(59 days)
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) is the remote control unit of legally marketed ancillary equipment. The new clinical functions are not added to the ancillary equipment by the subject device. The subject device enables the remote control of the ancillary equipment, the display of their active states and the memory of the previous set-up values. The remote control is achieved by a touch-panel monitor, remote controller, and voice control. The voice control function enables the subject device to control the ancillary equipment by voice. The subject device does not come in contact with patients and is not subject to sterilization.
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 did not conduct a study with specific performance metrics such as sensitivity, specificity, or AUC against a ground truth. Instead, the device's modifications were verified against established in-house acceptance criteria based on ISO 14971:2000 through design verification tests.
Here is the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Modification | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Operating function for additional ancillary equipment | 1. Nurse's control panel operation test: Confirmed whether the Nurse's control panel operation is performed correctly. 2. Surgeon's controller operation test: Confirmed whether the Surgeon's controller operation is performed correctly. 3. Voice operation test: Confirmed whether the voice operation is performed correctly. | 1. All the operations that are in specification operate. 2. All the operations that are in specification operate. 3. All the operations that are in specification operate. | The document implies that these tests were performed and passed, meeting the acceptance criteria, as the device was deemed substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the traditional sense of a dataset for evaluating AI performance. The tests described are functional verification tests of the device's operational capabilities. Therefore, there is no information on sample size or data provenance as it pertains to clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. The tests performed are functional verification tests related to the device's operation, not clinical performance requiring expert ground truth in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is a control unit for endosurgery, and the modifications involved adding operating functions for new ancillary equipment and different input methods (wireless microphone, larger touch panel). The studies were functional verification tests.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The device itself is a control unit that facilitates human interaction with other ancillary equipment. Its "performance" is inherently linked to its ability to control these devices. The tests performed are functional verification tests of these control capabilities, not an algorithm performing a task independently. Therefore, the concept of a "standalone" algorithm-only performance study as typically understood for AI/ML devices is not applicable here.
7. The Type of Ground Truth Used:
The "ground truth" for the functional verification tests was the device specification itself. The tests confirmed whether the operations performed by the device (nurse's control panel, surgeon's controller, voice operation) operated as specified.
8. The Sample Size for the Training Set:
Not applicable. The device is not described as an AI/ML device in the context of learning from a training set of data. The modifications are related to integrating new hardware and input methods.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or an AI/ML component that requires establishing ground truth for training.
{0}------------------------------------------------
AUG 1 5 2005
K051613
jzg 1 of 3
510(k) SUMMARY
Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3
May 31, 2005
1 General Information
- 를 Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No.: 8010047 ■ Official Correspondent Laura Storms-Tyler Executive Director, Regulatory Affairs & Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA Phone: 631-844-5688 FAX: 631-844-5554 Email:Laura.storms-tyler@olympus.com Establishment Registration No.: 2429304 체 Manufacturer Olympus Medical Systems Corp. Hinode Plant 34-3 Hirai Hinode-machi, Nishitama-gun,
Tokyo, Japan 190-0182
Establishment Registration No.: 3003637092
2 Device Identification
| Device Name | Olympus Integrated Endosurgery System EndoALPHA(Control Unit for Endosurgery UCES-2) Software Version 3 |
|---|---|
| Common Name | Endosurgery System |
| Regulation No: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | II |
| Product Code: | 78 KOG |
| Prescription Status: | Prescription device |
| Performance Standards: | None established under Section 514 of FDCA |
{1}------------------------------------------------
K051613
pg 293
3 Predicate Device Information
| Device Name | Olympus Integrated Endosurgery System EndoALPHA(Control Unit for Endosurgery UCES-2) Software Version 2 |
|---|---|
| 510(k) No: | K041494 |
| Decision Date: | 07/01/2004 |
4 Device Description
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) is the remote control unit of legally marketed ancillary equipment. The new clinical functions are not added to the ancillary equipment by the subject device. The subject device enables the remote control of the ancillary equipment, the display of their active states and the memory of the previous set-up values. The remote control is achieved by a touch-panel monitor, remote controller, and voice control. The voice control function enables the subject device to control the ancillary equipment by voice. The subject device does not come in contact with patients and is not subject to sterilization.
The only modifications that were made are:
- · Add the operating function for the new ancillary equipment, Panasonic DVD recorder LQ-MD800.
- · Enable the voice control of the ancillary equipment with the wireless microphone unit ew152G2 or Infrared Wireless Microphone System, in addition to the conventional wired microphone.
- · Enable the control of the ancillary equipment with the ELO 15inch touch panel monitor 1526L/1926L, in addition to the conventional 12inch-touch panel monitor.
- · Enable control of Audio Visual (AV) devices, Operating Room (OR) beds, and OR lights via the hospital's integrated audio-visual control system. The subject device sends commands for controlling these devices to the integrated audio-visual control system by remote control or voice control.
- · Add a simplified main screen for the control panel monitor, in addition to the conventional GUI screen.
5 Intended Use
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The intended use of the EndoALPHA as stated above is to enable a central system to control various pieces of ancillary equipment. However, the approved indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each ancillary piece of equipment.
This intended use is identical to the previously cleared one for the Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 2.
{2}------------------------------------------------
pg 3 of 3
6 Conclusion
The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2000. The design verifications that were performed as a result of this risk analysis assessment are described below.
| Modification | Test performed | Acceptance criteria |
|---|---|---|
| Operatingfunction foradditionalancillaryequipment | 1. Nurse's control panel operation test:We confirmed whether the Nurse's controlpanel operation is performed correctly.2. Surgeon's controller operation test:We confirmed whether the Surgeon'scontroller operation is performed correctly.3. Voice operation test:We confirmed whether the voice operationis performed correctly. | 1. All the operations that are inspecification operate.2. All the operations that are inspecification operate.3. All the operations that are inspecification operate. |
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 has the following similarities to the predicate device:
- has the same intended use, ,
- uses the same operating principle. -
In summary, the subject device described in this submission is, in our opinion, substantially equivalent to the predicate device.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines, suggesting movement and freedom. To the left of the bird, text curves along the edge of a circle, possibly indicating the name of an organization or company. The text is oriented vertically, following the circular path.
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
Olympus Medical Systems Corp. c/o Ms. Laura Storms-Tyler Executive Director, RA & QA Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157
Re: K051613
Trade/Device Name: Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG and GCI Dated: July 21, 2005 Received: July 25, 2005
Dear Ms. Storms-Tyler:
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. 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 (Special Controls) or class III (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 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); 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.
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics notificate 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), please 11 you acted office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
1051613 510(k) Number (if known):
Device Name: Olympus Integrated Endosurgery System EndoALPHA
(Control Unit for Endosurgery UCES-2) Software Version 3
Indications For Use:
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
Prescription Use_V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leggett
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Page 1 of _1
§ 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.