(87 days)
No
The summary does not mention AI, ML, or any related concepts like image processing or performance metrics typically associated with AI/ML devices. The description focuses on the physical characteristics and intended use of a catheter.
No
The device is used for diagnostic purposes (imaging with radiopaque medium) during a surgical procedure, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" states that the catheter is "designed to provide vital diagnostic information" and is used for "injecting radiopaque medium" which is a diagnostic procedure to visualize the cystic duct.
No
The device description clearly states it is a "Cholangiographic Balloon Catheter" and mentions physical components like a "radiopaque band" and "two lumen size," indicating it is a physical medical device, not software-only.
Based on the provided information, 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 description clearly states the catheter is used for "Accessing the cystic duct and injecting radiopaque medium during Laparoscopic Cholecystomy procedures." This is an invasive procedure performed directly on the patient's body, not on a sample taken from the body.
- Purpose: The purpose is to facilitate imaging (using radiopaque medium) during a surgical procedure to visualize the cystic duct, which is a diagnostic step, but it's done in vivo (within the living body).
Therefore, this device falls under the category of a medical device used for diagnostic purposes in vivo, but it is not an IVD.
N/A
Intended Use / Indications for Use
The catherer is designed to provide vital diagnostic information. It is indicated for:
Accessing the cystic duct and injecting radiopaque medium during Laparoscopic Cholecystomy procedures.
Product codes
GCJ
Device Description
This Cholangiographic Balloon Catheter is furnished in four French two lumen size, with a radiopaque band proximal to the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cystic duct
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)
The performance data such as mechanical strength tests remain the same as with the Predicate Device.
The Biological, Chemical. and Sterilization specifications remain the same as the Predicate Device, in that the only physical difference is the addition of Stainless Steel band.
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
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
974336
FEB 1 3 1998
415 Commerce Lane, Suite 6, Berlin, New Jersey 08009, U.S.A. Telephone 809-753-8339 Fax 609-753-8340
510 K SUMMARY (as required by 807.92 c)
Date: February 10, 1998
Submitter: James L. Skages, Sr. 415 Commerce Lane, Suite 6 Berlin, New Jersey 08009 Phone: 609-753-8339 FAX: 609-753-8340
Contact Person: Same as above.
Product: Cholangiography Balloon Catheter
I. Predicate Device:
The J-LLoyd Modical, Inc. Wedge Pressure Catheter has been approved by FDA 510K #K935403. The function of this device is to provide pressure data and the injection of drugs ..
II. Description of New Device:
This Cholangiographic Balloon Catheter is furnished in four French two lumen size, with a radiopaque band proximal to the balloon
III. Intended Use of New Device:
This catheter is designed for use as follows:
-
- Access the cystic duct and inject radiopaque medium during Laparoscopic cholecystomy procedures.
IV. Technological Characteristics of New Device and Predicate Device (510K #K935403).
- Access the cystic duct and inject radiopaque medium during Laparoscopic cholecystomy procedures.
- The Cholangiographic Balloon Catheter and the Predicate Catheter are basically the same, using the same materials, the same basic design and the same methods of assembly.
1
415 Commerce Lane, Suite 6, Berlin, New Jersey 08009, U.S.A. Telephone 609-753-8339 Fax 609-753-8340
-
The difference is the addition of a radiopaque band to the Predicate Device The addition of the band increases the functions of the catheters does not change the basic design.
-
The performance data such as mechanical strength tests remain the same as with the Predicate Device.
-
The Biological, Chemical. and Sterilization specifications remain the same as the Predicate Device, in that the only physical difference is the addition of Stainless Steel band.
V. Safety Statement:
-
As with any invasive procedure, there are certain inherent hazards, however, these hazards have been identified in the instruction sheet under the titles of Precautions and Warnings. It is immortant that the physicians be aware of the basic principles involved prior to using these devices in their varied application.
-
Based on engineering the J-LL oyd Medical, Inc. devices and the fact that the basic design has been in use since before May 28, 1976, by thousands of physicians, in hundreds of hospitals world wide, it is our judgement that this device presents an acceptable level of safety when properly used by a trained physician.
James L. Staggs, Jr.
General Manager
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Mr. James L. Skaggs, Sr. General Manager J-LLoyd Medical, Incorporated 415 Commerce Lane, Suite 6 West Berlin, New Jersey 08091
Re: K974336
Trade Name: Cholangiograph Balloon Catheter Regulatory Class: II Product Code: GCJ Dated: November 15, 1997 Received: November 18, 1997
Dear Mr. Skaggs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the ----current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
3
Page 2 - Mr. Skaggs
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
-Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
74336
CUKH UVE
Page _ of _
S10(k) Number (if known): ___ 510 -- K K974336
Device Name:__Cholangiograph Balloon Catheter
Indications For Use:
The catherer is designed to provide vital diagnostic information. It is indicated for:
Accessing the cystic duct and injecting radiopaque medium during Laparoscopic Cholecystomy procedures.
(FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994336
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use