(189 days)
No
The device description and performance studies focus on mechanical function and reprocessing, with no mention of AI or ML.
Yes
The device is used to entrap and remove renal stones and calculi, which directly treats a medical condition, classifying it as a therapeutic device.
No
The device is used to entrap and remove renal stones and calculi, which is an interventional or therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (handle, shaft/sleeve, wire basket) and mentions bench testing and process validation related to these physical aspects, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that this device is used to "entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures." This is a surgical or interventional device used within the body to physically remove something.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its purpose is purely mechanical removal.
Therefore, based on the provided information, this device falls under the category of a surgical or interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.
Product codes
FFL
Device Description
SterilMed's reprocessed stone retrieval baskets consist of a handle, shaft/sleeve, and a wire basket which serves as the stone capturing mechanism. They come in diameters ranging from 1.9 French to 8.0 French, and lengths ranging from 70 cm to 220 cm. The baskets are available in 3 to 8 wire configurations and flat or helical wire designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of reprocessed stone retrieval baskets underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K970121, K951309, K936721, K851965
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
K012581
Page 1 of 2
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SterilMed, Inc. | FEB 1 4 2002 |
|---|---|---|
| Contact Person: | Patrick Fleischhacker | |
| 11400 73 rd Avenue North | ||
| Minneapolis, MN 55369 | ||
| Ph: 888-856-4870 | ||
| Fax: 763-488-3350 | ||
| Date Prepared: | August 8, 2001 | |
| Trade Name: | SterilMed Reprocessed Stone Retrieval Baskets | |
| Classification Name | ||
| and Number: | Ureteral Stone Dislodger, | |
| Class II, 21 CFR 876.4680 | ||
| Product Code: | FFL | |
| Predicate Device(s): | SterilMed's reprocessed stone retrieval baskets are | |
| substantially equivalent to: | ||
| Boston Scientific Corporation's Stone Dislodger Baskets (K970121, K951309, K936721)Wilson-Cook Medical Inc.'s Stone Extractor (K851965)The counterpart devices from the original manufacturers | ||
| Device Description: | SterilMed's reprocessed stone retrieval baskets consist of a handle, shaft/sleeve, and a wire basket which serves as the stone capturing mechanism. They come in diameters ranging from 1.9 French to 8.0 French, and lengths ranging from 70 cm to 220 cm. The baskets are available in 3 to 8 wire configurations and flat or helical wire designs. | |
| Intended Use: | Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures. |
Revised Page 4 of Original Submission
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1
K012581
Page 2 of 2
Functional and Safety Testing:
Conclusion:
Representative samples of reprocessed stone retrieval baskets underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
SterilMed's Reprocessed Stone retrieval baskets are substantially equivalent to:
- Boston Scientific Corporation's Stone Dislodger . Baskets (K970121, K951309, K936721)
- Wilson-Cook Medical Inc.'s Stone Extractor . (K851965)
- The counterpart devices from the original . manufacturers.
This conclusion is based upon the fact that these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, and principles of operation.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird with three stylized wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB | 4 2002
Mr. Patrick Fleischhacker V.P. Regulatory and Quality Control SteriMed, Inc. 11400 73rd Avenue North MINNEAPOLIS MN 55369
Re: K012581
Trade/Device Name: As identified in Enclosure 1 Regulation Number: 21 CDR 876.4680 Regulation Name: Ureteral stone dislodger Regulatory Class: II Product Code: 78 FFL Dated: December 6, 2001 Received: December 7, 2001
Dear Mr. Fleischhacker:
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 (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 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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdin
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Enclosure 1 Device Trade Name: Reprocessed Stone Retrieval Baskets
Model Numbers
| Wilson-Cook MSB-21-2x4 |
|---|
| Wilson-Cook MSB-35-2x4 |
| Wilson-Cook MSB-1.5x3.5 |
| Wilson-Cook MSB-2x4 |
| Wilson-Cook MSB-2.5x5 |
| Wilson-Cook MSB-3x6 |
| Wilson-Cook MSB-1.5x3.5-F |
| Wilson-Cook MSB-2x4-F |
| Wilson-Cook MSB-2.5x5-F |
| Wilson-Cook MSB-3x6-F |
| Wilson-Cook MSB5-1.5x3.5 |
| Wilson-Cook MSB5-2x4 |
| Wilson-Cook MWB-1.5x3.5 |
| Wilson-Cook MWB-2x4 |
| Wilson-Cook MWB-2.5x5 |
| Wilson-Cook MWB-3x6 |
| Wilson-Cook MB5-2x4-8 |
| Wilson-Cook MB5-3x6-8 |
| Wilson-Cook WCMB-200-4 |
| Wilson-Cook MWB5-1.5x3.5 |
Olympus FG-16L-1 Olympus FG-23Q-1
5
FEB 1 4 2002 Indications for Use Page
K012581
Page 1 of 1
Device Name: Reprocessed Stone Retrieval Baskets
Indications for Use:
Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Proglon
(Division Sign-on)
Division of Reproductive, Abdominal,
and Radiological Devices
Radiological Devices
510(k) Number K012581
Prescription Use
(Per 21 CFR 801.109)
Revised Page 1 of Original Submission