(93 days)
The Epidural Catheter is indicated for the injection of local anesthetics into the epidural space. The duration of use should not exceed 72 hours.
The epidural catheter is made of flexible, nylon tubing. The catheters have a yellow radiopaque stripe. The catheter may be closed-ended with eyes or open-ended with a finished tip. The catheter has a marked tip with a single mark at 5cm from tip with 1cm increments, up to 15cm. The 10cm mark is indicated by two marks, 15cm by three marks, and 20mm by four marks.
The catheter is available in 20g (O.D. 1.05 mm/ I.D. 0.52 mm) or 21G (O.D. 0.83 mm/ I.D. 0.41 mm) sizes. The catheters have a nominal length of 36 inches.
The provided document is a 510(k) summary for the Portex® Epidural Catheter. It outlines the device description, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain detailed information regarding specific acceptance criteria for performance metrics, nor does it describe a study with specific performance results to prove the device meets such criteria.
The document states:
"All materials used in the fabrication of the Epidural Catheter were evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 "Biological Evaluation of Medical Devices". Design control activities have been completed and the results indicate that the subject device is safe and effective."
This statement indicates that testing was performed, but it does not provide the specific performance data, acceptance criteria, or the methodology of the study related to acceptance criteria as requested in your prompt.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory compliance through substantial equivalence to a predicate device and biological safety testing, rather than a detailed performance study with defined acceptance criteria and corresponding results.
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K 06 2005
Smi
Smiths Medical ASD, Inc.
Anesthesia and Safety Devices Division
10 Bowman Drive Keene NH 03431-0724 USA Tel: +1 603 352 3812 Fax: +1 603 352 3703 www.smiths-medical.com
510(K) SUMMARY:
OCT 1 8 2006
Company Information:
Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812, prompt 4, ext 2923 Contact: Cynthia Engelhardt Associate Regulatory Affairs Specialist
Summary Prepared: July 14, 2006
Product Name:
Trade Name: Portex® Epidural Catheter
Common Name: Anesthesia Conduction Catheter
Classification Name: Anesthesia Conduction Catheter (21 CFR 868.5120, Product Code BSO)
Predicate Device(s):
K992471, SIMS Portex Epidural Catheter
Device Description:
The epidural catheter is made of flexible, nylon tubing. The catheters have a yellow radiopaque stripe. The catheter may be closed-ended with eyes or open-ended with a finished tip. The catheter has a marked tip with a single mark at 5cm from tip with 1cm increments, up to 15cm. The 10cm mark is indicated by two marks, 15cm by three marks, and 20mm by four marks.
The catheter is available in 20g (O.D. 1.05 mm/ I.D. 0.52 mm) or 21G (O.D. 0.83 mm/ I.D. 0.41 mm) sizes. The catheters have a nominal length of 36 inches.
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Indications for Use:
The Epidural Catheter is indicted for the injection of local anesthetics into the epidural space. The duration of use should not exceed 72 hours.
Substantial Equivalence:
The substantial equivalence of the Epidural Catheter is supported by its similarities in design features, performance and indications for use to the SIMS Portex® Epidural Catheter (K992471).
Summary of Testing:
All materials used in the fabrication of the Epidural Catheter were evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 "Biological Evaluation of Medical Devices". Design control activities have been completed and the results indicate that the subject device is safe and effective.
Cimka EnAD
Cynthia Engelhardt Associate Regulatory Affairs Specialist
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes, oriented towards the right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0C1 1 8 2006
Ms. Cynthia Engelhardt Associate Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431-0724
Re: K062005
Trade/Device Name: Portex® Epidural Catheter Regulation Number: 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: September 26, 2006 Received: September 27, 2006
Dear Ms. Engelhardt:
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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Page 2 - Ms. Engelhardt
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Chiu Lien, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
KO62005 510(k) Number (if known):
Device Name: Portex® Epidural Catheter
Indications for Use:
The Epidural Catheter is indicated for the injection of local anesthetics into the epidural space. The duration of use should not exceed 72 hours.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K062005 |
13
§ 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).