The Colorado Catheter iCath™ and SterileSure™ are intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Device Description

The iCath" and SterileSure™ are intended to be disposable medical devices that offer a pre-lubricated self catheterization alternative that does not require the application of lubricant prior to use to facilitate the insertion of a urinary catheter. Although nearly identical, the iCath™ is designed and intended for outpatient use, and the SterileSure™ is designed and intended for inpatient use administered to a patient under the care of medical personnel.

The iCath" and SterileSure™ are intended to be used to drain urine from the bladder. The devices are provided sterile and for single-use only. Both consist of a catheter assembled within a thin, flexible sheath to minimize patient contact and reduce contamination. The sheath is connected to an introducer tip that is inserted into the urethra to facilitate advancement of the catheter into the urethra. The introducer tip of the iCath™ contains a lubricant reservoir feature in which the catheter is lubricated prior to insertion with a watcr-soluble hydrophilic water-based lubricant. The SterileSure™ is prelubricated with the water-soluble hydrophilic waterbased lubricant.

The devices are packaged singly with a urine drainage bag, or in a kit with accessories including benzalkonium chloride swabsticks or provodine iodine swabsticks, gauze pad, and urine collection container or urine drainage bag, and non-latex, powder-free gloves

AI/ML Overview

The provided text describes the 510(k) submission for the Colorado Catheter iCath™ and SterileSure™ urinary catheterization devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. The document focuses on regulatory approval, substantial equivalence to a predicate device, basic biocompatibility testing, and general performance requirements for a medical device of this type.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI/ML specific performance metrics cannot be extracted from this document.

Here's a breakdown of what can be inferred or is explicitly stated, alongside what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Acceptance Criteria Category	Reported Device Performance
Biocompatibility
Cytotoxicity (Agar Diffusion)	Induced mild reactivity (Grade 2) with introducer tip. Catheter portion pre-approved (K871999). Meets requirements.
Guinea Pig Maximization (Sensitization)	No signs of sensitization. Not considered to elicit contact dermal allergenicity.
Systemic Toxicity (Acute Systemic Injection)	Met the requirements of the systemic injection test.
Acute Vaginal Irritation	Met the requirements of the vaginal irritation test.
Performance Testing	Met all performance requirements for intended use. (Specific criteria not detailed in document)

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

Test Set Sample Size: Not specified for any of the biocompatibility or performance tests.
Data Provenance: Not specified, but likely from testing labs rather than clinical data. Given the nature of these tests, they are typically conducted on material samples or animal models, not human patients. The tests are focused on material safety and basic functionality.

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 to the presented data. The tests are laboratory-based assays (e.g., cell culture, animal studies) or engineering performance assessments, not clinical studies requiring expert ground truth in the context of diagnostic interpretation.

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

Not applicable to the presented data. This method is typically used for clinical study and image interpretation where expert consensus is needed. The tests described are objective, laboratory-based results.

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

No. This is a urinary catheter, a physical medical device, not an AI/ML diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.

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

No. This is a physical medical device. There is no AI algorithm to test in a standalone manner.

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

Ground Truth for Biocompatibility Tests: Established by specific biological reactions (e.g., cell reactivity, animal responses to extracts) as per ISO or similar standard methods.
Ground Truth for Performance Testing: Likely based on engineering specifications and functional requirements (e.g., flow rates, material strength, lubricity), but these are not detailed in the provided text.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set mentioned in this 510(k) submission.

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

Not applicable. As there is no AI/ML component, there is no training set or associated ground truth.

Summary of AI/ML Relevance:

This 510(k) summary is for a traditional physical medical device (urinary catheters) and therefore does not include any information pertinent to AI/ML device performance, acceptance criteria, or studies. The questions posed are highly relevant for AI/ML-powered medical devices, but not for this specific submission.

Summary

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K071496

AUG 15 2007

Colorado Catheter Company 510(k) Notification Section E.r.2

510(k) Summary

Colorado Catheter Company iCath™ and SterileSure™ Urinary Catheterization Devices

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is:

Contact Person: Andy Black Senior Biomedical Engineer Medical Murray, Inc. 400 North Rand Rd. North Barrington, IL 60010

Telephone:	(847) 620-7990
Fax:	(847) 620-7995

Date Prepared: May 8, 2007

Device Name and Classification

Classification Name:	Urological Catheter and Accessories
Common/Usual Name:	Urinary Catheter
Proprietary Name:	iCathTM, SterileSureTM
Device Classification:	Class II
Regulation Number:	21 CFR Ref. § 876.5130
Product Code:	EZD

Manufacturer

PyMPSA 3609 Juan de la Barrera St, Alamo Industrial Guadalajara, Jalisco, Mexico C.P. 44590

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Rellim
Kaye

Colorado Catheter Company 510(k) Notification Section E.r.2

Device Description

Substantial Equivalence Claim

Colorado Catheter Company believes the proposed iCath™ and SterileSure™ is substantially equivalent in form and function to Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter, which was cleared under 510(k) number K052440.

Indications for Use

The Colorado Catheter iCath" and SterileSure™ are intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Summary of Testing

Cytotoxicity (Agar Diffusion - ISO Method): The introducer tip of the iCath™ and SterileSure™ induced mild reactivity with a Grade of 2. The catheter portion of the device is pre-approved by the FDA (510k number K871999) for the intended use. Therefore the test devices meet the requirements of this test.

Guinea Pig Maximization (Two extracts): There were no signs of sensitization with the test article; the test article is not considered to elicit contact dermal allergenicity.

Systemic Toxicity (Acute Systemic Injection with Saline and Vegetable Oil Extracts: The test article met the requirements of the systemic injection test.

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Colorado Catheter Company 510(k) Notification Section E.r.2

Acute Vaginal Irritation: The test article mects the requirements of the vaginal irritation test.

Performance Testing: The iCath" and SterileSure™ met all performance requirements for their intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

AIIG 15 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Colorado Catheter Company, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K071496

Trade/Device Name: Colorado Catheter iCath and SterileSure Regulation Number: 21 CFR $876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: NWO and EZD Dated: July 13, 2007 Received: July 16, 2007

Dear Mr. 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.

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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Page 2 - Mr. Mark Job

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains Benzalkonium Chloride and Povidone-Iodine, which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division

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Page 3 – Mr. Mark Job

of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdone Director, Division of Reproductive, Abdominal, and Radiological Divices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

50-11496 510(k) Number: Device Name: Colorado Catheter iCath and Colorado Catheter SterileSure

Indications for Use:

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

Nancy C. Bredon

(Division Sign-Q Division of Reproductive, Ab and Radiological Devic

510(k) Number K111496

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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.