(159 days)
This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for
(1) endoscopic marking
(2) hemostasis for
(a) mucosal/sub-mucosal defects < 3 cm,
(b) bleeding ulcers,
(c) arteries < 2 mm,
(d) polyps < 1.5 cm in diameter,
(e) diverticula in the colon,
(3) anchoring to affix jejunal feeding tubes to the wall of the small bowel,
(4) as a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
The subject device is composed of two parts, the clip fixing device. The clip can be closed and re-opened. The clip is pre-loaded in the clip fixing device, connected with an operation wire. The clip will open when the slider of the clip fixing device is pushed, and close when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed.
The provided text is a 510(k) summary for a medical device (Single Use Repositionable Clip) and describes non-clinical testing performed to establish substantial equivalence to a predicate device. It does not describe a study involving a comparison of an AI device's performance against human readers or a standalone AI algorithm. Therefore, many of the requested sections regarding AI device performance, reader studies, and AI ground truth cannot be extracted from this document.
However, I can extract information related to the device's acceptance criteria and the non-clinical studies conducted to demonstrate its performance.
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
| Acceptance Criteria Category | Device Performance (Based on Bench Testing) |
|---|---|
| Basic Performance | Tested and met criteria |
| Clip Reopening Ability | Tested and met criteria |
| Opening Width | Tested and met criteria |
| Rotation Mechanism | Tested and met criteria |
| Compatibility with Endoscopes | Tested and met criteria |
| Tensile Strength | Tested and met criteria |
| Clip Retention (Locked) | Tested and demonstrated to remain locked under simulated conditions within a two-week duration. |
| Biocompatibility | Demonstrated to be biocompatible for both the clip and delivery device. |
| MRI Compatibility | Demonstrated to be MRI conditional. |
Study Details (Non-Clinical Testing):
- Sample size used for the test set and the data provenance: This information is not provided in a detailed manner. The document mentions "performance testing were conducted including the basic performance, ability of the clip to reopen, the opening width, the rotation mechanism, compatibility with endoscopes, and tensile strength," and "bench testing was performed to demonstrate that the clip remains locked." Specific sample sizes for each of these tests are not disclosed, nor is the data provenance beyond "bench testing" and "simulated conditions."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was non-clinical bench testing, not expert-adjudicated data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was non-clinical bench testing, not expert adjudication.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a traditional medical device (a repositionable clip), not an AI-powered device, and therefore no MRMC study with AI assistance was performed or reported.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this non-clinical testing was based on established engineering and biocompatibility standards and specific performance requirements for the device (e.g., measuring opening width, tensile strength, retention time, etc.).
- The sample size for the training set: Not applicable. This is not an AI device, so there is no training set in the context of machine learning.
- How the ground truth for the training set was established: Not applicable. As this is not an AI device, there is no training set mentioned in the context of machine learning.
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K123601 page 1 of 4
510(k) SUMMARY
APR 2 9 2013
Singe Use Repositionable Clip,
April 16, 2013
.
General Information 1
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507Establishment Registration No: 8010047 | |
|---|---|---|
| Official Correspondent: | Sheri L. MusgnungRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-3147FAX: 484-896-7128Email: sheri.musgnung@olympus.com | |
| Manufacturer: | Aomori Olympus Co., Ltd.248-1 Okkonoki 2-chome Kuroishi-shi,Aomori, Japan 036-0367Establishment Registration No.: 9614641 |
Device Identification 2
| Device Name | HX-Y0003-LHX-Y0003-U |
|---|---|
| Device Trade Name: | Single Use Repositionable Clip |
| Common Name: | Endoscopic clipping device |
| Regulation Number: | 21CFR 876.4400 |
| Regulation Name: | Hemorrhoidal ligator |
| Regulatory Class: | II |
| Product Code: | FHN (ligator, hemorrhoidal)MND (ligator, esophageal) |
| Classification Panel: | Gastroenterology and Urology |
{1}------------------------------------------------
Predicate Device Information 8
| Device Name: | Endoscopic Clipping Device HX-5LR-1, HX-6UR-1Standard Clip HX-600-135 |
|---|---|
| Common Name: | Endoscopic Clipping Device |
| Manufacturer: | Olympus Optical Co., Ltd. |
510(k) No. 대한 K013066
Device Description 4
This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for
- (1) endoscopic marking
- (2) hemostasis for
- (a) mucosal/sub-mucosal defects < 3 cm,
- (b) bleeding ulcers,
- (c) arteries < 2 mm.
- (d) polyps < 1.5 cm in diameter,
- (e) diverticula in the colon.
- (3) anchoring to affix jejunal feeding tubes to the wall of the small bowel.
- (4) as a supplementary method, closure of G1 tract luminal perforations < 20 mm that can be treated conservatively.
The subject device is composed of two parts, the clip fixing device. The clip can be closed and re-opened. The clip is pre-loaded in the clip fixing device, connected with an operation wire. The clip will open when the slider of the clip fixing device is pushed, and close when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed.
