(64 days)
The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.
The SIMS Portex Anesthesia 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 as 21g (O.D. .033"/I.D. .019"). 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, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).
The provided document, K994275, describes a 510(k) premarket notification for the SIMS Portex Anesthesia Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for a novel device, such as detailed performance metrics from a specific test set, expert adjudication, or MRMC studies, is not present in this document.
Instead, the document emphasizes equivalence through non-clinical data demonstrating that the new catheter performs equivalently to predicate devices for specific characteristics.
Here’s an analysis based on the provided text, addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalency to Predicate) | Reported Device Performance |
|---|---|---|
| Dimensional Characteristics | Identical design and materials to current catheter for: - Inner Diameter (ID) - Outer Diameter (OD) - Length | Demonstrated equivalency to predicate devices. |
| Functional Characteristics | - Flow Rate - Leakage - Eye Patency - Tensile Strength - Percentage Elongation - Luer Taper - Security of Connection of the catheter to the catheter connector - Hub/Catheter Detachment | Demonstrated equivalency to predicate devices. |
| Material Safety | - ETO residuals (Ethylene Oxide sterilization residuals) - Biological Safety per ISO 10993 | Data submitted covers ETO residuals and biological safety per ISO 10993. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the way one would for a clinical study with patients or a specific set of images for an AI algorithm. The performance evaluation was based on non-clinical data comparing the new device's characteristics against predicate devices. The exact sample sizes for each physical or material test (e.g., number of catheters tested for flow rate, tensile strength, etc.) are not provided in this summary.
Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these non-clinical, bench-top type tests. The tests would likely have been conducted in a lab setting by the manufacturer (SIMS Portex Inc., likely in Keene, NH, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation was based on objective, quantifiable physical and material tests against manufacturer specifications and predicate device characteristics, not subjective interpretations by experts to establish a "ground truth" in a clinical diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the non-clinical, bench-top tests conducted.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an anesthesia catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is an anesthesia catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate devices and recognized industry standards (e.g., ISO 10993 for biological safety). The new device's performance in dimensional, functional, and material safety tests was compared directly to these objective benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
This question is not applicable. The device is an anesthesia catheter and does not involve a training set as would be used for machine learning.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo is composed of two lines of text. The first line reads "SMITHS INDUSTRIES" in a bold, sans-serif font. The second line reads "Medical Systems" in a serif font.
FEB 2 2 2000
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 Director of Regulatory Compliance
PREPARATION DATE OF SUMMARY:
February 16, 2000
TRADE NAME:
SIMS Portex Anesthesia Catheter
COMMON NAME:
Anesthesia Conduction Catheter
PRODUCT CLASS/CLASSIFICATION:
Class II, 79 MEB, accessory to 21 CFR 880.5725 (infusion pump)
SIMS Portex Inc.
10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703
{1}------------------------------------------------
PREDICATE DEVICE(S):
SIMS Portex Inc., Epidural Catheter; 4910-18, 21g nylon, closed-end, three-eyed This device is marketed under 510(k), K992471.
- B. Braun Medical Inc., PERIFIX® Epidural Catheter Set, EC20-C This device is marketed under 510(k), K813186 and the indications for use are as specified in I-Flow Corporation's 510(k)s, K980558 and K991543.
DESCRIPTION:
The SIMS Portex Anesthesia 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 as 21g (O.D. .033"/I.D. .019"). 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, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).
INDICATIONS FOR USE:
The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Roures of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.
TECHNICAL CHARACTERISTICS:
The design of the catheter and materials are identical to our current catherer. The catheter has been evaluated and demonstrated equivalency to the predicate devices for the following dimensional and functional characteristics: ID, OD, length, flow rate, leakage, eye patency, tensile strength, percentage elongation, luer taper, and security of connection of the catheter to the catheter connector.
{2}------------------------------------------------
NON-CLINICAL DATA:
Data submitted demonstrates that the catheter performs equivalently to the predicate devices. Data submitted covers; dimensional characteristics, flow rate, leakage, hub/catheter detachment, tensile strength, elongation, ETO residuals, and biological safety per ISO 10993.
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. Fallon
Timothy J. Talcott Director of Regulatory Compliance
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2000
Mr. Timothy J. Talcott Manager, Regulatory Affairs SIMS Portex, Incorporated 10 Bowman Drive P.O. Box 0724 Keene, New Hamphshire 03431
Re : K994275 SIMS Portex Anesthesia Catheter Trade Name: Regulatory Class: II Product Code: FRN Dated: December 17, 1999 December 20, 1999 Received:
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 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 The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
{4}------------------------------------------------
Page 2 - Mr. Talcott
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.
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
U. Whitcomb
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
b
510(k) Number (if known): Unknown 13994275
Page 1 of 1
Device Name: Anesthesia Catheter
Indications For Use:
The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use __
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
Controly 994225
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).