(80 days)
Not Found
No
The device description focuses on traditional optical and mechanical components for image transmission and illumination, with no mention of AI/ML processing or algorithms.
No
The device is described as a rigid endoscope used for visualization during arthroscopic procedures, which aids in diagnosis and treatment but does not directly provide therapy itself.
Yes
The "Intended Use / Indications for Use" states that the devices are used to "provide visualization during endoscopic diagnosis and treatment of joints." The mention of "diagnosis" clearly indicates that it is a diagnostic device.
No
The device description explicitly states it is a rigid endoscope with an image relay system of rod lenses and optical fibers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arthroscopic procedures to provide visualization during endoscopic diagnosis and treatment of joints". This describes a device used in vivo (within the body) for direct visualization during a medical procedure.
- Device Description: The description details a rigid endoscope with an image relay system and light transmission for illuminating the surgical field. This is consistent with a surgical instrument used for visualization during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue, or other bodily fluids, to diagnose a condition.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device's function is to provide visual access to internal anatomical structures during a surgical procedure.
N/A
Intended Use / Indications for Use
These devices are indicated for use in arthroscopic procedures to provide visualization during endoscopic diagnosis and treatment of joints such as the knee, shoulder, hip, ankle, foot, elbow.
Product codes
HRX
Device Description
The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The "ULTRA" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).
Mentions image processing
An image relay system of rod lenses transmits the endoscopic image.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic image
Anatomical Site
joints such as the knee, shoulder, hip, ankle, foot, elbow.
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
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing: Conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995. Testing included:
- Biological Safety - toxicology: AAMI ANSI ISO 10993-1:2009; Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials
Electrical safety and electromagnetic compatibility (EMC):
- Electrical Safety: Tested according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010; Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance.
- Electromagnetic compatibility (EMC): Not applicable as devices are not electrically powered and use light from a light source.
Thermal Safety: Tested according to IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: IEC 60601-2-18 Edition 3.0 2009-08, medical electrical equipment - part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
Performance Testing Bench: Conducted tests cover optical and mechanical performance testing, shipping tests, tests related to the expected service life and testing of the illumination system. Additionally, design validation/usability tests were conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
Olympus Winter & Ibe Gmbh % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation Of The Americas 3500 Corporate Parkway Center Vallev, Pennsylvania 18034
Re: K160249
Trade/Device Name: "ULTRA" Telescopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 29, 2016 Received: February 1, 2016
Dear Sheri Musgnung:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160249
Device Name
"ULTRA" Telescopes
Indications for Use (Describe)
These devices are indicated for use in arthroscopic procedures to provide visualization during endoscopic diagnosis and treatment of joints such as the knee, shoulder, hip, ankle, foot, elbow.
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------ |
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3
510(k) Summary of Safety and Effectiveness
January 29, 2016
1. General information
- Manufacturer/Holder Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
- 트 Establishment Registration No.: 9610773
- . Official Correspondent: Sheri L. Musqnung Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-3147 484-896-7128 FAX: Email: sheri.musqnunq@olympus.com Establishment Registration No.: 2429304
2. Device identification
- 트 Proprietary name:
- 트 Common name:
- 트 Regulation Number:
- 트 Regulation Description:
- I Device Class:
- Product Code:
- Review Panel:
"ULTRA" Telescopes Arthroscopes 21 CFR 888.1100 Arthroscope ll HRX Orthopedic
4
3. Predicate device
K951354. Olympus Arthroscopy System
4. Description of device
The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The "ULTRA" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).
5. Indications of use
These devices are indicated for use in arthroscopic procedures to provide visualization during endoscopic diagnosis and treatment of joints such as the knee, shoulder, hip, ankle, foot, elbow.
6. Comparison of Technological characteristics
The subject and predicate devices are based on the same technological principles:
- 트 Rigid endoscopes consisting of insertion tube, locking cone, light-guide connector, eyepiece cup, rod-lens and light-guide system.
- 트 A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
- I The image relay system of rod lenses transmits the endoscopic image
- Identical portion width and optical system diameter
- I Telescopes are used with 4 mm trocar tubes
- I Identical Direction of Views (DOVs)
- The Field of View (FOV) of subject devices is wider (Ø Factor 1.2)
- I Maximum working length of subject device is minimally longer
- I The same materials in patient contact are used in predicate and subject device
7. Performance Data
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
5
510(k) Summary for K160249
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995.
The testing included the following tests:
- . Biological Safety - toxicology: AAMI ANSI ISO 10993-1:2009; Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- . Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety was tested according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010; Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance. Electromagnetic compatibility (EMC) is not applicable. The devices are not electrically powered and are just used with light from a light source.
Thermal Safety
Tested according to IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: IEC 60601-2-18 Edition 3.0 2009-08, medical electrical equipment - part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
Performance Testing Bench
Conducted tests cover optical and mechanical performance testing, shipping tests, tests related to the expected service life and testing of the illumination system. Additionally, design validation/usability tests were conducted.
6
The following standards have been applied to the "ULTRA" Telescopes:
Rec. No. Standard
| 19-5 | AAMI / ANSI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012 |
|---|---|
| ------ | --------------------------------------------------------- |
- 9-61 IEC 60601-2-18:2009
- 5-89 IEC 60601-1-6:2013
- 9-83 ISO 8600-1:2013
- 9-84 ISO 8600-3:1997 + AM1(2003)
- 9-94 ISO 8600-4:2014
- 9-39 ISO 8600-5:2005
- 9-40 ISO 8600-6:2005
- 2-156 AAMI ANSI ISO 10993-1: 2009
- 2-153 AAMI ANSI ISO 10993-5: 2009
- 2-191 ISO 10993-12: 2012
- 5-40 ISO 14971:2007
- ISO 17665-1:2006 14-333
8 Conclusions
The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified.
In summary, we believe the "ULTRA" Telescopes are substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use. The "ULTRA" Telescopes raise no new concerns of safety or effectiveness compared to the predicate devices.