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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a Special 510(k) for a device modification, focusing on proving substantial equivalence to a predicate device rather than setting new performance acceptance criteria for a novel device. Therefore, explicit, quantifiable acceptance criteria with corresponding reported performance values like sensitivity, specificity, or accuracy are not present as they would be for an AI/ML diagnostic.

Instead, the "acceptance criteria" are implied to be adherence to design specifications and demonstration that the modified device is as safe and effective as the predicate device. The "reported device performance" is the successful completion of Design Verification and Validation (V&V) testing.

Acceptance Criteria (Implied)	Reported Device Performance
Meets Design Specifications	V&V testing performed to ensure modified device meets design specifications.
Safe and Effective for Intended Use	Based on indications for use, technological characteristics, comparison to predicate device, and V&V testing results.
Compliant with 21 CFR 820.30 Design Control requirements	Certification of compliance provided.
Risk Analysis conducted	Description of internal Risk Analysis procedure provided.
Substantial Equivalence to Predicate Device (K901427) maintained	Demonstrated through comparison to predicate and V&V testing.

2. Sample Size and Data Provenance:

Test Set Sample Size: Not explicitly stated. The document refers to "Design Verification and Validation testing" but does not detail the number of units or data points used in this testing.
Data Provenance: Not specified. Given the nature of a medical device modification (Occlusion Balloon Catheter), the V&V testing would likely involve bench testing, simulated use, and potentially pre-clinical animal studies, but the origin (e.g., country) of any data used is not mentioned. It is implicitly prospective testing as it's part of design validation for a new modification.

3. Number of Experts and Qualifications:

Not applicable. This is a medical device submission for an occlusion balloon catheter, which does not involve interpretation of medical images or data by human experts for ground truth establishment in the way AI/ML diagnostic devices do.

4. Adjudication Method:

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. See point 3. This device is a physical medical instrument, not a diagnostic AI/ML algorithm.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. See point 3. This is not an algorithm but a physical device.

7. Type of Ground Truth Used:

The "ground truth" for this device is derived from engineering specifications, material properties, mechanical testing results, and functional performance benchmarks against the predicate device. For example, balloon inflation pressures, lumen patency, material strength, and sterilization efficacy would be assessed against predefined criteria. It is based on objective, measurable physical properties and functional outcomes rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the design and manufacturing process, where iterations and physical testing lead to the final design.

9. How Ground Truth for Training Set was Established:

Not applicable. As this is not an AI/ML device, there is no "training set." The design and manufacturing processes are guided by regulatory standards, engineering principles, internal quality management systems (e.g., 21 CFR 820.30 Design Control), and the performance characteristics of the predicate device. Ground truth for these processes is established through engineering design reviews, risk analysis, material specification, and rigorous physical testing of prototypes and production samples.

Summary

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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 DriveHudson, MA 01749
Manufacturing Site:	TeleMed Systems, Inc.8 Kane Industrial DriveHudson, MA 01749
Device Generic Name:	Occlusion Balloon Catheter
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.Performance Standards (FGE).
Predicate Devices:	TeleMed Systems Occlusion Balloon (K901427)

Product Description:

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.

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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.

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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.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

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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

Prescription Use
(Per 21 CFR 801.109)

Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

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.