Resection Electrodes

K161600 · Olympus Winter & Ibe GmbH · JOS · Sep 6, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161600
• Device Name: Resection Electrodes
• Applicant: Olympus Winter & Ibe GmbH
• Product Code: JOS · General, Plastic Surgery
• Decision Date: Sep 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in saline irrigation fluid. Specific indications: - transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - lysis of intrauterine septa - endometrial ablation

Device Story

Resection Electrodes are single-use electrosurgical accessories for resectoscope systems; used in gynecological procedures. Device consists of active tip (loops, rollers, needles, or buttons), PTFE color code, insulator, guiding tube, telescope clip, and shaft. Operated by physicians in clinical settings; powered by external electrosurgical generator. Device delivers electrical current to tissue in saline irrigation fluid to perform resection, vaporization, biopsy, cutting, and coagulation. Output is physical tissue modification; enables minimally invasive treatment of intrauterine pathologies. Benefits include precise tissue removal and reduced surgical trauma.

Clinical Evidence

No clinical data. Substantial equivalence is based on identical design, manufacturing, and technological characteristics to the predicate device (K152092), relying on previously reviewed performance and validation data.

Technological Characteristics

Single-use electrosurgical electrodes; active tips include loops, rollers, needles, buttons. Materials include PTFE insulation. Operates via bipolar electrosurgery in saline irrigation fluid. Compatible with resectoscope systems. Sterilization per ISO 11135; packaging per ISO 11607-1.

Indications for Use

Indicated for gynecological endoscopic diagnosis and treatment in patients requiring transcervical resection, vaporization, ablation, cutting, or coagulation of intrauterine tissue, including myomas, polyps, synechias, endometrium, and lysis of intrauterine septa.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• K152092

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

Olympus Winter & Ibe GmbH % Dolan Mills Sr. Specialist, Regulatory Affairs Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Re: K161600

> Trade/Device Name: Resection Electrodes (model numbers WA47505S, WA47506S. WA47507S, WA47540S, WA47551S, WA47555S, WA47560S, WA47566S) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: JOS, HIH Dated: June 8, 2016 Received: June 9, 2016

Dear Dolan Mills:

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.

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

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

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for 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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K161600

#### Device Name

Resection Electrodes (model numbers WA47505S, WA47507S, WA47507S, WA47551S, WA47551S, WA47550S, WA47566S

Indications for Use (Describe)

Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in saline irrigation fluid.

Specific indications:

- transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
- lysis of intrauterine septa
- endometrial ablation .

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

EF

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

# 510(k) Summary of Safety and Effectiveness June 8, 2016

## 1. General Information

| Manufacturer: | Olympus Winter & Ibe GmbH<br>Kuehnstr. 61<br>22045 Hamburg<br>Germany<br>Establishment Registration No.: 9610773 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dolan Mills<br>Sr. Specialist, Regulatory Affairs<br>Gyrus ACMI, Inc.<br>136 Turnpike Rd.<br>Southborough, MA 01772-2104<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Establishment Registration No.: 3003790304 |

## 2. Device Identification

| Common Name: | Electrode, Electrosurgical / Hysteroscope (and accessories) |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Regulation Number: | 878.4400 / 884.1690 |
| Classification | Electrosurgical cutting and coagulation device and accessories / Hysteroscope and accessories |
| Device Class: | II |
| Product Code: | JOS / HIH |
| Review Panel: | General & Plastic Surgery / Obstetrics/Gynecology |
| Proprietary/Trade Name: | Resection Electrodes |
| Model numbers: | WA47505S, WA47506S, WA47507S, WA47540S, WA47551S, WA47555S, WA47560S, WA47566S |

# 3. Predicate Devices

The subject devices have been previously cleared for urological indications under K152092 (product codes FAS / FJL).

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

The predicate devices have not been subject to a design-related recall.

No reference devices were used in this submission.

## 4. Product Description

The Olympus Resection Electrodes that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting.

The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, rollers, needles or buttons.

All subject Resection Electrodes are single-use electrodes and are delivered sterile and are used in combination with a reusable HF cable (the HF cable is not subject to this submission).

## 5. Indications for Use

Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in saline irrigation fluid.

Specific indications:

- transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
- lysis of intrauterine septa -
- endometrial ablation

Although the subject and predicate devices have different indications for use statements, the intended use is the same. The subject device is indicated for gynecologic applications while the predicate device is indicated for urological indications. However, when the decision-making criteria specified in the FDA

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

guidance document, "General/Specific Intended Use," (issued November 4, 1998) are applied, the subject device indications are determined to fall within the scope of the intended use of the predicate device. The specific gynecology indications of the subject device do not represent a different intended use since there is an extensive knowledge base regarding the use of bipolar electrosurgery for gynecological applications, including the disease states listed in the specific gynecologic indications. Therefore, the intended use comparison supports substantial equivalence.

## 6. Comparison of Technological characteristics

The subject and predicate devices are identical in design and are based on the same technological principle with the same elements:

- Identical in design
- I Used in combination with a resectoscope system (identical to predicate)
- I Like the predicate electrodes, the subject device resection electrode series features loops, needles, rollers, and buttons as active tip shapes
- I Utilizing resection in saline as mode of ablation (identical to predicate)

## 7. Performance Data

The subject device is identical in design and manufacturing to the predicate device (K152092). Therefore, the current submission relies on performance testing previously reviewed and deemed acceptable in K152092.

## 8. Sterilization and Shelf Life

Sterilization is performed according to ISO 11135 and packaging conforms with ISO 11607-1. Since the subject device is identical in design and manufacturing to the predicate device, the current submission relies on sterilization and packaging validation testing previously reviewed and deemed acceptable in K152092.

## 9. Conclusion

The subject device is substantially equivalent to the predicate device.