(99 days)
The MINI LAP Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues.
The MINI LAP Instruments are a family of minimally invasive devices. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip. The device is provided in the following configurations: 250mm Length with Retractor Fan Clamp Type and 250mm Length with Retractor Rake Clamp Type. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.
The provided text describes a 510(k) submission for the MINI LAP Retractors, a family of minimally invasive surgical devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Mini Lap Instruments - K070686), rather than presenting a de novo study with explicit acceptance criteria and performance data for a new, unproven device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device meeting those criteria.
Specifically:
- Table of acceptance criteria and reported device performance: Not present. The submission emphasizes substantial equivalence, not specific performance metrics against predefined acceptance criteria for a novel device.
- Sample size for the test set and data provenance: Not present. No clinical study data is reported for a test set.
- Number of experts and qualifications for ground truth: Not present. No ground truth establishment is described as no study data is presented.
- Adjudication method for the test set: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not present. No human-in-the-loop study is described.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI/software device.
- Type of ground truth used: Not applicable as no study data is presented.
- Sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
- How ground truth for the training set was established: Not applicable.
The "Performance Data" section states: "We believe the addition of these two jaw configurations are a minor expansion to a product family that already has 510(k) clearance. The subject device is composed of biocompatible materials and the sterilization process has been validated." This indicates that the performance justification relies on bench testing (biocompatibility, sterilization validation) and the argument of substantial equivalence to an already cleared device, rather than a new clinical or comparative effectiveness study with specific performance outcomes.
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FEB 1 2 2010
Image /page/0/Picture/2 description: The image contains the logo of Mini Lap Technologies Inc. with a stylized atom graphic. Below the logo, the text "510 (k) Summary" is present, with the phrase "510 (k)" underlined. The text is in a clear, sans-serif font and appears to be part of a document or presentation.
Submission Type:
Special 510(k)
Date Prepared [21 CFR 807.92(a)(1)]
2007.92 (a) 2000 November 2, 2009
Submitter's Information [21 CFR 807.92(a)(1)]
Regulatory Contact Joseph Azary Orchid Design Oreman Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130 Fax: (203) 922-0150
Email: joseph.azary(@orchil-orthopedics.com
Sponsor / Manufacturer Sponio Lap Technologies Inc. 88 Ashford Avenue 88 Asinorava vy 10522
FDA Establishment Registration is 3007123990
Tel: 914 591 8400
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Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name
-
MINI LAP Retractors o
Device Common, Usual, or Classification Names -
Laparoscopic Instruments, Retractors, Cannula, Trocar, Manual Surgical Instruments o
Classification Panel -
Classification of this device would fall under the responsibility of the Gastroenterology / Urology o panel.
Class
Based on our research we believe the device is a class 2 device classified under the following Product Codes:
- KOG, 21 CFR 876.1500, Endoscope Accessories o
- KOA, 21 CFR 876.4730 Manual Surgical Instruments o
- FBQ, 21 CFR 878.5090 Trocar o
Predicate Device [21 CFR 807.92(a)(3)]
Mini Lap Instruments - K070686 o
Description of the Device [21 CFR 807.92(a)(4)]
The MINI LAP Instruments are a family of minimally invasive devices. The devices penetrate soft tis-The NHT DFL mounterial areas of the human anatomy. The devices are used to manipulate other soft internal tissues.
Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip.
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The device is provided in the following configurations:
| Length | Clamp Type |
|---|---|
| 250mm | Retractor Fan |
| 250mm | Retractor Rake |
The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.
Intended Use [21 CFR 807.92(a)(5)]
The MINI LAP Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues..
Technological Characteristics [21 CFR 807.92(a)(6)]
We believe the MINI LAP instruments are substantially equivalent to the predicate devices.
Performance Data [21 CFR 807.92(b)(1)]
We believe the addition of these two jaw configurations are a minor expansion to a product family that already has 510(k) clearance. The subject device is composed of biocompatible materials and the sterilization process has been validated.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned diagonally, facing upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mini Lap Technologies, Inc. % Mr. Joseph Azary 80 Shelton Technology Center Shelton, Connecticut 06484
Re: K093449
Trade/Device Name: Mini Lap Retractors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 7, 2010 Received: January 12, 2010
Dear Mr. Azary:
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.
FEB 1 2 2010
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device 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 Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toable of advised that is a receint ation that your device complies with other requirements of the Act or mat For also and regulations administered by other Federal agencies. You must comply with all 1 castle statuivements, including, but not limited to: registration and listing (21 CFR Part 807); lan the Progations and 1); medical device reporting of medical device-related adverse laboring (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems
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(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/CDRHOffices/ucm115809.html 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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: MINI LAP Retractors
Indications For Use:
The MINI LAP Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues.
Prescription Use × (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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| Labels | Values |
|---|---|
| 510(k) Number | K093449 |
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.