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 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.

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

AI/ML Overview

This document is a 510(k) premarket notification for the GIMMI ALPHA® Endoscopic Instruments & Accessories. It establishes substantial equivalence to various predicate devices and describes the general characteristics of the device. However, it does not contain a detailed study with specific acceptance criteria and performance results directly comparable to those criteria in a quantitative manner.

Instead, the document states general compliance and conformance without providing numerical performance metrics or detailed study designs.

Therefore, many of the requested sections regarding specific acceptance criteria, performance data, sample sizes, ground truth establishment, and expert involvement cannot be extracted from this document based on the provided text.

Here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the provided text. The document broadly states "safety, effectiveness, and reliability."
Reported Device Performance: Not reported numerically. The document states, "All results were in conformance with the cited harmonized device standards" and "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

Sample Size: Not specified.
Data Provenance: Not specified, but likely from GIMMI GmbH's internal testing.

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

This information is not provided as the document does not detail specific clinical or performance studies involving "ground truth" established by experts. The "ground truth" in this context would typically refer to definitive diagnoses or outcomes for a clinical study comparing the device's output to reality, which is not described.

4. Adjudication method for the test set

Not applicable/not provided, as no expert-adjudicated test set is described.

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

This is not applicable. The device is described as "Endoscopic Instruments & Accessories" and devices "for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications." It is a physical medical device, not an AI-powered diagnostic tool, and therefore, an MRMC study with AI assistance is not relevant to this submission.

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

This is not applicable as the device is a physical instrument, not a standalone algorithm.

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

Not applicable/not specified for a clinical performance study involving "ground truth." The "performance and physical tests" would likely rely on engineering standards and measurements rather than medical ground truth.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a "training set."

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

Not applicable for the same reason as above.

Summary based on the provided text:

The document serves as a regulatory submission confirming that the GIMMI ALPHA® Endoscopic Instruments & Accessories are "substantially equivalent" to predicate devices. It states that:

The devices have the same intended use.
They are made of the same materials.
They are produced to the same international and FDA-recognized standards.
"All materials used... 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."
"The results of design validation raise no new issues of safety and effectiveness."

However, it refrains from providing detailed study protocols, quantitative performance data, or specific acceptance criteria with reported numerical results. The substantiation relies on adherence to general standards and comparison to existing, cleared predicate devices rather than a new, detailed clinical performance study with defined acceptance criteria.

Summary

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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 (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

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Abbreviated 510(k)

GIMMI GmbH

Kol2 660 510(k) Number

Device Name

ALPHA® Endoscopic Instruments & Accessories

INDICATIONS FOR USE

(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)]GIMMI GmbHJunkerstr. 1D-78532 TuttlingenGermany	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. MäserBusiness Support InternationalAmstel 320-I1017 AP AmsterdamThe 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 laparoscopicendoscopes, endoscopic accessories and GIMMIdevices for minimally invasive GI, GU, and laparoscopicdiagnostic and/or therapeutic indications.
	Common	Endoscopic Instruments & Accessories andMinimally Invasive Gl and GU Devices
	PANEL 78Cystoscope, 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

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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& 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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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.

Regulation Number and Section

§ 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.