(90 days)
Indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: endoscopic marking; hemostasis for mucosal/submucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm in diameter, diverticula in the colon; anchoring to affix jejunal feeding tubes to the wall of the small bowel; as a supplemental closure method of luminal perforations <20mm that can be treated conservatively.
The ResolutionTM Hemostasis Clipping Device is a single-use pre-loaded mechanical clip and delivery system used for endoscopic clipping.
Here's a breakdown of the acceptance criteria and study information for the Resolution™ Hemostasis Clipping Device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the device. Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The performance data section broadly states:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Similar technological characteristics to predicate device | The Resolution™ Hemostasis Clipping Device has similar technological characteristics to the predicate Olympus Clip Fixing devices. |
| No new issues of safety or effectiveness | The results of performance testing show no new issues of safety or effectiveness. |
| Substantially equivalent to predicate device | The device is substantially equivalent to the currently marketed Olympus Rotatable Clip Fixing Device (K013066). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in a clinical or performance study involving human or animal subjects. The "performance data" mentioned refers to "technological characteristics and functional testing," which implies bench testing rather than a clinical trial. Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Since there's no mention of a clinical test set with human data requiring expert review, there's no need for experts to establish ground truth in the context of this submission.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human-reviewed test set or a clinical study that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, or at least not reported in this document. The submission focuses on demonstrating substantial equivalence through technological and functional testing, not a comparative clinical study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical clipping device, not an algorithm, so there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
Given the nature of the device and the submission, the "ground truth" for the performance claims would primarily be based on engineering specifications and functional testing results rather than expert consensus, pathology, or outcomes data from a clinical trial. For example, successful deployment, clip retention, and mechanical strength would be evaluated against pre-defined engineering standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/ML algorithm.
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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 CorporationOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT PERSON: | James D. McMahonSenior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:Common Name:Classification: | ResolutionTM Hemostasis Clipping DeviceEndoscopic Clipping DeviceClass 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-usepre-loaded mechanical clip and delivery system used forendoscopic clipping. |
| INTENDED USE: | The ResolutionTM Hemostasis Clipping Device is intended forthe treatment of peptic ulcer bleeding, post polypectomy bleeds,wound closures, and general endoscopic closure that can bedeployed through a standard flexible gastroscope andcolonoscope. |
| COMPARISON OFCHARACTERISTICS: | The ResolutionTM Hemostasis Clipping Device is substantiallyequivalent to the predicate Olympus Clip Fixing devices, as theyhave similar technological characteristics. The results ofperformance testing shows no new issues of safety oreffectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",and the results of technological characteristics and functionaltesting support a determination of substantial equivalence for thenew device when compared to the predicate device. TheResolutionTM Hemostasis Clipping Device is substantiallyequivalent to the currently marketed Olympus Rotatable ClipFixing Device (K013066). |
000042
Proprietary and Confidential Information of Boston Scientific Corporation
§ 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.