(317 days)
The Olympus HX-5/6-1 Endoscopic Clipping Device is intended for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects <3 cm, bleeding ulcers and arteries <2 mm, polyps <1.5 cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.
The Olympus HX-5/6-1 Endoscopic Clipping Device is specifically designed for endoscopic clipping for marking, hemostasis, and temporary anchoring within the GI tract. The Olympus HX-5/6-1 Endoscopic Clipping Device is based on the design of predicate clipping devices and is substantially equivalent in design, method of operation, and safety to these predicate devices.
The provided document is a 510(k) premarket notification for the Olympus HX-5/6-1 Endoscopic Clipping Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document states that the Olympus HX-5/6-1 Endoscopic Clipping Device "is substantially equivalent in design, method of operation, and safety to these predicate devices" (Olympus HX-2, HX-3, and HX-4 Clipping Devices). The FDA's letter further confirms that they have determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
To answer your specific questions:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided document. A 510(k) submission generally relies on demonstrating similarity to existing devices rather than new performance data against specific acceptance criteria.
- Sample sizes used for the test set and the data provenance: Not applicable/not provided. No new clinical trials are described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No new clinical trials are described.
- Adjudication method for the test set: Not applicable/not provided. No new clinical trials are described.
- 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 device is a mechanical clipping device, not a diagnostic AI system, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
- The type of ground truth used: Not applicable/not provided. No new clinical trials are described.
- The sample size for the training set: Not applicable/not provided. This is a mechanical device, not an AI or machine learning algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable/not provided. This is a mechanical device, not an AI or machine learning algorithm.
In summary, the provided document is a regulatory approval for a medical device based on its substantial equivalence to previously approved predicate devices, not on the presentation of novel study data against specific performance acceptance criteria.
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JUN 27 1997
K 963160
ાના વિ
| Device Name: | Olympus HX-5/6-1 Endoscopic Clipping Device |
|---|---|
| Common/Usual Name: | Endoscopic Clipping Device |
| Classification Name: | Endoscopes and Accessories21 CFR 876.1500 |
| Predicate Devices: | Olympus HX-2, HX-3, and HX-4 Clipping Devices |
| Contact Person: | Subhash R. PatelOlympus America, Inc.Endoscope Division2 Corporate Center DriveMelville, NY 11747-3157(516) 844-5481 |
| Summary Preparation Date: | March 26, 1997 |
| Statement of Intended Use: | The Olympus HX-5/6-1 Endoscopic Clipping Device is intended forendoscopic clip placement within the gastrointestinal (GI) tract for thepurpose of endoscopic marking, hemostasis in the upper GI tract formucosal/submucosal defects <3 cm, bleeding ulcers and arteries <2mm, polyps <1.5 cm in diameter, and anchoring to affix jejunal feedingtubes to the wall of the small bowel. This device is not intended for therepair of GI tract lumenal perforations. |
| Device Description: | The Olympus HX-5/6-1 Endoscopic Clipping Device is specificallydesigned for endoscopic clipping for marking, hemostasis, andtemporary anchoring within the GI tract. The Olympus HX-5/6-1Endoscopic Clipping Device is based on the design of predicateclipping devices and is substantially equivalent in design, method ofoperation, and safety to these predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Olympus America, Inc. Subhash R. Patel Regulatory Affairs Manager Two Corporate Center Drive Melville, NY 11747-3157
Re: K963160 Trade/Device Name: HX-5/6-1 Endoscopic Clipping Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE Itr): April 24, 1997 Received (Date on orig SE ltr): May 2, 1997
Dear Subhash R. Patel,
This letter corrects our substantially equivalent letter of June 27, 1997.
We have reviewed vour 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
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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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Beniamin 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 STATEMENT
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| 510(k) Number (if known): | K963160 |
|---|---|
| Subject Device Name: | Olympus HX-5/6-1.Endoscopic Clipping.Device |
| Indications for Use: | The subject device has been designed for endoscopic clipplacement within the gastrointestinal (GI) tract for thepurpose of endoscopic marking, hemostasis in the upper GItract for mucosal/submucosal defects <3 cm, bleedingulcers and arteries <2 mm, polyps <1.5 cm in diameter,and anchoring to affix jejunal feeding tubes to the wall of thesmall bowel. This device is not intended for the repair of GItract lumenal perforations. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Dober D Sathing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K963160OR |
|---|---|
| Prescription Use(per 21CFR 801.109) | Over-the-Counter Use(Optional Format 1-2-96) |
§ 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.