The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dillatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

Device Description

The PPD Balloon Dilatation Catheter consists of a polymer balloon mounted on a plastic shaft. The balloon can be inflated to different diameters depending on the inflation pressure; each balloon is capable of inflation to three or four distinct and progressively larger sized diameters at the recommended pressures. Proximal luer connectors are provided for balloon inflation and quidewire passage.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided documents:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Safety & Performance	Balloon Burst Testing	Implied: Meet specifications for balloon integrity under pressure	Performed (specific results not detailed in summary)
Safety & Performance	Pressure vs. Diameter Confirmation	Implied: Achieve specified diameters at recommended inflation pressures	Performed (specific results not detailed in summary)
Safety & Performance	Scope Passage Testing	Implied: Proper functionality and compatibility with intended endoscopic equipment	Performed (specific results not detailed in summary)
Regulatory Compliance	Design Control Requirements (21 CFR 820.30)	Certification of compliance	Certified as compliant
Regulatory Compliance	Risk Analysis Procedure	Description of internal risk analysis procedure (to mitigate identified risks)	Description provided; risks analyzed as per internal procedure
Intended Use	Dilatation of GI strictures	Effective in dilatation of gastrointestinal strictures of various etiologies as indicated	Concluded to be safe and effective for intended use

Study Details

The provided documents describe a Special 510(k): Device Modification submission for the TeleMed Systems PPD™ Balloon Dilatation Catheter. This type of submission generally relies on bench testing (laboratory studies) and comparison to predicate devices, rather than clinical trials with human participants, especially for Class II devices with established mechanisms of action.

Given this context, many of the typical elements of a clinical study (like sample size for test sets, ground truth establishment for AI, MRMC studies) are not applicable here.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a "test set" from a patient population, as this was primarily bench testing. The "sample size" would refer to the number of catheters tested in each bench test (e.g., how many balloons were burst, how many were tested for pressure-diameter). This information is not provided in the summary.
- Data Provenance: The data provenance is from bench testing performed by TeleMed Systems, Inc. at their manufacturing site in Hudson, MA, USA. This is retrospective in the sense that the studies were performed on the device after its design, but not on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for bench testing is derived from engineering specifications and established test methodologies (e.g., a balloon bursts or it doesn't; it inflates to a certain diameter at a given pressure or it doesn't). Expert consensus in a clinical sense is not relevant for this type of testing.
Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretations of patient data. For bench testing, results are typically objective measurements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- The "ground truth" for the performance testing (balloon burst, pressure vs. diameter, scope passage) would be engineering specifications and physical measurements demonstrating the device's ability to meet its design requirements and function safely as intended.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable. As above, no training set is involved.

Summary

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SPECIAL 510(k) PREMARKET NOTIFICATION: DEVICE MODIFICATIO

510k) 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:	PPD™ Balloon Dilatation Catheter
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:	Balloon Dilatation Catheter
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II, PerformanceStandards (78KNQ).
Predicate Devices:	GI balloon dilatation catheters marketed by TeleMed Systemsand Boston Scientific

Product Description:

Indications for Use:

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 Premarket 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. Performance testing conducted in support of this submission included balloon burst testing, pressure vs. diameter confirmation and scope passage testing.

Conclusion:

Based on the indications for use, technological characteristics, performance testing results and comparison to predicate devices, the TeleMed Systems, Inc. PPD™ Balloon Dilatation Catheters have been shown to be safe and effective for their intended use.

TeleMed Systems, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 6 2002

Re: K020379

Trade/Device Name: PPDTM Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Product Code: 78 KNT Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Product Code: 78 FGE Regulatory Class: II Dated: April 4, 2002 Received: April 8, 2002

Dear Mr. Carroll:

Mr. Michael Carroll

TeleMed Systems, Inc.

8 Kane Industrial Drive HUDSON MA 01749

President & CEO

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.

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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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510(k) Number (if known): _ K020379

TeleMed Systems, Inc. PPD*™ Balloon Dilatation Catheter Device Name:

Indications for Use:

The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dilatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, diffation of gastromotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

(PLEASE 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 Reproductive, Abdominal, and Radiological Devices
510(k) Number	K020379
Prescription Use(Per 21 CFR 801.109)
OR	Over-the-Counter Use

TeleMed Systems, Inc.

PPD™ Balloon Dilatation Catheter K020379/Amendment 1

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.