(9 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on its similarity to a predicate device and compatibility with light sources, with no mention of AI/ML capabilities.
No
The device is described as an instrument for endoscopic diagnosis and treatment within the bladder, urethra, and kidney, which encompasses both diagnostic and therapeutic uses. Its primary function is not solely therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "endoscopic diagnosis and treatment."
No
The device description clearly states it is a flexible endoscope, which is a hardware device. It also mentions being used with other hardware components like light sources, documentation equipment, and monitors.
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 instrument is for "endoscopic diagnosis and treatment within the bladder, urethra and kidney." This involves directly visualizing and potentially treating internal body structures.
- Device Description: The description confirms it's a "flexible endoscope." Endoscopes are used for direct visualization inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to obtain diagnostic information. IVDs typically involve analyzing biological samples.
Therefore, this device falls under the category of a medical device used for direct internal examination and treatment, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus Light Source, documentation equipment, display monitor, suction pump, Endo-Therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.
Product codes
FAJ, FGA,FCL, FDI, KGE, KNS
Device Description
The subject device, the XCYF-TP3 is basically identical to the predicate device (XCYF-1T3) which is the flexible endoscope for use in the bladder, urethra and kidney.Subject device may be used with three different Light source as follow,· A rechargeable powered Miniature Light source, or,· A battery powered Miniature Light source as predicate device, XENF-DP, or,· Light guide cable as predicate device, XENF-DP.In conclusion, this subject device is technically the same as the predicate device, which we describe in the table above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra 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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three curved lines that form the shape of a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus America, Inc. % Mr. Donald James Sherratt Medical Stream Director Intertek Testing Systems NA, Inc. 70 Codman Hill Road Boxborough, MA 01719
JUL 27 2015
Re: K032092
Trade/Device Name: Olympus XCYF-TP3 Cystofiberscope/Nephrofiberscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ, FGA,FCL, FDI, KGE and KNS Dated (Date on orig SE Itr): July 3, 2003 Received (Date on orig SE ltr): July 7, 2003
Dear Mr. Sherratt.
This letter corrects our substantially equivalent letter of July 16, 2003.
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
1
Page 2 -
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 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
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number(if known): Device Name: XCYF-TP3 CYSTOEIBERSCOPE/NEPHROFIBERSCOPE
Indications for Use:
This instrument has been designed to be used with an Olympus Light Source, documentation equipment, display monitor, suction pump, Endo-Therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use. $\checkmark$
(Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)
Nancy C brisdon
OR
510(k) Number
3
JUL 16 2003
SMDA 510(k) SUMMARY
XCYF-TP3, Cysto-Nephrofiberscope,
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
3003637092
Olympus Optical Co., Ltd. 34-3 Hirai Hinode-machi,
A. GENERAL INFORMATION
-
- Applicant
Name & Address:
- Applicant
Registration Number:
2. Initial Importer
Name & Address:
Registration Number:
Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 2429304
Nishitama-gun, Tokyo, 190-0182, Japan
3. Submission Correspondence
Name : Address :
Telephone : Facsimile : E-mail address : Establishment Registration No. : Masao Wada Olympus Optical Co., Ltd. 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, Japan 81-426-42-2891 81-426-42-2291 m wada@ot.olympus.co.jp 8010047
B. DEVICE IDENTIFICATION
1. Common/Usual Name Cystofiberscope/ Nephrofiberscope
2.Device Name
XCYF-TP3 Cystofiberscope/ Nephrofiberscope
3. Classification Name
| CFR Number | Classification Name | Class | Product Code |
|---|---|---|---|
| 876.1500 | Endoscopes and accessories | II | 78KOG, 78FAJ, 78FGA, FTI |
C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE
4
The following listed devices are seem to be as predicate devices in consideration of its characteristic and the following table shows regulatory history.
| Model | 510(k)# | Manufacturer | Class | Product
Code |
|-------------------------------------------------------------------------------------------------|----------|--------------------------|-------|-------------------------------------------------------------|
| XCYF-1T3
OES Cystrofiberscope/
Nephrofiberscope
Accessories and ancillary
equipment | #K993041 | Olympus Optical Co., Ltd | II | 78FCL
78FAJ
78FGA
78KOG
78FDI
78KGE
78KNS |
| XENF-DP
Laryngofiberscope, its
Accessories and ancillary
Equipment | #K011869 | Olympus Optical Co., Ltd | II | EOB |
D. DEVICE DESCRIPTION
1. Summarv
The subject device, the XCYF-TP3 is basically identical to the predicate device (XCYF-1T3) which is the flexible endoscope for use in the bladder, urethra and kidney.
Subject device may be used with three different Light source as follow,
- · A rechargeable powered Miniature Light source, or,
- · A battery powered Miniature Light source as predicate device, XENF-DP, or,
- · Light guide cable as predicate device, XENF-DP.
In conclusion, this subject device is technically the same as the predicate device, which we describe in the table above.
2. Design
XCYF-TP3 has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-1and IEC60601-2-18.
3. Materials
All the patient contacting materials used in this endoscope and ancillary equipments are identical materials that have been cleared in the past 510(k) submissions. And all materials have been confirmed with ISO 10993-1.
4. Intended Use of the device
This instrument has been designed to be used with the OLYMPUS Light source, Documentation equipment, Display monitor, Endo-Therapy Accessories and other Ancillary Equipment for endoscopic diagnosis and treatment.
5. Summary including conclusion drawn form Non-clinical Tests
When compared to the preamendment/predicate device, XCYF-1T3 does not incorporate any significant changes in the intended use, method of operation, material, or designed that could affect the safety effectiveness. Therefore, the clinical data is not necessary for its evaluation of safety and efficacy.