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 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. 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.

AI/ML Overview

The provided documents describe the Resection Pump 2228, a medical device for tissue chip resection and removal. However, the information regarding "acceptance criteria" and the "study that proves the device meets the acceptance criteria" is limited from the perspective of an AI-based device's performance metrics and clinical studies.

Based on the provided text, the device's performance is primarily established through design to standards and lack of clinical tests. The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to establish efficacy unique to this device.

Here's an analysis based on your requested categories, acknowledging the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance
Safety and Effectiveness: Meets general requirements for medical devices.	"These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (General statement, no specific metrics provided.)
Compliance with Standards: Designed to meet recognized medical device safety standards.	"The resection pump 2228 is designed to meet the standards IEC601-1/ UL2601-1." (Compliance with specific electrical safety standards.)
Functional Performance (Suction Mechanism): Ability to effectively suction tissue chips.	"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." (Detailed description of the mechanism, implying it functions as intended by design. No quantitative performance metrics like suction pressure, efficiency of chip removal, or percentage of successful aspirations are provided.)
Automated Monitoring and Safety Features: Key functions and components are monitored for safe operation.	"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." (Confirms the presence of automated monitoring and fault indication. No specific metrics on fault detection rates or response times are given.)
Substantial Equivalence: Device is as safe and effective as existing legally marketed predicate devices.	"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." (Conclusion of the 510(k) review, indicating regulatory acceptance based on comparison to predicate devices, not on de novo clinical performance studies.)

Study Proving Acceptance Criteria:

The document explicitly states: "No clinical tests performed."

The "study" proving the device meets its acceptance criteria is primarily based on technical design, adherence to recognized safety standards, and a demonstration of substantial equivalence to already legally marketed predicate devices. This is typical for a 510(k) premarket notification. The FDA's acceptance is based on the review of the submitted documentation, including product specifications, design principles, and comparison to predicates, rather than new clinical trials.

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable, as no clinical tests or specific "test sets" for performance evaluation (in the AI/clinical study sense) were performed.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical tests were performed, and thus no "ground truth" was established through expert review for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-assisted diagnostic or interpretive tool, but a mechanical pump.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm; it's a physical pump that operates with human interaction (endoscopic view, high-frequency electrode).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of clinical performance data for this submission. The "ground truth" for the 510(k) submission is the functional and safety specifications of the device, proven by engineering design, internal testing (not detailed), and compliance with standards, establishing substantial equivalence to predicates.

8. The sample size for the training set:

Not applicable for this type of device. There is no "training set" in the context of an AI/machine learning model.

9. How the ground truth for the training set was established:

Not applicable for this type of device.

Summary

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

MAR 1 8 2005

1.0 Description

ummer i

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...........

12-2

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

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.

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

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 (800) 638-2041 or (301) 443-6597 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

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

5.0 Indications for Use

510(k) Number (if known): K042523

Resection Pump and Resectoscope for Chip Aspiration Device Name:

Indications For Use:

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

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.