GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25

K012869 · Gimmi GmbH · HIH · Mar 11, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K012869
• Device Name: GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
• Applicant: Gimmi GmbH
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Mar 11, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

GIMMI ALPHA Hysteroscopes are rigid, panoramic telescopes utilizing rod lens technology; accessories include reusable handle/shaft assemblies and tip assemblies for tissue manipulation (grasping, cutting, dissecting, coagulating, suturing). Used in clinical settings by physicians for gynecological diagnostic and surgical procedures. Devices provide access, illumination, and visualization of the cervical canal and uterine cavity. Benefits include enabling minimally invasive visualization and surgical intervention within the uterus.

Clinical Evidence

Bench testing only. Performance and physical tests conducted to evaluate safety, effectiveness, and reliability. All results conformed to harmonized device standards.

Technological Characteristics

Rigid, panoramic telescopes using rod lens technology. Body contact portions composed of surgical grade stainless steel. Reusable handle, shaft, and tip assemblies. Compliant with relevant ISO/EN/ASTM/AAMI/ANSI/IEC standards.

Indications for Use

Indicated for use by qualified physicians for access, illumination, and visualization of the cervical canal and uterine cavity to perform diagnostic and surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Günter Bissinger Medizintechnik
• Comeg Endoscopy
• Dufner Instrumente GmbH
• Henke-Sass Wolf, GmbH
• Optus, Inc.
• Pilling Weck Group
• Wolf
• Karl Storz Endoscopy

Submission Summary (Full Text)

{0}------------------------------------------------

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 [e-mail]

- 2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Mäser Business Support International [phone] Amstel 320-l Tel. [phone] AP Amsterdam Fax [e-mail] 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,<br>Non-Disposable | 78 FBM | 876.5090 |
| Tenaculum, Uterine | 85 HDC | 884.4530 |
| Laparoscope, Gynecologic (and<br>Accessories) | 85 HET | 884.1720 |
| Screw, Fibroid, Gynecological | 85 HHO | 884.4530 |
| Hysteroscope & Accessories | 85 HIH | 884.1690 |

2-1

{1}------------------------------------------------

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)]

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).

#### 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.

{2}------------------------------------------------

#### 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.

{3}------------------------------------------------

## 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.

{4}------------------------------------------------

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

GIMMI GmbH

K012869

510(k) Number Device Name

GIMMI ALPHA® Hysteroscopes & Accessories

# INDICATIONS FOR USE

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.

(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

V

Over-The-Counter Use _

(Optional Format 1-2-96)

David A. Flynn

(Division Si Division and Ra 510(k) Nun