K102274 · Arvik Enterprises/ Mini Lap Technologies · GAA · Jun 15, 2011 · General, Plastic Surgery
Device Facts
Record ID
K102274
Device Name
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
Applicant
Arvik Enterprises/ Mini Lap Technologies
Product Code
GAA · General, Plastic Surgery
Decision Date
Jun 15, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4800
Device Class
Class 1
Indications for Use
Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids and retain tissue during aspiration of fluids.
Device Story
RaviNeedle Aspiration Instrument is a 12-inch stainless steel needle with a chisel-point tip for percutaneous application. It features a proximal luer adapter for connection to a standard user-supplied syringe. The distal end includes an optional expandable wire cage/balloon mechanism to secure the needle tip to small structures (e.g., gallbladder) during multiple aspirations. Used by surgeons in OR settings during open or laparoscopic procedures to aspirate small fluid volumes. The device is single-use and disposable. It is intended solely for fluid removal, not for drug injection or irrigation. The security feature helps maintain needle position, potentially reducing tissue damage and improving procedural efficiency.
Clinical Evidence
Bench and in-vivo testing performed. Evaluated mechanical integrity, tissue penetration forces, laparoscopic visualization, cage deployment/retraction forces, removal from tissue, flow rate, leak rate, pneumoperitoneum loss, security in tissue, and tissue/device damage. Results demonstrated the device meets all design criteria and surgical user requirements.
Technological Characteristics
Stainless steel shaft; polyurethane, polyethylene, and polycarbonate handle components. 2.8mm diameter, 12-inch length. Manual operation via external syringe suction. Sterile, single-use, gamma radiation sterilized (SAL 10^-6). No software or electronic components.
Indications for Use
Indicated for patients undergoing endoscopic or open surgical procedures requiring fluid aspiration and tissue retention during aspiration.
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.
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K102274
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# 510 (k) Summary
(revised)
#### Submission Type: Traditional
Date Prepared [21 CFR 807.92(a)(1)] Revised June 13, 2011
# Submitter's Information [21 CFR 807.92(a)(1)]
Sponsor / Manufacturer Mini Lap Technologies Inc. 88 Ashford Avenue - Dobbs Ferry, NY 10522 FDA Establishment Registration: 3007123990
Regulatory Contact Curtis Raymond Orchid Design - 80 Shelton Technology Center Shelton, CT 06484
# Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: RaviNeedle™ Aspiration Instrument .
- Common/Usual Name: Aspiration Needle .
- Classification Names: Disposable Aspiration & Injection Needle ● Product code: GAA Class I per 21CFR 878.4800
#### Predicate Device [21 CFR 807.92(a)(3)|
Ximed Prosure Injection/Aspiration Needle Probes/Devices (Ximed Medical/Prosure, Inc. - San Jose, CA) Product Code: GAA . Premarket Notification: K983200
#### Description of the Device [21 CFR 807.92(a)(4)]
The RaviNeedle Aspiration Instrument is stainless steel needle approximately 12 inches in overall length. The proximal end of the device is fitted with a luer adapter which is fitted to a standard syringe (not supplied with the device). Using the standard syringe, the device is used to aspirate small volumes of fluid during either open or laparoscopic procedures. The device has a chisel-point tip to allow for percutaneous application. To maintain the position of the needle tip during multiple aspirations, the distal end of the needle is equipped with expandable wire cage/balloon which secures the needle to small structures being aspirated (e.g., the gallbladder). Use of the security feature is optional on the part of the user.
| Specifications: | |
|-------------------|---------------------------------------------------------------------------------------------------------|
| Materials | Stainless steel shaft with polyurethane; handle portion is made of poly-<br>ethylene and poly carbonate |
| Diameter | 2.8mm |
| Overall length | Approx 12 inches |
| Sterilization | Sterile/single use-disposable, gamma radiation; SAL = $10^{-6}$ |
| Suction Connector | Luer fitting to connect to standard syringe |
JUN 1 5 2011
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K102274
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# Intended Use [21 CFR 807.92(a)(5)]
Mini-Lap Technologies RaviNeedle™ Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids.
# Technological Characteristics [21 CFR 807.92(a)(6)]
The device has similar handle, safety, and needle design as other Mini Lap instruments. The device operates under low pressure as supplied by the syringe fitted to the device is composed of similar materials to other Mini Lap instruments. The device is sterile and a single-use/disposable; users are specifically cautioned against reuse. The device is intended for removal of fluids only; it is not intended for injection of drugs or irrigation fluids. The device is substantially equivalent to other suction devices that have received FDA marketing clearance.
### Performance Data [21 CFR 807.92(b)(1)]
The device has been assessed using either bench top or in-vivo testing for:
- . Mechanical Integrity
- Tissue Penetration Forces .
- Laparoscopic Visualization .
- Cage deployment/retraction Forces .
- . Removal from Tissue
- . Flow Rate
- Leak Rate .
- Pneumoperitoneum Loss .
- Security in Tissue .
- Damage to Tissue .
- Damage to Device
Testing showed the device meets all design criteria as well as the requirements of surgical users.
#### Conclusion [21 CFR 807.92(b)(3)]
We believe the features of the subject device are equivalent to those of other predicate devices. In-vitro and in-vivo testing demonstrates that the device will perform as stated in the indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble a bird in flight or a series of waves. The emblem is rendered in black, providing a stark contrast against the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mini Lap Technologies Inc. % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, Connecticut 06484
JUN 1 5 2011
Re: K102274
Trade/Device Name: Mini Lap Technologies - RaviNeedle Aspiration Needle Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: GAA Dated: June 9, 2011 Received: June 10, 2011
Dear Mr. Raymond:
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 to 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Curtis Raymond
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Eune Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use
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K102274
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# Indications for Use
510(k) Number (if known): K102274
Device Name: Mini Lap Technologies - RaviNeedle Aspiration Needle
Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids and retain tissue during aspiration of fluids.
x AND/OR Over-The-Counter Use ------Prescription Use (Part 21 CFR 801 Subpart D) (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)
Nit RPOglen for mxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102274
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.
