OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 by IMPLEMED, INC.

The OLIGON™ FOLEY CATHETER is an all silicone, dual lumen Folcy catheter (manufactured for Implemed, Inc. by Kendall I Icalthcare Products Company) which has been coated with Implemed's proprietary OLIGON'IM matcrial. The OLIGON™ coating is a patented silver based coating which has been shown in laboratory testing to actively release silver ions when exposed to saline. Under these test conditions, the 16 Fr catheters (91 cnt surface area) released a total of 3,4 milligrams of silver over 28 days and the 18 Fr catheters (96 cm2 surface arca) would release a total of 3.6 milligrams of silver over 28 days.

The OLIGON™ FOLEY CATHETER is supplied in two sizes; 16 Fr. and 18 Fr. (outer diameler). OLIGON™ Folcy catheters are supplied storile for single use. Individual catheters are packaged in sterilizable Tyvek/mylar pouches.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the absence of information rather than making assumptions:

Acceptance Criteria and Device Performance

This document describes a medical device (a Foley catheter) that is being put forward for substantial equivalence to a predicate device. The primary "performance" being evaluated is its equivalence to an existing device and its compliance with relevant standards.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Compliance
Intended Use	The device is intended to pass fluids to or from the urinary tract.	The OLIGON™ FOLEY CATHETER has the same intended use as the predicate device: to pass fluids to or from the urinary tract.
Technological Characteristics	Substantial equivalence to the predicate device, especially regarding functional aspects for passing fluids to and from the urinary tract.	The technological characteristics of the OLIGON™ FOLEY CATHETER are substantially equivalent to those of the predicate device. Functionally, they are identical with respect to intended use.
Performance Standard (Foley Catheter)	Conformance to ASTM Standard F 623-89, "Standard Performance Specification for Foley Catheter."	Both the subject device and the predicate device conform to the requirements of the ASTM Standard F 623-89.
Biocompatibility	Evaluation and successful meeting of biocompatibility requirements contained within applicable parts of ANSI/AAMI/ISO Standard 10993: Biological Evaluation of Medical Devices.	The OLIGON™ FOLEY CATHETER has been evaluated according to the applicable Parts of the ANSI/AAMI/ISO Standard 10993 and has successfully met the biocompatibility requirements.
Sterilization	Supply as sterile via EtO sterilization processes conforming to ANSI/AAMI/ISO Standard 11135, "Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization."	Both the subject device and the predicate device are supplied sterile via EtO sterilization processes conforming to the ANSI/AAMI/ISO Standard 11135.
Silver Ion Release (Specific to OLIGON™)	Active release of silver ions when exposed to saline. (Specific quantitative criteria from the document: 16 Fr catheters release a total of 3.4 mg of silver over 28 days; 18 Fr catheters release 3.6 mg of silver over 28 days. Release rate ≥ 5.0 x 10-5 mg/cm2 · hour on first extraction).	Laboratory testing showed the OLIGON™ coating actively releases silver ions when exposed to saline: 16 Fr catheters released 3.4 mg over 28 days; 18 Fr catheters released 3.6 mg over 28 days. The coating has been shown to release silver ions at a rate of ≥ 5.0 x 10-5 mg/cm2 · hour on first extraction. The predicate device does not have such a coating.

Study Details:

Based on the provided text, this submission is for a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than an extensive clinical trial or AI performance study typically associated with device performance claims like sensitivity, specificity, etc. The "study" referenced is primarily a series of bench tests and laboratory evaluations confirming physical, chemical, and biological properties, and conformance to standards.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "16 Fr catheters (91 cm2 surface area)" and "18 Fr catheters (96 cm2 surface area)" for silver ion release testing. It does not specify the number of individual catheters tested for this or any other criteria (e.g., biocompatibility, ASTM standard conformance).
- Data Provenance: The data is from "laboratory testing" and refers to "Implemed's proprietary OLIGON™ material." This is likely internal company testing, not specified as retrospective or prospective, nor does it specify country of origin beyond the company's US address.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is compliance with established engineering and biocompatibility standards, and measurable physical/chemical properties (like silver release), not clinical diagnoses or interpretations by human experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used for clinical studies involving human interpretation or diagnosis, which is not described here.
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) submission, not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is mentioned or relevant in this context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device (catheter) submission, not an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the silver release data: Laboratory measurements and quantitative chemical analysis.
- For standard conformance: Engineering and design specifications and test results demonstrating compliance with recognized standards (ASTM, ISO/AAMI).
- For biocompatibility: Laboratory assays and tests confirming the absence of adverse biological reactions as per ISO/AAMI 10993.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device submission, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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MAY 1 8 1999

