(119 days)
No
The device description and performance studies focus on mechanical and electrosurgical components and do not mention any AI/ML capabilities.
Yes
The device is used to perform endoscopic mucosal resection in the upper GI tract, which is a therapeutic procedure to remove tissue.
No
The device is described as an endoscopic mucosal resection device used for removing mucosal tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components including a ligator cap, ligation bands, a band ligator handle, an electrosurgical snare, and a pathology kit.
Based on the provided information, the Captivator TM EMR Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "endoscopic mucosal resection in the upper GI tract." This is a procedure performed in vivo (within the living body) to remove tissue.
- Device Description: The description details a device used for a surgical procedure involving banding and electrosurgical removal of tissue from the body. It also includes a pathology kit for handling tissue samples after removal.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue in a lab setting.
The device is clearly designed for a therapeutic procedure performed directly on the patient's tissue within the body.
N/A
Intended Use / Indications for Use
The Captivator EMR Device is indicated for endoscopic mucosal resection in the upper GI tract.
Product codes
FIDI
Device Description
The CaptivatorTM EMR Device is an endoscopic mucosal resection device consisting of a ligator cap with ligation bands, a band ligator handle, an electrosurgical snare, and a pathology kit. The ligator cap and band ligator handle are attached to an endoscope, and bands are deployed one at a time to capture mucosal tissue as pseudopolyps, which are clectrosurgically removed using the snare. The device is capable of performing multiple resections. The banding portion of the device is made up of a clear ligator cap with elastic bands stretched around the outer circumference of the cap. Bands are deployed by actuating the handle. The ligator device allows the introduction of an electrosurgical snare for endoscopic therapies. A pathology kit is also provided as a procedural aid which is used to handle tissue samples for histological processing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper 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)
Non-clinical testing was successfully performed on the proposed Captivator™ EMR Device.
Biocompatibility Test Summary: Biocompatibility was evaluated in accordance with EN ISO 10993-1:2009, and the following tests were performed with acceptable results on the patient contacting portions of the Captivator™ EMR Device: Cytotoxicity, Sensitization, Acute Systemic Toxicity, and USP Physicochemical Test.
Performance Testing Summary: Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence between the proposed Captivator™ EMR Device and the predicate Cook Ireland Duette Multi-Band Mucosectomy Device (K050578). This testing included but was not limited to system suction delivery efficiency with snare, band ultimate tensile force, and snare loop to pull wire tensile strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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K140726 Pg. 1 of 2
SECTION 5 510(k) SUMMARY
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4296 Fax: 508-683-5939
Contact: Tara Paul Regulatory Affairs Specialist II Date Prepared: March 21, 2014
2. Device
Trade Name: Common Name: Classification Name: Regulation Number: Product Code: Classification:
CaptivatorTM EMR Device Endoscopic Mucosal Resection (EMR) Device Endoscope and/or accessories 876.4300 FIDI Class II
3. Predicate Devices
Cook Ireland Duette Multi-Band Mucosectomy Device (K050578)
4. Device Description
The Captivator™ EMR Device is an endoscopic mucosal resection device consisting of a ligator cap with ligation bands, a band ligator handle, an electrosurgical snare, and a pathology kit. The ligator cap and band ligator handle are attached to an endoscope, and bands are deployed one at a time to capture mucosal tissue as pseudopolyps, which are clectrosurgically removed using the snare. The device is capable of performing multiple resections. The banding portion of the device is made up of a clear ligator cap with elastic bands stretched around the outer circumference of the cap. Bands are deployed by actuating the handle. The ligator device allows the introduction of an electrosurgical snare for endoscopic therapies. A pathology kit is also provided as a procedural aid which is used to handle tissue samples for histological processing.
1
5. Indication for Use:
The Captivator™ EMR Device is indicated for endoscopic mucosal resection in the upper GI tract
6. Technological Characteristics:
The proposed Captivator™ EMR Device shares similar design features and function with the Cook Ireland Duette Multi-Band Mucosectomy Device (K050578) and the cap size of the Olympus Distal Attachment (K984358).
The proposed device has the same intended use and is placed using the same methodology as the predicate device (Cook Ireland Duette Multi-Band Mucosectomy Device (K050578)) via ligation-assisted EMR. The Cook Ireland Duette Multi-Band Mucosectomy Device is a ligationassisted device and the Olympus Distal Attachment is used to perform cap-assisted EMR. All three devices utilize a cap to suction and capture tissue during an EMR procedure. In addition to sharing a similar cap feature, the Captivator™ EMR Device and the Cook Ireland Duette Multi-Band Mucosectomy Device function similarly, as they are both used to perform ligation-assisted EMR.
7. Performance Data:
Non-clinical testing was successfully performed on the proposed Captivator™ EMR Device.
Biocompatibility Testing Summary:
Biocompatibility was evaluated in accordance with EN ISO 10993-1:2009, and the following tests were performed with acceptable results on the patient contacting portions of the Captivator™ EMR Device: Cytotoxicity, Sensitization, Acute Systemic Toxicity, and USP Physicochemical Test.
Performance Testing Summary:
Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence between the proposed Captivator™ EMR Device and the predicate Cook lreland Duette Multi-Band Mucosectomy Device (K050578). This testing included but was not limited to system suction delivery efficiency with snare, band ultimate tensile force, and snare loop to pull wire tensile strength.
8. Conclusion:
Boston Scientific has demonstrated that the proposed Captivator™ EMR Device is substantially equivalent to the currently marketed Cook Ireland Ductic Multi-Band Mucosectomy Device (K050578).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2014
Boston Scientific Corporation Tara Paul Regulatory Affairs Specialist 100 Boston Scientific Way Marlboro, MA 01752
- K140726 Re:
Trade/Device Name: Captivator™ EMR Device Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscope and/or accessories Regulatory Class: Class II Product Code: FDI Dated: June 04, 2014 Received: June 06, 2014
Dear Tara Paul,
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
3
Page 2 - Tara Paul
(21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 contact the Division of Industry and Consumer Education 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. 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/Safetv/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjar
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | To Be Determined |
|---|---|
| Device Name: | Captivator TM EMR Device |
| Indications for Use: | The Captivator TM EMR Device is indicated for endoscopic mucosal resection in the upper GI tract. |
Prescription Use X (Part 21 CFR 801 Part 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)
Benjamin R. Fisher -S 2014.07.21 17:39:21 -04'00'
Premarket Notification, Captivator™ EMR Device