The Single Use Reloadable Clip Applicators and Clips 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 GI tract luminal perforations < 20 mm that can be treated conservatively.
The subject devices are composed of the applicator and clip. The devices are used in a combined state. The clip that is attached to the applicator is controlled by the operator using the slider. The clip 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 portion of 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.

AI/ML Overview

This is a traditional 510(k) submission for a medical device (Single Use Reloadable Clip Applicators and Clips) and not an AI/ML medical device. Therefore, the information regarding acceptance criteria and study proving AI/ML device performance (e.g., sample size, expert ground truth, MRMC studies) is not applicable or present in the provided text.

The provided document describes the predicate device and the new device, and focuses on demonstrating substantial equivalence primarily through non-clinical performance data (sterilization/shelf life, biocompatibility, and bench testing). No clinical or animal studies were conducted.

Here's how the provided information relates to your request, with a clear indication of what is not present because it's not an AI/ML device:

1. A table of acceptance criteria and the reported device performance:

The document mentions that "The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment" (Section 5.7 (6)). However, it does not provide a specific table laying out the acceptance criteria and the reported performance results for each test. It lists the types of performance tests conducted:

Performance Tests Performed (Bench Testing):
- Insertability
- Clip opening width
- Clip rotatability
- Clip capability
- Withdrawal from endoscope
- Applicator repetition
- Endoscope compatibility
- Clip tail length
- Retention capability
- MRI testing
- Package integrity testing
- Mechanical testing

The document states these tests were conducted "to ensure that the subject device performs as intended and meet design specifications," implying they met the internal acceptance criteria, but the specific values or thresholds are not detailed.

Regarding your other points (which are highly relevant for AI/ML devices but not for this traditional device):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable/Not Provided for this device. This device did not undergo clinical or animal studies for substantial equivalence. Bench testing data is typically generated in a lab setting, not from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the context of expert review for diagnostic AI, is not relevant for this device. Its performance is evaluated through physical and mechanical bench tests, not through expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No expert review or adjudication process is mentioned, as it's not relevant for this type of device's performance evaluation.

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:

No, an MRMC study was NOT done. This is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. The "ground truth" for this device's performance is derived from physical measurements and engineering specifications in bench testing, not clinical outcomes or expert interpretation of patient data.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established:

Not Applicable. As there's no training set, there's no ground truth establishment process for it.

In summary: The provided document is a 510(k) premarket notification for a traditional, non-AI medical device (surgical clips and applicators). Therefore, the detailed requirements for AI/ML device performance studies, such as data provenance, expert ground truth, MRMC studies, and training set information, are not present or applicable. The submission relies on non-clinical (bench) testing, sterilization, and biocompatibility data to demonstrate substantial equivalence to a predicate device.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 1, 2019

Olympus Medical Systems Corp. Sheri L. Musgnung Manager, Regulatory Affairs Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K183590

Trade/Device Name: Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: July 2, 2019 Received: July 5, 2019

Dear Sheri Musgnung:

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/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.

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.

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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) 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-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 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-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-regulatoryassistance/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.

for Martha W. Betz, Ph.D. Acting Assistant Division 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)

K183590

Device Name

Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip

Indications for Use (Describe)

(1) Endoscopic marking,

(2) Hemostasis for

(a) Mucosal/sub-mucosal defects < 3 cm,

(b) Bleeding ulcers,

(d) Polyps < 1.5 cm in diameter.

(e) Diverticula in the colon,

(3) As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, creating a solid block of text. Underneath the word, there is a horizontal gold line that spans the length of the word. The overall design is simple and clean, with a focus on the brand name.

Date Prepared: July 30, 2019

K183590 Page 1 of 7

Section 5

510(k) Summary

5.1 GENERAL INFORMATION

510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Contact Person: Sheri L. Musgnung Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com

5.2 DEVICE IDENTIFICATION

■ Device Name	■ Model 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

(Hereinafter, described collectively as "Single Use Reloadable Clip Applicators and Clips")

Endoscopic Clipping Device ■ Common Name
21CFR 876.4400 ■ Regulation Number
Regulation Name Hemorrhoidal ligator
Regulatory Class II
Product Code PKL
Classification Panel Gastroenterology/Urology

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5.3 PREDICATE DEVICE AND REFERENCE DEVICE

■ Predicate device

Device name	Applicant	510(k) No.
Resolution Clip	Boston Scientific Corporation	K142973

■ Reference device

Device name	Applicant	510(k) No.
Endoscopic Clipping DeviceHX-5LR-1, HX-6UR-1Standard Clip HX-600-090/135,Long Clip HX-600-090L,Short Clip HX-600-090S/135S	Olympus Optical Co., Ltd	K013066
HX-Y0003-L, HX-Y0003-U	Olympus Medical SystemsCorp.	K123601

5.4 DEVICE DESCRIPTION

■ General Description of the subject device

(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 GI tract luminal perforations < 20 mm that can be treated conservatively.

Principle of Operation

The subject devices are composed of the applicator and clip. The devices are used in a combined state. The clip that is attached to the applicator is controlled by the operator using the slider.

The clip 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 portion of the clip connector is broken. Upon completion,

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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.

5.5 INDICATIONS FOR USE

(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 GI tract luminal perforations < 20 mm that can be treated conservatively.

