(135 days)
Not in text
Not Found
No
The summary describes a physical medical device (epidural catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an epidural catheter intended for the administration of local anesthetics to provide continuous epidural or caudal anesthesia, which is a therapeutic intervention to manage pain.
No
The device is an epidural catheter intended for the administration of local anesthetics, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical epidural catheter made of Fluoropolymer and stainless steel, and the performance studies involve bench testing of physical characteristics like tensile strength and flow rate.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of local anesthetics into the epidural space for anesthesia. This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is an epidural catheter, a physical tool used to deliver medication.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for drug delivery.
N/A
Intended Use / Indications for Use
The Epimed Feth-R-Kath epidural catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
Product codes
73 BSO
Device Description
The Epimed Feth-R-Kath epidural catheter is a Class II device that is substantially equivalent to the Arrow International Flex Tip Plus® epidural catheter in design, composition, performance characteristics and intended use.
Both devices incorporate a Fluoropolymer tube encompassing a stainless steel spring. The Arrow Flex Tip Plus® is a 19G catheter 36 inches in length. The Feth-R-Kath will be offered in both a 19G and 20G size each with a length of 36 inches. The Flex Tip Plus® has a .019 inch inner diameter while the Feth-R-Kath has a .021 inch inner diameter.
The 20G version of the Feth-R-Tip is identical to the 19G Feith-R-Tip in all regards except dimensional specifications. The smaller outer diameter creates a smaller inner diameter.
The catheter is designed to be introduced into the epidural space via an epidural needle. Connection to an epidural filter or syringe is facilitated by attaching a connector to the proximal end. Both catheters are sold as sterile, single-use devices. Both catheters are radiopaque and designed to administer continuous epidural and/or caudal anesthesia. The Epimed Feth-R-Kath has been proven to be non-pyrogenic and biocompatible in it's finished state.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
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
Bench testing was performed on each epidural catheter to compare performance characteristics. The Feth-R-Kath either met or exceeded the performance characteristics of the Flex Tip Plus®. The catheters were tested with regard to tensile strength, percent elongation, flow rate and kink resistance and the results were compared to the predicate device as well as other epidural catheters currently on the market.
The 20G catheter was tested for performance characteristics in an identical fashion as the 19G. These results were compared to other 20G epidural catheters currently on the market as well as the predicate device. Epimed International, Inc. determined the 20G Feth-R-Kath was substantially equivalent in performance to the predicate device and posed no additional safety or effectiveness issues.
Key Metrics
Not Found
Predicate Device(s)
Arrow International Flex Tip Plus® epidural catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
0
AUG 26 1998
SECTION II
510(K) SUMMARY
Feth-R-Kath® Epidural Catheter Proprietary Name: Epidural Catheter Common Name: Classification Name: Anesthesia Conduction Catheter
Prepared: Tuesday, April 07, 1998
Epimed International, Inc. 6 Division Street Gloversville, NY 12078
The Epimed Feth-R-Kath epidural catheter is a Class II device that is substantially equivalent to the Arrow International Flex Tip Plus® epidural catheter in design, composition, performance characteristics and intended use.
Both devices incorporate a Fluoropolymer tube encompassing a stainless steel spring. The Arrow Flex Tip Plus® is a 19G catheter 36 inches in length. The Feth-R-Kath will be offered in both a 19G and 20G size each with a length of 36 inches. The Flex Tip Plus® has a .019 inch inner diameter while the Feth-R-Kath has a .021 inch inner diameter.
The bench testing performed on each epidural catheter to compare performance characteristics confirmed that the Feth-R-Kath either met or exceeded the performance characteristics of the Flex Tip Plus®. The catheters were tested with regard to tensile strength, percent elongation, flow rate and kink resistance and the results were compared to the predicate device as well as other epidural catheters currently on the market.
The 20G version of the Feth-R-Tip is identical to the 19G Feith-R-Tip in all regards except dimensional specifications. The smaller outer diameter creates a smaller inner diameter. The 20G catheter was tested for performance characteristics in an identical fashion as the 19G. These results were compared to other 20G epidural catheters currently on the market as well as the predicate device. Epimed International, Inc. determined the 20G Feth-R-Kath was substantially equivalent in performance to the predicate device and posed no additional safety or effectiveness issues.
The intended use of the subject device is equivalent to the predicate device. The catheter is designed to be introduced into the epidural space via an epidural needle. Connection to an epidural filter or syringe is facilitated by attaching a connector to the proximal end. Both catheters are sold as sterile, single-use devices. Both catheters are radiopaque and designed to administer continuous epidural and/or caudal anesthesia. The Epimed Feth-R-Kath has been proven to be non-pyrogenic and biocompatible in it's finished state.
DAY02RH/ODE/OHC
1
All known problems associated with the safety and/or effectiveness of the device have been investigated and evaluated. The Feth-R-Kath poses no additional risks in safety and/or effectiveness than the Arrow Flex Tip Plus® epidural catheter. The risks or hazards associated with the device are clearly defined on the products' label as warnings and/or precautions.
Submitted By: Epimed International Incorporated 6 Division Street Gloversville, NY 12978
Contact:
ﻬﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ
Donald R. Henderson
Donald R. Henderson, Director RA/QA
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 1998
Mr. Donald R. Henderson Epimed International, Inc. 6 Division Street P.O. Box 1128 Gloversville, NY 12078
Re: K981329 FETH-R-KATH Regulatory Class: II (two) Product Code: 73 BSO June 23, 1998 Dated: Received: June 25, 1998
Dear Mr. Henderson:
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, Druq, and Cosmetic Act (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 II (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.
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Page 2 - Mr. Donald R. Henderson
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ K 9 & 1329 Device Name: Feth - R- KAth
Indications For Use:
The Epimed Feth-R-Kath epidural catheter is intended for __ administration of local anesthetics into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
crane
(Division
Division o
and Neuro
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use -------
(Optional Format 1-2-96)