(45 days)
The URO Pro is an irrigation roller pump intended for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urologic procedures. It is indicated for the infusion of sterile solutions through an endoscope into the urogenital tract to irrigate the ureter and upper urinary tract in a controlled manner and to improve visibility of the surgical field during urologic procedures.
The URO Pro is a microprocessor controlled pump which functions according to the peristaltic principle and incorporates the following major components and features: a power supply, a main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active sensor monitoring ensures the conformity of the preset nominal pressure value with the actual measured pressure. In addition, the URO Pro is designed with several alarms to inform the operator in case of an overpressure.
The provided text is a 510(k) summary for the URO Pro device, which is an irrigation roller pump. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety and electromagnetic compatibility standards. It does not contain information about specific acceptance criteria related to device performance in a clinical or simulated clinical setting, nor does it describe a study that proves the device meets such criteria in terms of efficacy or diagnostic accuracy.
Therefore, many of the requested sections about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be answered from the provided document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from this document) | Reported Device Performance (from this document) |
|---|---|
| Compliance with electrical safety standards | The device complies with the International Standard IEC 60601-1 (Electrical Safety). |
| Compliance with electromagnetic compatibility standards | The device complies with IEC 60601-1-2 (Electromagnetic Compatibility). |
| Substantial equivalence in design and characteristics to predicate devices | The URO Pro is substantially equivalent to the Hysteroscopy Pump HM4 in regards to its design and characteristics, using the same basic principles of operation, technological characteristics, and tubing sets. |
| Substantial equivalence in intended use to predicate devices | The URO Pro is substantially equivalent to the Karl Storz Uromat and ENDO FMS Urology in its intended use for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urological procedures. |
| Technological characteristics and principles of operation similar to predicate devices | The URO Pro has similar technological characteristics and principles of operation as the Karl Storz Uromat and ENDO FMS Urology. |
The following information is NOT available in the provided text:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information about a test set or its provenance is given. The "Performance Data" section refers to compliance with safety standards, not clinical performance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No information about experts or ground truth establishment for a test set is provided.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set performance is described.
- 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: This device is an irrigation pump, not an AI-assisted diagnostic device, so an MRMC study is not relevant and not mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical performance study requiring ground truth is described.
- 8. The sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
- 9. How the ground truth for the training set was established: Not applicable.
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OCT 2 5 2004
510(K) SUMMARY
K042457
Page 1 of 2
URO Pro
I. Applicant:
w.o.m. world of medicine ag Alte Poststraße 11 96337 Ludwigsstadt Germany
Phone number: + 49 30 39981610 + 49 30 39981593 Fax number:
8043980 Establishment registration number:
Susanne Raab Official Correspondent: 119 South Street Hingham, MA 02043
781 749 4656 Phone number:
Date Prepared: September 2, 2004
II. Device Names:
| 1. | Classification Name: | URO Pro |
|---|---|---|
| 2. | Common or Usual Name: | Urological Irrigation System |
| 3. | Proprietary Name: | Urological Irrigation System and Tubing Set |
III. Product Classification:
| Product Code: | LHJ |
|---|---|
| Device Class: | II |
IV. Predicate Devices:
- Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD . OF MEDICINE AG
- Karl Storz Uromat (K940983) manufactured by Karl Storz Endoscopy-. America, Inc.
- ENDO FMS Urology (K980808) manufactured by Future Medical Systems, . Inc.
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K042457
Page 2 of 2
Intended Use: V.
The URO Pro is an irrigation roller pump intended for the infusion of sterile The ONO 110 to the ureter and upper urinary tract during diagnostic and/or sonations meo the droic urologic procedures. It is indicated for the infusion of therapouries shaoscopy an endoscope into the urogenital tract to irrigate the storie solutions anvage and in a controlled manner and to improve visibility of the surgical field during urologic procedures.
Device Description: VI.
The URO Pro is a microprocessor controlled pump which functions according to the cristaltic principle and incorporates the following major components and features: a power supply, a main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active sensore to perform ensures the conformity of the preset nominal pressure value probate retual measured pressure. In addition, the URO Pro is designed with several alarms to inform the operator in case of an overpressure.
Substantial Equivalence: VII.
The URO Pro is substantial equivalent to the Hysteroscopy Pump HM4 in regards to its design and characteristics. Both the URO Pro and the Hysteroscopy Pump HM4 use the same basic principles of operation, incorporate the same technological characteristics and are used with the same tubings sets. Although there are some technological differences between the devices, these differences to not raise new questions of safety and effectiveness considering the different intended use of the devices. In addition, the URO Pro is substantial equivalent to the Karl Storz Uromat (K940983) and the ENDO FMS Urology (K980808). Specifically, the URO Pro like the Karl Storz Uromat and ENDO FMS Urology is intended to be used for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urological procedures. The URO Pro has also similar technological characteristics and principles of operation as the Karl Storz Uromat and ENDO FMS Urology and the minor technological characteristics do not raise any new issues of safety or effectiveness.
VIII. Performance Data:
The device complies with the International Standard IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2004
W.O.M. WORLD OF MEDICINE AG c/o Ms. Susanne Raab Regulatory Consultant 119 South Street HINGHAM MA 02043
Re: K042457
Trade/Device Name: URO Pro Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJH Dated: September 2, 2004 Received: September 10, 2004
Dear Ms. Raab:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your boother is substantially equivalent (for the indications for use stated in above and have a le legally marketed predicate devices marketed in interstate commerce prior to the enclosure) to regally maximent date of the Medical Device Amendments, or to devices that have been May 20, 1770, the character 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 do not require approval or a ve visions of the Act. The general controls provisions of the Act device, subjor to the generaual 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 Apployally, It ifay of babyers of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA acrise ban of arther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I toase or actives and in a water complies with other requirements of the Act or any I Dri nas made a addressions administered by other Federal agencies. You must comply with all the I carat suiteres and regulaing, but not limited to registration and listing (21 CFR Part 807); labeling / 1 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 80 77, government 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) I his letter will anow you to begin manisting of substantial equivalence of your device to a legally premarket nothication: "The FDA midning of backannal con 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 If you desire specific advice for your acrise for 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 Also, prease note the regulation emilion on your responsibilities under the Act from the 807.97). I ou may outlik other general missistance at its toll-free number (800) DWISION of Sthan Manufactures, Internamet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Brogdon Nancy C. I Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number (if known): K042457
Device Name: URO Pro
Indications for Use:
The URO Pro is an irrigation roller pump intended for the infusion of sterile The UNO ITo is an irrigation regarion react during diagnostic and/or Sundtions into the areter und air procedures. It is indicated for the infusion of therapedit chaoscopic an endoscope into the urogenital tract to irrigate the sterne solutions through atract in a controlled manner and to improve the ureter and appeargical field during urologic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Nancy Brogdon
(Division Sign-Off)/ Division of Reproductive, Abdo and Radiological Device 510(k) Number
Over-The-Counter Use (Per 21 C.F.R. 801.109)
(Optional Format 3-10-98)
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.