(41 days)
Not Found
No
The description focuses on the mechanical and electrical function of a polypectomy snare and does not mention any AI or ML components.
Yes.
The device is used for the "removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract," which describes a therapeutic purpose.
No
The device is used for the removal and/or cauterization of polyps and tissue, which are therapeutic actions, not diagnostic.
No
The device description clearly outlines physical components (flexible wire cable, loop, outer sheath, three-ring handle) and its function involves mechanical action and electrical current delivery, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract." This is a surgical or therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "flexible wire cable and loop" used "endoscopically" to "cut and cauterize tissue." This describes a surgical instrument used for physical manipulation and treatment of tissue within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
This device is clearly used within the body for a therapeutic purpose, not for analyzing samples taken from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FDI, FGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
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)
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
- 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.
Key Results:
Predicate Captivator (27mm, 30mm, 33mm), Captiflex (27mm) and Sensation (30mm) Single-Use Polypectomy Snares Maximum Cutting Force:
- Captiflex Medium Oval Flexible – 27mm: Mean (lbf) 5.4, Standard Deviation (lbf) 0.54
- Captivator Large Oval Thin Wire Flexible – 30mm: Mean (lbf) 4.4, Standard Deviation (lbf) 0.38
- Captivator Large Oval Medium Stiff – 30mm: Mean (lbf) 5.0, Standard Deviation (lbf) 0.34
- Captivator II Extra Large Rounded Stiff – 33mm: Mean (lbf) 5.7, Standard Deviation (lbf) 0.36
- Sensation Large Oval Medium Stiff – 30mm: Mean (lbf) 12.0, Standard Deviation (lbf) 0.55
Modified Captivator (27mm, 30mm, 33mm) and Captiflex (27mm) Single-Use Polypectomy Snares Maximum Cutting Force:
- Captiflex Medium Oval Flexible: Mean (lbf) 6.4, Standard Deviation (lbf) 0.47
- Captivator Large Oval Thin Wire Flexible: Mean (lbf) 6.2, Standard Deviation (lbf) 0.39
- Captivator Large Oval Medium Stiff: Mean (lbf) 6.7, Standard Deviation (lbf) 0.85
- Captivator II Extra Large Rounded Stiff: Mean (lbf) 7.1, Standard Deviation (lbf) 0.77
- Captivator Medium Oval Stiff: Mean (lbf) 7.4, Standard Deviation (lbf) 0.81
- Captivator Medium Hexagonal Stiff: Mean (lbf) 6.2, Standard Deviation (lbf) 0.57
- Captivator Medium Crescent Stiff: Mean (lbf) 6.8, Standard Deviation (lbf) 0.45
All sizes of the modified Captivator and Captiflex Snares within scope of the 510(k) were tested.
The bench testing performed demonstrates that the modified Captivator Snares are substantially equivalent to the predicate snares (K131700).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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)
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.
| 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 Gorman
Sr. Regulatory Affairs Specialist, Endoscopy |
|--------------------|------------------------------------------------------------------|
| Telephone: | (508) 683-5692 |
| E-mail: | Stephanie.Gorman@bsci.com |
| Secondary Contact: | Ashley Santos
Director, 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 Snares
Captivator II Single-Use Polypectomy Snares
Captiflex Single-Use Polypectomy Snares
Profile Single-Use Polypectomy Snares
Sensation Single-Use Polypectomy Snares
Rotatable 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
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.
Table 5-1 lists the Captivator and Captiflex Single-Use Polypectomy Snares within scope of this 510(k).
| Sellable
UPN/Product Code
(Box Quantity) | UPN/Product Code
(Single Unit) | Product Description | Loop Size |
|------------------------------------------------|-----------------------------------|-----------------------------------------|-----------|
| M00562371 (Box 10) | M00562370 | Captivator Medium Crescent
Stiff | 27mm |
| M00562401 (Box 10) | M00562400 | Captiflex Medium Oval
Flexible | 27mm |
| M00562402 (Box 40) | | | |
| M00561311 (Box 10) | M00561310 | Captivator Large Oval
Medium Stiff | 30mm |
| M00562341 (Box 10) | M00562340 | Captivator Medium
Hexagonal Stiff | 27mm |
| M00562321 (Box 10) | M00562320 | Captivator Medium Oval Stiff | 27mm |
| M00561291 (Box 10) | M00561290 | Captivator Extra Large Round
Stiff | 33mm |
| M00562391 (Box 10) | M00562390 | Captivator Large Oval Thin
Wire 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 ●
5
- . 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 Oval | ||
| Flexible – 27mm | 5.4 | 0.54 | |
| M00562390 | Captivator Large Oval Thin | ||
| Wire Flexible – 30mm | 4.4 | 0.38 | |
| M00561310 | Captivator Large Oval | ||
| Medium Stiff – 30mm | 5.0 | 0.34 | |
| M00561290 | Captivator II Extra Large | ||
| Rounded Stiff – 33mm | 5.7 | 0.36 | |
| M00562650 | Sensation Large Oval | ||
| Medium 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 Oval | ||
| Flexible | 6.4 | 0.47 | |
| M00562390 | Captivator Large Oval Thin | ||
| Wire Flexible | 6.2 | 0.39 | |
| M00561310 | Captivator Large Oval | ||
| Medium Stiff | 6.7 | 0.85 | |
| M00561290 | Captivator II Extra Large | ||
| Rounded Stiff | 7.1 | 0.77 | |
| M00562320 | Captivator Medium Oval Stiff | 7.4 | 0.81 |
| M00562340 | Captivator Medium | ||
| Hexagonal Stiff | 6.2 | 0.57 | |
| M00562370 | Captivator Medium Crescent | ||
| Stiff | 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).