The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

Device Description

The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endoscope valve assembly. It is designed for controlled irrigation through an endoscope during urological and/or endoscopic procedures. The design of the valve allows the irrigation to be controlled between the finger and the thumb of the hand holding the endoscope, leaving the other hand completely froe for stone extraction, lithotripsy, or biopsy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Kosin Technologies, LLC Piggyback Irrigating System:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel safety and effectiveness criteria. Therefore, the "acceptance criteria" are primarily based on demonstrating comparable performance and characteristics to the predicate device, the C.R. Bard Syringe Assist Irrigation System.

The table below summarizes the key comparative performance aspects mentioned in the document:

Acceptance Criteria (inferred from predicate comparison)	Kosin Piggyback Irrigating System (Reported Device Performance)	C.R. Bard Syringe Assist Irrigation System (Predicate Performance)
Intended Use	Irrigation of ureter and renal pelvis during therapeutic and diagnostic ureteroscopy/ureteropyescopy. Manual control of irrigation flow.	Irrigation of ureter and renal pelvis during therapeutic and diagnostic ureteroscopy/ureteropyescopy. Connects to endoscope with standard luer adapters.
Users	Hospitals, clinics, laboratories	Hospitals, clinics, laboratories
Materials	Polycarbonate, nylon, PVC, thermoplastic elastomer, silicone rubber, stainless steel	Natural Rubber Latex, polycarbonate, PVC, lubricant
Lubricant Composition	Medical grade silicone	Medical grade silicone
Sterility Assurance Level (SAL)	10^-6 SAL	10^-6 SAL
Packaging Material	Tyvek pouch	Tyvek pouch
Modes of Irrigation	1. Continuous by gravity 2. Intermittent by depressing plunger	1. Continuous by gravity 2. Intermittent by depressing plunger
Flow Rate (4-foot head height)	9.8 L/hr	14.7 L/hr
Flow Rate (6-foot head height)	12.0 L/hr	17.8 L/hr
Flow Rate (6-foot head height with pressure cuff)	14.4 L/hr	22.9 L/hr
Plunger Activation Force	0.76 lbf	3.99 lbf
Single Use Only	Single Use	Single Use
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Systemic Toxicity	Same (Implies similar satisfactory results)
Sterilization Method	Gamma	EtO

Note on "Acceptance Criteria": In a 510(k) for substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device by having similar technological characteristics and performance, or that any differences do not raise new questions of safety or effectiveness. The document highlights the differences in flow rate and plunger activation force, implying that these differences were deemed acceptable by the FDA for the device to be substantially equivalent.

Study Details

The provided document describes a comparative performance testing study.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the sample size (e.g., number of devices tested, number of measurements taken for flow rate or plunger activation).
- Data Provenance: The data is generated from "comparative performance testing" between the proposed and predicate devices. No information is provided regarding the country of origin or whether it was retrospective or prospective, but it implies a prospective lab-based testing scenario.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of performance testing (flow rate, plunger force, biocompatibility) typically does not involve human experts establishing "ground truth" in the way a clinical study or diagnostic imaging study would. The ground truth for characteristics like flow rate and activation force is established by objective physical measurements using calibrated equipment.
- For biocompatibility, the tests are performed according to established standards, and the results are interpreted against those standards, which are based on expert consensus in toxicology and materials science, but individual experts are not adjudicating cases.
Adjudication method for the test set:
- Not applicable. The study involves objective measurements and standard biocompatibility tests, not subjective interpretations requiring adjudication.
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 physical performance comparison between two medical devices, not an AI-assisted diagnostic study. Therefore, an MRMC comparative effectiveness study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used:
- For physical characteristics (flow rate, plunger activation), the ground truth is derived from objective, quantitative physical measurements using scientific instruments.
- For biocompatibility, the ground truth is established through standardized in vitro and in vivo testing that assesses cellular responses, sensitization, irritation, and systemic toxicity against accepted safety profiles for medical device materials.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

Confidential Kosin Technologies, LLC Piggyback Irrigating System Abbreviated 510(k)

