(312 days)
No
The device description focuses on mechanical components, materials, and traditional optical technology (rod lens). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are also focused on mechanical and material properties, sterilization, and biocompatibility, not algorithmic performance.
Yes
The device is described as manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) within internal body structures, which are therapeutic interventions.
No
The device is described as an endoscopic instrument and accessory for visualization and manipulation (grasping, cutting, coagulating, dissecting, and suturing) of internal structures, not for diagnosing conditions.
No
The device description explicitly lists numerous physical components made of materials like surgical grade stainless steel and plastic, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing access and visualization of internal structures and manipulating soft tissue within the body. This is an in-vivo (within a living organism) application.
- Device Description: The description details instruments for surgical procedures (grasping, cutting, coagulating, dissecting, suturing) and visualization of internal organs. These are all in-vivo actions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be used within the body for surgical or visualization purposes.
N/A
Intended Use / Indications for Use
"Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing)."
Product codes
FBP, FAJ, FBK, FDC, FGC, FJL, EZO, LQR, KQT
Device Description
"Endoservice Endoscopic Instruments & Accessories are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility.
The urological-gastroenterological accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue, body cavities, hollow organs and canals (grasping, cutting, dissecting, coagulating and suturing).
The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive gastrointestinal GI and genitourinary GU Devices contain different components such as Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Forceps, Scissors, Punches, Tubes, Trocars, Trocar Sleeves, Sheat, Needle holder, and Inserts.
The device is made out of following materials: Body: steel 1.4301; plastic PPSU Handle: adhesive hysol-resin Lens: saphir"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra, kidneys, prostate. Also "internal structures," "soft tissue," "body cavities," "hollow organs and canals."
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"qualified physicians"
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)
"On the Endoservice Endoscopic devices were performed Bending Tests, Material Tests, Bench Tests, Validation Tests of Sterilization, Disinfection and Cleaning (automatically), Cytotoxicity Test, and Microbiological Test for determination of microorganisms."
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.
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AUG 2 1 2012
113062 page 1 of 3
510(k) Summary
510(k) Summary as required by section 807.92
Submission Applicant: From: Endoservice Optical Instruments GmbH Rudolf-Diesel-Straße 16 78576 Emmingen/Germany Establishment Registration Number: 3009110146 Phone: +49 74 65 / 90 97 80 Fax: +49 74 65 / 90 97 81 E-mail: info@endorep.com
Application Correspondent/Contact: think! Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany Phone: +49-7462-924 051 Fax: +49-7462-924 128 E-mail: andrea@thinkworks.biz
>> Device Identification:
Trade name: Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices
Common name: Endoscopes
Classification name: Endoscope and accessories, Review Panel Gastroenterology/Urology (21 CFR 876.1500, FBP) Subsequent Codes: FAJ, FBK, FDC, FGC, FJL, EZO, LQR, KQT
>> Predicate Device Information:
510(k)-Number: K012660, GIMMI ALPHA® Instruments & Accessories Firm: GIMMI GMBH
Endoservice
(työkalut/tools)
08/17/2012
1
113062 Page 2 of 3
Image /page/1/Picture/1 description: The image shows a logo with the word "Endoservice" in a stylized font. Below the word, there is some smaller text that is difficult to read. The logo is surrounded by abstract lines and shapes, creating a modern and dynamic design. The overall impression is that of a company or service related to medical or technical fields.
510(k) Summary
>>Description of the Device:
Endoservice Endoscopic Instruments & Accessories are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility.
The urological-gastroenterological accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue, body cavities, hollow organs and canals (grasping, cutting, dissecting, coagulating and suturing).
The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive gastrointestinal GI and genitourinary GU Devices contain different components such as Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Forceps, Scissors, Punches, Tubes, Trocars, Trocar Sleeves, Sheat, Needle holder, and Inserts.
The device is made out of following materials: Body: steel 1.4301; plastic PPSU Handle: adhesive hysol-resin Lens: saphir
>>Indications for Use:
Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing).
>> Technological characteristics compared to the Predicate Device:
The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are identical to the predicate device GIMMI ALPHA® Instruments in terms of design, technical characteristics, intended use, indications for use, sterilization processes. In terms of components the predicate device has a comparable product range included in the submission as the new device. The Endoservice devices are belonging to the Urology and Gastroenterology Panel. Furthermore the used materials stainless steel and insulation material are also similar in both products.
For more details see table below.
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K113062 Page 3 of 3
Image /page/2/Picture/1 description: The image shows a logo with the word "Endoservice" in a stylized font. There are geometric shapes surrounding the word, including lines and a partial circle. The text below "Endoservice" is smaller and harder to read, but appears to be additional information about the company or service. The logo has a modern and abstract design.
510(k) Summary
| | Endoservice Endoscopic Instruments
New device | GIMMI ALPHA®
Instruments
K012660 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter
Lengths | >>Tube
3,5-12,5mm Tube, various from 70cm to
150cm
Cystoscope, Resectoscope, Urethrotome
Length: 298-310mm
Diameter: 2.7mm, 2.8mm, 2.9mm, 4.0mm | >>Tube
3,5-12,5mm Tube, various from 40 cm to
105 cm
Laparoscope
Length: 270mm-330mm
Diameter: 5.0mm, 10mm, 11mm
Cystoscope, Resectoscope, Urethrotome
Length: 300mm
Diameter: 4.0mm |
| Material | Stainless Steel1.4301;
plastic PPSU
adhesive hysol-resin
saphir lens | Stainless Steel
Insulation material |
| Components | Scissors, Forceps, Connections (inner Rod,
Sheath insulated), Handles, Sheaths,
Endoscopes, Cystoscopes, Resectoscopes,
Urethrotomy, Retractor, Forceps, Scissors,
Punches, Tube, Sheath, Needle holder, and
Inserts. | Dismantable and Non-dismantable
Insulated and non-insulated
Forceps, Probes, Needle Holders, Clamps,
Dissectors, Scissors, Knife, Hook, Knot
Guide, Retractors, Divers and Blades |
>> Non-clinical performance data:
On the Endoservice Endoscopic devices were performed Bending Tests, Material Tests, Bench Tests, Validation Tests of Sterilization, Disinfection and Cleaning (automatically), Cytotoxicity Test, and Microbiological Test for determination of microorganisms.
>>Summary:
The product components which are covered by this 510(k) premarket notification have been successfully tested among others according to ISO 8600, ISO 10993, ISO 11737, ISO 17665, ISO 15883, and ISO 14971. The conclusions drawn from the nonclinical test performed on the Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices show in its results that the devices are as safe and as effective, and perform as well as or better than the legally marketed device, therefore do not raise new issues regarding safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Endoservice Optical Instruments GmbH % Ms. Andrea Pécsi Regulatory Affairs Specialist think! Schwarzwaldstraße 5 TUTTLINGEN 78532 GERMANY
AUG 2 1 2012
Re: K113062
Trade/Device Name: Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices
Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBP Dated: July 31, 2012 Received: August 2, 2012
Dear Ms. Pécsi:
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
4
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerély vours,
Benjamin K. Ticho
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
5
Indications for Use Statement
K 113062 510(k) Number (if known):
Device Name: Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices
Indications for Use:
Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of_1__
Helmut Werner
roductive. Gastro-Renal, and