BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER by BUSSE HOSPITAL DISPOSABLES

The catheter consist of a PVC tube with 2 or 3 drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. The Catheter is used in urinary collection procedure is a way of obtaining a urine sample through a catheter (a thin PVC tube) inserted through the urethra into the bladder. The urine is obtained by this method to avoid contamination from the urethra, or if urine cannot be collected by the clean catch method. The Urethral Catheter is packaged as part of a convenience kit for Urine Catheter Kit. The Urethral Catheter packaged in a soft pouch with Tyvek lid. The pouch is heat-sealed. The convenience kit includes a variety of devices used in the Urinary Catheter procedure including vial, gloves, iodophor PVP Swabsticks, embossed drape, and lubricating jelly.

AI/ML Overview

The provided text is a 510(k) summary for a Urethral Catheter, which is a medical device. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive studies on device performance against specific acceptance criteria.

Therefore, the document does not contain information on acceptance criteria or a study proving the device meets them in the way modern AI/software as a medical device (SaMD) clearances would.

Here's a breakdown based on your requested information, explaining why certain elements are not present:

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified.	Not specified.

Explanation: The document does not define specific "acceptance criteria" (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) that the device is intended to meet. Instead, the focus is on demonstrating "substantial equivalence" to a legally marketed predicate device. This means that the device is considered acceptable if it is as safe and effective as a device already on the market, based on similar technological characteristics and intended use.

Study Details (as requested, but largely not applicable to this 510(k) type):

Sample size used for the test set and the data provenance:
- Not applicable. This submission doesn't describe a performance study with a test set in the modern sense of evaluating a device's diagnostic or predictive capabilities. It's for a physical medical device (catheter) where substantial equivalence is typically demonstrated through material comparisons, manufacturing processes, and intended use comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. See explanation above.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See explanation above.
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 physical catheter, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There is no "ground truth" as it would be understood in an AI/diagnostic performance study. The "ground truth" in a 510(k) for a physical device like this is implicitly the safety and effectiveness of the predicate device.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning device.
How the ground truth for the training set was established:
- Not applicable. See explanation above.

Summary of the Document's Approach to "Proof":

The "study" or "proof" for this Urethral Catheter's acceptability in this 510(k) submission relies entirely on substantial equivalence to a predicate device. The manufacturer (Busse Hospital Disposables, Inc.) asserts that:

The device has the same intended use: "a tubular device that is inserted through the urethra and utilized for passage of fluids from or to the urinary tract."
The device has similar technological characteristics to the predicate. While not explicitly detailed in the provided text, this typically involves comparing materials (e.g., clear virgin PVC), dimensions (French sizes, lengths), design (drainage eyes), and manufacturing processes. The document states a PVC tube with 2 or 3 drainage eyes and indicates available sizes.
The differences between the subject device and the predicate device are minor, leading to the conclusion that the device is "as safe and effective as the predicate devices."

The FDA's letter concurs with this assessment, finding the device "substantially equivalent" to legally marketed predicate devices, thereby permitting its marketing.

Summary

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K041164
Page 1 of 2

510 (K) SUMMARY (ANNEXURE 5)

Date prepared May 24, 2004 Muhamad Ansari Busse Hospital Disposables PO Box: 11067 75 Arkav Dr. Hauppauge NY 11788

Device Common, Usual, or Classification Names: Urethral Catheter,

Classification Panel: Classification of this device would fall under the responsibility of the Gastroenterology - Urology device panel.

Classification: Class II, 21 CFR 876.5130, GBM

Description of the Device:

5FR 9", 8FR 9" and 8FR 6" Catheters: clear virgin PVC.

The Catheter is used in urinary collection procedure is a way of obtaining a urine sample through a catheter (a thin PVC tube) inserted through the urethra into the bladder. The urine is obtained by this method to avoid contamination from the urethra, or if urine cannot be collected by the clean catch method.

The Urethral Catheter is packaged as part of a convenience kit for Urine Catheter Kit. The Urethral Catheter packaged in a soft pouch with Tyvek lid. The pouch is heat-sealed.

The convenience kit includes a variety of devices used in the Urinary Catheter procedure including vial, gloves, iodophor PVP Swabsticks, embossed drape, and lubricating jelly. The other convenience kit are either exempt from 510(k) or are purchased from other manufacturers who have obtained 510(k) clearance on the devices. Busse certifies that the devices in the kit are either legally marketed preamendment devices, are exempt from premarket notification, or have been found to be substantially equivalent through the premarket notification process for the use for which the kit is to be intended.

The subject devices are composed of the following materials:

Component-----------------------------------------------------------------------------		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Cataile
Cathator1 4 80 40------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A	---------------------------------------------------------------------11 10	incerted into the Uninary tract

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Kotitet
Page 2 of 2

Intended Use [21 CFR 807.92(a)(5)] This device is a tubular device that is inserted through the urethra and utilized for passage of fluids from or to the urinary tract.

Technological Characteristics [21 CFR 807.92(a)(6)] Busse Hospital Disposables, Inc. believes that the subject device is substantially equivalent to the predicate device.

Busse Hospital Disposables, Inc. believes that the subject device is substantially equivalent to other devices that have previously received FDA 510(k) clearance including the predicate device.

Conclusion [21 CFR 807.92(b)(3)]

We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling an eagle's head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2004

Mr. Muhamad Ansari Quality Manager Busse Hospital Disposables P.O. Box 011067 HAUPPAUGE NY 11788

Re: K041464

Trade/Device Name: Busse Hospital Disposable Urethral Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZD Dated: October 20, 2004 Received: October 20, 2004

Dear Mr. Ansari:

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.

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

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Page 2 - Mr. Muhamad Ansari

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Errt 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.

In addition, we have determined that your device kit contains Iodophor PVP Swabsticks and Lubricant Jelly 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 (301) 594-4616. 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 of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/dsma/dsmamain.html

Sincerely yours,

Nancy C Brogdon

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

Enclosure

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FDA 510(k) Premarket Notification Busse Hospital Disposables - Urethral Catheter

INDICATIONS FOR USE

510(k) Number (if known): KO41464 ----

Device Name: Busse Hospital Disposable Urethral Catheter.

The device is a tubular device that is inserted through the urethra and utilized for passage of fluids from or to the urinary tract.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use	✓	OR
(Per 21 CFR 801.109)
	Nancy C Hogdon
(Division Sign-Off)

(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041464

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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.