(101 days)
Not Found
No
The summary describes standard video signal processing and control functions for an endoscope, with no mention of AI, ML, or related concepts like image analysis for detection or diagnosis.
Yes
The device is intended to provide "therapeutic access" for "endoscopic surgery" and includes a working channel for "biopsies and polypectomies," which are therapeutic procedures.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is "intended to provide visualization and diagnostic / therapeutic access".
No
The device description clearly outlines multiple hardware components including a colonoscope with a camera and LEDs, a signal processing unit, a controller, and a drying adapter. While software is involved in signal processing and control, the system is fundamentally a hardware-based medical device.
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 system is for "visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract". This describes a device used in vivo (within the living body) for direct observation and intervention.
- Device Description: The description details a colonoscope with a camera, illumination, working channel, and functions for insufflation, irrigation, and suction. These are all components and functions of a device used for internal examination and procedures within the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not collect or analyze such specimens in vitro. While it can be used to obtain biopsies (which would then be analyzed in vitro by a separate IVD process), the device itself is not performing the in vitro diagnostic test.
The device is a medical device used for endoscopy and endoscopic surgery, which are in vivo procedures.
N/A
Intended Use / Indications for Use
The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.
Product codes (comma separated list FDA assigned to the subject device)
FDF
Device Description
The invendoscopy E200 System consists of an invendoscope SC200, an invendo SPU E200, an invendo ScopeController and an invendo E200 Drying Adapter.
The invendoscope SC200 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC200 is furthermore equipped with insufflation, irrigation and suction functions.
The invendo SPU E200 contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E200 supplies the colonoscope and controls its functions according to the commands of the operator.
The operator uses the invendo ScopeController unit to control the invendoscopy E200 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images.
The invendo E200 Drying Adapter is intended to support drying of the inner parts of the invendo SPU E200. It is used to connect a waste container to the invendo SPU E200.
Mentions image processing
The invendo SPU E200 contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic images
Anatomical Site
lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve)
Indicated Patient Age Range
adult
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 following non-clinical testing was performed to validate the design and to assure conformity with the following design standards:
- IEC 60601-1 "Medical electrical equipment part 1 General requirements for safety" incl. national deviations
- IEC 60601-2-18 "Medical electrical equipment part 2 Particular requirements for the basic safety and essential performance of endoscopic equipment"
- IEC 60601-1-2 "Medical electrical equipment part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility –Requirements and tests"; including national deviations FCC CFR 47 part 15
- ISO 10993-5; -7; -10 "Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity"; Part 7: Ethylene Oxide Sterilization Residuals"; Part 10: Tests for irritation and skin sensitization"
- -IEC 62366 "Medical devices: Application of usability engineering to medical devices"
- -ASTM 4169 "Standard Practice for Performance Testing of Shipping Containers and Systems"
- -ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
- ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical -Packaging by Dye Penetration"
- -ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- -ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- -ISO 11135 "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices"
- -Evaluation of insertion forces
In all instances, the invendoscopy E200 System functioned as intended, performed as well as or better than the predicate and met individual test specifications.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
invendo medical GmbH Oliver v. Ruepprecht Head of RA/QA Peterhofstr. 3b Kissing, Bavaria 86438 GERMANY
Re: K161355
Trade/Device Name: invendoscopy E200 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: July 15, 2016 Received: July 18, 2016
Dear Oliver v. Ruepprecht:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161355
Device Name invendoscopy E200 System
Indications for Use (Describe)
The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/2 description: The image shows the logo for "nvendo medical". The text is in gray, with the words "nvendo medical" in a larger font and "STERILE SINGLE-USE ENDOSCOPY" in a smaller font below. To the right of the text is a circular orange logo with a white swirl inside.
Applicant Information
| Name: | invendo medical GmbH |
|---|---|
| Address: | Peterhofstr. 3b |
| 86438 Kissing | |
| Germany | |
| Contact: | Oliver v. Ruepprecht |
| Head of QA/RA | |
| Phone : +49 – 8233 – 744 98 16 | |
| Fax : +49 – 8233 – 744 98 15 | |
| Mail : oliver.ruepprecht@invendo-medical.de |
Date Prepared: 13.May 2016
Identification of the proposed device
| Device Name | invendoscopy E200 System |
|---|---|
| Components | invendoscope SC200 (SC200 colonoscope) |
| invendo SPU E200 | |
| invendo ScopeController | |
| invendo E200 Drying Adapter | |
| Common Name | Colonoscopy System |
| Classification/name | Class II (876.1500) / Colonoscope and Accessories, flexible/rigid |
| Product Code | FDF |
| Review Panel | Gastroenterology/Urology |
Predicate Devices
| K100624 | invendo C20 Colonoscopy System |
|---|---|
| K121582 | invendo C25 Colonoscopy System |
| K100584 | Olympus EVIS EXERA II 180 SYSTEM |
4
Intended Use
The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single-use disposable device. The invendoscope SC200 cannot be reprocessed.
