to the Low-Profile Balloon Feeding Device cleared in K161413 for a different indication.

The Suprapubic Catheter is used to provide urinary diversion and drainage through the lower abdomen, placed and maintained in a percutaneously prepared cystostomy opening. The Drainage Set is intended to allow a connection between the suprapubic catheter device and a urinary collection bag system. The device is designed for bladder drainage by way of a secured (initial placement) or formed (replacement) cystostomy tract and may be used for irrigation. Patients may include: any user with urethral trauma, those who require long-term catheterization and urethral catheterization is intolerable, or those with a spinal cord injury and an inability to self-catheterize who may find the suprapubic method simpler to manage.

The LPSPC is a urinary drainage device made principally of silicone elastomer. The device consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlocking irrigation port, and safety plug. The catheter is inserted through the stoma and into the urinary bladder and is secured by the internal retention balloon. The device is offered in various sizes to accommodate different stoma diameters and lengths. On the shaft near the end is located a balloon which, when properly inflated, acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device.

The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set.

The Drainage Set is identical in material and manufacturing process to certain configurations of the Irrigation Set included with the AMT Bowel Management Device previously cleared in K180026. The right-angle connector of the Drainage Set is compatible with the interlock on the LPSPC and is used to direct fluids drained from the bladder, through the catheter, and into a separate urinary collection bag.

The AMT Low-Profile Suprapubic Catheter & Drainage Set may optionally be marketed with a Foley Insertion Tray accessory. If included, the accessory would be a legally marketed Foley Insertion Tray, such as:

AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664)
Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt)
Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, 510(k) exempt)

The device is sold as sterile and can be initially placed in an outpatient-setting by a health care professional. The device may be replaced in an outpatient-setting or home setting by a health care professional or care giver.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "AMT Low-Profile Suprapubic Catheter & Drainage Set." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document. The document primarily describes the types of testing performed and concludes that the device met acceptance criteria, but generally does not specify these criteria or report quantitative performance results against them.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that the device "met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate/reference devices." However, specific numerical acceptance criteria and precise performance data are not detailed in this summary. The performance is generally stated as meeting standards.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met acceptance criteria for permanent contact (>30 days) with mucosal membrane and breached/compromised surfaces, based on ISO 10993 standards.
Sterilization	Achieved a Sterility Assurance Level (SAL) of 10-6. Complies with ISO 11135 and ISO 10993-7.
Shelf Life	Packaging complies with ASTM F1980-21, ISO 11607-1 & 2, and ISTA 3A 2018.
Bench Testing (General)	Met or exceeded all predetermined specifications for performance principles.
Bench Testing (Specific Examples - criteria not detailed, assumed to be 'met')	Balloon Assembly Bond Peel/Tear Strength, Balloon Burst, Fill Valve Blow Out, Fill Valve Pullout, Flow Rate, Leak Test, Tubing Tensile Strength, Minimum Overmold Bond Strength, Stoma Pullout, Tubing Cyclic and Tensile Test, Main Strap Tensile Strength, Side Strap Tensile Strength.
MR Compatibility	Complies with ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), ASTM F2119-07 (Reapproved 2013) (MR image artifacts), ASTM F2182-19e2 (radio frequency induced heating).
Enteral Feeding Systems Design & Testing	Complies with ISO 20695 First edition 2020-03.
Enteral Feeding Devices with Retention Balloon	Complies with ASTM F2528-06 (Reapproved 2023).
Small-bore Connectors	Complies with ISO 80369-1 Second edition 2018-11.
Clinical Performance (based on literature review)	Determined to function clinically as intended and benefits outweigh risks in the target user population. Risks (hematuria, wound infection, UTI, leakage, poor fit, discomfort, bladder spasms) are similar to those seen with this device type.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- Bench Testing: Not specified. The document lists the types of tests but not numbers of samples.
- Clinical Performance (Literature Review): Clinical experience was reported on 34 adults and 188 pediatric patients across 22 published articles.
Data Provenance: The clinical data is from a systematic literature review (retrospective). The countries of origin are not specified, only that the literature from "independent organizations" was reviewed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This was a systematic literature review, not a study where experts established ground truth for newly collected patient data. The "ground truth" for the clinical performance was derived from the findings reported in the published literature.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The clinical evidence was gathered through a systematic literature review. The "reporting of this systematic review was guided by the standards of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement, as well as the Cochrane Handbook for Systematic Reviews of Interventions. Assessment of the included literature was completed using the critical appraisal tools published by the Joanna Brigges Institute." This describes the methodology for reviewing existing literature, not an adjudication process for a new test set.

