(22 days)
Indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
The Boston Scientific Extractor™ RX Retrieval Balloon is a stone retrieval balloon catheter used for biliary stone retrieval.
Here's an analysis of the provided text regarding the Boston Scientific Extractor™ RX Retrieval Balloon, focusing on the acceptance criteria and the study proving its performance.
Overview:
The submission K041606 for the Extractor™ RX Retrieval Balloon is a 510(k) premarket notification. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information provided focuses on this comparative approach.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in operating principle and intended use. | "The modified device is substantially equivalent to the predicate device, as they have the same operating principal and intended use." |
| Absence of new issues of safety or effectiveness compared to predicate. | "In addition, the results of design control activities do not raise any new issues of safety or effectiveness." |
| Performance characteristics similar to predicate. | "The results of physical comparison and functional testing support a determination of substantial equivalence for the modified device when compared to the predicate device." "The modified device is substantially equivalent to the currently marketed Boston Scientific Extractor™ RX Retrieval Catheter in terms of performance characteristics, biocompatibility, and intended use." |
| Biocompatibility similar to predicate. | "The modified device is substantially equivalent to the currently marketed Boston Scientific Extractor™ RX Retrieval Catheter in terms of... biocompatibility..." |
| Intended Use for removing stones from the biliary system or facilitating contrast injection. | "The Boston Scientific Extractor™ RX Retrieval Balloon is intended to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon." (This is the stated intended use, and substantial equivalence implies the modified device performs this as effectively as the predicate). |
Note: For 510(k) submissions demonstrating substantial equivalence, explicit acceptance criteria in the sense of numerical targets for accuracy, sensitivity, or specificity are typically not provided. Instead, the "acceptance criteria" are demonstrating similarity to a predicate device across various aspects (design, materials, performance, intended use).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "physical comparison and functional testing" and "design control activities" but does not detail the number of devices or components tested.
- Data Provenance: The testing appears to be internal to Boston Scientific Corporation ("results of design control activities," "physical comparison and functional testing"). No information on country of origin of data or whether it was retrospective or prospective is provided. Given the nature of medical device testing (e.g., sterilization validation, material strength, balloon inflation tests), it's generally prospective in design and conducted in a controlled lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided. For this type of 510(k) submission, ground truth typically refers to objective measurements of physical and functional properties against specifications, rather than expert interpretation of a diagnostic outcome. Clinical experts would be involved in defining the predicates and intended use, but not typically in establishing "ground truth" for the engineering performance tests cited.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. This document describes physical and functional testing of a mechanical device, not diagnostic image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human readers' performance is being evaluated with and without assistance from the device. The Extractor™ RX Retrieval Balloon is a mechanical device for stone retrieval and contrast injection, not an AI or diagnostic imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a manual catheter operated by a human clinician for a physical intervention. There is no "algorithm only" performance to evaluate. The device's performance is intrinsically linked to its operation by a human, and its functionality relies on its physical characteristics.
7. Type of Ground Truth Used
- The "ground truth" for the functional and physical testing would be established by engineering specifications, material standards, and validated test methods. For example, balloon inflation pressures, burst strength, shaft flexibility, or biocompatibility test results against established safety limits. It would not typically be based on expert consensus, pathology, or outcomes data in the context of device performance testing for a 510(k).
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the computational sense. Device design and manufacturing processes are refined through engineering, materials science, and iterative testing, not by training a model on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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JUL - 7 2004
Boston Scientific Corporation June 14, 2004
510 (L) St MMARY
| SPONSOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT PERSON: | James McMahonSenior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name: | Extractor™ RX Retrieval Balloon |
| Common Name: | Catheter, Biliary, Diagnostic |
| Classification: | Class II per 21 CFR Part 876, Section |
| PREDICATE DEVICE: | Extractor™ RX Retrieval Balloon |
| DESCRIPTION: | The Boston Scientific Extractor™ RX Retrieval Balloon is astone retrieval balloon catheter used for biliary stone retrieval. |
| INTENDED USE: | The Boston Scientific Extractor™ RX Retrieval Balloon isintended to remove stones from the biliary system, or to facilitateinjection of contrast medium while occluding the duct with theballoon. |
| COMPARISON OFCHARACTERISTICS: | The modified device is substantially equivalent to the predicatedevice, as they have the same operating principal and intendeduse. In addition, the results of design control activities do notraise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",and the results of physical comparison and functional testingsupport a determination of substantial equivalence for themodified device when compared to the predicate device. Themodified device is substantially equivalent to the currentlymarketed Boston Scientific Extractor™ RX Retrieval Catheter interms of performance characteristics, biocompatibility, andintended use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized depiction of a bird or eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
Mr. James D. McMahon Senior Regulatory Affairs Specialist Boston Scientific Corporation, Endoscopy One Boston Scientific Place NATICK MA 01760
Re: K041606
Trade/Device Name: Extractor" RX Retrieval Balloon Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 14, 2004 Received: June 15, 2004
Dear Mr. McMahon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of 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 r loase or note a determination that your device complies with other requirements of the Act that x 12 Pix a 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 Scellon SIV(k) This letter will allow you to begin marketing of sylvalence of your device to a legally premarket nothication - The F17A momig of anyone 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 If you desire specific advice for your dones on be of the following numbers, based on the regulation number at the top of the 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 Additionally, Tor questions on the promotion in the regulation entitled, "Misbranding Other of Compliance at (301) 574 1059. Fizes Part 807.97) you may obtain. Other general by reference to premarked notification (2) or Act may be obtained from the Division of Small information on your responsionities uncer at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free main transmin http:/ Manufacturers, International and Collsanter - 2015
(301) 443-6597 or at its Internet address http://www.fda.gov/cdch/dsmamain.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
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INDICATIONS FOR USE STATEMENT
| 510(k) Number: | To be determined K041606 |
|---|---|
| Device Name: | Extractor™ RX Retrieval Balloon |
| Indications For Use: | Indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon. |
Prescription Use __ X (Part 21 CFR 801 subpart D)
AND/OR
Over the Counter Use (21 CFR 807 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 Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.