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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the GIMMI ALPHA Sinuscopes and Bronchoscopes. Based on the information presented, a traditional clinical performance study with acceptance criteria and a detailed study design to prove the device meets those criteria was not conducted. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

Here's an breakdown based on your requested information, highlighting what was done according to this document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Same intended use as predicate devices	"The GIMMI ALPHA Sinuscopes and Bronchoscopes have the same intended use as predicate devices."
Made of the same material as predicate devices	"They are made of the same material..."
Produced to the same international and FDA-recognized standards as predicate devices	"...and are produced to the same international and FDA-recognized standards." GIMMI "certifies compliance with relevant ISO/EN/ASTM/AAMI/ANS// IEC and other device-related standards."
Slight modifications in design do not adversely affect safety and effectiveness	"Slight modifications in design do not adversely affect the safety and effectiveness of these devices."
Equivalence in design and materials to predicate devices	"Based on the equivalence in design and materials to predicate devices, performance testing was not warranted."
Meet the same criteria of safety and effectiveness as SE devices (predicate)	"The devices will meet the same criteria of safety and effectiveness as SE devices."
Identical and/or substantially equivalent intended use, performance attributes, materials, and basic design to predicate devices	"In summary, the intended use, performance attributes, materials, and basic design are identical and/or substantially equivalent to SE devices."
Design validation raises no new issues of safety and effectiveness	"The results of design validation raise no new issues of safety and effectiveness."

2. Sample size used for the test set and the data provenance

No specific "test set" in the context of a clinical performance study was used. The submission relies on a comparison to predicate devices rather than a direct study on the GIMMI ALPHA devices in a clinical setting.
Data provenance is therefore not applicable in the traditional sense, as no new clinical data was generated for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new clinical performance study was conducted that would require experts to establish ground truth for a test set. The assessment relied on regulatory evaluation of equivalence to existing predicate devices.

4. Adjudication method for the test set

Not applicable. No clinical performance study was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a submission for an endoscopic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness assessment was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the acceptance of this device implicitly relies on the proven safety and effectiveness of the identified predicate devices in clinical use. The assessment is based on the substantial equivalence of the GIMMI ALPHA devices to these predicates in terms of intended use, materials, operating principles, and compliance with recognized standards. No new ground truth specific to the GIMMI ALPHA devices was established through a clinical trial or expert review.

8. The sample size for the training set

Not applicable. No training set was used, as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable.

In summary: The 510(k) submission for GIMMI ALPHA Sinuscopes and Bronchoscopes does not include a new clinical study with acceptance criteria and device performance evaluation in the typical sense. Instead, it demonstrates the device's safety and effectiveness by asserting substantial equivalence to legally marketed predicate devices, based on similarities in intended use, materials, design, and adherence to established industry standards. The FDA's clearance (K013731) indicates their agreement with this claim of substantial equivalence.

Summary

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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 orRigid)	77 EOB	874.4760
Bronchoscope (Flexible orRigid)	77 EOQ	874.4680

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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)]

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

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

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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.

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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.

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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

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Abbreviated 510(k)

GIMMI GmbH

510(k) Number

K013731

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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Karen Baker /s/
(Division Sign-Off)

Division of Ophthalmic Devices 510(k) Number _

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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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Karen H. Boker

(Division Sign-Off)

wision of Ophthalmic Devices Vol3731 : 0(k) Number .

Regulation Number and Section

§ 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.