K052286 · The Catheter Exchange, Inc. · GBX · Oct 21, 2005 · General, Plastic Surgery
Device Facts
Record ID
K052286
Device Name
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
Applicant
The Catheter Exchange, Inc.
Product Code
GBX · General, Plastic Surgery
Decision Date
Oct 21, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4200
Device Class
Class 1
Attributes
Therapeutic
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.
Device Story
Deutsch Anti-Blockage Wound Drain is a surgical wound drainage system designed to prevent post-operative occlusion. Device components include a silicone elastomer drain segment with distal side holes, an internal tubular mesh, a luer fitting adapter, a transition tube, and a stainless steel trocar. The trocar facilitates placement through tissue. The drain segment is elastic; applying pulling force reduces its cross-sectional area to minimize tissue gripping. The internal tubular mesh, connected to the luer fitting, serves as a mechanism to clear obstructions; if occlusion occurs, the luer adapter is removed and the mesh is pulled through the lumen to extract debris. The device connects to an external suction source to remove fluids (bloody, chylous, purulent, etc.) from the operative site. Used in clinical settings by surgeons to promote wound healing by preventing fluid buildup.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Materials: Silicone elastomer (drain and transition segments), stainless steel (trocar). Design: Multi-component assembly including drain segment, internal tubular mesh, luer fitting, and transition tube. Principle: Passive/active suction drainage with mechanical anti-clogging feature. Radiopacity provided by internal tubular mesh. Sterilization: Not specified.
Indications for Use
Indicated for patients undergoing open surgical procedures (abdominal, thoracic, head/neck, gynecological, urological, spinal, orthopedic) to prevent post-operative fluid accumulation at the operative site.
Regulatory Classification
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.
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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.<br>Suite 735<br>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<br>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:
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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.
- 1. 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.
- 2. 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.
- 3. 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.
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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.
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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
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## 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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
