(90 days)
The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:
(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) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treated conservatively.
The instruments (AKA EZClip) have been designed to be used with an Olympus endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:
(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) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treatively.
The Single Use Reloadable Clip Applicators and Clips are single-use devices. The HX-810 series Applicators are sterilized by Ethylene Oxide Gas and the HX-610 series Clips are sterilized by Gamma-ray radiation.
The Single Use Reloadable Clip Applicators and Clips are used in a combined state. The clip connected to the hook portion of the applicator is controlled via operation wire by the slider. The clip protruded from the coil sheath opens to the maximum opening width when the slider of the applicator is pulled towards the operator. Clipping is achieved when the slider of the applicator is pulled completely and the clip connector is broken. Upon completion, the clip and the applicator are no longer connected. Once the clipping is performed, the closure force of clips remains in place until tissue necrosis occurs, and the clip is excreted naturally.
The provided text is a 510(k) summary for a medical device cleared by the FDA. It does not include information about a study based on analyzing medical images/data, establishing ground truth using experts, or evaluating AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria for such a system.
The document describes pre-clinical (bench) testing performed on a physical medical device (endoscopic clip applicator) and its components to demonstrate substantial equivalence to a predicate device.
Here's an analysis of what is available in the document, which primarily focuses on engineering and performance characteristics of the physical device:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but it does not provide a table detailing specific acceptance criteria values and the quantitative reported performance for each criterion. It only states that "The subject Single Use Reloadable Clip Applicators (HX-810 Series) have satisfied the pre-defined acceptance criteria for each test item described in the test plan."
The tests performed were:
- Insertability
- Clip opening width
- Clip rotatability
- Clip capability
- Withdrawal from Endoscope
- Mechanical integrity of clip assembly
- Tensile Strength/coil to handle strength
- Applicator repetition
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The tests were performed on "finished devices, prior to and after simulated distribution and accelerated aging." This indicates bench testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the type of device and testing described. Ground truth established by medical experts is typically for diagnostic or prognostic systems that interpret medical data. The tests here are physical performance tests of a medical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for expert review of data/images, which is not what was performed for this device. These were bench tests against engineering specifications.
5. 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 is for an AI-powered diagnostic/interpretive system, not a physical medical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical device, the "ground truth" would be the engineering specifications and performance standards against which the device was tested (e.g., a clip's opening width must be X mm, a tensile strength must be Y Newtons). These are not established by expert consensus or pathology in the medical sense, but rather by engineering design and regulatory requirements.
8. The sample size for the training set
Not applicable. This is not a data-driven model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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.
June 3, 2024
Olympus Medical Systems Corp. % Rebecca Walker Regulatory Program Manager Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K240617
Trade/Device Name: Single Use Reloadable Clip Applicator (HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: March 5, 2024 Received: March 5, 2024
Dear Rebecca Walker:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.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.
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sivakami Venkatachalam -S
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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K240617
Device Name
Single Use Reloadable Clip Applicator (HX-810LR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
Indications for Use (Describe)
The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:
- (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) As a supplementary method, closure of G1 tract luminal perforations < 20 mm that can be treated conservatively.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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коло , D 13
05
| K240617 Page 1 of | |||
|---|---|---|---|
| 510(k) Summary | Prepared on: 2024-03- |
| Contact Details | |
|---|---|
| ----------------- | -- |
21 CFR 807.92(a)(1)
| 21 CFR 807.92(a)(1) | |||
|---|---|---|---|
| Applicant Name | Olympus Medical Systems Corp. | ||
| Applicant Address | 2951 Ishikawa-cho Hachiochi-shi Tokyo 192-8507 Japan | ||
| Applicant Contact Telephone | +81 42-642-2111 | ||
| Applicant Contact | Ms. Seiko Yunoki | ||
| Applicant Contact Email | seiko.yunoki@olympus.com | ||
| Correspondent Name | Olympus Corporation of the Americas | ||
| Correspondent Address | 800 West Park Drive Westborough MA 01581 United States | ||
| Correspondent Contact Telephone | 805-551-3023 | ||
| Correspondent Contact | Ms. Rebecca Walker | ||
| Correspondent Contact Email | Rebecca.walker@olympus.com | ||
| 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR);Clip (HX-610-090, HX-610-135);Long Clip (HX-610-090L, HX-610-135L);Short Clip (HX-610-090S, HX-610-135S);Super Short Clip (HX-610-135XS) | ||
| Common Name | Hemorrhoidal ligator | ||
| Classification Name | Hemostatic Metal Clip For The Gi Tract | ||
| Regulation Number | 876.4400 | ||
| Product Code(s) | PKL | ||
| 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K183590 | Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip | PKL | |
| 21 CFR 807.92(a)(4) | |||
| Device Description Summary |
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The instruments (AKA EZClip) have been designed to be used with an Olympus endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:
(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) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treatively.
The Single Use Reloadable Clip Applicators and Clips are single-use devices. The HX-810 series Applicators are sterilized by Ethylene Oxide Gas and the HX-610 series Clips are sterilized by Gamma-ray radiation.
The Single Use Reloadable Clip Applicators and Clips are used in a combined state. The clip connected to the hook portion of the applicator is controlled via operation wire by the slider. The clip protruded from the coil sheath opens to the maximum opening width when the slider of the applicator is pulled towards the operator. Clipping is achieved when the slider of the applicator is pulled completely and the clip connector is broken. Upon completion, the clip and the applicator are no longer connected. Once the clipping is performed, the closure force of clips remains in place until tissue necrosis occurs, and the clip is excreted naturally.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:
(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) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treated conservatively.
Indications for Use Comparison
21 CFR 807.92(a)(5)
Indications for use are the same as the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
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The subject device and the predicate device have technological characteristics except for design modifications to the Single Use Reloadable Clip Applicator. The subject device has the following design modifications to the Single Use Clip Applicator:
-
Structure of operation wire has been coated with silicone oil and covered with an inner tube composed of PTFE. The outer dimensions of the operator wire and number of stranded wires have been decreased.
-
Structure inside the handle. Dimensional changes have been introduced due to the decreased outer diameter of the operator wire.
-
Patient contacting materials. Silicone oil and PTFE have been added to the operation wire assembly.
The differences between the subject and predicate devices have been validated and testing demonstrations do not raise new questions of safety or efficacy and that the subject device is substantially equivalent to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Product performance testing was conducted on the modified Single Use Reloadable Clip Applicator (HX-810 Series) to demonstrate equivalency and ensure the device meets its intended use and design specifications after a shelf life of three (3) years. The performance tests were conducted on finished devices, prior to and after simulated distribution and accelerated aging for the terminally sterilized medical device in accordance with ASTM F1980-16(2016). The following tests were performed:
-
- Insertability
-
- Clip opening width
-
- Clip rotatability
-
- Clip capability
-
- Withdrawal from Endoscope
-
- Mechanical integrity of clip assembly
-
- Tensile Strength/coil to handle strength
-
- Applicator repetition
Based on the risk analysis, the design modification to the Reloadable Clip Applicator (HX-810 Series) did not require additional MRI Testing, Package Integrity Testing or Human Factors Studies; therefore, testing provided under K183590 is hereby incorporated as reference to this submission. As there were no changes to the Clip (HX-610 Series), product performance testing was not repeated for the Clips.
The subject Single Use Reloadable Clip Applicators (HX-810 Series) have satisfied the pre-defined acceptance criteria for each test item described in the test plan. Therefore, it is determined that the device is as safe, as effective, and performs as well as the predicate.
§ 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.