The Captivator and Captiflex Polypectomy Snares are used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Device Description

The Captivator and Captiflex Single-Use Polypectomy Snares consist of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

AI/ML Overview

This document describes a 510(k) premarket notification for Captivator and Captiflex Single-Use Polypectomy Snares. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests but does not explicitly define acceptance criteria as numerical thresholds for all tests. It generally states that the modified snares "met all pre-defined specifications." For cutting force, comparative data is provided, implying that the modified devices should perform comparably to or better than the predicate.

Test Description	Undefined Acceptance Criteria	Reported Device Performance
Loop Extension Functionality	"met all pre-defined specifications"	All snare configurations were tested and met specifications in a simulated-use tortuous path.
Loop Retraction Functionality	"met all pre-defined specifications"	All snare configurations were tested and met specifications in a simulated-use tortuous path.
Snare Actuation Force	"met all pre-defined specifications"	The largest snare (M00561290) was tested as a worst-case and met specifications in a simulated-use tortuous path.
Maximum Cutting Force	Implied: Comparable or superior to predicate device performance	Predicate Device Means (lbf): Captiflex Medium Oval (5.4), Captivator Large Oval Thin (4.4), Captivator Large Oval (5.0), Captivator II Extra Large Rounded (5.7), Sensation Large Oval (12.0) Modified Device Means (lbf): Captiflex Medium Oval (6.4), Captivator Large Oval Thin (6.2), Captivator Large Oval (6.7), Captivator II Extra Large Rounded (7.1), Captivator Medium Oval Stiff (7.4), Captivator Medium Hexagonal Stiff (6.2), Captivator Medium Crescent (6.8). The modified devices generally show higher mean cutting force compared to the specific predicate versions measured.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the numerical sample size (n) for each test. It mentions "All snare configurations were tested" for loop extension and retraction, and "the largest snare (M00561290) was tested to represent all snares" for actuation force. For maximum cutting force, multiple UPNs for both predicate and modified devices are listed, with mean and standard deviation provided, suggesting multiple measurements were taken for each UPN, but the exact number of units/measurements per UPN is not specified.
Data Provenance: The data is generated from bench testing conducted by Boston Scientific Corporation. This is a controlled, in-vitro environment, not human or animal data. There is no mention of country of origin of the data beyond Boston Scientific's location being Marlborough, MA. The study is effectively a prospective evaluation of the modified devices against internal specifications and comparative data from existing predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this submission. The "ground truth" here is defined by engineering specifications and objective physical measurements (e.g., force, functionality), not subjective expert assessment as would be the case for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

This is not applicable. As the testing involves objective bench measurements against specifications, there is no need for adjudication by experts.

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 is not applicable. This submission is for physical medical devices (polypectomy snares), not an AI-assisted diagnostic or therapeutic system that would involve human readers or AI.

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

This is not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this device's performance demonstration is based on engineering specifications and objective physical measurements obtained through bench testing. This includes:

Functionality (extension, retraction)
Force measurements (actuation force, maximum cutting force)
These are established through internal design validation processes to ensure the devices meet their intended technical performance.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device. The development process would involve iterative design and testing, but not a formally defined "training set" in the context of AI.

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

This is not applicable for the same reasons as point 8.

Summary

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October 8, 2020

Boston Scientific Corporation Stephanie Gorman Sr. Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K202478

Trade/Device Name: Captivator Single-Use Polypectomy Snares (27mm, 30mm, 33mm), Captiflex Single-Use Polypectomy Snares (27mm) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and accessories Regulatory Class: II Product Code: FDI Dated: August 27, 2020 Received: August 28, 2020

Dear Stephanie Gorman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202478

Device Name

Captivator Single-Use Polypectomy Snares (27mm, 30mm, 33mm) Captiflex Single-Use Polypectomy Snares (27mm)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Primary Contact:	Stephanie GormanSr. Regulatory Affairs Specialist, Endoscopy
Telephone:	(508) 683-5692
E-mail:	Stephanie.Gorman@bsci.com
Secondary Contact:	Ashley SantosDirector, Regulatory Affairs Endoscopy
Telephone:	(508) 683-4359
E-mail:	Ashley.Santos@bsci.com

Date Prepared: August 27, 2020

2. Proposed Device

Trade Name:	Captivator Single-Use Polypectomy Snares (27mm, 30mm, 33mm)Captiflex Single-Use Polypectomy Snares (27mm)
Common Name:	Polypectomy Snares
Product Code:	FDI, FGX
Regulation Class:	Class II
Regulation Number:	876.4300
Regulation Name:	Endoscopic Electrosurgical Unit and accessories
3. Predicate Device
Trade Name:	Captivator Single-Use Polypectomy SnaresCaptivator II Single-Use Polypectomy SnaresCaptiflex Single-Use Polypectomy SnaresProfile Single-Use Polypectomy SnaresSensation Single-Use Polypectomy SnaresRotatable Single-Use Polypectomy Snares
Manufacturer:	Boston Scientific Corporation
Clearance Number:	K131700
Common Name:	Polypectomy Snares
Product Code:	FDI, FGX
Regulation Class:	Class II
Regulation Number:	876.4300
Regulation Name:	Endoscopic Electrosurgical Unit and accessories

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4. Device Description

Table 5-1 lists the Captivator and Captiflex Single-Use Polypectomy Snares within scope of this 510(k).

