(108 days)
Not Found
No
The device description and intended use focus on a mechanical catheter with lumens and a balloon. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on design verification and validation of the physical device.
Yes
The device is used for "removal of stones from the bile duct," which is a direct treatment aimed at alleviating a medical condition.
No
The device is indicated for "fluoroscopic examination of and removal of stones from the bile duct," which involves both visualization (examination) and intervention (removal of stones). While examination can be part of diagnosis, the primary function, as described, is not solely diagnostic. It's a procedural device used for removing stones, with examination being a part of that procedure.
No
The device description clearly states it is a physical catheter with a balloon and lumens, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fluoroscopic examination of and removal of stones from the bile duct." This describes a procedure performed within the body (in vivo) for diagnostic imaging and therapeutic intervention.
- Device Description: The device is a catheter with a balloon, lumens for guidewire passage and fluid injection. This is a medical device used for direct interaction with anatomical structures.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a patient's health. This device does not perform such analysis.
Therefore, the TeleMed Systems 3-Lumen Occlusion Balloon Catheter is a medical device used for an in-vivo procedure, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TeleMed Systems 3-Lumen Occlusion Balloon is indicated for use in fluoroscopic examination of and removal of stones from the bile duct.
Product codes
78 FGE
Device Description
The 3-Lumen Occlusion Balloon consists of a compliant polymer balloon mounted on a plastic shaft. The shaft has 3 internal lumens, each of which terminates in a proximal connector and connection tube. The lumens are used for balloon inflation, guidewire passage and distal fluid injection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bile 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)
Design Verification and Validation testing has been performed to ensure that the modified device meets design specifications: V&V testing has been summarized in this Special 510(k). The proposed 3-Lumen Occlusion Balloon has been compared to the TeleMed Systems' Occlusion Balloon as cleared in K901427.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
MAR 1 2002
XIV. 510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, TeleMed Systems, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." TeleMed Systems chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | 3-Lumen Duralon Occlusion Balloon |
|---|---|
| Owner/Operator: | TeleMed Systems, Inc. |
| 8 Kane Industrial Drive | |
| Hudson, MA 01749 | |
| Manufacturing Site: | TeleMed Systems, Inc. |
| 8 Kane Industrial Drive | |
| Hudson, MA 01749 | |
| Device Generic Name: | Occlusion Balloon Catheter |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Performance Standards (FGE). | |
| Predicate Devices: | TeleMed Systems Occlusion Balloon (K901427) |
Product Description:
The 3-Lumen Occlusion Balloon consists of a compliant polymer balloon mounted on a plastic shaft. The shaft has 3 internal lumens, each of which terminates in a proximal connector and connection tube. The lumens are used for balloon inflation, guidewire passage and distal fluid injection.
Indications for Use:
The TeleMed Systems 3-Lumen Occlusion Balloon is indicated for use in fluoroscopic examination of and removal of stones from the bile duct.
Safety and Performance:
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Pre-Market Notifications." In support of this 510(k), TeleMed Systems. Inc. has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Design Verification and Validation testing has been performed to ensure that the modified device meets design specifications: V&V testing has been summarized in this Special 510(k). The proposed 3-Lumen Occlusion Balloon has been compared to the TeleMed Systems' Occlusion Balloon as cleared in K901427.
Conclusion:
Based on the indications for use, technological characteristics, comparison to a predicate device and V&V testing results, the TeleMed Systems, Inc. 3-Lumen Occlusion Balloon Catheter has been shown to be safe and effective for its intended use.
1
Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850
MAR 1 2002
Mr. Michael Carroll President and CEO TeleMed Systems, Inc. 8 Kane Industrial Drive HUDSON MA 01749
Re: K013737
Trade/Device Name: TeleMed Systems, Inc. 3-Lumen Occlusion Balloon Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: January 30, 2002 Received: January 31, 2002
Dear Mr. Carroll:
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.
Image /page/1/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
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 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.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 Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page _ 1 _ of __ 1
510(k) Number (if known): _ K 0 /373 7
TeleMed Systems, Inc. 3-Lumen Occlusion Balloon Device Name:
Indications for Use:
The TeleMed Systems 3-Lumen Occlusion Balloon Catheter is indicated for use The Telemed Oystembe of and removal of stones from the bile duct.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Durand C. Sisson
(Division Sign-Division of Reprod and Radiological L 510(k) Numb
OR
Prescription Use
(Per 21 CFR 801.109)
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________