5. 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 suprapubic catheter, not an AI-assisted diagnostic or therapeutic device. The submission does not mention any AI components or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical performance aspects, the "ground truth" was derived from "clinical experience... reported on 34 adults and 188 pediatric patients" across published literature, guidelines from organizations like the Pediatric Urologists of Canada and the Canadian Urological Association, operative textbooks, and information from the International Continence Society (ICS). This can be broadly categorized as published clinical outcomes data and expert-derived guidelines/clinical experience.

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2024

Applied Medical Technology, Inc. Jennifer Hazou Regulatory Affairs Specialist 8006 Katherine Boulevard Brecksville, OH 44141

Re: K240514

Trade/Device Name: AMT Low-Profile Suprapubic Catheter & Drainage Set Regulation Number: 21 CFR§ 876.5090 Regulation Name: Suprapubic urological catheter and accessories Regulatory Class: II Product Code: KOB Dated: October 4, 2024 Received: October 4, 2024

Dear Jennifer Hazou:

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.

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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" (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 QS 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 Rule"). 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.

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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 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,

Angel A. Soler-garcia -S

for

Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology 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) K240514

Device Name

AMT Low-Profile Suprapubic Catheter & Drainage Set

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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510(k) Summary

AMT Low-Profile Suprapubic Catheter & Drainage Set

I. SUBMITTER:

Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 Phone: 440-717-4000 Fax: 440-717-4200

Contact Person: Jennifer Hazou - Regulatory Affairs Specialist Email: Jennifer.Hazou(@appliedmedical.net Date Prepared: November 1, 2024

II. DEVICE INFORMATION:

Trade/Device Name: AMT Low-Profile Suprapubic Catheter & Drainage Set Regulation Name: Suprapubic Urological Catheter and Accessories Regulation Number: 21 CFR 876.5090 Review Panel: Gastroenterology/Urology Regulatory Class: II Product Code: KOB

III. PREDICATE/REFERENCE INFORMATION:

Predicate Device: K181097 (Cook Cystostomy Catheter Set; Cook Incorporated)

Reference Device: K161413 (Low-Profile Balloon Feeding Device; Applied Medical Technology, Inc.)

** The predicate/reference devices have not been subject to design-related recalls.

IV. INDICATIONS FOR USE:

The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction, congenital malformation or urethral obstruction, or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low-Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.

V. DEVICE DESCRIPTION:

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The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set.

AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664)
Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt) ●
Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, ● 510(k) exempt)

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE/REFERENCE DEVICES:

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TABLE 5.1-TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATE/REFERENCE DEVICES

	Subject Device:	Predicate Device(K181097):	Reference Device (K161413):
Class II; KOB	Class II; KOB	Class II; KNT
Substantial Equivalence:	Same	Different
Sterilization:	Sterile (Ethylene Oxide)	Sterile (Ethylene Oxide)	Sterile (Ethylene Oxide)
	Substantial Equivalence:	Same	Same
Prescription	Single use: Prescription Only	Single use: PrescriptionOnly	Single use: Prescription Only
	Substantial Equivalence:	Same	Same
Indications forUse:	The AMT Low-ProfileSuprapubic Catheter &Drainage Set is indicated forpatients 7 years of age andolder with lower urinary tractdysfunctions such asneurogenic bladderdysfunction, congenitalmalformation or urethralobstruction, or who areseverely disabled or requiringconstant care. The AMT Low-Profile Suprapubic Catheter &Drainage Set is indicated to beused for temporary suprapubicurinary diversion and drainagefor less than or equal to fourweeks. The AMT Low- ProfileSuprapubic Catheter isintended to be placed directlyinto the bladder through asecured (initial placement) orformed (replacement) stoma.	The Cook® CystostomyCatheter Set is used fortemporary suprapubicurinary diversion anddrainage for less than orequal to four weeks.	The Low-Profile Balloon FeedingDevice is indicated for use inpatients who require long termfeeding, are unable to tolerate oralfeeding, who are at low risk foraspiration, require gastricdecompression and/or medicationdelivered directly into the stomachthrough a secured (initialplacement) or formed(replacement) stoma. The Low-Profile Balloon Feeding Device isintended for all age groups.
	Substantial Equivalence:	Same	Different
Intended Use:	The AMT Low-ProfileSuprapubic Catheter &Drainage Set provides the usera channel through whichurinary bladder contents maybe diverted directly from thebladder through the abdominalwall by way of a stoma.	The Cook CystostomyCatheter Set provides theuser a channel throughwhich urinary bladdercontents may be diverteddirectly from the bladderthrough the abdominalwall by way of a stoma.	The Low-Profile Balloon FeedingDevice is indicated for use inpatients who require long termfeeding, are unable to tolerate oralfeeding, who are at low risk foraspiration, require gastricdecompression and/or medicationdelivered directly into the stomachthrough a secured (initialplacement) or formed(replacement) stoma.
Substantial Equivalence:	Same	Same	Different
	Subject Device:	Predicate Device(K181097):	Reference Device (K161413):
Principles ofOperation	The device features a bi-lumensilicone tube overmolded onone end with a low-profilesilicone bolster through whichbladder contents may bedrained, by way of apolycarbonate interlock.Opposite the bolster, the tubingis tipped on one end with asilicone tip, bonded directly toan inflatable silicone balloonthat acts as an internal bolsterto prevent outward migration ofthe device.The Drainage Set can interfacewith the polycarbonateinterlock of the catheter inorder to further direct the flowof drainage into an externalurinary collection device.	The Cook CystostomyCatheter Set iscomposed of a single-lumen silicone catheterthrough which bladdercontents may be drained.The catheter isexternally retained by asilicone catheter support.The external end of thecatheter may be affixedwith the providedstopcock, which can actto restrict flow andconnect the device to anexternal urinarycollection device.	The device features a bi-lumensilicone tube overmolded on oneend with a low-profile siliconebolster through which nutritionand medication may be delivered,by way of a polycarbonateinterlock. Opposite the bolster, thetubing is tipped on one end with asilicone tip, bonded directly to aninflatable silicone balloon thatacts as an internal bolster toprevent outward migration of thedevice.
	Substantial Equivalence:	Similar	Similar
DesignSimilarities	1. Devices have direct access to a hollow organ (bladder or stomach) through the abdominalwall.2. All devices permit flow in both directions (drainage/decompression and/orirrigation/feeding).3. All devices feature soft silicone components where in patient contact.4. All devices are offered in various French sizes for adult and pediatric use.
DesignDifferences	1. The subject and reference devices feature a balloon which provides internal retention of thedevice when inflated while the predicate device does not contain an internal retentionfeature.2. The subject and reference devices are low profile devices, featuring an anti-reflux devicethat requires the engagement of an extension set in order to permit flow from the holloworgan. The predicate device is a traditional length tube that does not require an additionalextension set to permit flow. Flow through the predicate device can only be stopped with theincluded stopcock.3. The low-profile device is configured in fixed lengths to be selected for certain abdominalwall thicknesses, while the predicate device is adjustable across a range of patientanatomy.4. The predicate device includes a trocar stylet to aid initial placement of the catheter.Subject and reference devices do not include an initial placement trocar.5. The predicate device is meant to be secured with sutures or tape to the abdominal wall. Thesubject device does not require suture securement.

