(81 days)
No
The summary does not mention any AI or ML capabilities, image processing beyond basic observation, or data related to training or testing AI/ML models.
No
The device is an imaging device used for observation of endoscopic images, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney." The term "diagnosis" directly indicates its role as a diagnostic device.
No
The device description explicitly states it is a "camera head," which is a hardware component used for imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney." This involves direct visualization of internal body structures, which is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The description confirms it's an "imaging device used with specified HD CAMERA FILAD... for observation of endoscopic image on a video monitor." This reinforces its role in capturing images during an endoscopic procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or performing tests on samples outside the body, which are hallmarks of IVD devices.
Therefore, this device is an endoscopic camera head used for visualization during medical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.
Product codes
KOG, NWB, FET
Device Description
HD CAMERA HEAD OTV-S7ProH-HD-L08E is an imaging device used with specified HD CAMERA FILAD OTV-811 1011 1017 1072 120 120 0ther ancillary equipment for observation of endoscopic image on a video monitor.
The new camera head is basically identical to predicate device shown in Table 14-1 in intended use, and similar in specifications, performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra, ureter, and kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and appears to be a blocky, slightly condensed style. The letters are closely spaced, creating a strong visual impact. The word is centered and dominates the image.
K 083,55
pg 1 of 4
510(k) SUMMARY
HD CAMERA HEAD OTV-S7ProH-HD-L08E JAN 1 3 2009
October 15, 2008
General Information 1
Official Correspondent
- Applicant: E
日
해
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Stacy Abbatiello Kluesner, RAC Requiatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com Establishment Registration No: 2429304
SHIRAKAWA OLYMPUS CO., LTD. 3-1. Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No .: 3002808148
Device Identification 2
-
행 Device Trade Name:
Manufacturer: -
월 Common Name:
-
Regulation Number: 만
-
Requiation Name: 대
-
Regulatory Class: I
-
Classification Panel: 원
-
Product Code: 曝
HD CAMERA HEAD OTV-S7ProH-HD-L08E
CAMERA HEAD
21 CFR 876.1500
Endoscope and accessories
ll
Gastroenterology/urology
KOG - Endoscope And/Or Accessories NWB - Endoscope, Accessories, Narrow Band Spectrum
1
pg 2 of 4
Predicate Device Information 3
The following table shows the primary components of the subject devices and the devices to which we claim substantial equivalence (predicate devices).
Table 14-1. Primary Components & Predicate Devices
| Subject Devices
(Part of this submission) | Predicate Devices | PD's
510(k) No. |
|----------------------------------------------|---------------------------------------------------------------|--------------------|
| HD CAMERA HEAD
OTV-S7ProH-HD-L08E | Camera Head for rigid endoscopes (with
Auto focus) MH-9721 | K955404 |
Device Description 4
HD CAMERA HEAD OTV-S7ProH-HD-L08E is an imaging device used with specified HD CAMERA FILAD OTV-811 1011 1017 1072 120 120 0ther ancillary equipment for observation of endoscopic image on a video monitor.
The new camera head is basically identical to predicate device shown in Table 14-1 in intended use, and similar in specifications, performance.
Indications for Use 5
This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.
6 Comparison of Technological Characteristics
The HD CAMERA HEAD OTV-S7ProH-HD-L08E is basically identical to the predicate device in intended use except for the limitation of the application to the bladder, urethra, ureter, and kidney, and similar in specifications except for addition of the Narrow Band Imaging function, embedded Remote Control Switches, and L-shaped configuration. Comparison between the subject and predicate device is shown in Table 14-2.
2
4 Ko83155
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૧૯ Pag-
:
.
. . .
Table 14-2. Comparison of Specifications
ProH-HD-L08E
PROPOSED RULES FOR
HIGH-DEFINITION VIDEO COMPRESSION
TECHNOLOGY
Draft 08
Sub-Committee on
Advanced Television Systems
Technology Advisory Committee
| Item | Specifications | Subject Device | Predicate Device | |
|---|---|---|---|---|
| Subject Device : HD CAMERA HEAD OTV-S7ProH-HD-L08E | ||||
| Predicate Device : Camera Head for rigid endoscopes (with Auto focus) MH-9721 (K955404) | ||||
| Dimension | Camera Head | O.D. 21mm x 83mm (from mount surface) | ||
| L-shape | O.D. 40mm x 104mm (from mount surface) | |||
| Straight shape | ||||
| Cable | O.D. 3.3mm x 4m | O.D. 6.6mm x 4m | ||
| Weight | 60g (excluding cable) | 100g (excluding cable) | ||
| Video plug | Card-edge type connector | Round shape type connector | ||
| Remote | ||||
| switches | control | |||
| Embedded | Separated | |||
| Observation | Pickup System | Interline type CCD solid-state image pickup | Interline type CCD solid-state image pickup | |
| Auto Iris | Not available | Available | ||
| Narrow Band Imaging | ||||
| (NBI) function | Available | Not available | ||
| Operating | ||||
| Environment | Ambient Temperature | 10 to 40°C | 10 to 40°C | |
| Relative Humidity | 30 to 85% | 30 to 85% | ||
| Atmospheric Pressure | 700 to 1060 hPa | 700 to 1060 hPa | ||
| Reprocessing | Cleaning | Immersible in detergent solution without | ||
| water-resistant cap | Immersible in detergent solution with a | |||
| water-resistant cap | ||||
| Disinfection | Immersible in disinfectant solution without | |||
| water-resistant cap | Immersible in disinfectant solution with a | |||
| water-resistant cap | ||||
| Sterilization | Ethylene oxide gas sterilization | Ethylene oxide gas sterilization | ||
| Patient | ||||
| contacting | ||||
| material | No patient contacting material | No patient contacting material |
:
:
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:
3
K 08315-5
pg 4 of 4
7 Conclusion
When compared to the predicate device, the HD CAMERA HEAD OTV-S7ProH-HD-L08E
r When compared to the predicale changes in intended use, method of operation, or design does not incorporate any orghineen energy of the device.
4
Image /page/4/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, which is a common symbol of the United States.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2009
OLYMPUS MEDICAL SYSTEMS CORP. % Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K083155
Trade/Device Name: HD CAMERA HEAD OTV-S7ProH-HD-L08E Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: October 23, 2008 Received: October 29, 2008
Dear Ms. Kluesner:
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 (PMA), 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.
5
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 not 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 elections product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, perior courted in the to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3064 - You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fida.gov/cdrh/industry.suppo/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: HD CAMERA HEAD OTV-S7ProH-HD-L08E
Indications for Use:
This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
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)
Aoqum Whang
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number_
Page 1 of __ 1