(89 days)
Not Found
No
The description focuses on the material properties and physical characteristics of a Foley catheter with a silver coating, with no mention of AI or ML.
No.
The device description states it is "used to pass fluids to or from the urinary tract," which is a diagnostic or supportive function, not a therapeutic one. While it has an antimicrobial coating, its primary function as described in the "Intended Use / Indications for Use" is not therapeutic.
No
The device is described as a Foley catheter used to pass fluids to or from the urinary tract, which is a therapeutic rather than a diagnostic function. It does not mention detection, diagnosis, or monitoring of medical conditions.
No
The device description clearly states it is a physical Foley catheter, which is a hardware device, and describes its material composition and physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pass fluids to or from the urinary tract." This describes a device used in vivo (within the body) for a therapeutic or diagnostic procedure directly on the patient.
- Device Description: The description details a Foley catheter, which is a medical device inserted into the bladder.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are typically used in laboratories or point-of-care settings to analyze samples from the body. This device is clearly designed for direct use within the patient's urinary tract.
N/A
Intended Use / Indications for Use
The OLIGON™ FOLEY CATHETER is used to pass fluids to or from the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
78 EZL
Device Description
The OLIGON™ FOLEY CATHETER is an all silicone, dual lumen Foley catheter (manufactured for Implemed, Inc. by Kendall Healthcare Products Company) which has been coated with Implemed's proprietary OLIGON™ material. 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 cm2 surface area) released a total of 3.4 milligrams of silver over 28 days and the 18 Fr catheters (96 cm2 surface area) 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 diameter). OLIGON™ Foley catheters are supplied sterile for single use. Individual catheters are packaged in sterilizable Tyvek/mylar pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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)
Not Found
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
§ 876.5130 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.
0
MAY 1 8 1999
510(k) SUMMARY [Refer to 21 CFR §807.92] Page 1 of 2
(99050
| Submitted by: | Implemed, Inc.
313 Pleasant Street
Watertown, 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 Catheter
Kendall Healthcare Products Company
510(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.
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.
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
1
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.
2
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
3
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)
OR
Over-The-Counter Use __
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number __K990509
000020