INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM

K042069 · Acmi Corporation · GCJ · Nov 1, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042069
• Device Name: INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
• Applicant: Acmi Corporation
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

The Invisio IRL Digital Rigid Laparoscope is a rigid endoscope for laparoscopic surgery. It replaces traditional rod lens systems with a CMOS sensor located at the distal tip to capture images. The device is inserted into the abdomen or chest through small incisions, allowing surgeons to visualize the cavity. It is operated by qualified physicians in a clinical or surgical setting. The device provides real-time video output to a display, assisting the surgeon in navigating and performing endoscopic procedures. This visualization capability facilitates minimally invasive surgery, potentially reducing the need for large incisions.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and design validation as indicated by the inclusion of product validation protocols and system/software risk analysis in the submission attachments.

Technological Characteristics

Rigid laparoscope incorporating a distal-tip CMOS sensor (Micron Tech. Brief MI-0133). Replaces traditional rod lens optics. Designed for endoscopic visualization. System includes video processing subsystems. Sterilization and specific material standards are referenced in internal engineering specifications (Attachments 2 and 3).

Indications for Use

Indicated for use by qualified physicians for access, illumination, and visualization of body cavities during endoscopic laparoscopic surgical procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Circon's USA Series Laparoscope (K013165)
• ACMI Electronic Video Cystonephroscope (ECN) System (K030960)
• Olympus Deflectable Tip Video Laparoscope (K955404)

Submission Summary (Full Text)

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NOV = 1 2004

K042069

Page 1 of ②

## 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: [phone] 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

- 2. Predicate Devices:
Circon's USA Series Laparoscope with various Tradenames (K013165)

ACMI Electronic Video Cystonephroscope (ECN) System (K030960)

Olympus Deflectable Tip Video Laparoscope (K955404)

- 3. 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.

- 4. 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.

- 5. 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:

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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Page 2 of (2)

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 (ACMI<br>Engineering Specification) |
| Attachment 3 | Laparoscope Video Subsystems Specifications |
| Attachment 4 | Software Requirements Specification |
| Attachment 5 | Cmos Sensor CMOS Sensor specificationinformation<br>(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 [phone]. 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 [phone] or [phone] 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):

K042069

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

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510(k) Number_________________________________________________________________________________________________________________________________________________________________