(91 days)
The Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified physicians, to provide access to, illumination, and visualization of body cavities, during endoscopic laparoscopic surgical procedures.
The Invisio IRL Digital Rigid Laparoscope is a standard USA Series Laparoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image replacing the rod lens system typically used in the rigid laparoscope The Invisio IRL Digital Rigid Laparoscope can be inserted into the abdomen or chest through small skin cuts allowing the surgeon to explore the whole cavity without the need of making large standard openings dividing skin and muscle.
I am sorry, but without a clear description of acceptance criteria or a study within the provided text, I cannot complete your request. The provided text primarily describes a device for a 510(k) submission, including its name, predicate devices, and intended use. It does not contain information on acceptance criteria, device performance results, study methodologies (like sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or training/test set details.
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NOV = 1 2004
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Section 14.0 510(k) SUMMARY
ACMI Invisio IRL Digital Laproscope System
ACMI Corporation l . Sponsor: 136 Turnpike Road Southborough, MA 01771-2104
Contact: Terrence E. Sullivan Telephone: 508-804-2739 Date: July 30, 2004
2. Device Name:
Proprietary Name: Common/Usual Name: Classification Name:
ACMI Invisio IRL Digital Laproscope System Laparoscope Video Camera and accessories Laparoscope Surgical Camera and accessories
-
- Predicate Devices:
Circon's USA Series Laparoscope with various Tradenames (K013165)
- Predicate Devices:
ACMI Electronic Video Cystonephroscope (ECN) System (K030960)
Olympus Deflectable Tip Video Laparoscope (K955404)
-
- Device Description:
The Invisio IRL Digital Rigid Laparoscope is a standard USA Series Laparoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image replacing the rod lens system typically used in the rigid laparoscope The Invisio IRL Digital Rigid Laparoscope can be inserted into the abdomen or chest through small skin cuts allowing the surgeon to explore the whole cavity without the need of making large standard openings dividing skin and muscle.
- Device Description:
-
- Intended Use:
The Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified physicians, to provide access to, illumination, and visualization of body cavities, during endoscopic laparoscopic surgical procedures.
- Intended Use:
-
- Technological Characteristics and Substantial Equivalence:
The Invisio IRL Digital Rigid Laparoscope System is substantially equivalent to features incorporated into the following legally marketed predicate devices:
- Technological Characteristics and Substantial Equivalence:
The Invisio IRL Digital Rigid Laparoscope utilizes the rigid laparoscope technology (design and materials) of the following ACMI rigid laparoscope
Circon's USA Series Laparoscope with various Tradenames
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The Invisio IRL Digital Rigid Laparoscope system incorporates the video sensor technology I he Invisio IRL Digital Rigit Eaparoscope system acceppediate in the following device:
located in the distal tip of the endoscope similar to that utilized in the following d
ACMI Electronic Video Cystonephroscope (ECN) System (K030960)
The Invisio IRL Digital Rigid Laparoscope incorporates the CMOS sensor technology I he invisio IRL Digital Kigid Laparoscope neorperated in the Progethroscope (ECN) System (K030960)
Finally, the Invisio IRL Digital Rigid Laparoscope uses generally similar video processing Finally, the IIVIsio IIC Digital Right Laparooops Deflectable Tip Video Laparoscope (K955404)
ATTACHMENTS
| Number | Description |
|---|---|
| Attachment 1 | System Drawings |
| Attachment 2: | Invisio IRL Digital Rigid Laparoscope System Specifications (ACMIEngineering Specification) |
| Attachment 3 | Laparoscope Video Subsystems Specifications |
| Attachment 4 | Software Requirements Specification |
| Attachment 5 | Cmos Sensor CMOS Sensor specificationinformation(Micron Tech. Brief MI-0133) |
| Attachment 6 | System & Software Risk Analysis |
| Attachment 7 | Level of Concern Document |
| Attachment 8 | Product Validation Protocol |
| Attachment 9 | Invisio IRL Digital Rigid Laparoscope IFU |
| Attachment 10 | Circon's USA Series Laparoscope with Various Tradenames |
| Attachment 11 | ACMI Electronic Video Cystonephroscope (ECN) IFU |
| Attachment 12 | Olympus Deflectable Tip Laparoscope Brochure |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized graphic of three wavy lines.
NOV - 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terrance E. Sullivan Director, Regulatory Affairs ACMI Corporation 136 Turnpike Road Southborough, Massachusetts 01772
Re: K042069
Ko+2007
Trade/Device Name: Invisio IRL Digital Rigid Laparoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 30, 2004 Received: August 3, 2004
Dear Mr. Sullivan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassince (toonal controls. Existing major regulations affecting your device can may be subject to back adders and 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 r lease be actived that I Drivination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I edotar statutes act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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.
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Page 2 - Mr. Terrance E. Sullivan
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosire of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gollers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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: Invisio IRL Digital Rigid Laparoscope System
Indications For Use:
The Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified The Invisio IHL Digital Nigio Eaparosoope Oyclom is Indization of body cavities, during endoscopic laparoscopic surgical procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.