The Extractor™ Pro Retrieval Balloon Catheters are 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.

Device Description

Extractor™ Pro Retrieval Balloon Catheters are a stone retrieval balloon catheter used for biliary stone retrieval. The catheter may be placed with or without the aid of a guidewire. The catheter is capable of accepting a 0.035 in. (0.89 mm) guidewire. Injection ports for contrast are set either below or above the retrieval balloon.

AI/ML Overview

The document is a 510(k) Premarket Notification for the Extractor™ Pro Retrieval Balloon Catheters. This notification is for a medical device, specifically a catheter for retrieving biliary stones, and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to performance testing and demonstrating substantial equivalence to a predicate device, rather than clinical efficacy studies in the same way one might describe for a diagnostic AI device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Meet required specifications for components, subassemblies, and/or full devices.	All components, subassemblies, and/or full devices met the required specifications.
Substantial equivalence to predicate devices in design, materials, and manufacturing processes.	The proposed Extractor™ Pro Retrieval Balloon Catheters are similar in design, materials, and manufacturing processes to the predicate devices.
Intended Use	Matches the predicate devices: Endoscopically remove stones from the biliary system, or facilitate contrast injection while occluding the duct.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document states "In-vitro testing has been performed." It does not specify the sample size for this testing.
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of "in-vitro testing," it refers to laboratory bench testing rather than patient data.

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)

This section is Not Applicable in the context of this 510(k) submission. The "ground truth" here is based on engineering specifications and physical performance measurements (in-vitro testing) rather than expert interpretation of medical images or patient outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving expert assessments, which is not what was performed for this device's submission. The "test set" here refers to physical devices undergoing in-vitro performance testing.

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 section is Not Applicable. An MRMC study is relevant for AI-powered diagnostic devices involving human interpretation of medical images. This 510(k) is for a physical medical device (a retrieval balloon catheter) and does not involve AI or human readers for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is Not Applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluation of this device is based on engineering specifications and measurable physical properties tested through in-vitro methods. For example, balloon inflation pressures, catheter flexibility, guidewire compatibility, and material strength would be measured against predefined specifications.

8. The sample size for the training set

This section is Not Applicable. This device is not an AI algorithm and therefore does not have a "training set."

9. How the ground truth for the training set was established

This section is Not Applicable. As stated above, this device is not an AI algorithm.

Summary

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K102082

SECTION 5 510(k) SUMMARY

510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4872 Fax: 508-683-5939

Contact: Laurie Pannella, RAC Regulatory Affairs Specialist Date Prepared: July 23, 2010

2. Proposed Device:

Trade Name: Extractor™ Pro RX Retrieval Balloon, Extractor™ Pro XL Retrieval Balloon, and Extractor™ Pro DL Retrieval Balloon Classification Name: Endoscopic Biliary Stone Retrieval Balloon Catheter (Catheter, Biliary, Diagnostic) Regulation Number: 876.5010 Product Code: FGE Classification: Class II

3. Predicate Device:

Trade Name: Extractor™ RX Retrieval Balloon Manufacturer and Clearance Number: Boston Scientific Corporation, K041606 Classification Name: Endoscopic Biliary Stone Retrieval Balloon Catheter Regulation Number: 876.5010 Product Code: FGE Classification: Class II

Trade Name: Endoscopic Biliary Stone Retrieval Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K931619 Classification Name: Catheter, Biliary, Surgical Regulation Number: 876.5010 Product Code: GCA Classification: Class II

Trade Name: Tri-Ex Extraction Balloon with Multiple Sizing Manufacturer and Clearance Number: Wilson-Cook Medical, K040129 Classification Name: Catheter, Biliary, Surgical Regulation Number: 876.5010 Product Code: GCA . . Classification: Class II

AUG 2 3 2010

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Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters

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4. Proposed Device Description:

Extractor™ Pro Retrieval Balloon Catheters are a stone retrieval balloon catheter used for biliary stone retrieval.

. The catheter may be placed with or without the aid of a guidewire.
. The catheter is capable of accepting a 0.035 in. (0.89 mm) guidewire
Injection ports for contrast are set either below or above the retrieval balloon. .

5. Intended Use:

6. Technological Characteristics:

The proposed Extractor™ Pro Retrieval Balloon Catheters are similar in design, materials, and manufacturing processes to the predicate Extractor™ RX Retrieval Balloon (K041606) and Endoscopic Biliary Stone Retrieval Catheter (K931619).

7. Performance Data:

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications.

8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Extractor™ Pro Retrieval Balloon Catheters are substantially equivalent to Boston Scientific Corporation's currently marketed Extractor™ RX Retrieval Balloon (K041606) and Endoscopic Biliary Stone Retrieval Catheter (K931619).

000014

Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters

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SECTION 6 TRUTHFUL AND ACCURACY STATMENT

Premarket Notification Truthful and Accurate Statement (As Required by 21 CFR 807.87(k))

I certify that, in my capacity as a Regulatory Affairs Specialist at Boston Scientific Corporation, I believe to the best of my knowledge that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

$\lim_{x \to \infty} \frac{x^2}{e^x} = 0$

$\lim_{x \to \infty} \frac{x^n}{e^x} = 0$

$\lim_{x \to \infty} \frac{\ln x}{x} = 0$

$\lim_{x \to 0^+} x \ln x = 0$

$\lim_{x \to \infty} x^{1/x} = 1$

$\lim_{x \to 0} (1+x)^{1/x} = e$

$\lim_{x \to \infty} (1+\frac{1}{x})^x = e$

$\lim_{n \to \infty} \sqrt[n]{n} = 1$

$\lim_{n \to \infty} \frac{x^n}{n!} = 0$

$\lim_{n \to \infty} (1-\frac{1}{n})^n = \frac{1}{e}$

Laurie Pannella, RAC Regulatory Affairs Specialist Boston Scientific Corporation

July 23, 2010 Date

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Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters Proprietary and Confidential Information of Boston Scientific Corporation

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Laurie Pannella Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752

AUG 2 3 2010

Re: K102082

Trade/Device Name: Extractor™ Pro Retrieval Balloon Catheter Regulation Number: 21 CFR& 876,5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 23, 2010 Received: July 26, 2010

Dear Ms. Pannella:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K102082

SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

To Be Determined

Device Name:

Indications For Use:

Extractor™ Pro Retrieval Balloon Catheter

102002

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)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

000012

Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters

Regulation Number and Section

§ 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.