Device Description
The invendoscopy E200 System consists of an invendoscope SC200, an invendo SPU E200, an invendo ScopeController and an invendo E200 Drying Adapter.
The invendoscope SC200 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC200 is furthermore equipped with insufflation, irrigation and suction functions.
The invendo SPU E200 contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E200 supplies the colonoscope and controls its functions according to the commands of the operator.
The operator uses the invendo ScopeController unit to control the invendoscopy E200 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images.
| Technology/Specification | Comparison to predicate devices |
|---|---|
| Deflection technology and | |
| deflecting capability | Same technology as invendo SC20 colonoscope (K121582); |
| both devices work with water-filled bellows and are | |
| pressure controlled | |
| Irrigation | Same performance as invendo SC20 colonoscope |
| (K121582); irrigation control via peristaltic pump instead of | |
| pressure chamber as by the invendo SC20 colonoscope |
The invendo E200 Drying Adapter is intended to support drying of the inner parts of the invendo SPU E200. It is used to connect a waste container to the invendo SPU E200.
5
| Technology/Specification | Comparison to predicate devices |
|---|---|
| Insufflation | Same performance and control technology as invendo |
| SC20 colonoscope (K121582) | |
| Suction | Identical to the invendo SC20 colonoscope (K121582) |
| Light Source | Identical to the invendo SC20 colonoscope (K121582) |
| Camera | Same technology (CMOS) as SC20 colonoscope (K121582); |
| Both the camera of the SC20 colonoscope and the | |
| invendoscope SC200 works with standard resolution. | |
| Diameter | Identical to the invendo SC20 colonoscope (K121582) |
| Working Length | Similar length as Olympus colonoscope (K100584); The |
| working length of the invendoscope SC200 is longer than | |
| the working length of the Olympus colonoscope. The | |
| difference has no impact on safety or efficiency because | |
| the introduction deep depends from operator's decision. | |
| Working channel | Identical to the invendo SC20 colonoscope (K121582) |
| Insertion | Manually pushed as the Olympus colonoscope (K100584) |
| Sterility | The invendoscope SC200 is sterile delivered, the predicate |
| devices are unsterile delivered | |
| The invendo SPU E200, the invendo ScopeController and | |
| the invendo E200 Drying Adapter is unsterile delivered as | |
| the predicate devices. | |
| Material | The materials of the invendoscope (synthetic plastics) and |
| the predicate devices are different but the whole device is | |
| biocompatible as required by the ISO10993-1 Standard. |
Performance testing
The following non-clinical testing was performed to validate the design and to assure conformity with the following design standards:
- IEC 60601-1 "Medical electrical equipment part 1 General requirements for safety" incl. national deviations
- IEC 60601-2-18 "Medical electrical equipment part 2 Particular requirements for the basic safety and essential performance of endoscopic equipment"
6
- IEC 60601-1-2 "Medical electrical equipment part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility –Requirements and tests"; including national deviations FCC CFR 47 part 15
- ISO 10993-5; -7; -10 "Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity"; Part 7: Ethylene Oxide Sterilization Residuals"; Part 10: Tests for irritation and skin sensitization"
- -IEC 62366 "Medical devices: Application of usability engineering to medical devices"
- -ASTM 4169 "Standard Practice for Performance Testing of Shipping Containers and Systems"
- -ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
- ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical -Packaging by Dye Penetration"
- -ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- -ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- -ISO 11135 "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices"
- -Evaluation of insertion forces
In all instances, the invendoscopy E200 System functioned as intended, performed as well as or better than the predicate and met individual test specifications.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Substantial Equivalence
The invendoscopy E200 System has the same intended use and indications for use, and similar technological characteristics and principles of operation as the predicate devices.
The minor technological differences between the invendoscopy E200 System and its predicate devices raise no new issues of safety or effectiveness.
Performance data demonstrate that the device is as safe and effective as the predicate devices. Thus, the invendoscopy E200 System is substantially equivalent to its predicate devices.