GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES

K012660 · Gimmi GmbH · FET · Dec 20, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012660
• Device Name: GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
• Applicant: Gimmi GmbH
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

Device Story

GIMMI ALPHA devices are rigid, panoramic endoscopes and associated endoscopic instruments used for minimally invasive GI, GU, and laparoscopic procedures. The endoscopes utilize rod lens technology for visualization. Instruments consist of reusable handle, shaft, and tip assemblies, or one-piece designs for manual tissue manipulation. Devices are operated by qualified physicians in clinical settings to access internal structures, provide illumination, and perform surgical tasks like grasping, cutting, and suturing. The devices are designed for short-term use. Clinical benefit is derived from enabling minimally invasive access to internal anatomy, reducing the need for open surgery. Output is direct visualization for the physician and physical tissue interaction.

Clinical Evidence

Bench testing only. Performance and physical tests were conducted to evaluate safety, effectiveness, and reliability. All results conformed to cited harmonized device standards (ISO/EN/ASTM/AAMI/ANSI/IEC).

Technological Characteristics

Rigid, panoramic telescopes using rod lens technology. Body contact portions composed of surgical grade stainless steel. Reusable handle, shaft, and tip assemblies. Manual operation. Compliance with relevant ISO, EN, ASTM, AAMI, ANSI, and IEC standards for manufacture, packaging, labeling, and reprocessing.

Indications for Use

Indicated for qualified physicians to provide access, illumination, visualization, and soft tissue manipulation (grasping, cutting, coagulating, dissecting, suturing) during diagnostic and therapeutic gastrointestinal, genitourinary, and laparoscopic procedures.

Regulatory Classification

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2016

GIMMI Gmbh % Ms. Dagmar S. Mäser FDA Laison Business Support International 1017 AP Amsterdam Amstel 320-1 The Netherlands

Re: K012660 Trade/Device Name: GIMMI ALPHA® Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ, FBK, FDC, FDE, FED, FGC, FJL, GCJ, FET, GCT, EZO, FAS KNS, KQT, FBM, LQR, FHA, KOD, KOE, GEI, FCL, MNL, KOA, FAX, GBZ, FSM and GEA Dated (Date on orig SE Itr): October 17, 2001 Received (Date on orig SE Itr): October 19, 2001

Dear Ms. Mäser,

This letter corrects our substantially equivalent letter of July 27, 2015.

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.

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Page 2 – Dagmar S. Mäser

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 801); medical device reporting (reporting of medical devicerelated 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 [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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

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Abbreviated 510(k)

GIMMI GmbH

Kol2 660 510(k) Number

Device Name

ALPHA® Endoscopic Instruments & Accessories

## INDICATIONS FOR USE

GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use } (Per CFR 801 109) ાર

Over-The Counter Use __

David W. Wegmann

(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012660

(Optiona) Foru.st 1-2-96)

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Abbreviated 510(k)

Gimmi GmbH

K012660
pg 1 of 4

DEC 2 0 2001

## 510(k) SUMMARY of Safety and Effectiveness 2.

## GIMMI GmbH

As required by Section 807.92(c)

