(208 days)
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.
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.
Here's an analysis of the provided text regarding the Axiom Multipurpose Wound Drain, focusing on acceptance criteria and study information:
Based on the provided document (K993592), there is no specific information about detailed acceptance criteria or a dedicated study with performance metrics for this device.
The document, a 510(k) Summary for the Axiom Multipurpose Wound Drain, states that the device is "substantially equivalent" to predicate devices. This type of clearance relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring a full-scale clinical trial with specific performance targets.
Here's an attempt to answer the questions based on the limited information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The core "acceptance criteria" for 510(k) clearance is showing substantial equivalence to predicate devices. | The document states: "The test results demonstrate that the device is substantially equivalent to the legally marketed predicate devices." |
Explanation: The 510(k) process focuses on demonstrating equivalence to existing devices. Therefore, the "performance" here refers to the device being able to perform the same functions (drainage, irrigation, local anesthetic application) with similar safety and efficacy profiles as the predicate devices, rather than achieving specific quantitative metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document refers to "test results" in a general sense, not a specific clinical study with a defined sample size. These "tests" would likely have been bench testing or performance testing against engineering specifications, rather than patient data.
- Data provenance: Not specified. It's highly probable that any testing conducted would have been internal, pre-market bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. For this type of device and 510(k) submission, "ground truth" established by experts in a clinical context (e.g., radiologists, pathologists) is not typically required or mentioned. The assessment would be against engineering specifications and comparison to the predicate device's design and functionality.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. Performance evaluation for this device in a 510(k) context would likely involve engineering testing and comparison to predicate device specifications, not expert adjudication of clinical outcomes.
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
- MRMC study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI or image interpretation. The Axiom Multipurpose Wound Drain is a surgical fluid management device, not a diagnostic one.
- Effect size of human reader improvement with AI: Not applicable. The device does not involve AI or human "readers" in the context of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This device is not an algorithm. Its performance is related to its physical capabilities for drainage and irrigation. The "performance data" mentioned in the document would refer to mechanical and functional integrity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not explicitly stated, but for this type of device, "ground truth" would likely involve engineering specifications and functional performance metrics (e.g., flow rates, pressure resistance, material compatibility, sterility) demonstrated through bench testing and validated against the predicate device's known performance characteristics. It would not involve clinical ground truth like pathology or outcomes data in the way a diagnostic device would.
8. The sample size for the training set
- Sample size for training set: Not applicable. This device is not an AI algorithm, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable, as there is no training set for this device.
In summary: The provided document is a 510(k) submission which primarily focuses on demonstrating substantial equivalence to a predicate device. This process typically relies on bench testing, material characterization, and comparison to the predicate's design and intended use, rather than extensive clinical studies with detailed performance metrics or "ground truth" established by an expert panel in the way that AI-powered diagnostic devices would require.
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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
-
(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.
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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
§ 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).