(189 days)
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.
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.
The provided document describes the 510(k) premarket notification for SterilMed's Reprocessed Stone Retrieval Baskets. This is a medical device submission for reprocessing existing devices, not a new AI/ML-driven device. Therefore, many of the requested categories in the prompt, such as acceptance criteria based on performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable here.
The "device" in this context is the reprocessed version of existing stone retrieval baskets, and the study focuses on validating the reprocessing methods to ensure the reprocessed devices are substantially equivalent to new, predicate devices.
Here's the information that can be extracted from the provided text, framed within the context of a medical device submission for reprocessing:
Acceptance Criteria and Study for SterilMed's Reprocessed Stone Retrieval Baskets
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description of Criterion | Reported Device Performance / Evidence of Meeting Criterion |
|---|---|---|
| Functional Characteristics | Device performs as intended (e.g., stone entrapment and removal). | "Representative samples of reprocessed stone retrieval baskets underwent bench testing to demonstrate appropriate functional characteristics." The FDA's substantial equivalence determination implies that the reprocessed devices perform functionally similar to the predicate devices. |
| Cleaning Validation | Reprocessing procedures effectively clean the device to remove biological and other contaminants. | "Process validation testing was done to validate the cleaning [...] procedures." |
| Sterilization Validation | Reprocessing procedures effectively sterilize the device, rendering it free of viable microorganisms. | "Process validation testing was done to validate the [...] sterilization procedures." |
| Packaging Validation | Repackaged device maintains sterility and integrity until point of use. | "Process validation testing was done to validate [...] the device's packaging." |
| Visual and Functional Inspection | Each reprocessed device meets quality standards before release. | "In addition, the manufacturing process includes visual and functional testing of all products produced." |
| Substantial Equivalence (Overall) | The reprocessed device is as safe and effective as a legally marketed predicate device. | "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 on "...these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, and principles of operation." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states "Representative samples" were used for bench testing and process validation. A specific numerical sample size is not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's bench testing and process validation, it's likely internal laboratory testing conducted by SterilMed, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable to this type of submission. "Ground truth" for this device relates to objective physical and biological properties (e.g., cleanliness, sterility, mechanical function) rather than expert interpretation of data. The validation work would be conducted by qualified engineers and microbiologists, but they are not "experts establishing ground truth" in the same way as, for example, radiologists interpreting images.
4. Adjudication method for the test set
- This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations or annotations, typically in fields like medical imaging. The tests performed here (bench testing for function, process validation for cleaning/sterilization) involve objective measurements and established protocols, not subjective expert judgment requiring adjudication.
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
- No, an MRMC comparative effectiveness study was not done. This is a reprocessed medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device does not involve an algorithm.
7. The type of ground truth used
- The "ground truth" here is based on objective measurements and validated protocols demonstrating device function, cleanliness, sterility, and packaging integrity. This is derived from:
- Bench test results (e.g., mechanical performance specifications).
- Microbiological testing results (e.g., sterility assurance levels, residual protein/bioburden).
- Packaging integrity tests.
- Visual and functional inspection criteria.
8. The sample size for the training set
- This concept is not applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- This concept is not applicable. As there is no training set for an algorithm, there is no ground truth established for it.
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K012581
Page 1 of 2
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SterilMed, Inc. | FEB 1 4 2002 |
|---|---|---|
| Contact Person: | Patrick Fleischhacker11400 73 rd Avenue NorthMinneapolis, MN 55369Ph: 888-856-4870Fax: 763-488-3350 | |
| Date Prepared: | August 8, 2001 | |
| Trade Name: | SterilMed Reprocessed Stone Retrieval Baskets | |
| Classification Nameand Number: | Ureteral Stone Dislodger,Class II, 21 CFR 876.4680 | |
| Product Code: | FFL | |
| Predicate Device(s): | SterilMed's reprocessed stone retrieval baskets aresubstantially 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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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.
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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.
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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
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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
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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
§ 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.