(88 days)
The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
The SIMS Portex Epidural Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks. The catheter is available in 20g (O.D. .042"/I.D. .023") or 21g (O.D. .033"/I.D. . 019") sizes. The catheters have a nominal length of 38 inches. The catheters may include a stylete. The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics and/or analgesics. They are provided sterile in individual packages or as a component of a continuous epidural procedure tray (K965017).
The provided 510(k) summary for the SIMS Portex Epidural Catheter indicates that no clinical data was submitted to demonstrate the device meets acceptance criteria. Instead, the submission relies on non-clinical data to establish substantial equivalence to a predicate device.
Therefore, many of the requested sections regarding clinical study design, ground truth, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted and a clear indication where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Characteristics | Performs equivalently to predicate device |
| Flow Rate | Performs equivalently to predicate device |
| Compression Resistance | Performs equivalently to predicate device |
| Hub/Catheter Detachment | Performs equivalently to predicate device |
| Deflection Resistance | Performs equivalently to predicate device |
| Modulus of Elasticity | Performs equivalently to predicate device (with an increase in percent elongation compared to predicate due to material change, but this has "no affect on performance criteria"). |
| Tensile Strength | Performs equivalently to predicate device |
| Elongation | Performs equivalently to predicate device (with an increase in percent elongation compared to predicate due to material change, but this has "no affect on performance criteria"). |
| ETO Residuals | Data submitted (implies acceptable levels) |
| Biological Safety (per ISO 10993) | Data submitted (implies acceptable levels based on ISO 10993 standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set. Non-clinical data was used.
- Data Provenance: Not applicable. Non-clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size of Human Readers with/without AI assistance: Not applicable, as this is neither an AI device nor was an MRMC study performed.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Not applicable. This is not an AI algorithm. The device is a physical epidural catheter.
7. Type of Ground Truth Used
- For Non-Clinical Data: Engineering specifications, material science standards (e.g., ISO 10993 for biological safety), and comparative measurements against the predicate device.
8. Sample Size for the Training Set
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI algorithm requiring a training set or ground truth establishment for training.
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OCT 222 1999
SIMS Portex Inc.
10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION:
SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs
PREPARATION DATE OF SUMMARY:
July 23, 1999
TRADE NAME:
SIMS Portex Epidural Catheter
COMMON NAME:
Anesthesia Conduction Catheter
PRODUCT CLASS/CLASSIFICATION:
Class II, 73 BSO, 21 CFR 868.5120
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PREDICATE DEVICE(S):
SIMS Portex Inc. epidural catheters; 4910-16/17, 20g nylon, closed-end. three-eved 4910-18, 21g nylon, closed-end, three-eyed
These devices are marketed as 'Preamendment'.
DESCRIPTION:
The SIMS Portex Epidural Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks.
The catheter is available in 20g (O.D. .042"/I.D. .023") or 21g (O.D. .033"/I.D. . 019") sizes. The catheters have a nominal length of 38 inches. The catheters may include a stylete.
The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics and/or analgesics. They are provided sterile in individual packages or as a component of a continuous epidural procedure tray (K965017).
INDICATIONS FOR USE:
The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
TECHNICAL CHARACTERISTICS:
The design of the catheter is identical to the predicate device, accept for the change in material. This change in material has no affect on performance criteria, accept an increase in percent elongation.
NON-CLINICAL DATA:
Data submitted demonstrates that the epidural catheter performs equivalently to the predicate device. Data submitted covers; dimensional characteristics, flow rate, compression resistance, hub/catheter detachment, defection resistance modulus of elasticity, tensile strength, elongation, ETO residuals, and biological safety per ISO 10993.
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CLINICAL DATA:
Not applicable
CONCLUSION:
The comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.
Very truly yours,
SIMS PORTEX INC.
Timothy J. Talbott
Timothy J. Palcott Manager, Regulatory Affairs
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human figure in profile, with three flowing lines representing the body and head. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1999
Mr. Timothy J. Talcott SIMS Portex Inc. 10 Bowman Drive Keene, NH 03431
K992471 Re: Epidural Catheter Requlatory Class: II (two) Product Code: 73 BSO Dated: July 23, 1999 Received: July 26, 1999
Dear Mr. Talcott:
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 (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 requlations 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 Requlation (QS) for Medical Devices: General requlation (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 requlatory 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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Paqe 2 - Mr. Timothy J. Talcott
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) 594-4648. 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,
Jean A Welsh-fer,
Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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B: INTENDED USE OF DEVICE
PROPOSED INDICATIONS FOR USE:
Page 1 of 1
510(k) Number (if known): Unknown
Device Name: Epidural Catheter
Indications For Use:
The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use Prescription Use
ter Use
(Division Sign Off)
(Div Div sion of Cardiovascular, Respiratory, and Neurological Devi
510(k) Number K99247/
7
§ 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).