Indications for Use ਤੋ
This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for
- (1) endoscopic marking
- (2) hemostasis for
- (a) mucosal/sub-mucosal defects < 3 cm,
- (b) bleeding ulcers,
- (c) arteries < 2 mm,
- (d) polyps < 1.5 cm in diameter,
- (e) diverticula in the colon,
- (3) anchoring to affix jejunal feeding tubes to the wall of the small bowel.
(4) as a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
{2}------------------------------------------------
Comparison of Technological Characteristics ర్
:
The proposed subject device HX-Y0003-L and HX-Y0003-U have similar technological characteristics as the predicate device.
| Item | Subject device | Predicate device | ||
|---|---|---|---|---|
| Model Name | HX-Y0003-LHX-Y0003-U | HX-6LR-1HX-6UR-1 | HX-600-135 | |
| Trade Name | Single useRepositionableClip | Endoscopicclipping device | StandardClip | |
| Indicationsfor use | This instrument is intended to beused with Olympus endoscope forendoscopic clip placement within thegastrointestinal (GI) tract.It is indicated to be used for(1) endoscopic marking(2) hemostasis for(a) mucosal/sub-mucosal defects <3 cm,(b) bleeding ulcers,(c) arteries < 2 mm,(d) polyps < 1.5 cm in diameter,(e) diverticula in the colon,(3) anchoring to affix jejunal feedingtubes to the wall of the small bowel,(4) as a supplementary method,closure of GI tract luminalperforations < 20 mm that can betreated conservatively. | Olympus Rotatable Clip Fixing Device havebeen designed to be used with Olympusendoscope for endoscopic clip placementwithin the gastrointestinal (GI) tract for thepurpose of(1) endoscopic marking (2) hemostasis for(a) mucosal/sub-mucosal defects<3cm,(b) bleeding ulcers,(c) arteries<2mm,(d) polyps<1.5cm in diameter, (e)diverticula in the colon,(3) anchoring to affix jejunal feeding tubesto the wall of the small bowel,(4) as a supplementary method, closure ofGI tract luminal perforations <20mm thatcan be treated conservatively. | ||
| Sterilization | Ethylene oxide gas sterilized,disposable | Non sterilized, reusable | Ethyleneoxide gassterilized,disposable | |
| Composition | Clip and a clip fixing device | Clip and a clip fixing device | ||
| Preloadedready for use | Yes | No | ||
| Tentativeclipping | Available | Not available | ||
| Materialcomposition | Clip: Elgiloy and 6Al-4V TitaniumClip Fixing Device: Stainless Steel;HDPE | Clip: Stainless steel and siliconeClip Fixing Device: Stainless Steel | ||
| MRI | MRI conditional | No mention of MRI safety and compatibility |
{3}------------------------------------------------
K123601 page 4 of 4
Summary of non-clinical testing 7
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Performance testing were conducted including the basic performance, ability of the clip to reopen, the opening width, the rotation mechanism, compatibility with endoscopes, and tensile strength. In addition, bench testing was performed to demonstrate that the clip remains locked under simulated conditions within a two-week duration time period.
Biocompatibility testing was performed on the clip and the delivery device separtely, which demonstrated the devices to be biocompatible.
MRI testing was conducted in accordance with various applicable ASTM standards, which demonstrated the device to be MRI conditional.
The following standards have been applied to the HX-Y0003-L and HX-Y0003-U, Single Use Repositionable Clip:
- · ISO 14971
- · ANSI/AAMI/ISO 11135-1
- · ISO 10993-1
- · ISO 10993-3
- · ISO 10993-5
- · ISO 10993-6
- · ISO 10993-10
- · ISO 10993-11
- · ASTM F1980-7
- · ASTM F2052-06e01
- · ASTM F2213-06
- · ASTM F2182-11a
- · ASTM F2119-07
- · ASTM F2503-08
7 Conclusion
Based on results of the bench testing performance in comparison to the predicate device, the changes did not affect the safety or effectiveness of the device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
OLYMPUS MEDICAL SYSTEMS CORP. % Sheri L. Musgnung Associate Manager, Regulatory Affairs Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610
Re: K123601
Trade/Device Name: Single Use Repositionable Clip, HX-Y0003-L and HX-Y0003-U Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): March 25, 2013 Received (Date on orig SE ltr): March 26, 2013
Dear Sheri L. Musgnung,
This letter corrects our substantially equivalent letter of April 29, 2013.
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
{5}------------------------------------------------
Page 2 -
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 (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for 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
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Indications for Use
510(k) Number (if known):
Device Name: K123601
Single Use Repositionable Clip,HX-Y0003-L and HX-Y0003-U
Indications For Use:
This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for
- (1) endoscopic marking
(2) hemostasis for
(a) mucosal/sub-mucosal defects < 3 cm,
(b) bleeding ulcers,
(c) arteries < 2 mm,
(d) polyps < 1.5 cm in diameter,
(e) diverticula in the colon,
(3) anchoring to affix jejunal feeding tubes to the wall of the small bowel,
(4) as a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
Prescription Use (Part 21 CFR 801 Subpart 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)
Page 1 of _ 1
Herbert 開通iner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123601 510(k) Number _
§ 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.