(129 days)
Not Found
Not Found
No
The device description focuses on traditional optical and mechanical components, and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "diagnostic and/or therapeutic indications" and for "manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing)". This directly describes therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are for "minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications."
No
The device description explicitly details physical components like rigid telescopes, surgical grade stainless steel, handle and shaft assemblies, and tip assemblies, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device's intended use is for "access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing)" within the body. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- No mention of samples or testing: The text does not mention the device being used to analyze samples or perform any kind of diagnostic test on bodily fluids or tissues outside of the body.
Therefore, the GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes and related devices are surgical and diagnostic tools used within the body, not IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FAJ, FBK, FDC, FDE, FED, FGC, FJL, GCJ, KOG, EZO, FAS, KNS, KQT, LQR, FHA, KOD, KOE, GEL, FCL, MNL, KOA, FAX, GBZ, FSM, GEA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal structures, gastrointestinal (GI), genitourinary (GU)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
Description of the training set, sample size, data source, and annotation protocol
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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)
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.
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.
Not Found
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 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.
1
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 (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" (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 (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
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)
3
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)]
GIMMI GmbH
Junkerstr. 1
D-78532 Tuttlingen
Germany | Tel. | +49-7461 - 9 65 90-0 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | | Fax | +49-7461 - 9 65 90-33 |
| | | e-mail | info@gimmi.de |
| 2.2 | Contact Person: [807.92 (a)(1)]
Dagmar S. Mäser
Business Support International
Amstel 320-I
1017 AP Amsterdam
The Netherlands | Tel. | +31-20-428 95 91 |
| | | Fax | +31-20-428 94 29 |
| | | eMail | bsi@xs4all.nl |
| 2.3 | Date Summary Prepared: [807.92 (a)(1)] December 10, 2001 | | |
| 2.4 | Device Names:
Proprietary | [807.92 (a)(2)]
GIMMI ALPHA® gastro-urology and laparoscopic
endoscopes, endoscopic accessories and GIMMI
devices for minimally invasive GI, GU, and laparoscopic
diagnostic and/or therapeutic indications. | |
| | Common | Endoscopic Instruments & Accessories and
Minimally Invasive Gl and GU Devices | |
| | PANEL 78
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
& Plastic Surgery | 78 GCJ | 876.1500 |
| | Endoscopes & Accessories | 78 KOG | 876.1500 |
| | Urethrotome | 78 EZO | 876.4770 |
| | Electrode, Electrosurgical,.
Active, Urol | 78 FAS | 876.4300 |
| | Unit, Electrosurgical,
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
& 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,
Manual & Acces | 78 KOA | 876.4300 | I Exempt |
| Bougies, Urological | 78 FAX | 876.5520 | I Exempt |
Suprapubic
4
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 | |||
| & 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.
5
Image /page/5/Picture/2 description: The image contains handwritten text. The text at the top reads 'K 012660'. Below that, the text reads 'pg 3 of 4'. The text appears to be a page number or document identifier.
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.
6
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.