(108 days)
No
The description focuses on the mechanical aspects of the clip and delivery system, with no mention of AI/ML, image processing, or data sets for training/testing algorithms.
Yes
The device is used for therapeutic purposes such as hemostasis, anchoring, and closure of luminal perforations within the gastrointestinal tract.
No
The MANTIS Clip is an endoscopic clipping device used for therapeutic purposes such as hemostasis, anchoring, and closure of perforations within the GI tract. Its functions are interventional and not for diagnosing conditions.
No
The device description clearly outlines physical components made of stainless steel, polyester, and cobalt chrome, and describes a delivery system and clip that are deployed during use. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the MANTIS Clip is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of the MANTIS Clip is for clip placement within the gastrointestinal tract for various therapeutic and marking purposes. This is an in vivo application, meaning it is used directly on or inside a living organism.
- Device Description: The device description details a physical, sterile device designed for endoscopic delivery and deployment within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be used within the body for treatment or marking.
N/A
Intended Use / Indications for Use
The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of.
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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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 the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 4, 2022
Boston Scientific Corporation Jia Huang Principal Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K221124 Trade/Device Name: MANTIS Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: July 1, 2022 Received: July 5, 2022
Dear Jia Huang:
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.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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21
1
CFR Part 801); medical device 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.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) K221124
Device Name MANTISTM Clip
Indications for Use (Describe)
The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of.
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K221124 Page 1 of 5
SECTION 5: 510(K) SUMMARY
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Jia Huang Principal Regulatory Affairs Specialist Tel: 617-912-0826 Date Prepared: April 15, 2022
2. Proposed Device
Trade Name: MANTIS™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II
3. Predicate Device
Primary Predicate Device:
Trade Name: Resolution 360™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K151802
Secondary Predicate Device:
Trade Name: Resolution 360™ ULTRA Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K193424
Reference Device:
Trade Name: OTSC (Over-the scope-clip) System Set Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K101428
Reference Device:
Trade Name: Resolution™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract
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Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K142987
4. Device Description
The MANTIS Clip is a sterile device consisting of a pre-loaded, radiopaque, singleuse, endoscopic clipping device consisting of two main components: the delivery system and the clip.
The delivery system consists of a handle assembly and delivery catheter. The deliverv system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The MANTIS Clip delivery system is offered in a 235cm working length. The clip consists of a stainlesssteel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The MANTIS Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The clip jaw teeth are designed with smaller angle between the teeth and the clip arm body.
5. Indications for Use
The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
-
- Endoscopic marking
-
- Hemostasis for:
- Mucosal/sub-mucosal defects