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TABLE 5.1-TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATE/REFERENCE DEVICES

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VII. PERFORMANCE DATA:

A. Biocompatibility Testing: The AMT Low-Profile Suprapubic Catheter & Drainage Set was tested for biocompatibility based on the applicable sections of the following standards:
- ISO 10993-1 Fifth edition 2018-08 - Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process
- ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices ● --Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices . -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices ● --Part 6: Tests for local effects after implantation
- ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices ● --Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-10 Fourth edition 2021-11 - Biological evaluation of medical devices --Part 10: Tests for skin sensitization
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices ● --Part 11: Tests for systemic toxicity
- . ISO 10993-12 Fourth edition 2012-07-01 - Biological evaluation of medical devices --Part 12: Sample preparation and reference materials
- ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices ● --Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 Biological evaluation of . medical devices

--Part 18: Chemical characterization of medical device materials within a risk management process

ISO 10993-23 First edition 2021-01 - Biological evaluation of medical devices --Part 23: Tests for irritation
It was determined that the AMT Low-Profile Suprapubic Catheter & Drainage Set met the acceptance criteria for permanent contact (greater than 30 days) with mucosal membrane and breached/compromised surfaces.
B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device.
C. Electromagnetic Compatibility & Electrical Safety: There are no electronic components related in any way to this device.

D. Performance Testing:

1. Sterilization

Testing has been completed to evaluate the sterilization process for the subject device, and is outlined below:

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Testing per ISO 11135, Second edition 2014-07-15 ●
- o Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical devices
Testing per ISO 10993-7, Second edition 2008-10-15 ●
- Biological evaluation of medical devices Part 7: Ethylene oxide sterilization o residuals

The subject device is ethylene oxide sterilized, and has been validated to confirm a Sterility Assurance Level (SAL) of 106. The sterilization processing complies with the standards.

2. Shelf Life

The sterilized packaging for the subject device was tested in accordance with the following:

Testing in accordance with ASTM F1980-21: .
- Standard guide for accelerated aging of sterile barrier systems for medical O devices
Testing per ISO 11607-1 & 2, Second edition 2019-02: ●
- Packaging for terminally sterilized medical devices O
Testing per ISTA 3A 2018:
- O Packaged products for parcel delivery system shipment 70kg (150 lb) or less

Testing of the sterile barrier system has indicated that the packaging for the subject device complies with the standards.