510(k) SUMMARY [Refer to 21 CFR §807.92] Page 1 of 2

(99050

Submitted by:	Implemed, Inc.313 Pleasant StreetWatertown, MA 02472(617) 923-6375
Contact Person:	Anthony L. Blank
Date Prepared:	May 13, 1999
Proprietary Name:	OLIGON™ FOLEY CATHETER
Common Name:	Urinary Drainage Catheter (Foley)
Classification Name:	urological catheter, retention type, balloon (78 EZL)Class II as described in 21 CFR 876.5130 (b)
Predicate Device:	Kendall 100% Silicone Foley CatheterKendall Healthcare Products Company510(k) Document Control Number: K933400

The OLIGON™ FOLEY CATHETER is an all Description of the Device: siliconc, dual lumen Folcy catheter (manufactured for Implemed, Inc. by Kendall I Icalthcare Products Company) which has been coated with Implemed's proprietary OLIGON'IM matcrial. The OLIGON™ coating is a patented silver based coating which has been shown in laboratory testing to actively release silver ions when exposed to saline. Under these test conditions, the 16 Fr catheters (91 cnt surface area) released a total of 3,4 milligrams of silver over 28 days and the 18 Fr catheters (96 cm2 surface arca) would release a total of 3.6 milligrams of silver over 28 days.

Intended Use of the Device: The subject device has the same intended use as the prodicate device. The device is intended to pass fluids to or from the urinary lract.

Technological Characteristics: The technological characteristics of the OLIGON™ FOLEY CATHETER are substantially equivalent to those of the predicate device. Both the subject device and the predicate device conform to the requirements of the ASTM Standard F 623-89, entitled Standard Performance Specification for Foley Catheter. In addition, the OLIGON™ FOLEY CATHETER has been evaluated according to the applicable Parts of the

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K990509
1.2k

510(k) SUMMARY [Refer to 21 CFR §807.92] Page 2 of 2

ANSI/AAMI/ISO Standard 10993: Biological Evaluation of Medical Devices and has successfully met the biocompatibility requirements contained within the standard. Both the subject device and the prodicate device are supplied sterille via EtO sterilization processes conforming to the ANSUAAMI/ISO Standard 11135, entitled Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.

Functionally the OLIGON™ FOLEY CATHETER and the Kendall Curity 100% Silicone Folcy Cathetcr are identical with respect to intended use of the catheter to pass fluids to and from the urinary tract. The only technological difference in the subject device and predicate device concerns the OLIGON™ coating of the OLIGON™ FOLEY CATHETER. The OLIGON™ coating applied to the surface of the subject device has becn shown to release silver ions at a rate of ≥ 5.0 x 10-5 mg/cm2 · hour on first extraction. The predicate device does not have such a coating.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/16 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", also in black. The text is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 1999

Mr. Anthony Blank Director, Regulatory and Clinical Affairs Implemed. Inc. 313 Pleasant Street Watertown, Massachusetts 02472

Re: K990509 Implemed Oligon™Foley Catheter Dated: February 9, 1999 Received: February 18, 1999 Regulatory Class: II 21 CFR §876.5130/Product Code: 78 EZL

Dear Mr. Blank:

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 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). 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 III (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 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 your 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) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT VII.

#K 510(k) Number:

)

OLIGON™ FOLEY CATHETER Device Name:

The OLIGON™ FOLEY CATHETER is used to pass fluids to or from Indications for Use: the urinary tract.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __
(Per 21 CFR §801.109)

Over-The-Counter Use __

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number __K990509

000020

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.