(223 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML components or data processing related to AI/ML.
Yes
The device is described as being used for hemostasis and closure of GI tract luminal perforations, which are therapeutic actions to treat or ameliorate a condition.
No
The device is intended for therapeutic purposes such as marking, hemostasis, and closure of perforations, not for diagnosing conditions.
No
The device description clearly states it is composed of an applicator and clip, which are physical hardware components used for endoscopic clip placement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the GI tract) for mechanical purposes like marking, hemostasis, and closure of perforations. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health status.
- Device Description: The description details a mechanical clip and applicator system for internal use. It does not mention any reagents, assays, or analysis of biological samples.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, sterilization, and shelf life – all typical for a medical device used internally, not for an IVD. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics relevant to IVD performance.
In summary, this device is a therapeutic medical device used for mechanical intervention within the body, not a diagnostic device used to analyze samples from the body.
N/A
Intended Use / Indications for Use
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
§ 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.
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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)
Device Name
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
Indications for Use (Describe)
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 Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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 Device | ||
| HX-5LR-1, HX-6UR-1 | ||
| Standard 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 Systems | |
| Corp. | K123601 |
5.4 DEVICE DESCRIPTION
■ General Description of the subject device
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 24 hours to 30 days) | Unknown |
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K183590 Page 5 of 7
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K183590 Page 6 of 7
Image /page/8/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are slightly slanted to the right, giving the word a sense of movement. Underneath the word, there is a thin, horizontal line in yellow. The line is slightly curved upwards in the middle, adding a subtle design element to the logo.
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.