(18 days)
Not Found
Not Found
No
The device description and intended use focus on the physical instrument (rigid telescope with rod lens technology) and its function in endoscopic procedures, with no mention of AI/ML, image processing, or data analysis capabilities.
Yes
The device is described as being used for "therapeutic surgical procedures" in the 'Intended Use / Indications for Use' section.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are intended "to perform endoscopic diagnostic and therapeutic surgical procedures."
No
The device description clearly states it is comprised of rigid, panoramic telescopes using rod lens technology and surgical grade stainless steel, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The GIMMI ALPHA Sinuscopes and Bronchoscopes are described as reusable, hand-held instruments used for endoscopic diagnostic and therapeutic surgical procedures. They are inserted directly into the body (sinus, larynx, tracheobronchial tree) to visualize and potentially treat these areas.
- Intended Use: The intended use clearly states they are for performing procedures on the patient, not for analyzing samples from the patient.
The device is a surgical instrument used for direct visualization and intervention within the body, which is distinct from the function of an IVD.
N/A
Intended Use / Indications for Use
GIMMI ALPHA Sinuscopes and Bronchoscopes are intended for use by qualified physicians to perform endoscopic diagnostic and therapeutic surgical procedures of the sinus and larynx/tracheobronchial tree respectively.
GIMMI ALPHA® Bronchoscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic surgical procedures of the larynx and tracheobronchial tree.
GIMMI ALPHA® Sinuscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic sinus surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
77 EOB, 77 EOQ
Device Description
GIMMI ALPHA Sinuscopes and Bronchoscopes are reusable, hand-held instruments designed for performing diagnostic and therapeutic sinus and bronchial procedures. The devices have the same operating principles and intended uses as many of the competitive sinuscopes and bronchoscopes already in commercial distribution.
The devices 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
sinus, larynx, tracheobronchial tree
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)
Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The devices will meet the same criteria of safety and efectiveness as SE devices.
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
机
K01373 |
NOV 2 7 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
+49-7461 - 9 65 90-0 Tel. +49-7461 - 9 65 90-33 Fax e-mail info@gimmi.de
- 2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Mäser Business Support International +31-20-428 95 91 Tel. Amstel 320-l +31-20-428 94 29 1017 AP Amsterdam Fax eMail bsi(axs4all.nl The Netherlands
- Date Summary Prepared: [807.92 (a)(1)] 2.3 November 7, 2001
.2.4 Device Names: [807.92 (a)(2)] GIMMI ALPHA Sinuscopes & Bronchoscopes Proprietary
- Endoscopic ENT Devices Common
| Classification Names | Product Codes | CFR Reg'n |
|---|---|---|
| Nasopharyngoscope (Flexible or | ||
| Rigid) | 77 EOB | 874.4760 |
| Bronchoscope (Flexible or | ||
| Rigid) | 77 EOQ | 874.4680 |
1
2.5 Reason for Submission: New Devices
2.6 Predicate Devices: [807.92 (a)(3)]
Predicate devices are produced by Henke-Sass Wolf, GmbH Optus, Inc. Karl Storz Endoscopy and a wide range of other manufacturers
2.7 Device Description: [807.92(a)(4)+(6)]
GIMMI ALPHA Sinuscopes and Bronchoscopes are reusable, hand-held instruments designed for performing diagnostic and therapeutic sinus and bronchial procedures. The devices have the same operating principles and intended uses as many of the competitive sinuscopes and bronchoscopes already in commercial distribution.
The devices 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.
2.8 Intended Use: 1807.92 (a)(5)]
GIMMI ALPHA Sinuscopes and Bronchoscopes are intended for use by qualified physicians to perform endoscopic diagnostic and therapeutic surgical procedures of the sinus and larynx/tracheobronchial tree respectively.
Industry Standards/Performance Data: [807.92 (d)] 2.9 GIMMI certifies compliance with relevant ISO/EN/ASTM/AAMI/ANS// 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 Non-Clinical Test Results
Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The devices will meet the same criteria of safety and efectiveness as SE devices.
2.11 · Information Bearing on the Safety and Effectiveness: [807.92 (b)(3)]
The GIMMÌ ALPHA Sinuscopes and Bronchoscopes have the same intended use as predicate devices. They are made of the same material and are produced to the same international and FDArecognized standards. Slight modifications in design do not adversely affect the safety and effectiveness of these devices.
2-2
2
Gimmi GmbH
.
In summary, the
- intended use .
- performance attributes .
- materials and .
- basic design .
are identical and/or substantially equivalent to SE devices.
The results of design validation raise no new issues of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the United States Department of Health and Human Services, which is an abstract image of an eagle. The text "HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle. The seal appears to be a low-resolution image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2001
GIMMI GmbH c/o Dagmar S. Mäser Business Support International Amstel 320-I 1017 AP Amsterdan The Netherlands
Re: K013731
K015751
Trade/Device Name: GIMMI Alpha Sinuscopes and Bronchoscopes Regulation Number: 21 CFR 874.4760; 21CFR 874.4680 Regulation Name: Nasopharyngoscope and accessories; Bronchoscope and accessories Regulatory Class: Class II Product Code: EOB; EOQ Dated: November 8, 2001 Received: November 9, 2001
Dear Mr. Mäser:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section > Forty from the results and the mail and cations for use to use above and we have delectimited the uevice is interstate commerce prior to May 28, 1976, the stated in the enclosure) to device Amendments, or to devices that have been reclassified in
enactment date of the Medical Device Amendments on to Commercia Art (Act) - You ma enactment date of the Medical Doviet Innentials Food, Drug, and Cosmetic Act (Act). You may, a accordance with the provisions of the reachers rooming, would be the Act. The general therefore, market the device, subject to the generats for annual registration, listing of devices, controls provisions of the Act mende requirentibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into such additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additions Title 21 Perts (Premarket Approval), it may of Subject to Subject to Subletions, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Coront Go allecting your device can be tourn intinu assumes compliance with the Current Good A substantially equivalent determination assumts version in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that the securestions Medical Devices: Gelleral regulation (21 - 2111 - an verify such assumptions. Failure to inspections, the Food and Drug Administration. In addition, FDA may publish in
comply with the GMP regulation may result in the Paciety, Places note: this comply with the GMI Tegalation may reason in the Federal Register. Please note: this further alliouncenting your premarket notification does not affect any obligation your might response to your premarket nonmoution successes under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin mainstally your antial equivalence of your device to a legally premarket nothication. The PDA midnig of basicallian of 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact a duction of additionally 21 CFK Fall 807.10 for in viac vices in the promotion and advertising of Compliance at (301) 594-6017. Tuditionally 10. quests of Compliance at (301) 594-4639. Also, please note the your device, piease comate the Office of economic of contrication" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division (880) Other general information on your respensional 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/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Abbreviated 510(k)
GIMMI GmbH
510(k) Number
Device Name
GIMMI ALPHA® Bronchoscopes
Classification
77 EOQ II 874.4680
INDICATIONS FOR USE
GIMMI ALPHA® Bronchoscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic surgical procedures of the larynx and tracheobronchial tree.
(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)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Karen Baker /s/
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number _
6
Abbreviated 510(k)
GIMMI GmbH
Ko13731
510(k) Number Device Name
GIMMI ALPHA® Sinuscopes
Classification
77 EOB II 874.4760
INDICATIONS FOR USE
GIMMI ALPHA® Sinuscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic sinus surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Prescription Use (Per CFR 801 109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Karen H. Boker
(Division Sign-Off)
wision of Ophthalmic Devices Vol3731 : 0(k) Number .
22