(90 days)
Not Found
No
The summary describes a mechanical clipping device and delivery system with no mention of AI or ML capabilities.
Yes
The device is used for therapeutic purposes such as hemostasis, anchoring feeding tubes, and supplementing closure of luminal perforations, all of which involve treating or palliating a disease or injury.
No
Explanation: The device is indicated for therapeutic purposes such as endoscopic clip placement for hemostasis, marking, anchoring, and closure of perforations, not for diagnosing medical conditions.
No
The device description explicitly states it is a "single-use pre-loaded mechanical clip and delivery system," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this device is a mechanical clip and delivery system used within the gastrointestinal tract for procedures like clip placement, hemostasis, and anchoring. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Lack of IVD Characteristics: The information does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the ResolutionTM Hemostasis Clipping Device is a therapeutic and procedural device, not an IVD.
N/A
Intended Use / Indications for Use
Indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: endoscopic marking hemostasis for mucosal/submucosal defects
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation, Endoscopy Mr. James D. McMahon Senior Regulatory Affairs Specialist One Boston Scientific Place Natick. MA 01760-1537
K040148 Re:
Trade/Device Name: Resolution™ Hemostasis Clipping Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: FHN, MND, MCH Dated (Date on orig SE Itr): January 22, 2004 Received (Date on orig SE Itr): January 23, 2004
Dear Mr. McMahon,
This letter corrects our substantially equivalent letter of April 22, 2004.
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.
JUL 2 7 2015
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
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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 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 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/ResourcesforYou/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/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,
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number | To be determined K040148 |
|---|---|
| Device Name | Resolution™ Hemostasis Clipping Device |
| Indications For Use | Indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: endoscopic markinghemostasis for mucosal/submucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm in diameter, diverticula in the colonanchoring to affix jejunal feeding tubes to the wall of the small bowelas a supplemental closure method of luminal perforations <20mm that can be treated conservatively. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODI3)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
WinnOR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
000031
(Division Sign-Off) Proprietary and Confidential Information of Boston Scientific Corporation 8 Division of Reproductive, Abdominal, and Radiological Device 510(k) Number .
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Traditional 510(k) Premarket Notification Resolution™ Hemostasis Clipping Device
and the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states o
.
APR 2 2 2004
Boston Scientific Corporation March 29, 2004
1000
510 (k) SUMMARY
| SPONSOR: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | James D. McMahon
Senior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:
Common Name:
Classification: | ResolutionTM Hemostasis Clipping Device
Endoscopic Clipping Device
Class II, per 21 CFR Part 876.4400 |
| PREDICATE DEVICE: | Olympus Clip Fixing Device (K013066, K990687, K963160) |
| DESCRIPTION: | The ResolutionTM Hemostasis Clipping Device is a single-use
pre-loaded mechanical clip and delivery system used for
endoscopic clipping. |
| INTENDED USE: | The ResolutionTM Hemostasis Clipping Device is intended for
the treatment of peptic ulcer bleeding, post polypectomy bleeds,
wound closures, and general endoscopic closure that can be
deployed through a standard flexible gastroscope and
colonoscope. |
| COMPARISON OF
CHARACTERISTICS: | The ResolutionTM Hemostasis Clipping Device is substantially
equivalent to the predicate Olympus Clip Fixing devices, as they
have similar technological characteristics. The results of
performance testing shows no new issues of safety or
effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",
and the results of technological characteristics and functional
testing support a determination of substantial equivalence for the
new device when compared to the predicate device. The
ResolutionTM Hemostasis Clipping Device is substantially
equivalent to the currently marketed Olympus Rotatable Clip
Fixing Device (K013066). |
000042
Proprietary and Confidential Information of Boston Scientific Corporation