APR 1 5 2004

K040094
Page 1 of 2

Section II

510(k) SUMMARY

Submitted by:	Kosin Technologies, LLC.3305 Greyfox DriveValparaiso, IN 46383Phone: (219) 508-3419
	Small Business Decision No.: SBD047023
	Expires: Sep, 30, 2004
	Payment Identification No.: 012216-956733
Contact Person:	Avtar S. Dhindsa, M.D.
Date Prepared:	January 14, 2004
Proprietary Name:	Piggyback Irrigating System
Common Name:	Endoscope Irrigation Tubing Set
Classification Name:	Endoscope And/Or Accessories
Predicate Device:	C.R. Bard Syringe Assist Irrigation510(k) #K905102

Description of the Device:

Intended Use of the Device:

The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

Technological Characteristics:

The Piggyback Irrigating System is substantially equivalent to the Bard Syringe Assist Irrigation under 510(k) number K905102. It has the same intended use, and is manufactured from similar biocompatible materials as the predicate device.

Performance Data:

Comparative performance testing was done, between the proposed Piggyback Irrigating System and the current C.R. Bard Syringe Assist Irrigation System. Data summaries and results from the testing are included in Table 1.

A biocompatibility assessment was performed on the materials with satisfactory results. Test results are included in Appendix B.

{1}------------------------------------------------

K04 oc 94
Page 2 of 2

Section II continued

	KosinPiggyback Irrigating System	C.R. BardSyringe Assist IrrigationSystem
Intended Uses	This device is intended for use inthe irrigation of the ureter andrenal pelvis during thetherapeutic and diagnosticureteroscopy/ureteropyescopy.Once the valve assembly ismounted to the endoscope, thephysician can manually controlthe flow of irrigation fluid duringurological and/or endoscopicprocedures.	This device is intended for use inthe irrigation of the ureter andrenal pelvis during thetherapeutic and diagnosticureteroscopy/ureteropyescopy. Itis connected to the endoscopewith standard luer adapters.
Users	Hospitals, clinics, laboratories	Hospitals, clinics, laboratories
Materials	Polycarbonate, nylon, PVC,thermoplastic elastomer, siliconerubber, stainless steel	Natural Rubber Latex,polycarbonate, PVC, lubricant
Lubricantcomposition	Medical grade silicone	Medical grade silicone
Sterility AssuranceLevel	10-6 SAL	10-6 SAL
Packaging material	Tyvek pouch	Tyvek pouch
Modes of irrigation	1. Continuous by gravity2. Intermittent by depressingplunger	1. Continuous by gravity2. Intermittent by depressingplunger
Flow Rate	- 4 foot head height = 9.8 L/hr- 6 foot head height = 12.0 L/hr- 6 foot head height = 14.4 L/hr(with pressure cuff)	- 4 foot head height = 14.7 L/hr- 6 foot head height = 17.8 L/hr- 6 foot head height = 22.9 L/hr(with pressure cuff)
Plunger activation	0.76 lbf	3.99 lbf
Single Use Only	Single Use	Single Use
Biocompatibility	CytotoxicitySensitizationIrritationSystemic Toxicity	Same
Sterilization method	Gamma	EtO

Table 1. Device Comparison Information - Similarities and Differences

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2004

Avtar S. Dhindsa, M.D. Kosin Technologies, LLC 3305 Greyfox Drive VALPARAISO IN 46383

Re: K040094

Trade/Device Name: Piggyback Irrigating System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJH Dated: January 14, 2004 Received: January 16, 2004

Dear Dr. Dhindsa:

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 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 CFR Part 807); labeling (21 CFR Part 801); 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.

{3}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonitiation. The I Dry intelligence 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 (21 CFR Part 801), please rr you the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/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

{4}------------------------------------------------

K0400094

Confidential Kosin Technologies, LLC Piggyback Irrigating System Abbreviated 510(k)

Section V

INDICATIONS FOR USE STATEMENT

510(k) Number:

K040094

Piggyback Irrigating System

Device Name:

Indications For Use:

The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR §801.109)

Over-The-Counter Use__

Nancy C. Hogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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.