(41 days)
Not Found
No
The summary describes a standard endoscopic camera system with basic image capture and display capabilities, and there is no mention of AI, ML, or advanced image processing features.
No.
The device functions as an imaging tool to visualize body cavities during endoscopic procedures but does not perform any therapeutic action or treatment.
No
The device is an endoscopic camera used for visualization, not for generating a diagnosis. It captures images that can be displayed, but it does not interpret those images or provide diagnostic information.
No
The device description explicitly lists hardware components such as a camera control unit (CCU), camera head, connecting objectives, cables, and adapters.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "visualization of body cavities, hollow organs and canals during endoscopic procedures." This involves directly viewing internal structures of the body, which is an in vivo (within the living body) procedure, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a camera system designed to capture images from endoscopes and display them on a monitor. This aligns with an imaging device used for direct observation during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific substances, or performing any kind of laboratory test, which are hallmarks of IVD devices.
Therefore, the Endoscopic Camera MC404/C3 is an imaging device for endoscopic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Endoscopic Camera MC404/C3 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.
Product codes
GCJ
Device Description
The Endoscopic Camera MC404/C3 is a 1-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera MC404/C3 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 25 mm endofocus objective but may also be used with a 16 mm, 30 mmm or zoom (f = 13 to 28 mm) objective. The device is programmable by two head key bottons and offers focusing for both right-handed and left-handed users.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Endoscopic Camera MC404/C3 complies with the International Standard IEC 601-1, IEC 601-1-2, the European Standard EN 55011 and conforms to the Medical Device Directive 93/42/EEC. The device will be tested in accordance with UL2601-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR 1 4 2002
510(K) SUMMARY Endoscopic Camera MC404/C3
I. Submitter:
WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany
II. Device Names:
- Classification Name: 1.
- Common or Usual Name: 2.
-
- Proprietary Name:
Accessory to an Endoscope Endoscopic Camera Endoscopic Camera MC404/C3
III. Classification:
Class II. This device is described in 21 C.F.R. § 876.1500. The product code for the device is GCJ.
IV. Predicate Devices:
- Karl Storz Endovision XL Endoscopic Camera System (K974391) .
V. Intended Use:
The Endoscopic Camera MC404/C3 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.
VI. Device Description:
The Endoscopic Camera MC404/C3 is a 1-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera MC404/C3 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 25 mm endofocus objective but may also be used with a 16 mm, 30 mmm or zoom (f = 13 to 28 mm) objective. The device is programmable by two head key bottons and offers focusing for both right-handed and left-handed users.
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K020336
510(K) SUMMARY Page -2- / -2-
VII. Substantial Equivalence:
The Endoscopic Camera MC404/C3 described in this notification is similar in design and construction to the Karl Storz Endovision XL Endoscopic Camera System (K974391) manufactured by Karl Storz Imaging, Inc.
The Endoscopic Camera MC404/C3 and the predicate device are both intended to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. The camera head of the Endoscopic Camera MC404/C3 and the camera head of the predicate device is designed to attach to standard, commercially available, endoscopes and the endoscopic image in the proposed and predicate device can be displayed on any standard video monitor.
The differences between the Endoscopic Camera MC404/C3 and predicate device are limited to picture quality and handling convenience.
Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the proposed new device, the Endoscopic Camera MC404/C3, is substantially equivalent to the predicate device currently on the market.
VIII. Performance Data:
The Endoscopic Camera MC404/C3 complies with the International Standard IEC 601-1, IEC 601-1-2, the European Standard EN 55011 and conforms to the Medical Device Directive 93/42/EEC. The device will be tested in accordance with UL2601-1.
Signed:
S Road
Susanne Raab Official Correspondent
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the left. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2002
World of Medicine Lemke GmbH c/o Susanne Raab 91 Trowbridge Street Cambridge, Massachusetts 02138
Re: K020336
Trade Name: Endoscopic Camera MC404/C3 Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 30, 2002 Received: February 1, 2002
Dear Ms. Raab:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 such 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.
3
Page 2 - Ms. Susanne Raab
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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
for 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
4
STATEMENT OF INDICATIONS FOR USE
| APPLICANT: | WORLD OF MEDICINE Lemke GmbH |
|---|---|
| 510(K) NUMBER (if known): | K020336 |
| DEVICE NAME: | Endoscopic Camera MC404/C3 |
INDICATIONS FOR USE:
The Endoscopic Camera MC404/C3 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
Miriam C. Provost
neral, Restorative and Neurological Devices
HOLO 336 510(k) Number __