(163 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for continuous or intermittent regional anesthesia, which is a therapeutic intervention to manage pain.
No
The device is described as an anesthesia catheter used for administering anesthetics and/or analgesics, not for diagnosing a condition.
No
The device description clearly details a physical catheter made of nylon tubing with a stylet and connector, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is a device used to deliver anesthetic and/or analgesic medications directly into the body (epidural, caudal, or peripheral spaces) for pain management. This is an in vivo application (within the living body).
The description clearly states its use for administering substances into the patient, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatric applications (children under 12 years, infants and necures) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and periodenal blocks. The duration of use should not exceed 72 hours.
Product codes
BSO, CA7
Device Description
The Portex® 24g Pediatric Epidemiological and Peripheral Block Anesthesia Catherer is made of flexible, nylon tubing. The catheter is open-ended catheter with finished tip. The tipe 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 catherer is available in 24g (O.I). 0.022"/I.D. 0.012") size. The catheters have a nominal length of 36 inches. The catheter includes a stylet. The catheters are provided with a catheter connector to provide a means of administration of anesthetics and/or analgesics. They are provided sterile as a component of a continuous anesthesia conduction catheter mini tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric applications (children under 12 years, infants and necures)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical data was submitted demonstrating equivalence to predicate devices, covering: dimensional characteristics, flow rate, compression resistance, hub/catheter detachment, deflection resistance mounts of elasticity, tensile strength, and elongation. Clinical data was not applicable.
Key Metrics
Not Found
Predicate Device(s)
K962696, K992471, K924541, K935927
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text "K033080" written in a handwritten style. The text is oriented diagonally, starting from the bottom left and moving towards the upper right. The characters are slightly slanted, giving the impression of cursive writing, and the numbers are clearly distinguishable.
MAR 1 0 2004
smiths
Smiths Medical ASD, Inc.
Anesthesia and Safety Devices Division
10 Buwman Drive Keene NI103431-0724 USA [et: +] 403 352 3812 Fax: +1 603 352 3703 www.smiths-modical.com
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION:
Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Cynthia Engelhardt Technical Writer, Regulatory Affairs
PREPARATION DATE OF SUMMARY:
March 94, 2004
TRADE NAME:
Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter
COMMON NAME:
Anesthesia Conduction Catheter
PRODUCT CLASS/CLASSIFICATION:
Class II, 73 BSO, 21 CFR 868.5120
1
PREDICATE DEVICE(S):
Predicate 1: The B. Braun Periflex Continuous Epidural Pediatric Tray, K962696. This is the main predicate device cited for catheter size, design characteristics and indication for use.
Predicate 2: Our current 16g and 18g Epidural Catheter kits, K992471. This predicate device is cited, in conjunction with Predicate 1 above for materials, biocompatibility, sterilization and packaging.
Predicate 3: Our 23g Pediatric Epidural Minipack, K924541. This predicate device is cited, in conjunction with Predicate 1 above for tensile strength and elongation.
Predicate 4: Our 21g High Durometer Epidural; Catheter, K935927. This predicate device is cited, in conjunction with Predicate 2 above for biocompatibility for the ink.
DESCRIPTION:
The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catherer is made of flexible, nylon tubing. The catheter is open-ended catheter with finished tip. The tipe 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 catherer is available in 24g (O.I). 0.022"/I.D. 0.012") size. The catheters have a nominal length of 36 inches. The catheter includes a stylet.
The catheters are provided with a catheter connector to provide a means of administration of anesthetics and/or analgesics. They are provided sterile as a component of a continuous anesthesia conduction catheter mini tray.
INDICATIONS FOR USE:
The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatric applications (children under 12 years, infants and necures) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and periodenal blocks. The duration of use should not exceed 72 hours.
2
TECHNICAL CHARACTERISTICS:
The design of the proposed catheter is similar to predicate 1 marketed under premarket notification K962696 by B. Braun and predicate 3 that we have authorization to market under premarket notification K924541 . The catherer material is identical to predicate 2 that we have authorization to market under premarket notification K965017. The loak is identical to predicate 4 that we have authorization to market under premarket not fination K935927. The technical characteristics of the characteristics fall within the values of the predicate Portex catheters and the B. Braun catheter.
NON-CLINICAL DATA:
Data submitted demonstrates that the anesthesia conduction catheter performs equivalently to the predicate devices. Data submitted covers; dimensional characteristics, flow rate, compression resistance, hub/catheter detachment, deflection resistance mounts of elasticity, tensile strength, and elongation.
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.
SMITHS MEDICAL ASD, INC.
Cynthia Errigott
Cynthia Engelhardt Technical Writer, Regulatory Affairs
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2004
Ms. Cindy Engelhardt Regulatory Affairs/Technical Writer Portex Incorporated 10 Bowman Drive Keene, NH 03431
Re: K033080
Trade Name: Portex 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthetic Conduction Kit Regulatory Class: II Product Code: CA7. Dated: February 18, 2004 Received: February 19, 2004
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 classificd (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.
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
4
Page 2 – Ms. Cindy Engelhardt
CFR Part 807); labeling (21 ClFR 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,
Chiu Lin, 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
5
Indications for Use
510(k) Number (if known): K033080
Device Name: Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter
Indications for Use:
The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatic applications (children under 12 years, infants and neonates) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and peripheral blocks. 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)
tAill
510(k) Number: