The Macy Catheter has been designed for comfort and safety by utilizing a flexible silicone body that enables administration of liquids/medications to the rectum. The device has two lumens, one for administering the liquids/medications and the other for inflation of the retention balloon. The catheter is inserted into the rectum and a small, soft retention balloon is inflated with water via the inflation valve. Liquids/medications are delivered via the medication valve, through the catheter, and into the rectum. The retention balloon can be easily deflated for removal of the catheter. The Macy Catheter remains in the recturn until expelled upon defecation (or removed for defecation if the patient prefers).

AI/ML Overview

The provided text describes a 510(k) submission for the Macy Catheter, a rectal catheter designed to administer liquids/medications. The submission focuses on establishing substantial equivalence to a predicate device through a comparison of features and performance data, primarily non-clinical bench testing and biocompatibility assessments.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" against those criteria in a table. However, it implicitly states that the device met "design specifications established under the Design Control Process with successful results" and successfully passed various tests.

Implicit Acceptance Criterion 1: Meet Design Specifications.
- Reported Performance: "Bench testing was conducted on the device to verify that it met design specification established under the Design Control Process with successful results."
Implicit Acceptance Criterion 2: Biocompatibility.
- Reported Performance: "Biocompatibility testing was conducted in compliance with applicable parts of ISO 10993 as determined by ISO 10993 Part 1." Specific tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Sub-chronic Toxicity, Genotoxicity, Muscle Implantation) were performed with successful results.
Implicit Acceptance Criterion 3: Mechanical Verification (e.g., ASTM F 2528-06).
- Reported Performance: Tests included "balloon and shaft size, balloon integrity and reliability via balloon volume maintenance and balloon burst volume tests, device tensile strength, lumen patency and flow rate, balloon and shaft mechanical properties" with successful results.
Implicit Acceptance Criterion 4: Packaging and Shipping Stress Simulation.
- Reported Performance: Tests were conducted with successful results.
Implicit Acceptance Criterion 5: Mitigation of Misconnections (ISO 80369-1).
- Reported Performance: "Verification of design features intended to mitigate mistaken connections per ISO 80369-1" was conducted with successful results.
Overall Implicit Acceptance Criterion: As Safe and Effective as Predicate.
- Reported Performance: "The results of the tests performed demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified in Part A of this summary."

2. Sample Size Used for the Test Set and Data Provenance

The document discusses non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests. Data provenance is implied to be from the manufacturer's internal testing ("Bench testing was conducted on the device," "Biocompatibility testing was conducted"). These are laboratory-based tests, not clinical studies. The data is thus prospective in the sense that the tests were specifically conducted for this submission. The "country of origin of the data" is not explicitly stated but is implicitly within the regulatory framework of the US FDA as the submission is to the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the submission describes an electromechanical device with an intended use of administering liquids/medications, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for the performance tests would be the established scientific and engineering standards and methods for assessing device functionality and safety.

4. Adjudication Method for the Test Set

This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or for establishing ground truth in AI performance studies involving human readers, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. The Macy Catheter is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The Macy Catheter is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

For the performance data described:

Bench Testing: The "ground truth" is defined by established engineering design specifications and recognized test standards (e.g., ASTM F 2528-06, ISO 80369-1). Pass/fail criteria are based on these specifications.
Biocompatibility Testing: The "ground truth" is determined by compliance with international standards for biocompatibility (ISO 10993 and its relevant parts), where specific biological responses (e.g., cytotoxicity, sensitization) are assessed against predefined acceptable limits.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the evaluations presented.

8. The Sample Size for the Training Set

This is not applicable. The Macy Catheter is a physical medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for a physical medical device.

Summary

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510(k) Summary Prepared July 15, 2013

Sponsor:	Hospi Corporation2384 Gehringer DriveConcord, CA 94520
Contact Person:	Igal Ladabaum
Telephone:	650-483-1035
Fax:	925-676-0151
Submission Date:	July 15, 2013
Device Name:	Macy Catheter
Common Name:	Rectal Catheter
Classification:
Regulatory Class:	II
Review Category:	21 CFR Gastrointestinal Tube and Accessories(ref. 21 CFR 876.5980
Classification Panel:	Gastroenterology/Urology

A. Legally Marketed Predicate Devices

The Macy Catheter is substantially equivalent to the Indwelling Fecal Management System- Non-Sterile, (IFMS) manufactured by Bowel Management Systems (K023344).

