RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES

K042523 · Richard Wolf Medical Instruments Corp. · FJL · Mar 18, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042523
• Device Name: RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FJL · Gastroenterology, Urology
• Decision Date: Mar 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myomas or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.

Device Story

Resection Pump 2228 operates with resectoscope for tissue chip aspiration. System monitors pressure changes in control tube; when working element grip reaches end position during tissue cutting, pressure change triggers pump to open tube clamp valve. Brief vacuum generated via secretion trap pulls tissue chips into chip fluid trap. Used in clinical settings by physicians during endoscopic procedures under continuous flow. Software monitors key functions; faults trigger LCD messages and acoustic signals. Benefits include efficient tissue removal during endoscopic surgery.

Clinical Evidence

No clinical tests performed. Bench testing only.

Technological Characteristics

Software-controlled pump; pressure-sensing mechanism for vacuum activation; LCD display and acoustic alarm for fault monitoring. Meets IEC601-1/UL2601-1 standards. System includes secretion trap and chip fluid trap.

Indications for Use

Indicated for patients requiring endoscopic removal of intrauterine polyps, intrauterine myomas, or prostate adenomas following resection with a high-frequency electrode.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Richard Wolf 510(k) devices
• FemRx 510(k) devices

Submission Summary (Full Text)

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MAR 1 8 2005

## 1.0 Description

The Resection Pump 2228 is used in combination with a large diameter resectoscope to suction off tissue chips by a short pulse vacuum after the removal with a high-frequency electrode. The complete procedure is done under endoscopic view and continuous flow conditions.

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#### 2.0 Intended Use

The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myoma or prostate adenomas via suction channel under continuous flow conditions following resection using a high- frequency electrode with a resectoscope.

# 3.0 Technological Characteristics

The airflow of the control tube is interrupted when the grip of the working element is in the end position and the tissue is cut. This results in a change in pressure which triggers the resection pump to open the tube clamp valve for a short period of time. This generates a brief vacuum pressure via the secretion trap and the tissue chip is sucked off and collected in the chip fluid trap.

The resection pump 2228 is software controlled. Key functions and components are automatically monitored to ensure safe operation. If there is a fault, a message is shown on the LCD display in conjunction with an acoustic signal.

#### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf and FemRx.

## 5.0 Performance Data

The resection pump 2228 is designed to meet the standards IEC601-1/ UL2601-1.

#### 6.0 Clinical Tests

No clinical tests performed.

# 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.

Revised 03/08/05

By: .&

Robert L. Casarsa

Quality Assurance Manager

Date: ...Moz 8, 05...........

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo. The logo features a stylized bird with three curved lines representing its wings. The bird is facing to the right. Encircling the bird is text that reads "MINISTRY OF HEALTH & HUMAN SERVICES".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2005

Mr. Robert L. Casarsa Ouality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway VERNON HILLS IL 60061-3110

Re: K042523

Trade/Device Name: Resection Pump and Resectoscope for Chip Aspiration Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: FJL Regulation Number: 21 CFR §876.4370 Regulation Name: Gastroenterology-urology-urology evacuator Product Code: KOT Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Product Code: HIH Regulatory Class: II Dated: March 8, 2005 Received: March 9, 2005

Dear Mr. Casarsa:

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.

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 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 Section 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/dsmaldsmamain.html

Sincerely yours,

Nancy C. brogdon
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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# 5.0 Indications for Use

# 510(k) Number (if known): K042523

Resection Pump and Resectoscope for Chip Aspiration Device Name:

Indications For Use:

The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myomas or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.

Prescription Use

AND/OR

Over-The Counter

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Nancy C. Hogdon
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K42623

**510(k) Number** K642523