KSEA MONOPOLAR VAPORIZATION ELECTRODES

K983569 · KARL STORZ Endoscopy-America, Inc. · HIH · Jan 8, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983569
• Device Name: KSEA MONOPOLAR VAPORIZATION ELECTRODES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jan 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Monopolar Vaporization Electrodes are indicated for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including: abnormal uterine bleeding, infertility, transuterine resection of fibroids, endometrial ablation, resectoscopic management of Mullerian fusion defects, resectoscopic management of intrauterine lesions, and resectoscopic management of intractable uterine bleeding.

Device Story

KSEA Monopolar Vaporization Electrodes are manual, single-use, sterile surgical instruments used in hysteroscopic procedures. Operated by qualified surgeons in clinical settings, these electrodes facilitate tissue vaporization and resection. The device consists of a metallic tip (stainless steel, tungsten, copper/nickel alloy) that delivers monopolar electrosurgical energy to target uterine tissue. By applying electrical current, the device enables precise cutting or vaporization of lesions, fibroids, or endometrium. This allows surgeons to manage conditions like abnormal bleeding or infertility with minimal invasiveness. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, single-use, sterile electrosurgical electrodes. Materials: surgical grade stainless steel, tungsten, and copper/nickel alloy. Insulated with standard materials. Energy source: external monopolar electrosurgical generator. Form factor: various tip configurations (spike, roller, cutting).

Indications for Use

Indicated for qualified surgeons performing hysteroscopic procedures in patients with abnormal uterine bleeding, infertility, fibroids, Mullerian fusion defects, intrauterine lesions, or intractable uterine bleeding.

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.

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Monopolar Electrodes |
| | Trade Name: (optional)<br>KSEA Monopolar Vaporization Electrodes |

Indication: The KSEA Monopolar Vaporization Electrodes are indicated for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including:

- abnormal uterine bleeding,
- infertility, .
- transuterine resection of fibroids, ●
- endometrial ablation, .
- resectoscopic management of Mullerian fusion defects, ●
- resectoscopic management of intrauterine lesions, and
- resectoscopic management of intractable uterine bleeding.

Device Description: The KSEA Monopolar Vaporization Electrodes are manual single-use sterile surgical devices. The body contact materials are surgical grade stainless steel, tungsten, and a copper/nickel alloy. The Monopolar Vaporization Electrodes are insulated with commonly used materials.

Substantial Equivalence: The KSEA Monopolar Vaporization Electrodes are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Monopolar Vaporization Electrodes and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

Signed:

Kevin Keenan

Senior Regulatory Affairs Specialist

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1999 JAN

Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983569

Spike 5mm 27050 VG, Spike 3mm 27050 VK, Roller 5mm 27050 RG, Roller 3mm 27050 RK, Roller Cutting 27050 KG, VAPOR Cutting 27050 SG, VAPOR CUT 27050 WG Dated: October 7, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85HIH 21CFR 884.4160/Procode: 85KNF

Dear Mr. Kennan

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act include requirements for annual registration, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known):

## Device Name: Monopolar Vaporization Electrodes

Indications for Use: These instruments are intended for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including:

- abnormal uterine bleeding, ●
- . infertility,
- transuterine resection of fibroids, .
- . endometrial ablation,
- resectoscopic management of Mullerian fusion defects, .
- resectoscopic management of intrauterine lesions, and .
- resectoscopic management of intractable uterine bleeding. .

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Seggerman

(Division Sign-Off) Division of Reproductive, Anominal, ENT and Radiological Devices 983469 510(k) Number .

Prescription Use: ***_*** OR Over-The-Counter Use: **_**
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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