(30 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, interlocking of the ancillary equipment.
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, interlocking operation of the ancillary equipment.
The additional voice control function enables the subject device to control the ancillary equipment by voice, while the conventional products control them manually. You could find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" of this section.
Addition of Image switching, recording and playback functions enables the followings;
- Images input into the UCES-2 and MAJ-1139 are displayed on two monitors by switching from one to another.
- · Images input into the UCES-2 and MAJ-1139 are displayed on the MAJ-1176 as reference images.
- · Still images input into UCES-2 and MAJ-1139 are recorded in a PC card (SmartMedia) The images recorded in the PC card (SmartMedia) are displayed on the MAJ-1176.
The intended use of the EndoALPHA 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.
The provided text describes the Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) and the non-clinical tests performed for its voice operation function. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Voice recognition test: Confirmed the voice recognition rate by some sample voice data recorded by members of Olympus America Inc. | Recognize all words that are in specifications. | "We confirmed the voice recognition rate by some sample voice data that is recorded by members of Olympus America Inc." (Implies it met the criteria, but no specific rate is given). |
| Wrong recognition test: Confirmed whether EndoALPHA doesn't work by noise in the operation room. | Never do wrong recognition. | "We confirmed whether EndoALPHA doesn't work by noise in operation room." (Implies it met the criteria, meaning it did not do wrong recognition due to noise). |
2. Sample size used for the test set and the data provenance
- Sample size for voice recognition test: "some sample voice data" - The exact number of samples is not specified.
- Data provenance: Recorded by "members of Olympus America Inc." This suggests retrospective data from internal company personnel, likely collected in the USA for the purpose of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section of the document describes non-clinical tests for software functionality (voice control). While "members of Olympus America Inc." provided the voice samples for testing, these are not described as "experts" establishing a medical ground truth for a diagnostic or clinical outcome. The ground truth for voice recognition would be the intended interpretation of the spoken commands, which is inherent in the device's design specifications. No medical experts are mentioned as being involved in establishing this ground truth.
4. Adjudication method for the test set
The document does not describe an adjudication method for these non-clinical tests. The tests appear to be direct verification against predefined functional specifications.
5. 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
No MRMC study is mentioned. The device described, the Olympus Integrated Endosurgery System EndoALPHA, is a control unit for ancillary surgical equipment with added voice control and image management functions. It is not an AI diagnostic or interpretive tool that would typically be evaluated in an MRMC study for human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is essentially what the voice recognition and wrong recognition tests describe. They assess the algorithm's performance (voice recognition system) independently of a human "in-the-loop" making clinical decisions. The tests evaluate the system's ability to correctly interpret voice commands and avoid misinterpretations from noise.
7. The type of ground truth used
For the voice recognition test, the ground truth is the correct interpretation of the spoken command as defined in the device's specifications. For the wrong recognition test, the ground truth is the absence of an action when noise is present, implying the noise should not be recognized as a command. This is a functional truth, not a clinical or pathological one.
8. The sample size for the training set
The document does not mention a training set for the voice recognition function. It only describes the test phase.
9. How the ground truth for the training set was established
Since no training set is mentioned, information on how its ground truth was established is not available in the provided text.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings outstretched.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus America, Inc. Two Corporate Center Drive Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Melville, NY 11747-3157
JUL 2 7 2015
Re: K022270
Trade/Device Name: Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2), Models MAJ-1177, MA-2E and M-128/64/32/16/8PIE and PIU
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA, GCJ, FAL, FCG, FEH, FWF, GEI, HIF, IYO, ITX and LFL Dated (Date on orig SE ltr): July 12, 2002 Received (Date on orig SE ltr): July 15, 2002
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of August 14, 2002.
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. 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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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510(k) Number(if known): Not.assigned.yet_________________________________________________________________________________________________________________________________
Device Name:
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)_
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, interlocking 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)
| Prescription Use | / | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |||
| (Division Sign-Off) | ||||
| Division of Reproductive, Abdominal, and Radiological Devices | ||||
| 510(k) Number | K022270 |
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AUG 1 4 2002
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SMDA 510(k) SUMMARY
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)
A. Submitter's Name, Address, Phone and Fax Numbers
| Name & Address of manufacturer: | Olympus Optical Co., Ltd.2-3-1 Shinjuku Monolis Nishi-Shinjuku,Shinjuku-ku Tokyo, Tokyo 163-0914Japan |
|---|---|
| Registration No.: | 8010047 |
| Address, Phone and Fax Numbers:of R&D Department, EndoscopeDivision | 2951 Ishikawa-Cho,Hachioji-shi, Tokyo 192-8507Japan |
| TEL 81-426-42-2891 | |
| FAX 81-426-46-5613 |
B. Name of Contact Person
| Name: | Laura Storms-Tyler |
|---|---|
| Address, Phone and Fax Numbers: | Olympus America Inc. |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| TEL: (631) 844-5688 | |
| FAX: (631) 844-5416 |
C. Device Name, Common Name, Classification Name and Predicate Devices
| Trade Name: | #K981993 OLYMPUS INTEGRATED ENDOSURGERY SYSTEMEndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) |
|---|---|
| Common Name: | ENDOSURGERY SYSTEM |
| Classification: | 21 CFR 876.1500 Endoscope and accessories21 CFR 876.1075 Gastroenterology-urology biopsy instrument21 CFR 876.4300 Endoscopic electrosurgical unit and accessories21 CFR 878.4160 Surgical camera and accessories21 CFR 878.4400 Electrosurgical cutting and coagulation device andaccessories21 CFR 884.1730 Laparoscopic insufflator21 CFR 892.1560 Ultrasonic pulsed echo imaging system21 CFR 892 1570 Diagnostic ultrasonic transducerNo Class (Ultrasonic Surgical Instrument) |
Predicate Device: OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES) x981993
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K 0.222 70
jy 2 of 2
D. Description of the Device(s)
The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-21" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.
The additional voice control function enables the subject device to control the ancillary equipment by voice, while the conventional products control them manually. You could find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" of this section.
Addition of Image switching, recording and playback functions enables the followings;
- Images input into the UCES-2 and MAJ-1139 are displayed on two monitors by switching from one to another.
- · Images input into the UCES-2 and MAJ-1139 are displayed on the MAJ-1176 as reference images.
- · Still images input into UCES-2 and MAJ-1139 are recorded in a PC card (SmartMedia) The images recorded in the PC card (SmartMedia) are displayed on the MAJ-1176.
The intended use of the EndoALPHA 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.
E. Intended Use of the Device(s)
The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-21" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.
This is the same intended use as previously cleared one for the "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA(CONTROL UNIT FOR ENDOSURGERY UCES)".
F. Summary including Conclusions drawn from Non-clinical Tests
The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO14971-1. The design verification that were performed as a result of this risk analysis assessment are listed below. Refer to Attachment 3 for detail.
| Modification | Test performed | Acceptance Criteria |
|---|---|---|
| Added theVoiceOperation | 1. Voice recognition testWe confirmed the voice recognition rateby some sample voice data that isrecorded by members of OlympusAmerica Inc. | 1. Recognize all words that is inspecifications. |
| Function | 2. Wrong recognition testWe confirmed whether EndoALPHAdoesn't work by noise in operation room. | 2. Never do wrong recognition. |
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ATTACHMENT
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Product Code: 78 KOG, GCJ and FAL Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Product Code: 78 FCG Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Product Code: 78 FEH Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical camera and accessories Product Code: 79 FWF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Product Code: 79 GEI Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Product Code: 85 HIF Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: 90 ITX Regulation Number: Unclassified Product Code: 90 LFL
§ 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.