(329 days)
For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
The Versa-Kath Epidural Catheter consists of a stainless steel spring lumen with a dual coating. The inner coating is Polyester tube and the outer coating is Fluorinated Ethylene Polypropylene tube. A stylet is also provided with the device which consists of a stainless steel wire and a molded plastic hub. The Versa-Kath will be provided as a sterile, single use, disposable device. The Versa-Kath will be a 21 gauge catheter available in various lengths.
Here's an analysis of the provided document regarding the acceptance criteria and study for the Versa-Kath Epidural Catheter:
The document does not describe an AI/ML medical device. It pertains to a physical medical device, the Versa-Kath Epidural Catheter, which is anesthesia conduction catheter. Therefore, many of the typical questions for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication, MRMC studies, standalone performance, etc.) are not applicable in this context.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench) testing.
Here's the information that can be extracted relevant to acceptance criteria and the study, as far as it applies to a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
| Flow | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
| Deflection (Stiffness) | Conformance to BS 6196 | Confirmed conformance to BS 6196 and similar to predicate device |
| Fluid Pressure (Catheter/Adapter Connection) | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
| Luminal Integrity | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the bench testing. It refers to "Bench Testing performed," implying that a sufficient number of samples were tested to support the conclusions. As this is bench testing of a physical device, data provenance (country of origin, retrospective/prospective) is not relevant in the same way it would be for clinical data or AI data. The tests were performed in a lab setting by the manufacturer, Epimed International, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is a physical device. "Ground truth" in this context would be objective physical measurements from testing, not expert consensus on medical images or clinical data.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling or diagnoses, which is not applicable here.
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
N/A. This is not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective engineering measurements and adherence to recognized standards (like BS 6196) during bench testing, and comparison to the characteristics of a legally marketed predicate device.
8. The Sample Size for the Training Set
N/A. This is not an AI device. There is no concept of a "training set" for this type of device.
9. How the Ground Truth for the Training Set was Established
N/A. This is not an AI device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study was a non-clinical bench testing evaluation designed to demonstrate that the Versa-Kath Epidural Catheter has substantially equivalent physical and technical characteristics and performance to its identified predicate device, the Racz Epidural Catheter (K954584).
Key aspects of the study:
- Type of Study: Bench testing (non-clinical).
- Tests Performed:
- Tensile strength
- Flow
- Deflection (stiffness)
- Fluid Pressure of the catheter/adapter connection
- Luminal integrity
- Methodology: The Versa-Kath Epidural Catheter was tested and its performance characteristics were directly compared to those of the predicate device. For deflection (stiffness), conformance to standard BS 6196 was also evaluated.
- Conclusion: The manufacturer concluded that the testing confirmed the Versa-Kath's performance is "similar to that of the device [predicate]" and demonstrated substantial equivalence, leading to its determination as "safe and effective."
The FDA's decision to clear the device (K023140) signifies their concurrence with the manufacturer's conclusion that the non-clinical data supported the substantial equivalence claim.
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Section II
510(K) Summary
Company Information:
Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Christopher B. Lake Manager of RA/QA
Date Prepared:
September 16, 2002 (revised January 15, 2003)(revised May 16, 2003)
Trade Name:
Versa-Kath Epidural Catheter
Common Name:
Anesthesia Conduction Catheter
Product Class/Classification:
Class II 73 BSO
Predicate Device(s):
Racz Epidural Catheter (K954584)
Description:
The Versa-Kath Epidural Catheter consists of a stainless steel spring lumen with a dual coating. The inner coating is Polyester tube and the outer coating is Fluorinated Ethylene Polypropylene tube. A stylet is also provided with the device which consists of a stainless steel wire and a molded plastic hub.
The Versa-Kath will be provided as a sterile, single use, disposable device. The Versa-Kath will be a 21 gauge catheter available in various lengths.
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Intended Use:
For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
Comparison to Predicate:
The Versa-Kath Epidural Catheter has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device.
Non-Clinical Data:
Bench Testing performed on the Versa-Kath Epidural Catheter to compare performance characteristics to the predicate device confirmed that the performance of the Versa-Kath is similar to that of the device. The devices were tested with regard to Tensile strength, Flow, and Deflection(stiffness) Conformance to BS 6196. Fluid Pressure of the catheter/adapter connection, luminal integrity were also compared to the predicate.
Conclusion:
The testing performed and comparison to the predicate device demonstrates that the Versa-Kath Epidural Catheter is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
Epimed International, Inc.
Carl Ah
Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs
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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 eagle with its wings forming three curved lines. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 2003
Mr. Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, NY 12095
Re: K023140
Trade/Device Name: Versa-Kath Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: May 16, 2003 Received: May 19, 2003
Dear Mr. Lake:
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 such 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.
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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.
This letter will allow you to begin marketing your device as described in your Section 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 (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Susan Runner, DDS/MA
Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure Indications for Use statement
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of____________________________________________________________________________________________________________________________________________________________________________ Page 1
510(k) Number (if known): K023140
Device Name: Versa-Kath Epidural Catheter
Indications For Use:
For administration of anesthetic agents 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)
Sthunk
I Hospital.
(Optional Format 3-10-98)
510(k) Number: K123140
\Prescription DEVICE
§ 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).