5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The Single Use Reloadable Clip Applicators and Clips have the same intended use and similar technological characteristics and design as the predicate device except for the following main differences:

(1) Dimension and material of delivery system (clip applicator) and clip

(2) Clip reloadability

(3) Sterilization method of clip

Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.

A side-by-side comparison of the subject devices and the predicate device is provided below.

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K183590 Page 4 of 7

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	Subject Device (SD)	Predicate Device (PD)
Item	HX-810, HX-610	Resolution Clip (K142973)
Indicationsfor Use	The Single Use Reloadable ClipApplicators and Clips have beendesigned to be used with anOlympus endoscope forendoscopic Clip placement withinthe gastrointestinal (GI) tract inadult patients only for the purposeof.(1) Endoscopic marking,(2) Hemostasis for(a) Mucosal/sub-mucosaldefects < 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 GI tract luminalperforations < 20 mm that can betreated conservatively.	The Resolution™ HemostasisClipping Device is indicated forclip placement within thegastrointestinal (GI) tract for thepurpose of:1. Endoscopic marking2. Hemostasis for:Mucosal/sub-mucosal defects< 3 cmBleeding ulcersArteries < 2 mmPolyps < 1.5 cm in diameterDiverticula in the colonProphylactic clipping toreduce the risk of delayedbleeding post lesion resection3. Anchoring to affix jejunalfeeding tubes to the wall of thesmall bowel; and Anchoring toaffix fully covered esophagealselfexpanding metal stents to thewall of the esophagus4. As a supplemental closuremethod of luminal perforations <20 mm that can be treatedconservatively.
Model name	HX-810LR, HX-810UR,HX-610-090, HX-610-135HX-610-090L, HX-610-135L,HX-610-090S, HX-610-135SHX-610-135XS	M00522600, M00522601,M00522602, M00522610,M00522611, M00522612
Commonname	Endoscopic Clipping Device	Endoscopic Clipping Device
RegulationNumber	21CFR 876.4400	21CFR 876.4400
RegulationName	Hemorrhoidal ligator	Hemorrhoidal ligator
RegulatoryClass	II	II
Product Code	PKI	PKI
Item	Subject Device (SD)HX-810, HX-610	Predicate Device (PD)Resolution Clip (K142973)
Classification Panel	Gastroenterology/Urology	Gastroenterology/Urology
Environment of use	Healthcare facility/hospital	Healthcare facility/hospital
Sterilization	HX-810:EOG(Marketed as a sterilized device)HX-610:Gamma radiationMarketed as a sterilized device	EOG
Reprocessing	Unknown	Unknown
Single-Use/Reusable	HX-810: Single Use(multiple clipping to one patient)HX-610: Single Use	Single use
Reloadability	Yes	No
Materialcompositionof patient-contact parts	[HX-810]Stainless steelPolytetrafluoroethyleneSilver solder[HX-610]Stainless steelPolyphthalamideLiquid Crystal Polymer	Unknown
Duration andtype ofcontact	[HX-810]Surface-contacting device incontact with mucosal membranes.The contact duration is limitedexposure (<24 hours).[HX-610]Surface-contacting device incontact with mucous membraneand breached or compromisedsurfaces.The contact duration is prolongedexposure (>24 hours to 30 days)	Unknown

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K183590 Page 6 of 7

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Traditional 510(k) Notification Single Use Reloadable Clip Applicators / Clips HX-810 / HX-610

5.7 PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

(1) Sterilization/Shelf life testing
Sterilization/shelf life testing for the Single Use Reloadable Clip Applicators and Clips were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Accelerated aging test for the Single Use Reloadable Clip Applicators and Clips was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three-years will be performed to demonstrate longer stability and support the results of the accelerated aging test.

(2) Biocompatibility testing

Biocompatibility testing for the Single Use Reloadable Clip Applicators and Clips were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:

[HX-810]

Cytotoxicity Study Using the Colony Assay ।
Intracutaneous Study in Rabbits ।
Guinea Pig Maximization Sensitization Test ।
। Systemic Toxicity Study in Mice
Material-Mediated Pyrogenicity ।

[HX-610]

। Cytotoxicity Study Using the Colony Assay
Intracutaneous Study in Rabbits ı
Guinea Pig Maximization Sensitization Test ।
Systemic Toxicity Study in Mice ।
Material-Mediated Pyrogenicity ।
Bacterial Reverse mutation Test ।
In Vitro Chromosomal Aberration Assay ।
Muscle Implantation Test ।
Subchronic Toxicity Test
Chemical characterization

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K183590 Page 7 of 7

OLYMP

Traditional 510(k) Notification Single Use Reloadable Clip Applicators / Clips HX-810 / HX-610

(3) Performance testing - Bench

Bench testing for the Single Use Reloadable Clip Applicators and Clips as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.

Insertability
Clip opening width
Clip rotatability
Clip capability
Withdrawal from endoscope
Applicator repetition
Endoscope compatibility
Clip tail length
Retention capability
MRI testing*
Package integrity testing
Mechanical testing

*MRI testing was conducted in accordance with various applicable ASTM standards, which demonstrated the device to be MRI conditional.

(4) Performance testing Animal
No animal study was performed to demonstrate substantial equivalence.
(5) Performance testing Clinical
No clinical study was performed to demonstrate substantial equivalence.
(6) Risk analysis
Risk analysis for the Single Use Reloadable Clip Applicators and Clips was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

5.8 CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the Single Use Reloadable Clip Applicators and Clips raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.

Regulation Number and Section

§ 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.