(229 days)
Not Found
No
The device description focuses on mechanical components and their physical manipulation for placement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended for intraoperative cholangiography, which is a diagnostic procedure to image the bile ducts, not to treat a condition.
No.
The device is used to facilitate intraoperative cholangiography, which is a procedure to visualize the bile ducts. While the cholangiography itself is a diagnostic imaging procedure, the device, a catheter, is a tool for delivering contrast or guiding other tools, not for diagnosing on its own.
No
The device description clearly outlines physical components like catheters, a guide handle, and introduction tubing, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Rüsch Guided Cholangiography Catheter is a surgical instrument used during a surgical procedure (laparoscopic cholecystectomy) to facilitate the injection of contrast material into the bile ducts for imaging (cholangiography). It is a tool used in vivo (within the living body) to aid in visualization, not a test performed on a sample in vitro (outside the living body).
- Intended Use: The intended use clearly states it's for "intraoperative cholangiography during laparoscopic cholecystectomy," which is a surgical procedure.
- Device Description: The description details the physical components of a catheter system designed for insertion into the body.
The device is a surgical tool used to enable a diagnostic imaging procedure (cholangiography), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Rüsch Guided Cholangiography Catheter is intended for intraoperative cholangiography during laparoscopic cholecystectomy.
Product codes
78 FGE
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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.
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.
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.
2
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.
3
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
4
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)
OR
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