← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K963046

# ENDOCAM (K963046)

_Corin USA · GCJ · Nov 1, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K963046

## Device Facts

- **Applicant:** Corin USA
- **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md)
- **Decision Date:** Nov 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

Endoscopic video camera to transmit an image from an endoscope or arthroscope to a remotely located video monitor

## Device Story

Endoscopic video camera system; transmits images from endoscope/arthroscope to remote video monitor. Components: power source, video board, camera head with 1/2" CCD chip, camera cable. Operation: captures optical input via CCD; performs pre-signal conditioning (+6 dB); automatic iris control (1:16000S). Used in clinical settings (OR/clinic) by physicians/surgeons. Output displayed on external monitor for real-time visualization. Benefits: enables remote viewing of internal anatomy during minimally invasive procedures.

## Clinical Evidence

Bench testing only. Safety testing conducted per IEC 601/1 1988 and DIN VDE 0750 TI/12.91. EMC testing performed per IEC 601/1 1988.

## Technological Characteristics

1/2" CCD sensor; 628 lines resolution; 0.9 lux minimum illumination; automatic iris (1:16000S); +6 dB pre-signal conditioning. Power: 100-240V, 0-440Hz. Compliance: IEC 601/1 1988, DIN VDE 0750 TI/12.91.

## Regulatory 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

- Dyonics Digital video camera system

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

8. 510(K) Summary: K963046 Nov. 1, 1996

Classification Name: Accessory to Endoscope

Device Trade Name: 500.204 Daycam & 500.404 Endocam

Sponsor: Corin U.S.A.
10500 University Center Drive
Suite 130
Tampa, Florida 33612
USA

Reason for Submission: New device

Intended Use: Endoscopic video camera to transmit an image from an endoscope or arthroscope to a remotely located video monitor

Major Component:
- Power source
- Video board
- Camera head holding video chip
- Camera cable

Video Data:
- 628 lines resolution
- 0.9 lux minimum illumination
- ½" CCD lens
- +6 dB pre-signal conditioning
- Automatic iris 1:16000S

Power Source: 100 - 240V ± 10% 0 - 440Hz

{1}

Page 14

Safety Testing:
- TUV testing to IEC 601/1 1988
- DIN VDE 0750 TI/12.91
- EMC tested as part of IEC 601/1 1988

The specification of the Corin Endocam & Daycam camera systems are substantially equivalent to the legally marketed Dyonics Digital video camera system in the following areas: Power source, controls, functions, output, iris control, iris shutter speed and light requirement (see 7(g)).

9. Truthful and Accurate Statement:

I hereby confirm that the attached information is, to the best of my knowledge, truthful and accurate.

PRINT NAME: Jack Thomas
SIGNED: C40
POSITION: President
DATE: 10 October 1996

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K963046](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K963046)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com