B. Device Description

C. Intended Use

The Macy Catheter is intended to provide rectal access to administer liquids/medications.

JAN 2 4 2014

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D. Substantial Equivalence

The submission device is substantially equivalent to the Indwelling Fecal Management System- Non-Sterile (IFMS) manufactured by Bowel Management Systems (K023344).

Feature	Predicate Device	Subject Device
Indication for use	Indwelling Fecal Management System-Non-Sterile(IFMS by Bowel ManagementSystems) K023344	Macy Catheter
	Diversion of fecal matter to minimizeexternal contact with the patient, tofacilitate the collection of fecal matterfor patients requiring stoolmanagement, and to provide access forcolonic irrigation to trigger adefecatory response, and administrationof enemas/medication.	The Macy Catheter is intendedto provide rectal access toadministerliquids/medications.
Intended Users	Healthcare Professionals	Healthcare Professionals
Class	II	II
Regulation number	21CFR 876.5980	21CFR 876.5980
Code	KNT	KNT
Catheter and lumen material	Silicone	Silicone,Compliant with ISO 10993
Retention Balloon	35-40ml water inflated siliconeballoon, 2.08 inch outer diameter wheninflated. Positioned adjacent tosphincter in distal rectum.	15 ml water inflated siliconeballoon, 1.1 inch outerdiameter when inflated.Positioned adjacent tosphincter in distal rectum.
Administration ofLiquids/Medications	Silicone lumen with flared tapered porttermination.	Silicone lumen with valvedport for enteral/oral syringe.
Insertion Diameter	1.2 inches nominal	0.29 inches maximum
Fecal drainagelumen and stop-flow balloon	Yes	No
Safety features	Not specified in device labeling	Compliant with ISO 80369-1minimizing risks ofmisconnection. Retentionballoon, smaller than mostformed stool, can be expelledwith defecation; meetsapplicable test criteria ofStandard Test Methods forEnteral Feeding devices withRetention Balloon.
Single use	Yes	Yes
Sterile	No	No
Length	64.5 Inches	20 Inches

E. Performance Data

Bench testing was conducted on the device to verify that it met design specification established under the Design Control Process with successful results. The performance

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verification test results are provided in the submission under the section on Performance Data, Section 18. Biocompatibility testing was conducted in compliance with applicable parts of ISO 10993 as determined by ISO 10993 Part 1. Biocompatibility test reports are provided in the submission under the section on Biocompatibility Testing, Section 15.

The nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence include:

Mechanical verification testing including ASTM F 2528-06 test methods (for . example balloon and shaft size, balloon integrity and reliability via balloon volume maintenance and balloon burst volume tests, device tensile strength, lumen patency and flow rate, balloon and shaft mechanical properties).
. Packaging and shipping stress simulations
Verification of design features intended to mitigate mistaken connections per ISO . 80369-1.
GLP test results for applicable biocompatibility testing. Test reports included are: .
- Cytotoxicity-medication valve as fabricated, leveraged catheter test o article of identical fabrication but slightly different geometry and sterile.
- Sensitization-medication valve as fabricated, leveraged catheter test o article of identical fabrication but slightly different geometry and sterile.
- Irritation-medication valve as fabricated, leveraged catheter test article O of identical fabrication but slightly different geometry and sterile.
- Systemic toxicity (acute)-catheter portion as fabricated. o
- Sub-chronic toxicity (sub-acute)-leveraged catheter test article of ം identical fabrication but slightly different geometry and sterile.
- Genotoxicity—leveraged catheter test article of identical fabrication but o slightly different geometry and sterile.
- Muscle Implantation (test for local effects after implantation, 4 week)-O test coupons cut from catheter as fabricated.

The results of the tests performed demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified in Part A of this summary.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 24, 2014

Hospi Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K133881

Trade/Device Name: Macy Catheter Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 8, 2014 Received: January 10, 2014

Dear Mark Job,

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 general condinaturing 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.

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Page 2 - Mark Job

ﻭﺍﻟﺘﺮﻛﻴﺐ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,

Herbert P. Lerner -S

for

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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Indications For Use

510(k) Number (if known): K133881

Device Name: Macy Catheter

2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indications for Use: The Macy Catheter is intended to provide rectal access to administer liquids/medications.

Prescription Use _ X (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)

Herbert P. Lerner -S 2014.01.24 13:12:20 -05'00'

Page 4-2

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.