(78 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is purely about imaging hardware.
No
The device is described as an "imaging device" used for "observation of endoscopic image" and "endoscopic diagnosis and treatment." While it assists in diagnosis and treatment, it does not directly apply a therapy or achieve a therapeutic effect itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed for "endoscopic diagnosis and treatment."
No
The device description explicitly states it is an "imaging device" and a "camera head," which are hardware components. It is designed to be used with other hardware like video system centers, endoscopes, and light sources.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "endoscopic diagnosis and treatment" and "observation of endoscopic image on a video monitor." This describes a device used for visualizing internal body structures, which is a clinical diagnostic procedure performed in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
- Device Description: The description reinforces its function as an "imaging device used with specified Olympus video system center, light source, endoscope, and other ancillary equipment for observation of endoscopic image." This aligns with in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or any other activities typically associated with in vitro diagnostics.
Therefore, this device is an endoscopic imaging component used for clinical diagnosis and treatment, not an IVD.
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.
Product codes (comma separated list FDA assigned to the subject device)
FET, NWB
Device Description
AUTOCLAVABLE CAMERA HEAD OTV-Y0017 is an imaging device used with specified Olympus video system center, light source, endoscope, and other ancillary equipment for observation of endoscopic image on a video monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K102059
pg. 1 of 4
510(k) SUMMARY AUTOCLAVABLE CAMERA HEAD OTV-Y0017
September 30, 2010
OCT 8 2010
l General Information
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Establishment Registration No: 8010047 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Stacy Abbatiello Kluesner, M.S., RAC
Regulatory 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 |
- SHIRAKAWA OLYMPUS CO., LTD. ■ Manufacturer: 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
Device Identification 2
- AUTOCLAVABLE CAMERA HEAD OTV-Y0017 Device Trade Name: 미
- CAMERA HEAD Common Name: ■
- Regulatory Information: ■
| Product Code | Device | Regulatory Description | Review Panel | Regulation Number | Device Class |
|---|---|---|---|---|---|
| FET | Endoscopic video imaging | ||||
| system/ component, | |||||
| gastroenterology -urology | Endoscope and | ||||
| accessories | Gastroenterology/ | ||||
| Urology | 876.1500 | II | |||
| NWB | Endoscope, accessories, | ||||
| narrow band spectrum | Endoscope and | ||||
| accessories. | Gastroenterology/ | ||||
| Urology | 876.1500 | II |
1
15/02059
pg 2 of 4
Predicate Device Information 3
- HD CAMERA HEAD OTV-S7ProH-HD-L08E 해 Device Name:
- CAMERA HEAD 0 Common Name:
D Manufacturer: SHIRAKAWA OLYMPUS CO., LTD. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
- 1 510(k) No. K083155
Device Description ব
AUTOCLAVABLE CAMERA HEAD OTV-Y0017 is an imaging device used with specified Olympus video system center, light source, endoscope, and other ancillary equipment for observation of endoscopic image on a video monitor.
The new camera head is basically identical to predicate device in intended use, and similar in specifications, performance.
ഗ 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.
Comparison of Technological Characteristics 6
OTV-Y0017 is basically identical to the predicate device except for a change to the intended use (expanding beyond the bladder, urethra and kidney), specifications and method of sterilization. Comparison between the subject and predicate devices is shown in Table 3.
2
/ 12 10 20 5-9
gg 5 og x
Table 3. Comparison of Specifications Subject Device: AUTOCLAVABLE CAMÈRA HEAD OTV-Y0017 Predicate Device: HD CAMERA HEAD OTV-S7ProH-HD-L08E (K083155)
| Specifications | | Subject Device
OTV-Y0017 | Predicate Device
OTV-S7ProH-HD-L08E |
|-----------------------------------|---------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Dimension | Camera Head | O.D. 38mm x 106mm
(from mount surface)
Straight-shape | O.D. 21mm x 83mm (from
mount surface)
L-shape |
| | Cable | O.D. 6.8mm x 4m | O.D. 3.3mm x 4m |
| | Weight | 215g (excluding cable)
620g (total weight) | 60g (excluding cable)
305g (total weight) |
| | Video plug | Card-edge type connector | Card-edge type connector |
| | Remote
control
switches | Embedded | Embedded |
| Observation | Pickup
System | Interline type CCD
solid-state image pickup | Interline type CCD
solid-state image pickup |
| | Auto Iris | Not available | Not available |
| | Narrow Band
Imaging
(NBI)
function | Available | Available |
| | Ambient
Temperature | 10 to 40°C | 10 to 40°C |
| Operating
Environment | Relative
Humidity | 30 to 85 % | 30 to 85 % |
| | Atmospheric
Pressure | 700 to 1060 hPa | 700 to 1060 hPa |
| | | | |
| Specifications | | Subject Device
OTV-Y0017 | Predicate Device
OTV-S7ProH-HD-L08E |
| Reprocessing | Cleaning | Immersible in detergent
solution without
water-resistant cap | Immersible in detergent
solution without
water-resistant cap |
| | Disinfection | Immersible in disinfectant
solution without
water-resistant cap | Immersible in disinfectant
solution without
water-resistant cap |
| | Sterilization | Autoclave sterilization | Ethylene oxide gas
sterilization |
| | | | |
| Patient
contacting
material | | No patient contacting
material | No patient contacting
material |
3
K 10205.9
pg 4.084
7 Conclusion
When compared to the predicate device, OTV-Y0017 does not incorporate any
significant changes in intended use, method of operation, material, or design that cou
4
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged vertically along the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
OCT. 8 2010
Re: K102059
Trade/Device Name: AUTOCLAVABLE CAMERA HEAD OTV-Y0017 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: July 17, 2010 Received: July 28, 2010
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. Please note: CDRH does not evaluate information related to contract liability w 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 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 of medical device-related
5
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): 102059 Device Name: AUTOCLAVABLE CAMERA HEAD OTV-Y0017 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.
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)
oductive.
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