(308 days)
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.
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.
The provided text describes the K102274 510(k) submission for the RaviNeedle™ Aspiration Instrument. However, it does not contain a detailed study report with specific acceptance criteria, numerical performance data against those criteria, or a description of the methodology for establishing ground truth, sample sizes, or expert qualifications as typically found in a clinical study report.
The document states: "Testing showed the device meets all design criteria as well as the requirements of surgical users." and "In-vitro and in-vivo testing demonstrates that the device will perform as stated in the indications for use."
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Integrity | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Tissue Penetration Forces | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Laparoscopic Visualization | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Cage deployment/retraction Forces | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Removal from Tissue | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Flow Rate | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Leak Rate | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Pneumoperitoneum Loss | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Security in Tissue | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Damage to Tissue | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
| Damage to Device | Meets design criteria and requirements of surgical users. (Specific numerical data or thresholds are not provided in this summary.) |
Missing Information (Not available in the provided text):
- Specific quantitative acceptance criteria (e.g., "Flow rate must be > X mL/min").
- Specific quantitative performance results (e.g., "Achieved flow rate of Y mL/min").
- Details on how "requirements of surgical users" were quantified and assessed.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "bench top or in-vivo testing" but does not give the number of samples, cases, or subjects used for any of the listed tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document mentions "requirements of surgical users" but does not detail the involvement of experts in establishing ground truth or evaluating performance.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a manual aspiration instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The performance data is based on "bench top or in-vivo testing" against "design criteria" and "requirements of surgical users." These would likely involve objective measurements for mechanical, flow, and leak tests, and potentially subjective assessments by surgical users for aspects like visualization and tissue interaction. However, the specific methodology for establishing these "ground truths" (i.e., the ideal or correct performance benchmark) is not detailed.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Study Type:
The K102274 submission is for a physical medical device, the RaviNeedle™ Aspiration Instrument. The performance data provided are for engineering and biocompatibility tests (benchtop and in-vivo testing) to demonstrate the device meets design specifications and user requirements. This is typical for a 510(k) submission for a Class I device and does not involve the kind of clinical study or AI performance evaluation details (like ground truth establishment, expert adjudication, or MRMC studies) that would be relevant for diagnostic software or AI-enabled devices. The level of detail you are asking for regarding "acceptance criteria" and "study" is generally not present in a 510(k) summary for this type of device, which focuses on substantial equivalence to a predicate.
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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-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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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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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
§ 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.