(74 days)
The Olympus Integrated Endosurgery System EndoALPHA has been designed to be used with an Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.
Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. This subject device enables the remote control of the ancillary equipment, the display of their action status and the memory of the previous set-up values.
The provided text describes the Olympus Integrated Endoscopy System EndoALPHA, but it does not contain any information about acceptance criteria, device performance metrics, or a study conducted to prove that the device meets specific criteria.
The document is a 510(k) summary from 1998, which primarily focuses on:
- Identification of the device and manufacturer.
- Comparison to predicate devices: It states the device is a remote control unit for legally marketed ancillary equipment and adds no new clinical functions. This is the core of its argument for substantial equivalence.
- Intended Use.
- Technological Characteristics: Emphasizes that "no new clinical functions are added" and therefore "does not affect safety or effectiveness when compared to the predicate devices."
- Non-clinical Tests: Mentions compliance with voluntary safety standards (IEC 60601-1, IEC 60601-2, CISPR 11) and software validation.
- FDA's finding of substantial equivalence.
Because the device is a remote control unit that does not add new clinical functions, the validation appears to be centered around demonstrating electrical safety, material compatibility (no new patient-contacting materials), software validation for the remote control functionality, and adherence to relevant safety standards. There is no mention of clinical performance studies, diagnostic accuracy, or human factor studies in the context of specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document positions the device as substantially equivalent to existing predicate devices due to its lack of new clinical functionality, rather than presenting new performance data against specific clinical criteria.
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AUG 21 1998
Page 1 of 3
K 981993 510(k) SUMMARY OLYMPUS INTEGRATED ENDOSCOPY SYSTEM EndoALPHA
A. Submitter's Name, Address, Phone and Fax Numbers 1. Manufacturer of the subject devices
Name & Address of manufacturer:
Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division
Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku, 1-Chome, Shinjuku-ku, Tokyo 163-8610 Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL 0426-42-5101 FAX 0426-46-2786
B. Name of Contact Person
Name: Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516) 844-5474 FAX (516) 844 - 5416
C. Trade Name, Common Name, Classification Number, Classification Name and Predicate Devices
Trade Name:
Common Name: Classification Number and Classification Name: Olympus Integrated Endosurgery System Endo ALPHA Control Unit for Endosurgery (UCES)
21CFR876.1500 Endoscope and accessories 21CFR876.4300 Endoscopic electrosurgical unit and accessories
ﺗﻪ: "
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K981993
Page 2 of 3
| MODEL | NAME | 510(k) Number |
|---|---|---|
| UES-20 | Electrosurgical Unit and its associated accessories | K970184 |
| SonoSurg | SonoSurg System | K972114 |
| UHI | UHI High Flow Insufflation Unit | K953163 |
| CLV-S20 | Subcutaneous Endoscopy System, OTV-S5C | K963184 |
| K971416 | ||
| OTV-SX | ||
| IU-E1 | Laparoscopic Ultrasound System | K944017 |
| MB-631 | Laparoscopic Ultrasound System | K944017 |
| 3DV | 3D Surgical Endoscopy System | K943304 |
| K943305 | ||
| K943307 | ||
| CrystalEye E | 3D Surgical Endoscopy System | K943304 |
| K943305 | ||
| K943307 |
E. Description of the Device
Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. This subject device enables the remote control of the ancillary equipment, the display of their action status and the memory of the previous set-up values.
F. Intended Use of the Device
Olympus EndoAlpha Integrated Endoscopy System has been designed to be used with Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.
G. Summary of the Technological Characteristics of the Device compared to the Predicate Devices
Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. Therefore, Olympus Endosurgery Integrated Endoscopy System does not affect safety of effectiveness when compared to the predicate devices.
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Image /page/2/Picture/2 description: The image shows a handwritten text that includes the alphanumeric string "K981993" on the top line. Below this, the word "Page" is written, followed by the number "3 of 3". The text appears to be part of a document or record, possibly indicating a page number within a larger set of documents.
Summary including a Brief Discussion of Non-clinical Tests and How their H. Results support Determination of Safety & Efficacy
Design -
Olympus EndoAlpha Integrated Endoscopy System has been designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 60601-1 and IEC 60601-2, as well as CISPR 11.
Materials -There are no new materials and patient-contacting materials.
Summary including Conclusions drawn from Non-Clinical Tests I.
When compared to the predicate devices, Olympus EndoAlpha Integrated Endoscopy System incorporates a significant change in the operating principle. However, no new clinical functions are added, and software validation has been conducted for the device relative to this change in operating principle. In terms of other issues of intended use, design and electrical safety, the subject device, EndoAlpha, does not incorporate any significant change that could affect the safety of effectiveness.
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Image /page/3/Picture/2 description: The image shows a partial view of a seal or emblem. The visible portion includes the words "DEPARTMENT OF HEALTH & HUM," arranged vertically along the left side of the image. To the right of the text is a stylized graphic consisting of three curved lines that resemble a series of waves or stylized human profiles. The overall impression is that of an official seal, likely from a government or health-related organization.
AUG 21 1998
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11042-1179
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K981993
Olympus EndoALPHA Integrated Endosurgery System Dated: June 4, 1998 Received: June 8, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG, GCJ, FAL 21 CFR 876.1075/Procode: 78 FCG 21 CFR 876.4300/Procode: 78 FEH 21 CFR 878.4400/Procode: 79 GEI 21 CFR 878.4160/Procode: 79 FWF 21 CFR 884.1730/Procode: 85 HIF 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX Unclassified/Procode: 90 LFL
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantiation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Not assigned yet
Device Name:
Indications for Use:
The Olympus Integrated Endosurgery System EndoALPHA has been designed to be used with an Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert R. Satiug/ | |
|---|---|
| (Division Sign-Off) |
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K981993 |
|---|---|
| --------------- | ---------------- |
| Prescription Use | OR | Over The Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.