10Fr, 30cm, Silicone-Sealed, Curved Polyurethane Guide Catheter . with Guide Handle
4Fr, 120cm, Curved, Polyvinylchloride Cystic Duct Catheter with ● Luer-Lock Syringe Connector 5mm OD, 27cm length, Silicone-Sealed Polyurethane Introduction Tub

The Guide Catheter is provided with a curved tip and a guide handle. The tip is directable toward the desired site by turning the guide handle thus facilitating placement. The direction of the tip is always known as it is in direct relation to the direction flange on the quide handle.

The Cystic Duct Catheter provides centimeter markings at the distal tip to aid in placement.

Each Rüsch Guided Cholangiography Catheter will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear poly pouch with a medical paper seal. Each device will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed 5 units per box.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Rüsch Guided Cholangiography Catheter." This document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical study or performance verification test might.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) cannot be directly extracted from this document because it describes a regulatory submission for clearance, not a performance study report.

The document states:

The device is "substantially equivalent in design and materials" to existing predicate cholangiography catheters.
"The following technological characteristics are the same as or equivalent to the predicate devices listed above: Materials: The materials used in the cystic duct catheter, the guide catheter and the introducer tube have all been used in predicate Rüsch devices."

This implies that the acceptance criteria were primarily about demonstrating this substantial equivalence in terms of materials, design, and intended use, aligning with the regulatory requirements for a 510(k) submission. Performance is inferred through equivalence, not explicitly detailed with quantitative metrics in this summary.

Based on the provided text, here's what can be answered:

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

Acceptance Criteria (Inferred from 510(k) context)	Reported Device Performance (as stated in 510(k) summary)
Design Equivalence: Catheter design and components are similar to predicate devices.	"The Rüsch Guided Cholangiography Catheter is substantially equivalent in design and materials to: The COOK Unger Endoscopic Cholangiography Set, The COOK Franklin Endoscopic Cholangiography Set, The COOK Directable Coaxial Catheter Set."
Material Equivalence: Materials used are safe and functionally similar to predicate devices.	"The materials used in the cystic duct catheter, the guide catheter and the introducer tube have all been used in predicate Rüsch devices."
Intended Use Equivalence: Device's purpose matches that of predicate devices.	"The Rüsch Guided Cholangiography Catheter is intended for intraoperative cholangiography during laparoscopic cholecystectomy." (Matches the general intended use of predicate cholangiography catheters).
Sterilization: Device can be manufactured sterile.	"Each Rüsch Guided Cholangiography Catheter will be provided sterile, by either Gamma Irradiation or Ethylene Oxide..."
Basic Functionality (Inferred): Tip directability, cystic duct catheter placement assistance.	"The Guide Catheter is provided with a curved tip and a guide handle. The tip is directable toward the desired site by turning the guide handle thus facilitating placement. The direction of the tip is always known as it is in direct relation to the direction flange on the quide handle.""The Cystic Duct Catheter provides centimeter markings at the distal tip to aid in placement."

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

This information is not provided in the 510(k) summary. A 510(k) submission for substantial equivalence generally focuses on engineering design, materials, and comparison to existing devices, rather than a clinical trial-style test set performance evaluation with sample sizes.

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)

This information is not provided as there is no mention of a formal clinical test set with expert ground truth establishment.

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

This information is not provided as there is no mention of a formal clinical test set with expert ground truth establishment.

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, a MRMC comparative effectiveness study was not done. This device is a physical medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

No, a standalone algorithm performance study was not done. This device is a physical catheter, not a software algorithm.

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

The "ground truth" for this 510(k) submission is primarily the established safety and effectiveness of the predicate devices and the established safety and biocompatibility of the materials used. No specific clinical ground truth based on expert review or pathology for a new performance claim is mentioned.

8. The sample size for the training set

This information is not provided as this is a physical device submission, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as this is a physical device submission, not an AI/machine learning algorithm.

Summary

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JUN 1 7 2003

Image /page/0/Picture/1 description: The image shows the brand name "RUSCH" in bold, black letters. Above the brand name is the text "KC23666 page" and "lofa". Below the brand name is the text "INTERNATIONAL Group Regulatory Affairs A Subsidiary of Teleflex Incorporated (USA)".

Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108

510 (k) Summary

1. Submitter Name, Address, and Date of Submission:

Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park Jaffrey, NH 03452 Telephone Number: (603) 532-0204 Fax Number: (603) 532-6179

rlykins@tfx.com E-Mail:

Contact :

Date of Submission: October 29, 2002

Name of the Device, Common, Proprietary (if known), and 2. Classification:
Same as above

Classification Name: Endoscope and Accessories

Common Name: Cholangiography Catheter

Proprietary Name: Rüsch Guided Cholangiography Catheter

3 . Identification of the legally marketed device to which the submitter claims equivalence:

Cholangiography Catheter is The Rüsch Guided substantially equivalent in design and materials to:

The COOK Unger Endoscopic Cholangiography Set - 510(k) Unknown
The COOK Franklin Endoscopic Cholangiography Set - 510(k) Unknown
The COOK Directable Coaxial Catheter Set - K891746

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2666

Page 2

Description of the Device: 4 .

The Rüsch Guided Cholangiography Catheter is a sterile, singleuse device that consists of the following components:

10Fr, 30cm, Silicone-Sealed, Curved Polyurethane Guide Catheter . with Guide Handle
4Fr, 120cm, Curved, Polyvinylchloride Cystic Duct Catheter with ● Luer-Lock Syringe Connector 5mm OD, 27cm length, Silicone-Sealed Polyurethane Introduction Tub

The Guide Catheter is provided with a curved tip and a guide The tip is directable toward the desired site by handle. turning the guide handle thus facilitating placement. The direction of the tip is always known as it is in direct relation to the direction flange on the quide handle.

The Cystic Duct Catheter provides centimeter markings at the distal tip to aid in placement.

5. Intended Use of the Device:

The Rüsch Guided Cholangiography Catheter is intended for intraoperative cholangiography during laparoscopic cholecystectomy.

6. Summary of Technological Characteristics:

The following technological characteristics are the same as or equivalent to the predicate devices listed above:

Materials:

materials used in the cystic duct catheter, the guide The catheter and the introducer tube have all been used in predicate Rüsch devices.

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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be part of a document or publication.

'JUN 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park 50 Plantation Drive JAFFREY NH 03452

Re: K023666

Trade/Device Name: Rusch Guided Cholangiography Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 25, 2003 Received: March 26, 2003

Dear Mr. Lykins:

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.

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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 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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.lxxx	(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/dsmaldsmamain.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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Page 1 of 1

510(k) Number (if known): K823666

Rüsch Guided Cholangiography Catheter Device Name:

Indications for Use:

Guided Cholangiography Catheter "is intended The Rüsch for laparoscopic cholangiography during intraoperative cholecystectomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The

Over-The-Counter Use

(Optional Format 1-2-96)

David A. Lyman

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

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.