SellableUPN/Product Code(Box Quantity)	UPN/Product Code(Single Unit)	Product Description	Loop Size
M00562371 (Box 10)	M00562370	Captivator Medium CrescentStiff	27mm
M00562401 (Box 10)	M00562400	Captiflex Medium OvalFlexible	27mm
M00562402 (Box 40)
M00561311 (Box 10)	M00561310	Captivator Large OvalMedium Stiff	30mm
M00562341 (Box 10)	M00562340	Captivator MediumHexagonal Stiff	27mm
M00562321 (Box 10)	M00562320	Captivator Medium Oval Stiff	27mm
M00561291 (Box 10)	M00561290	Captivator Extra Large RoundStiff	33mm
M00562391 (Box 10)	M00562390	Captivator Large Oval ThinWire Flex	30mm

Table 5-1. Impacted Captivator and Captiflex Single-Use Polypectomy Snares

5. Indications for Use

The Captivator and Captiflex Polypectomy Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

6. Technological Characteristics

The modified Captivator (27mm, 30mm and 33mm) and Captiflex (27mm) Polypectomy Snares share the same intended use, indications for use, and fundamental scientific technology as the predicate devices (K131700).

7. Performance Data

Bench testing has been performed on the Captivator (27mm, 33mm) and Captiflex (27mm) Single-Use Polypectomy Snares to demonstrate that the modified handle design meets required performance specifications and has restored performance to that of the predicate Captivator and Captiflex Snares (K131700). The testing included the following:

Loop Extension Functionality
Loop Retraction Functionality
Snare Actuation Force ●

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. Maximum Cutting Force
The modified Captivator and Captiflex Snares met all pre-defined specifications identified for snare loop extension functionality, retraction functionality, and actuation force in a simulated-use tortuous path. All snare configurations were tested for loop extension and retraction functionality. For snare actuation force, the largest snare (M00561290) was tested to represent all snares within scope of the change as a worst-case with regards to friction and resistance.

In addition, comparative maximum cutting force testing was performed on the predicate Captivator, Captiflex and Sensation Single-Use Polypectomy Snares and the modified snares. This bench testing was performed by measuring the maximum allowable force that could be applied by the snare on a non-compressible pin gauge. A summary of the maximum cutting force test results can be found in Table 5-2 and Table 5-3 below.

Table 5-2. Predicate Captivator (27mm, 30mm, 33mm), Captiflex (27mm) and Sensation (30mm) Single-Use Polypectomy Snares Maximum Cutting Force

UPN	Description	Mean (lbf)	Standard Deviation (lbf)
M00562400	Captiflex Medium OvalFlexible – 27mm	5.4	0.54
M00562390	Captivator Large Oval ThinWire Flexible – 30mm	4.4	0.38
M00561310	Captivator Large OvalMedium Stiff – 30mm	5.0	0.34
M00561290	Captivator II Extra LargeRounded Stiff – 33mm	5.7	0.36
M00562650	Sensation Large OvalMedium Stiff – 30mm	12.0	0.55

Table 5-3. Modified Captivator (27mm, 30mm, 33mm) and Captiflex (27mm) Single-Use Polypectomy Snares Maximum Cutting Force

UPN	Description	Mean (lbf)	Standard Deviation (Ibf)
M00562400	Captiflex Medium OvalFlexible	6.4	0.47
M00562390	Captivator Large Oval ThinWire Flexible	6.2	0.39
M00561310	Captivator Large OvalMedium Stiff	6.7	0.85
M00561290	Captivator II Extra LargeRounded Stiff	7.1	0.77
M00562320	Captivator Medium Oval Stiff	7.4	0.81
M00562340	Captivator MediumHexagonal Stiff	6.2	0.57
M00562370	Captivator Medium CrescentStiff	6.8	0.45

All sizes of the modified Captivator and Captiflex Snares within scope of the 510(k) were tested.

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The bench testing performed demonstrates that the modified Captivator Snares are substantially equivalent to the predicate snares (K131700).

8. Conclusion

The modified Captivator (27mm, 30mm, 33mm) and Captiflex (27mm) Polypectomy Snares met all bench testing acceptance criteria. Boston Scientific has demonstrated that the modified Captivator (27mm, 30mm, 33mm) and Captiflex (27mm) Polypectomy Snares are substantially equivalent to the predicate devices (K131700).

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).