(15 days)
No
The summary describes a standard endoscopic camera system with basic image capture and display capabilities. There is no mention of AI, ML, image processing beyond simple display, or any data processing that would suggest AI/ML functionality.
No
The device is used for visualization of body cavities and organs during endoscopic procedures, which is for diagnostic purposes, not therapeutic.
No
The device is an endoscopic camera system intended for visualization of body cavities, hollow organs, and canals during endoscopic procedures by displaying images on a monitor. Its primary function is to capture and display images, not to interpret or analyze them to provide a diagnosis.
No
The device description explicitly states it consists of a camera control unit, camera head, objectives, cables, and adapters, which are all hardware components.
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 used to "permit visualization of body cavities, hollow organs and canals during endoscopic procedures." This involves direct visualization of internal structures within the body.
- Device Description: The description reinforces this by explaining how the camera takes images through endoscopes and displays them on a monitor.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue samples, or other bodily fluids, for diagnostic purposes. IVDs are typically used to perform tests on these types of samples to provide information about a patient's health.
The device described is an endoscopic camera system, which is a medical device used for in vivo (within the body) visualization during medical procedures.
N/A
Intended Use / Indications for Use
The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A /Med Cam 300) are 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, FET
Device Description
The Endoscopic camera VP-1000C ( Med Cam 100) is a 1-CCD camera, the VP-3000A (Med Cam 300) is a 3-Chip camera; both consist of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) take the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera heads are supplied with an standard objective with the focal length 18, 25, 30 or 40mm. A Zoom objective can be used too. The devices allow focussing 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 Light source VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) will comply with the International Standard IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC.
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
2 2003 SEP
- 510 CUJ Summery/ Statement 8
- I Submitter
MGB Endoskopische Geräte GmbH Berlin Schwarzschildstraße 6 12489 Berlin Germany
- II Device Names
| 1. | Classification Name: | Accessory to an Endoscope |
|---|---|---|
| 2. | Common or Usual Name: | Endoscopic camera |
| 3. | Proprietary Name: | VP-1000C and VP-3000A for MGB brand, |
| Med Cam 100 and Med Cam 300 for LAWTON brand |
III Classification:
Class II. This device is described in21 C.F.R.§876.1500: The product code for the device is GCJ.
Predicate Device: IV
name/ manufacturer: World of Medicine Lemke GmbH For VP-1000C (Med Cam 100): Endoscopic Camera MC404/C3 labeling: For VP-3000A (Med Cam 300): Endoscopic Camera MC804/C4
V Intended Use:
The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A are 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 Describtion
The Endoscopic camera VP-1000C ( Med Cam 100) is a 1-CCD camera, the VP-3000A (Med Cam 300) is a 3-Chip camera; both consist of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) take the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera heads are supplied with an standard objective with the focal length 18, 25, 30 or 40mm. A Zoom objective can be used too. The devices allow focussing for both right-handed and left-handed users.
VII Substantial Equivalence
The submitted device pose the same type of questions about safety and effectiveness as the predicate device. The new device has no diminished safety or effectiveness.
ાર
1
The VP-1000C (Med Cam 100) is similar in design and technological characteristics to the Endoscopic camera MC404/C3 (K020336), the VP-3000A (Med Cam 300) is similar in design and technological characteristics to the Endoscopic camera TC804/C4 (K014158). manufactured by World of Medicine Lemke GmbH.
The Endoscopic camera VP-1000C (Med Cam 100), VP-3000A (Med Cam 300) and the predicate devices are all intended to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. The camera head of the The Endoscopic camera VP-1000C (Med Cam 100), VP-3000A (Med Cam 300) and of the predicate devices 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 VP-1000C (Med Cam 100), VP-3000A (Med Cam 300) and the predicate devices are minor and limited to picture quality and handling convenience. Accordingly, MGB Endoskopische Geraete GmbH Berlin believes that the Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) are substantially equivalent to the predicate devices currently on the market.
VIII Performance Data
The Endoscopic Light source VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) will comply with the International Standard IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2003 SEP
MBG Endoskopische Geräte GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K032544
Trade/Device Name: VP-1000C; Med Cam 100; VP-3000A; Med Cam 300 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FET Dated: August 9, 2003 Received: August 18, 2003
Dear Mr. Preiss:
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 adultcration.
If your device is classified (sec 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.
3
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), please contact the Office of Compliance at one of 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 Office of Compliance at (301) 594-4639. 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 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/dsmaldsmamain.html.
Sincerely yours.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ﻟﻠﺘﺮﺍ Statement of Indications for use
Applicant:
MGB Endoskopische Geräte GmbH Berlin
510(k) Number:
K1032544
Device Name: Endoscopic Camera
- i) VP-1000C (for MGB brand); Med Cam 100 (for Lawton brand)
- ii) VP-3000A (for MGB brand); Med Cam 300 (for Lawton brand)
Intended Use of the Device
The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A /Med Cam 300) are 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.
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 C.F.R. $ 801.109)
Nancy C. Shrodon
(Division Sign-Off)
of Reprodi iological Device
Prescription Use
✓
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