GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.

Device Description

GIMMI ALPHA Hysteroscopes 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 obstetric-gynecologic accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Some specialized instruments, such as the gynecologic fibroid screw and uterine tenaculum are one-piece.

The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gimmi Alpha Hysteroscopes & Accessories:

Based on the provided 510(k) summary (K012869), the device is cleared based on substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics through a clinical study with detailed acceptance criteria as one might expect for novel technology. This is a common approach for medical devices that are similar in design, materials, and intended use to products already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Identical to predicate devices.	"The GIMMI "ALPHA Hysteroscopes & Accessories have the same intended use as predicate devices." The intended use describes the device's function: "to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix... used to perform diagnostic and surgical procedures."
Performance Attributes	Equivalent to predicate devices.	"performance attributes ... are identical and/or substantially equivalent to SE devices." This is a general statement indicating that the device performs as expected for its class.
Materials	Identical to predicate devices, biocompatible.	"They are made of the same material [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."
Basic Design	Fundamentally similar to predicate devices, with slight modifications not adversely affecting safety/effectiveness.	"basic design are identical and/or substantially equivalent to SE devices. Slight modifications in design do not adversely affect the safety and effectiveness of these devices." The description notes "rigid, panoramic telescopes using rod lens technology."
Safety & Effectiveness	No new issues of safety and effectiveness compared to predicates.	"The results of design validation raise no new issues of safety and effectiveness." All materials "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."
Compliance with Standards	Compliance with relevant international and national device standards (ISO/EN/ASTM/AAMI/ANSI/IEC).	"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. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical "test set" with human subjects or a specific data provenance in the way a clinical trial for a novel device would. The evaluation is based on engineering and material testing and a comparison to known predicate devices. The "Summary of Testing" states: "All materials used in the composition of GIMMI ALPHA Hysteroscopes and Accessories were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices." No sample size or data provenance details like country of origin or retrospective/prospective nature are provided for these internal tests, as it's not a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable to this 510(k) submission. There was no "test set" requiring expert ground truth establishment in the context of a clinical performance study. The evaluation focused on material properties, design similarity, and compliance with manufacturing standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate reader performance (e.g., radiologists interpreting images) with and without AI assistance, which is not relevant for the type of device (hysteroscopes) being discussed here.

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

No, this is not an AI algorithm. It is a physical medical device (hysteroscopes and accessories). Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Predicate Device Performance: The safety, effectiveness, and performance of existing, legally marketed hysteroscopes serve as the primary reference point.
Engineering Standards and Material Specifications: Compliance with established international and national standards (ISO/EN/ASTM/AAMI/ANSI/IEC) for medical devices, materials, manufacturing, and reprocessing.
Biocompatibility Data: The historical biocompatibility of surgical grade stainless steel for human use.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI training set.

Summary

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4H.

Gimmi GmbH

Abbreviated 510(k)

MAR 11 2002

K012869
page 1 of 3

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 +31-20-428 95 91 Amstel 320-l Tel. +31-20-428 94 29 1017 AP Amsterdam Fax bsi@xs4all.nl eMail The Netherlands

2.3 Date Summary Prepared: [807.92 (a)(1)} November 30, 2001

2.4 Device Names: [807.92 (a)(2)] GIMMI ALPHA Hysteroscopes & Accessories Proprietary
Common

Endoscopic Instruments & Accessories

Classification Names	Product Codes	CFR Reg'n
Cannula & Trocar, Suprapubic,Non-Disposable	78 FBM	876.5090
Tenaculum, Uterine	85 HDC	884.4530
Laparoscope, Gynecologic (andAccessories)	85 HET	884.1720
Screw, Fibroid, Gynecological	85 HHO	884.4530
Hysteroscope & Accessories	85 HIH	884.1690

2-1

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Instrument, Manual, Specialized (Obstetric-Gynecologic) Endoscope & Accessories

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

2.7 Device Description: [807.92(a)(4)+(6)]

The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

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

GIMMI ALPHA Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.

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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 Hysteroscopes and Accessories 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.

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

The GIMMI "ALPHA Hysteroscopes & Accessories have the same intended use as predicate devices. They are made of the same material and produced to the same international and FDArecognized standards. Slight modifications in design do not adversely affect the safety and effectiveness of these devices.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2002

GIMMI GmbH % Mr. Dagmar S. Mäser Business Support International Amstel 320-I, 1017 AP Amsterdam THE NETHERLANDS

Re: K012869

Trade/Device Name: Gimmi Alpha Hysteroscopes & Accessories Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscopes and accessories Regulatory Class: II Product Code: 85 HIH Dated: December 18, 2001 Received: December 20, 2001

Dear Mr. Mäser:

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 recistration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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.

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 Part 801); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GIMMI GmbH

K012869

510(k) Number Device Name

GIMMI ALPHA® Hysteroscopes & 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)

Over-The-Counter Use _

(Optional Format 1-2-96)

David A. Flynn

(Division Si Division and Ra 510(k) Nun

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.