(308 days)
Not Found
No
The description focuses on mechanical components and manual operation, with no mention of AI/ML terms or functionalities.
No
The device is used to aspirate fluids and retain tissue, and it is not described as treating or mitigating a disease or condition. It is a surgical tool for fluid aspiration.
No
The device is described as an aspiration needle for collecting fluids and tissue during surgical procedures. While the collected samples might be used for diagnostic purposes later, the device itself is for collection, not for analyzing or diagnosing conditions.
No
The device description clearly describes a physical, stainless steel needle with a luer adapter and expandable wire cage/balloon, indicating it is a hardware medical device.
Based on the provided information, the Mini-Lap Technologies RaviNeedle Aspiration Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for aspirating fluids and retaining tissue during endoscopic and open surgical procedures. This is a direct surgical intervention on a patient, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The device is a needle designed for physical aspiration and securing its position within the body. It doesn't involve reagents, test strips, or any components typically associated with analyzing biological samples in vitro.
- Lack of IVD Characteristics: The description doesn't mention any analysis of the aspirated fluid or tissue for diagnostic purposes. The focus is on the physical act of aspiration and tissue retention during surgery.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the device during surgical use (tissue penetration, flow rate, security in tissue, etc.), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The RaviNeedle is a surgical tool used in vivo (within the body) during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
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.(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 the limitations in § 878.9.
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Page 1 of 2
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- |
| 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
1
Page 2 of (2)
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.
2
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
3
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
4
(Page 1 of 1)
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