3. Bench Testing

Bench tests have been carried out to demonstrate conformance to applicable recognized standards and to assure reliable design and performance under the specified testing parameters according to predetermined criteria. The tests carried out include:

Testing per AMT Design Specifications:
- Balloon Assembly Bond Peel/Tear Strength O
- Balloon Burst O
- Fill Valve Blow Out O
- Fill Valve Pullout O
- Flow Rate O
- Leak Test O
- Tubing Tensile Strength O
- Minimum Overmold Bond Strength O
- O Stoma Pullout
- Tubing Cyclic and Tensile Test O
- Main Strap Tensile Strength O
- Side Strap Tensile Strength O
Testing per ASTM F2052-21:
- Measurement of magnetically induced displacement force on medical devices O in the magnetic resonance environment

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K240514 Page 8 of 9

Testing per ASTM F2213-17:
- Measurement of magnetically induced torque on medical devices in the O magnetic resonance environment
Testing per ASTM F2119-07 (Reapproved 2013):
- Evaluation of MR image artifacts from passive implants o
Testing per ASTM F2182-19e2:
- Measurement of radio frequency induced heating on or near passive implants O during magnetic resonance
Testing per ISO 20695 First edition 2020-03
- Enteral feeding systems Design and testing O
Testing per ASTM F2528-06 (Reapproved 2023)
- o Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
Testing per ISO 80369-1 Second edition 2018-11 ●
- o Small-bore connectors for liquids and gases in healthcare applications - Part 1 : General requirements

The AMT Low-Profile Suprapubic Catheter & Drainage Set met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate/reference devices.

E. Animal Study: Animal testing was NOT performed.
F. Clinical Study: Clinical evidence gathered from independent organizations in the form of a systematic literature review was included in this submission to provide support for the use of a Low-Profile Balloon Feeding Device as a suprapubic catheter and allowing initial placement of the device. Articles from 1996 to 2024 were included. No date limiting parameters were applied to the database searches.

Sources Used to Identify Data:

Published Literature Databases:

PubMed
EBSCO
Google Scholar

Selection Criteria

The following criteria were used to assess the suitability of material (articles, reports, etc.) for inclusion in the analysis stage of this report:

Article addresses performance, risks, and/or safety of devices used for the proposed indication of suprapubic catheterization; or
. Article addresses technique for initial placement of a suprapubic catheter into the bladder, particularly the placement of a low-profile gastrostomy device.

A total of 22 articles were considered relevant to the proposed indications for use (IFU) and were reviewed and provided for FDA assessment. The reporting of this systematic review was guided by

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the standards of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement, as well as the Cochrane Handbook for Systematic Reviews of Interventions. Assessment of the included literature was completed using the critical appraisal tools published by the Joanna Brigges Institute. In addition, FDA's guidance for Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices was referenced to help identify published literature directly addressing the new IFU statement.

In these 22 published articles, clinical experience was reported on 34 adults and 188 pediatric patients undergoing vesicostomies with the subject device or similar devices used in initial placement or replacement procedures. Reports of use extended from days to months and as long as 3 years in duration. Information was also sourced from a guideline created through an independent collaboration by the Pediatric Urologists of Canada and the Canadian Urological Association regarding an evidence-based guideline for the multidisciplinary management of pediatric patients with neurogenic lower urinary tract dysfunction (NLUTD). Also source information from an operative textbook detailing a technique for button vesicostomy was reviewed. Finally, information cited by the International Continence Society (ICS) published to provide a clinically based guide on male lower urinary tract (LUT) terminology to aid clinical practice and research was considered.

Common risks associated with the device and its placement include hematuria, wound infection, urinary tract infection (UTI), leakage, poor fit, discomfort, and bladder spasms. The data shows that for the intended user population this device will allow for continent retention of urine with complete bladder emptying upon intermittent catheterization through the device and does not entail any anticipated risks apart from those seen with this device type (suprapubic cystostomy). The overall benefit of the device includes allowing a less conspicuous drainage site, convenient intermittent catheterization and much less interference with activities of daily living. Based on the clinical information, the device was determined to function clinically as intended and that the benefits outweigh the risks in the target user population.

G. CONCLUSION:

The AMT Low-Profile Suprapubic Catheter & Drainage Set can be found substantially equivalent to the predicate device cleared under K181097 in intended use, performance, and principles of operation. The subject device can be found substantially equivalent to the reference device cleared under K161413 in material composition and design. Bench testing of the AMT Low-Profile Suprapubic Catheter & Drainage Set demonstrates that the subject device meets or exceeds all predetermined specifications for performance principles. The design differences between the subject device and the legally marketed predicate chiefly reflect the differences between a traditional-length device and a low-profile one, and do not raise different questions of safety and/or efficacy. The information submitted in this application demonstrates that the subject device is substantially equivalent to existing legally marketed devices for the intended use, but in a low-profile form with a removable extension set.

Regulation Number and Section

§ 876.5090 Suprapubic urological catheter and accessories.

(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.