K110355 · Venx, LLC · GAH · Apr 22, 2011 · General, Plastic Surgery
Device Facts
Record ID
K110355
Device Name
VENX REVOLUTION
Applicant
Venx, LLC
Product Code
GAH · General, Plastic Surgery
Decision Date
Apr 22, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4800
Device Class
Class 1
Attributes
Therapeutic
Indications for Use
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
Device Story
VENX REVOLUTION™ is a sterile, single-patient-use manual surgical instrument for spider vein destruction in lower extremities. Device features thermoplastic handle with lever-actuated rack and gear mechanism; stainless steel needle-like tines at shaft end. Clinician places tines to straddle vein; actuating levers rotates shaft ~360°, disrupting vein via tine rotation. Internal springs return tines to original position upon lever release. Device is withdrawn and repositioned until all target veins are treated. Used in clinical settings by physicians. Benefits include mechanical disruption of spider veins via controlled rotation mechanism.
Clinical Evidence
Bench testing only. Simulated use conditions compared subject device to predicate. Metrics included tine deformation, cycle life, and rotating mechanism operation. Results demonstrated performance equivalent to the predicate device.
Technological Characteristics
Manual surgical instrument. Materials: thermoplastic handle, stainless steel tines. Mechanism: lever-actuated rack and gear for ~360° shaft rotation; internal spring return. Sterile, disposable, single-patient use. Dimensions vary by vein size.
Indications for Use
Indicated for the destruction of spider veins in the lower extremities of the body.
Regulatory Classification
Identification
A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
Predicate Devices
Advanced Medical Products, Arachnophlebectomy Needle (K000932)
Submission Summary (Full Text)
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K110355
510(k) Summary
VENX LLC 510(k) Notification Submission
APR 2 2 2011
Date: January 31, 2011
Submitted by: VENX LLC 2701 NW 2nd Avenue, Suite 218 Boca Raton, FL 33431
> 561-237-5008 Phone: 561-237-5040 Fax:
Contact: Navroze Mehta
Manual Surgical Instrument
Common Name: Manual Surgical Instrument
Trade Name: VENX REVOLUTION™
Classification Name:
Classification: Class I per 21 CFR 878.4800
Predicate Device: Advanced Medical Products, Arachnophlebectomy Needle (K000932)
## Description:
The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.
## Intended Use:
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
## Comparison to Predicate Devices:
The VENX REVOLUTION™ differs from the predicate device only in the mechanism for rotating the device tines. The predicate device relied on the clinician to manually rotate the pen-like device within the fingers to disrupt the vein. The VENX REVOLUTION™™
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110355
Page 2 of 2
VENX LLC
510(k) Notification Submission
incorporates a lever-actuated mechanism to rotate the tines a minimum 360° by actuating levers with the fingers. The basic construction, and available sizes of the tines remain unchanged.
## Testing:
Bench testing has been conducted using simulated actual use conditions comparing the new device and its ability to disrupt and destruct spider veins to that of the predicate device. The results of the testing show the new device to perform as intended and equivalent to the predicate device. Testing included tine deformation, cycle life, and rotating mechanism operation.
#### Conclusion:
In accordance with the Food, Drug, and Cosmetic Act and 21 CFR 807, and based on the information provided in the premarket notification, VENX LLC concludes that the VENX REVOLUTION™ is safe, effective and substantially equivalent to the predicate device discussed herein.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Venx. ILC % MRI Medical Mr. Ira Duesler 4700 S. Overland Drive Tucson, Arizona 85714
# APR 2 2 2011
Re: K110355 Trade Name: Venx Revolution™ Classification Regulation Name and Number: Manual Surgical Instrument for General Use,
21 CFR 878.4800
Regulatory Class: Class I Exempt Product Code: 79 GAH (Stylet, Surgical, General & Plastic Surgery) Dated: January 31, 2011 Received: February 7, 2011
Dear: Mr. Duesler
We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.
The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 878.4800. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code.
In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 878.9 to determine whether or not your new device meets the limitations of exemption from Section 510(k) of the Act.
If you have any questions regarding this letter, please contact George J.Mattamal, Ph.D at (301) 796-6396 or the Division of Small Manufacturers, International and Consumer Assistance at its
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Page 2 - Mr. Ira Duesler
toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
A.J. B. n h
fer
Mark N. Melkerson Director Division of Surgical, Orthopedic and Reconstructive Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications For Use
510(k) Number (if known): K110355
Device Name: VENX REVOLUTION™
Indications For Use:
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
Prescription Device × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel R.P. Ayde firmen
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110355
d
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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.
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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.
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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.
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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.
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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.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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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.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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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.
