(90 days)
Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.
The Suction pump 2207 is a roller pump that generates a continuous vacuum for aspirating the particles and liquids during ultrasound lithotripsy into a fluid trap (bottle).
The provided text describes a 510(k) summary for a medical device, the Richard Wolf Suction Pump 2207. It does not contain information about a study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would. Instead, it describes general safety and performance aspects for regulatory submission.
However, I can extract information related to what would be considered "performance" in a medical device context for this submission:
Here's the breakdown of the available information structured to match your request, with an emphasis on what's not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with electrical safety standards (UL 2601 and IEC 601-1) | The Suction pump 2207 is conforming to standards UL 2601 and IEC 601-1. |
| Functionality in generating continuous vacuum for aspiration | The Suction pump 2207 is a roller pump that generates a continuous vacuum for aspirating the particles and liquids during ultrasound lithotripsy into a fluid trap. |
| Functionality for aspirating disintegrated kidney, bladder, and ureter stones and liquids | Designed for combined use with ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved. |
| Feedback control of vacuum/suction rate | The vacuum applied to the fluid trap (and with it the suction rate) is continuously measured and feedback-controlled by software. |
| Suction monitoring | The suction is monitored by a flow detector. |
| Safety interruption if pump housing cover is opened | A safety circuit interrupts the suction if the cover of the pump housing is opened. |
| Interface for increasing suction rate during ultrasound activation | The suction pump has an interface to our Intracorporeal Ultrasound Lithotripter 2271 for increasing the suction rate during activation of ultrasound. |
| Safety and effectiveness when used according to instructions | These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document refers to the regulatory submission for a physical medical device (suction pump), not a diagnostic algorithm or a study with a test set of data. The "testing" mentioned is likely internal engineering and electrical safety testing.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on images) is not relevant for this type of device submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical suction pump, not a diagnostic imaging AI.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of AI/ML. For this physical device, "ground truth" would refer to its physical conformity to engineering specifications and safety standards. The document states it conforms to UL 2601 and IEC 601-1.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
In summary, the provided document describes a 510(k) submission for a medical device (a suction pump) focusing on its intended use, technological characteristics, and conformance to existing safety standards. It explicitly states, "No clinical tests performed." The "performance data" refers to compliance with electrical safety standards, not clinical efficacy trials or AI/ML diagnostic performance metrics.
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SEP 1 7 2001
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Image /page/0/Picture/2 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in bold, black letters, with "RICHARD" stacked above "WOLF". Below the company name is the text "Medical Instruments Corporation" in a smaller font. To the right of the company name is a square graphic with a black border, containing an abstract image of a wolf.
353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
| 12.0 510(k) Summary of Safety and Effectiveness | |||||
|---|---|---|---|---|---|
| Submitter: | Date of Preparation: | ||||
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | June 18, 2001 | |||
| Division name (if applicable): | N.A. | FDA establishment registration number: | |||
| 14 184 79 | |||||
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code): | |||
| ( 847 ) 913 1113 | |||||
| City: | Vernon Hills | State/Province: | Illinois | FAX number (include area code): | |
| ( 847 ) 913 0924 | |||||
| Country: | USA | ZIP / Postal Code: | IL 60061 | ||
| Contact name: | Mr. Robert L. Casarsa | ||||
| Contact title: | Quality Assurance Manager | ||||
| Product Information: | |||||
| Trade name: | Suction pump for Intracorporeal Ultrasound Lithotripter and accessories | Model number: | 2207.xxx | ||
| Common name: | Suction Pump | Classification name: | Gastroenterology-urology evacuator | ||
| Information on devices to which substantial equivalence is claimed: | |||||
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |||
| 1 pre-enact. | 1 Suction pump 2017.00 | 1 Richard Wolf | |||
| 2 K011065 | 2 Ultrasound Lithotriptor 2271 | 2 Richard Wolf |
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1.0 Description
The Suction pump 2207 is a roller pump that generates a continuous vacuum for aspirating the particles and liquids during ultrasound lithotripsy into a fluid trap (bottle).
2.0 Intended Use
Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It is designed for combined use with the ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.
3.0 Technological Characteristics
The vacuum applied to the fluid trap (and with it the suction rate) is continuously measured and feedback-controlled by software.
The suction is monitored by a flow detector.
A safety circuit interrupts the suction if the cover of the pump housing is opened. The suction pump has an interface to our Intracorporeal Ultrasound Lithotripter 2271 for increasing the suction rate during activation of ultrasound.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the predicate 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 competitors.
5.0 Performance Data
The Suction pump 2207 is conforming to standards UL 2601 and IEC 601-1.
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.
By: ....
Robert L. Casarsa Quality Assurance Manager
Date: June 18, 2001
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway VERNON HILLS IL 60061
Re: K011911
Trade/Device Name: Model 2270.011 Suction Pump for Intracorporeal Ultrasound Lithotriptor and Accessories Regulation Number: 21 CFR $876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: 78 FFK Dated: June 18, 2001 Received: June 19, 2001
Dear Mr. Casarsa:
This letter corrects our substantially equivalent letter of September 17, 2001, regarding the Model 2270 Suction Pump for Intracorporeal Ultrasound Lithotriptor and Accessories which was listed as a model 2270 Ultrasound Generator.
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). You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral 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 (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.
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Page 2 - Mr. Robert Casarsa
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.
This letter will allow you to continue market your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 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 Part 809.10 for in vitro diagnostic devices), Please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2031 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmanain.html.
Sincerely yours,
Yurid le. deponon
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): —
Device Name: Suction pump for Intracorporeal Ultrasound Lithotripter and accessories
- Intended use: Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound ultrasound litholipsy. It nas in with ultrasound generator 2271 the suction pump is generator 22711. In ochance of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.
- Contraindications: Contraindications directly related to the product are presently rannown. On the basis of the patient's general condition the doctor in charge must anklown. On the basianed use is possible or not. For further information see the latest medical literature.
- Combinations: The R.Wolf "Suction Pump 2207" is specially designed for use with an ultrasound lithotriptor. It is specially designed for combined use with the WOLF US-LITHO 2271.
If the suction pump is to be used in conjunction with other ultrasound lithotriptors if the buoten pamp to the user must check whether the device combination can (other maintain the required functions on a continuous basis.
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011911
Prescription Use ✓
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”