(135 days)
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.
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. Both catheters are sold as sterile, single-use devices. Both catheters are radiopaque and designed to administer continuous epidural and/or caudal anesthesia.
The provided text describes a 510(k) premarket notification for the Feth-R-Kath Epidural Catheter, focusing on its substantial equivalence to a predicate device. The information primarily comes from regulatory approval documents and thus lacks details on a traditional clinical study with specific acceptance criteria and detailed performance reporting.
However, based on the provided text, I can infer and summarize the information related to the device's acceptance criteria and the "study" (bench testing in this case) that supports it.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined as meeting or exceeding the performance characteristics of the predicate device, the Arrow International Flex Tip Plus® epidural catheter, and other epidural catheters currently on the market.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Tensile Strength (at least equivalent to predicate) | The Feth-R-Kath either met or exceeded the performance characteristics of the Flex Tip Plus® and other market catheters with regard to tensile strength. |
| Percent Elongation (at least equivalent to predicate) | The Feth-R-Kath either met or exceeded the performance characteristics of the Flex Tip Plus® and other market catheters with regard to percent elongation. |
| Flow Rate (at least equivalent to predicate) | The Feth-R-Kath either met or exceeded the performance characteristics of the Flex Tip Plus® and other market catheters with regard to flow rate. (Note: Feth-R-Kath has a slightly larger inner diameter, 0.021 inch vs. 0.019 inch for Flex Tip Plus, which would generally allow for higher flow rates, supporting the "exceeded" claim). |
| Kink Resistance (at least equivalent to predicate) | The Feth-R-Kath either met or exceeded the performance characteristics of the Flex Tip Plus® and other market catheters with regard to kink resistance. |
| Biocompatibility (non-pyrogenic and biocompatible) | The Epimed Feth-R-Kath has been proven to be non-pyrogenic and biocompatible in its finished state. |
| Radiopacity (equivalent to predicate) | Both catheters are radiopaque. |
| Substantial Equivalence (to predicate device in design, composition, performance, and intended use, and poses no additional safety/effectiveness issues) | "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." "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 Feth-R-Kath poses no additional risks in safety and/or effectiveness than the Arrow Flex Tip Plus® epidural catheter." |
2. Sample sizes used for the test set and the data provenance
The document refers to "bench testing" but does not specify the exact sample size for the test set for each performance characteristic (tensile strength, percent elongation, flow rate, kink resistance). It mentions that "the catheters were tested," implying a sufficient number for comparison, but no specific N is given.
- Sample size for test set: Not explicitly stated (implied to be sufficient for bench testing comparisons).
- Data provenance: Bench testing results, likely conducted internally by Epimed International, Inc. The document does not specify the country of origin of the data beyond the company's location (Gloversville, NY, USA). It is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device and study. Bench testing for physical performance characteristics of a medical device does not typically involve human experts establishing "ground truth" in the way it would for diagnostic imaging or clinical outcomes. The "ground truth" for these tests would be derived from calibrated measurement equipment and established engineering standards.
4. Adjudication method for the test set
This is not applicable as the "test set" involves physical measurements and comparisons, not subjective interpretations requiring adjudication.
5. 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
This is not applicable. The device is an epidural catheter, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
For the performance characteristics (tensile strength, percent elongation, flow rate, kink resistance), the "ground truth" was established by objective measurements using engineering principles and industry standards, compared against the performance of a predicate device and other market-available catheters. For biocompatibility, standard biocompatibility testing protocols were used.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this device's bench testing and 510(k) submission. This concept applies to machine learning algorithms.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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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
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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
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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
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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)
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(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)
§ 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).