(90 days)
No
The device description and performance studies focus on mechanical aspects of the clip applicator and clips, with no mention of AI or ML.
Yes
The device is used for hemostasis (stopping bleeding), endoscopic marking, and closing GI tract perforations, all of which are direct medical interventions aimed at treating or alleviating conditions within the body.
No
The device is described as being used for endoscopic marking, hemostasis, and closure of GI tract luminal perforations, which are all therapeutic or interventional purposes, not diagnostic ones.
No
The device description clearly details physical components (applicators, clips, coil sheath, operation wire, slider) and their mechanical function for endoscopic clip placement. It also mentions sterilization methods for these physical components. There is no mention of software as a primary or even secondary component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is used within the gastrointestinal tract for procedures like marking, hemostasis, and closing perforations. It is a therapeutic and procedural device, not one that analyzes samples in vitro.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a surgical or procedural medical device used directly on the patient, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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
§ 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 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
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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 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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| 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