(24 days)
The ACMI® INVISIO ICN (ICN) Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
Like the predicate ACMI® Electronic Video CystoNephroscope (ECN) System, the ACMI® INVISIO ICN (ICN) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. The ICN can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney.
The ICN incorporates the same basic video imaging technology located in the endoscope as the predicate device. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.
Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
This Special 510(k) proposes modifications in the proximal handle design, a reduction in flexible shaft outer diameter, elimination of the secondary active deflection mechanism, and a minor software algorithm modification for the ACMI® INVISIO ICN. The indications for use, principles of operation, working channel length and diameter of the ACMI® INVISIO ICN remain the same as in the predicate device.
The provided document is a 510(k) Summary of Safety and Effectiveness for a medical device (ACMI® INVISIO ICN). It states that the device is substantially equivalent to a predicate device and outlines its intended use and modifications. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
This type of submission (Special 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "summary of safety and effectiveness" here is an assertion that the modifications do not significantly affect safety or efficacy, based on the principle of substantial equivalence to the predicate.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used, ground truth establishment, or details about MRMC or standalone studies because this information is not present in the provided text.
The document states: "The proposed modifications for the ACMI® INVISIO ICN, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, dimensional specifications, and software specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This suggests that the primary "proof" relies on the established safety and effectiveness of the predicate device and the minor nature of the changes to the new device.
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ACMI® INVISIO ICN ACMI Corporation 136 Turnpike Road Southborough, MA 01772
SEP 1 0 2004
Special 510(k) Notification Statement of Intended Use August 16, 2004
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® INVISIO ICN
K04 2225
General Information
| Manufacturer: | ACMI Corporation136 Turnpike Rd.Southborough, MA 01772-2104 |
|---|---|
| Establishment Registration Number: | 2020483 |
| Contact Person: | Terrence E. SullivanDirector, Regulatory Affairs |
| Date Prepared: | August 16, 2004 |
| Device Description | |
| Classification Name: | Endoscope and accessories(21 CFR 876.1500), Class IISurgical camera and accessories(21 CFR 878.4160), Class I |
| Trade Name: | ACMI® INVISIO ICN |
| Generic/Common Name: | Endoscope, Video Camera and accessories |
| Predicate Device | |
| ACMI® ECN Video CystoNephroscope System | |
| K030960 |
Intended Uses
The ACMI® INVISIO ICN (ICN) Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
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ACMI® INVISIO ICN CMI Corporation 136 Turnpike Road Southborough, MA 01772 Ko42225
Special 510(k) Notification Summary of Safety and Effectiveness August 16, 2004
Product Description
Like the predicate ACMI® Electronic Video CystoNephroscope (ECN) System, the ACMI® INVISIO ICN (ICN) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. The ICN can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney.
The ICN incorporates the same basic video imaging technology located in the endoscope as the predicate device. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.
Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
This Special 510(k) proposes modifications in the proximal handle design, a reduction in flexible shaft outer diameter, elimination of the secondary active deflection mechanism, and a minor software algorithm modification for the ACMI® INVISIO ICN. The indications for use, principles of operation, working channel length and diameter of the ACMI® INVISIO ICN remain the same as in the predicate device.
Summary of Safety and Effectiveness
The proposed modifications for the ACMI® INVISIO ICN, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, dimensional specifications, and software specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Mr. Terrence E. Sullivan Director, Regulatory Affairs ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772-2104
Re: K042225
Trade/Device Name: ACMI® INVISIO ICN Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Codes: 78 FAJ and FGA Regulation Number: 21 CFR §878.4160 Regulation Name: Surgical camera and accessories Product Code: 79 FWF Regulatory Class: II Dated: August 16, 2004 Received: August 17, 2004
Dear Mr. Sullivan:
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.
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); good manufacturing practice requirements as set 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will allow you to ocgin mative of substantial equivalence of your device to a legally premarket notheation. The PDA mailing of cation 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 desire specific advice tor your dones on the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the presses on the regulation entitled, "Misbranding Other of Compliance at (501) 57 - 155 - 155 - 157.97) you may obtain. Other general by relerence to premation on the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manutacturers, International and Octoballitter//www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure -
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Special 510(k) Notification Statement of Intended Use August 16, 2004
Device Name: ACMI® INVISIO ICN
510(k) Number:
Indications for use:
The ACMI® INVISIO ICN (ICN) Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used nonew - ergans and mine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X _
OR Over-the-Counter Use:
(Per 21 CFR 801.109)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 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.