(247 days)
Not Found
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
Not Found
No
The device description and intended use focus on a physical catheter for drainage and anesthesia delivery, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is used to deliver local anesthetic to relieve postoperative pain, which is considered a therapeutic application. The drainage function also contributes to therapeutic intervention.
No
Explanation: The device is described as a catheter used for draining fluids and administering local anesthetic, with no mention of diagnostic capabilities. Its function is to facilitate drainage and provide pain relief, not to identify or monitor medical conditions.
No
The device description clearly details a physical catheter made of silicone with multiple lumens, funnels, and a stopcock. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Function: The description clearly states the device is a catheter used to drain fluids and exudates during or after surgery and to deliver local anesthetic into the body (specifically, the pleural space). This is an invasive procedure performed in vivo (within the body).
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its function is therapeutic (drainage and pain relief).
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Typical applications include: - For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of topical anaesthetic to relieve pleural pain.
Product codes
73 BSO
Device Description
This Axiom Interpleural Anesthesia Catheter is simplicity of design assures effective operation with added convenience. The sterile single patient use component includes the following: - A conveniently sized two Lumen Catheter made of Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 18 Fr. up to 28 Fr. will be offered. - The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first Funnel as a fluid outlet (Drainage function). - The second Lumen connected to the second Funnel as a fluid inlet (Irrigation function) and the Funnel is equipped with a three-way or four-way Stopcock.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
AXIOM MEDICAL, INC.
555 West Victoria Rancho Dominguez, California 90220 Telephone 310-898-1779 • Facsimile 310-632-1326
JAN 2 2 1998
In compliance with the requirements of section 510(k) of the Food, Drug, and Cosmetic Act as amended, and 21 CFR Section 807.92(a)(1), This "510(k) Summary" is on a product we intend to market in 90 days.
Company name : Axiom Medical Inc. 555 W. Victoria Street Address : Rancho Dominguez, Ca. 90220 (310) 898 - 1779 Phone number : (310) 632 - 1326 Fax number : Contact person : Ridwan Hardy
Date of Submission: 05/16/1997
1
DEVICE NAMES 1.0
- 1.1 Trade Name: Axiom Interpleural Anesthesia Catheter
- 1.2 Common Name: Anesthesia Catheter
- 1.3 Classification Name: Anesthesia Conduction Catheter (Per 21 CFR section 868.5120)
2.0 PRODUCT DESCRIPTION
This Axiom Interpleural Anesthesia Catheter is simplicity of design assures effective operation with added convenience. (see Exhibit A: Photograph and Exhibit B: Engineering Drawing) The sterile single patient use component includes the following:
- 2.1 A conveniently sized two Lumen Catheter made of Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 18 Fr. up to 28 Fr. will be offered.
- 2.2 The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first Funnel as a fluid outlet (Drainage function).
- 2.3 The second Lumen connected to the second Funnel as a fluid inlet (Irrigation function) and the Funnel is equipped with a three-way or four-way Stopcock.
2
3.0 SUBSTANTIAL EQUIVALENCE COMPARISON
This device is substantially equivalent in sterility, material and drainage function with our Mills Filtered Mediastinal Sump, also is substantially equivalent in indications for use to Interpleural Anesthesia Kit with Polyurethane Catheter marketed by Arrow International, Medical Disposable Inc. and Baxter Pharmaseal. These companies offer Interpleural Anesthesia Kit and teflon epidural catheter.
4.0 INTENDED USE OF THE DEVICE
Typical applications include:
- For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of topical anaesthetic to relieve pleural pain.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol, with three parallel lines curving upwards and to the right, resembling a stylized human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Mr. Ridwan Hardy Axiom Medical, Inc. 555 West Victoria Street Rancho Dominguez, CA 90220
K971851 Re : Interpleural Anesthesia Catheter Regulatory Class: II (two) Product Code: 73 BSO Dated: November 3, 1997 November 5, 1997 Received:
Dear Mr. Hardy:
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 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 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodio (QS) --inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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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Page 2 - Mr. Ridwan Hardy
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 leqally 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 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 requlation 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas Y. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if Known): K971851
Device Name: Axiom Interpleural Anesthesia Catheter
Indications For Use:
Typical applications include:
- For use where a routine chest tube is required to drain fluids and exudates . during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.
(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 Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K971851 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
Revised: 01/16/98