(25 days)
Cannulation of the Papilla of Vater to deliver contrast medium for fluoroscopic visualization of the biliary/pancreatic system.
The ProFormaTM HF 4.5 Cannula is used for endoscopic cannulation of the biliary ductal system. With a tapered, atraumatic tip, and high flow injection port, this device provides cannulation of the papilla and access into the biliary system. The 4.5 French tip accepts a 0.035" (0.889 mm) guidewire. The unique multi-lumen port design at the proximal end, allows for injection of contrast medium through two lumens with a separate port for guidewire passage.
Colored visual markers located on the distal tip endoscopically aid in the assessment of cannulation and insertion into the biliary system. A distal radiopaque maker band aids in fluoroscopic visualization. A proximal marker band indicates when the catheter exists the duodenoscope.
The provided K050777 document does not contain information about a study proving device performance against acceptance criteria for an AI/ML powered device.
This document describes a 510(k) submission for a medical device called the "ProForma™ HF 4.5 Cannula," which is used for endoscopic cannulation of the biliary ductal system. The submission is from 2005, significantly predating the widespread use and regulatory framework for AI/ML in medical devices.
Therefore, I cannot fulfill your request for information related to acceptance criteria and a study proving an AI/ML device meets them based on this document. The document focuses on establishing substantial equivalence for a physical medical device based on its technological characteristics, biocompatibility, and functionality testing, not on the performance of a software algorithm.
{0}------------------------------------------------
APR 2 2005
Image /page/0/Picture/2 description: The image shows the logo for CONMED Endoscopic Technologies. The logo features a stylized "C" shape in black, followed by the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the phrase "ENDOSCOPIC TECHNOLOGIES" in a smaller, sans-serif font. There is a line above the phrase "ENDOSCOPIC TECHNOLOGIES".
VI 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.
| A. Submitter Information | |
|---|---|
| Submitter's Name: | ConMed Endoscopic Technologies, Inc.ConMed Corp. |
| Address: | 129 Concord Road, Bldg. #3Billerica, MA 01821 |
| Phone: | (978) 964-4253 |
| Fax: | (978) 964-4250 |
| Contact Person: | Michael A. Patz |
| Date of Preparation: | March 24, 2005 |
| B. Device Name | |
| Trade Name: | ProForma™ HF 4.5 Cannula |
| Common/Usual Name: | Dilator, Esophageal, Biliary |
| Classification Name: | Biliary Catheter/Accessories, Esophageal Dilator |
| C. Predicate Device Name(s) | |
| Trade Name: | ProForma™ Cannula |
{1}------------------------------------------------
- D. Device Description:
The ProFormaTM HF 4.5 Cannula is used for endoscopic cannulation of the biliary ductal system. With a tapered, atraumatic tip, and high flow injection port, this device provides cannulation of the papilla and access into the biliary system. The 4.5 French tip accepts a 0.035" (0.889 mm) guidewire. The unique multi-lumen port design at the proximal end, allows for injection of contrast medium through two lumens with a separate port for guidewire passage.
Colored visual markers located on the distal tip endoscopically aid in the assessment of cannulation and insertion into the biliary system. A distal radiopaque maker band aids in fluoroscopic visualization. A proximal marker band indicates when the catheter exists the duodenoscope.
-
E. Intended Use:
The ProForma™ HF 4.5 Cannula is used for "Cannulation of the Papilla of Vater to deliver contrast medium for fluoroscopic visualization of the biliary/pancreatic system. -
F. Technological Characteristics Summary:
The ProForma" HF 4.5 Cannulas are comprised of the similar medical grade plastics, inks and radiopaque material as the current device. -
G. Performance Data:
Functionality, biocompatibility and ship testing were completed and demonstrated that the modified ProForma" HF 4.5 Cannula is substantially equivalent to the current ProForma" Cannula and that the device is safe for its intended use and patient population.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white logo. The logo is circular and contains an image of a bird in the center. The bird is stylized with three curved lines representing its body and wings. The text "INSTITUTI I LUFTES DHE KULTURES" is written around the top half of the circle.
APR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael A. Patz Sr. Regulatory Affairs Specialist ConMed® Endoscopic Technologies, Inc. ConMed® Corporation 129 Concord Road, Building #3 BILLERICA MA 01821
Re: K050777
Trade/Device Name: Proforma™ HF 4.5 Cannula Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 24, 2005 Received: March 28, 2005
Dear Mr. Patz:
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 (Premarket Approval), it may be subject to such 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 r carreres and eng, 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) (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 Scetion 510(k) I his letter will anow you to ocgin manceang your antial equivalence of your device to a legally premarket nothleation: The PDA mainly of basification 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 If you desire specific advice for your device of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation charies, formation on your responsibilities under the Act from the 807.97). Tou may odually other general intenational and Consumer Assistance at its toll-free number (800) DVNSIon of 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}------------------------------------------------
Indications for Use Statement
| 510(k) Number (if known): | TBD K050777 |
|---|---|
| Device Name: | ProForma™ HF 4.5 Cannula |
| Indications For Use: | Cannulation of the Papilla of Vater to deliver contrast medium for fluoroscopic visualization of the biliary/pancreatic system. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 11 (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
David h. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 1050777 510(k) Number _
Page 17 of 95
§ 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.