(60 days)
No
The 510(k) summary describes a mechanical wound drain and does not mention any AI or ML components or functionalities.
No
The device is described as an "adjunctive device" used to prevent fluid accumulation post-surgery, which aids in healing but does not directly treat a disease or medical condition.
No
Explanation: The device description states its purpose is to prevent fluid accumulation post-surgery by draining fluids from the operative site. This is a therapeutic or supportive function, not a diagnostic one. Diagnostic devices are used to identify or determine a disease, condition, or its cause.
No
The device description explicitly details physical components like a catheter, mesh, adapter, tube, and trocar, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used during and after open surgical procedures to drain fluids from the operative site. This is a therapeutic and post-surgical management function, not a diagnostic one.
- Device Description: The description details a physical drain catheter and its components, designed for fluid removal. There is no mention of reagents, samples of human origin being tested in vitro, or any process for analyzing biological samples to provide diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) outside the body.
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays.
- Performing tests in vitro.
The device is a surgical drain, which is a medical device used for fluid management, not for diagnosis.
N/A
Intended Use / Indications for Use
The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.
The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures.
Product codes
GBX
Device Description
The wound drain catheter comprises a proximal drain segment, an internal tubular mesh assembled with a luer fitting adapter, a distal transition tube segment, and a metal trocar. The final assembly of the Deutsch Anti-Blockage Wound Drain is illustrated as in the following figure:
-
- The drain segment has a uniform cross-sectional area and is made from a silicone elastomer having sufficient elasticity to permit the cross-sectional area of the drain decrease when a pulling force is applied to it, thereby reducing the gripping force of tissue surrounding the wound. The drain segment has distal side holes which are used to drain fluids and exudates during and after surgery.
-
- The internal tubular mesh is permanently connected to the inner surface of the luer fitting adapter. In this subassembly, the luer fitting adapter acts as a handle. The tubular mesh is used to re-establish the drain patency when a post-operative occlusion occurs. To do this, the luer fitting adapter needs to be removed from the drain segment end and the luer fitting adapter and the mesh segment to be pulled from the drain lumen to remove the obstructing material. The tubular mesh also provides the catheter radiopacity.
-
- The transition tube segment is made from a silicone elastomer with a sufficient elasticity, similar to the drain segment. This transition segment has an internal cavity opening. One end of this transition tube goes over one end of the luer fitting adapter and the other end to the source of suction. When necessary this end is used to insert a metal trocar.
- The trocar with a sharp distal tip is made from stainless steel. The trocar is used to pull 4. the drain through the surrounding tissue to the intended drainage site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
K052286.,/
Premaket Notification - The CEI Anti-Blockage Wound Drain Device
OCT 2 1 2005
Image /page/0/Picture/3 description: The image contains a logo with the words "Catheter Exchange" written in bold, sans-serif font. Above the text is a stylized graphic of a circle with a swirl inside, set against a black square. The logo appears to be for a medical or healthcare-related service, given the reference to catheters.
16633 Ventura Blvd Suite 735 Encino, CA 91436 Phone: 323-442-2936 Fax: 323-442-2913
SUMMARY
| Submitter's name: | The Catheter Exchange, Inc. |
|---|---|
| Address: | 16633 Ventura Blvd. |
| Suite 735 | |
| Encino, CA 91436 | |
| Phone: | 323-442-2936 |
| Fax: | 323-442-2913 |
| Name of contact person: | George P. Teitelbaum, M.D. |
| Telephone: | 323-442-8948 |
| Fax: | 323-442-8969 |
| Date the summary was prepared: | August 12, 2005 |
| Name of the device: | Deutsch Anti-Blockage Wound Drain |
| Trade or proprietary name: | Deutsch Anti-Blockage Wound Drain |
| Common or usual name: | Surgical Wound Drain |
| Classification name: | Catheter, Irrigation |
| The legally marketed device to which we are claiming equivalence: | Jackson-Pratt Wound Drains. The clearance number K973703 |
| Axiom Multipurpose Wound Drain. The clearance number K993592 |
DEVICE DESCRIPTION
The wound drain catheter comprises a proximal drain segment, an internal tubular mesh assembled with a luer fitting adapter, a distal transition tube segment, and a metal trocar. The final assembly of the Deutsch Anti-Blockage Wound Drain is illustrated as in the following figure:
1
Image /page/1/Figure/2 description: The image shows a medical device with several labeled components. The device includes a curved transition tube connected to a drain tube. Other labeled parts are the trocar, male luer fitting, female luer fitting, and tubular mesh.
-
- The drain segment has a uniform cross-sectional area and is made from a silicone elastomer having sufficient elasticity to permit the cross-sectional area of the drain decrease when a pulling force is applied to it, thereby reducing the gripping force of tissue surrounding the wound. The drain segment has distal side holes which are used to drain fluids and exudates during and after surgery.
-
- The internal tubular mesh is permanently connected to the inner surface of the luer fitting adapter. In this subassembly, the luer fitting adapter acts as a handle. The tubular mesh is used to re-establish the drain patency when a post-operative occlusion occurs. To do this, the luer fitting adapter needs to be removed from the drain segment end and the luer fitting adapter and the mesh segment to be pulled from the drain lumen to remove the obstructing material. The tubular mesh also provides the catheter radiopacity.
-
- The transition tube segment is made from a silicone elastomer with a sufficient elasticity, similar to the drain segment. This transition segment has an internal cavity opening. One end of this transition tube goes over one end of the luer fitting adapter and the other end to the source of suction. When necessary this end is used to insert a metal trocar.
- The trocar with a sharp distal tip is made from stainless steel. The trocar is used to pull 4. the drain through the surrounding tissue to the intended drainage site.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms.
Public Health Service
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
George P. Teitelbaum, M.D. CEO/President The Catheter Exchange, Inc. 16633 Ventura Boulevard, Suite 735 Encino, California 91436
Re: K052286
Trade/Device Name: Deutsch Anti-Blockage Wound Drain Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: I Product Code: GBX Dated: August 16, 2005 Received: August 22, 2005
Dear Dr. Teitelbaum:
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 10 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 classified (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 CFR Part 807); labeling (21 CFR 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.
3
Page 2- George P. Teitelbaum, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maning of substantial equivalence of your device to a legally prematics notication: "The PDF intents sification 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 If you desire spocitie acries 101 500 (240) 276-0115. Also, please note the regulation entitled, Comaci the Office of Compulation (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Barbara Bouckund
tor
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_
Device Name: Deutsch Anti-Blockage Wound Drain
The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.
The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures."
Prescription Use X (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)
Barbara Brehm
(Division Sign-Division of General, Restorative. and Neurological Devices
Page 1 of __ 1 September 2004
510(k) Number K052286
Page 12