(208 days)
Not Found
Not Found
No
The description focuses on the mechanical function and design of a wound drain, with no mention of AI or ML capabilities.
Yes.
The description explicitly states "application of anesthetic to relieve postoperative pain" as an intended function, which is a therapeutic purpose.
No
Explanation: The device description states its purpose is for "draining fluids and exudates during or after surgery" and for "sump gravity, irrigation function or application of anesthetic." These are therapeutic or supportive functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly describes a physical catheter made of silicone with lumens, ports, a suture ring, and a connector. This is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes draining fluids and exudates during or after surgery, providing sump gravity, irrigation, or anesthetic application. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a catheter designed for drainage and fluid management within the body. This aligns with a surgical or therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to manage fluids and potentially deliver medication within the body.
N/A
Intended Use / Indications for Use
For use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumen allows for sump gravity, irrigation function or application of anesthetic to relieve postoperative pain.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
This Axiom Multipurpose Wound Drain is simplicity of design assures effective operation with added convenience. It is a conveniently sized double Lumens Catheter made of silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 14 Fr. up to 36 Fr. coated or no coated 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 proximal end and connected with polypropylene Christmas tree connector as a fluid outlet (Drainage function). The Catheter equips with suture ring to secure the catheter in the position.
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)
The test results demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Axiom Sump Drain with Filter, Axiom Interpleural Anesthesia Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SUMMARY
SAFETY AND EFFECTIVENESS for 510(K) OF AXIOM MULTIPURPOSE WOUND DRAIN
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.
- (1) Submitter's name, address, telephone number, contact person, date of preparation
| Company name: | Axiom Medical Inc. |
|---|---|
| Address: | 555 W. Victoria Street |
| Rancho Dominguez, Ca. 90220 | |
| Phone number: | (310) 898 - 1779 |
| Fax number: | (310) 632 - 1326 |
Contact person: Ridwan Hardy
Date of preparation: 10/01/1999
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(2) Name of the device
Trade Name: Axiom Multipurpose Wound Drain Common Name: Irrigation Drainage Catheter Classification Name: Anesthesia Conduction Catheter (Per 21 CFR 868.5120) -
(3) ldentification of predicate devices
Axiom Sump Drain with Filter Axiom Interpleural Anesthesia Catheter -
(4) Description of the device
This Axiom Multipurpose Wound Drain is simplicity of design assures effective operation with added convenience. It is a conveniently sized double Lumens Catheter made of silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 14 Fr. up to 36 Fr. coated or no coated 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 proximal end and connected with polypropylene Christmas tree connector as a fluid outlet (Drainage function). The Catheter equips with suture ring to secure the catheter in the position.
1
Christmas tree connector as a fluid outlet (Drainage function). The Catheter equips with suture ring to secure the catheter in the position.
-
(5) Intended use of the device
For use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumen allows for sump gravity, irrigation function or application of anesthetic to relieve postoperative pain. -
(6) Comparison to predicate devices
This device is substantially equivalent in material, indications for use, sterility, drainage and irrigation function with the predicate devices. The lumen of Axiom Multipurpose Wound Drain is designed with full internal diameter and various lengths for drainage and irrigation function. Suture Ring is provided on each catheter to secure the position of the catheter in the body. -
(7) Performance data
The test results demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle.
Public Health Service
MAY 1 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ridwan Hardy Development Engineer Axiom Medical, Incorporated 555 West Victoria Street 90220 Rancho Dominquez, California
K993592 Re : Axiom Multipurpose Wound Drain Trade Name: Requlatory Class: II Product Code: FRN Dated: March 13, 2000 Received: March 14, 2000
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 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) regulation (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 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
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Page 2 - Mr. Hardy
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT F STATEMENT OF INDICATIONS FOR USE
warry 510(K) Number (if Known): NA
Device Name: Axiom Multipurpose Drain
Indications For Use:
Typical applications include:
- For use where a routine drainage tube is required to drain fluids and . exudates during surgery or after surgery. The additional lumen allows for sump gravity, irrigation function or application of local anaesthetic to relieve postoperative pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR Over-The-Counter Use
Patrice Crescent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K993597