| 2.1 | Submitter: [807.92 (a)(1)]<br>GIMMI GmbH<br>Junkerstr. 1<br>D-78532 Tuttlingen<br>Germany | Tel. | +49-7461 - 9 65 90-0 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | | Fax | +49-7461 - 9 65 90-33 |
| | | e-mail | [e-mail] |
| 2.2 | Contact Person: [807.92 (a)(1)]<br>Dagmar S. Mäser<br>Business Support International<br>Amstel 320-I<br>1017 AP Amsterdam<br>The Netherlands | Tel. | [phone] |
| | | Fax | [phone] |
| | | eMail | [e-mail] |
| 2.3 | Date Summary Prepared: [807.92 (a)(1)] December 10, 2001 | | |
| 2.4 | Device Names:<br>Proprietary | [807.92 (a)(2)]<br>GIMMI ALPHA® gastro-urology and laparoscopic<br>endoscopes, endoscopic accessories and GIMMI<br>devices for minimally invasive GI, GU, and laparoscopic<br>diagnostic and/or therapeutic indications. | |
| | Common | Endoscopic Instruments & Accessories and<br>Minimally Invasive Gl and GU Devices | |
| | PANEL 78<br>Cystoscope, Diagnostic | 78 FAJ | 876.1500 |
| | Needle, Endoscopic | 78 FBK | 876.1500 |
| | Resectoscope & Accessories | 78 FDC | 876.1500 |
| | Set, Laparoscope | 78 FDE | 876.1500 |
| | Sheath, for Endoscope | 78 FED | 876.1500 |
| | Urethroscope | 78 FGC | 876.1500 |
| | Resectoscope | 78 FJL | 876.1500 |
| | Laparoscope, General<br>& Plastic Surgery | 78 GCJ | 876.1500 |
| | Endoscopes & Accessories | 78 KOG | 876.1500 |
| | Urethrotome | 78 EZO | 876.4770 |
| | Electrode, Electrosurgical,.<br>Active, Urol | 78 FAS | 876.4300 |
| | Unit, Electrosurgical,<br>Minimally Invasive Gl and GU Devices | 78 KNS | 876.4300 |
| | Evacuator, Gastro-Urology | 78 KQT | 876.4370 |
| Dislodger, Stone Biliary | 78LQR | 876.5010 | II |
| Clamp, Penile | 78 FHA | 876.5160 | II |
| Catheter, Urological | 78 KOD | 876.5130 | II |
| Dilator, Urethral | 78 KOE | 876.5520 | II |
| PANEL 79 | | | |
| Device, Electros., Cutting<br>& Coag'n & Acc | 79 GEL | 878.4400 | II |
| PANEL 78: EXEMPT DEVICES | | | |
| Forceps, Biopsy, Non-Electric | 78 FCL | 876.1500 | I Exempt |
| Accessories, Cleaning | 78 MNL | 876.1500 | I Exempt |
| Brushes for Endoscope | | | |
| Surg Instruments,G-U,<br>Manual & Acces | 78 KOA | 876.4300 | I Exempt |
| Bougies, Urological | 78 FAX | 876.5520 | I Exempt |

Suprapubic

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KC12660
jpg 2 of

### PANEL 79: EXEMPT DEVICES

| Catheter, Cholangiography | 79 GBZ | 878.4200 | I Exempt |
|----------------------------------------------|--------|----------|----------|
| Tray, Surgical, Instrument | 79 FSM | 878.4800 | I Exempt |
| Cannula, Surgical, General<br>& Plastic Surg | 79 GEA | 878.4800 | I Exempt |

#### 2.5 Reason for Submission: New Devices

#### 2.6 Predicate Devices: [807.92 (a)(3)]

- Predicate devices are produced by Günter Bissinger Medizintechnik Comeg Endoscopy Dufner Instrumente GmbH Henke-Sass Wolf, GmbH Optus, Inc. Pilling Weck Group Wolf Karl Storz Endoscopy and a wide range of other manufacturers, including: Jarit (J. Jamner Surgical Instruments, Inc.) Snowden-Pencer, Inc. SurgiTech, Inc. (Surgical Technologies International, Inc.) United States Surgical Corp. Allegiance Healthcare Corp.
### 2.7 Device Description: [807.92(a)(4)+(6)] GIMMI ALPHA Endoscopes 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 for human use.

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Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures

#### 2.8 Intended Use: 1807.92 (a)(5)]

GIMMI ALPHA® gastro-urology and laparoscopic endoscopes, endoscopic accessories and GIMMI devices for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing} in a wide vanety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures.

- 2.9 Industry Standards/Performance Data: [807.92 (d)] GIMMI certifies compliance with relevant ISO/EN/ASTM/ AAMI/ANSI/IEC and other device-related standards that apply to the manufacture, packaging, labeling, and reprocessing of subject devices including the validation of these processes.
#### 2.10 Summary of Testing

All materials used in the composition of GIMMI ALPHA® gastrourology and laparoscopic endoscopes, endoscopic accessories and GIMMI devices for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices. All results were in conformance with the cited harmonized device standards.

#### Information Bearing on the Safety and Effectiveness: 2.11 [807.92 (b)(3)]

The GIMMI ALPHA® gastro-urology and laparoscopic endoscopes, endoscopic accessories and GIMMI devices for minimally invasive GI. GU. and laparoscopic diagnostic and/or therapeutic indications have the same intended use as predicate devices. They are made of the same material and produced to the same international and FDA-recognized standards. Slight modifications in design do not adversely affect the safety and effectiveness of these devices.

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Gimmi GmbH

K012660
pg 4 of 4

Abbreviated 510{k)

In summary, the

- intended use .
- performance attributes .

ﺮ

- materials and .
- . basic design

are identical (endoscopes and HF accessories) and identical/ substantially equivalent to SE devices.

The results of design validation raise no new issues of safety and effectiveness.