Who is the manufacturer of OSI Q SYSTEM ARTHROSCOPES?

Orthopedic Sciences, Inc. filed the 510(k) submission for OSI Q SYSTEM ARTHROSCOPES (K133018).

What is the FDA product code for OSI Q SYSTEM ARTHROSCOPES?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for OSI Q SYSTEM ARTHROSCOPES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OSI Q SYSTEM ARTHROSCOPES?

Orthopedic Sciences, Inc., Arthroscope (K091398); NuVasive, Inc., Spinal Arthroscope (K992782).

Who can help prepare an FDA 510(k) submission like OSI Q SYSTEM ARTHROSCOPES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OSI Q SYSTEM ARTHROSCOPES

K133018 · Orthopedic Sciences, Inc. · HRX · Feb 26, 2014 · Orthopedic

Device Facts

Record ID	K133018
Device Name	OSI Q SYSTEM ARTHROSCOPES
Applicant	Orthopedic Sciences, Inc.
Product Code	HRX · Orthopedic
Decision Date	Feb 26, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2
Attributes	Therapeutic

Intended Use

OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots. foramina, intervertebral discs and the surrounding spinal structures.

Device Story

Rigid, fixed arthroscope with rod lens imaging and fiber optic illumination; provides visualization of joint and spinal structures. Input: optical light signals from surgical site; Output: visual image for surgeon via attached video camera. Used in clinical settings (OR) by surgeons. Device facilitates minimally invasive diagnostic and operative procedures; enables removal of loose bodies and soft tissue; assists in spinal surgery. Benefits include improved visualization of anatomical structures during surgery.

Clinical Evidence

No clinical data submitted. Substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Rigid, reusable arthroscope. Materials: 304 stainless steel (body/insertion/optic tubes), 316 stainless steel (sheaths), sapphire (objective window), eutectic solder, USP Class VI epoxy. Fiber optic illumination; rod lens imaging. Diameters 3.1-5mm; working lengths 175.5-212.5mm; 30°/70° view angles; 90°/100° field of view. Non-sterile, reusable arthroscopes; sterile, single-use visualization sheaths. Connectivity: attaches to external video camera.

Indications for Use

Indicated for diagnostic and operative arthroscopic procedures in the hip, shoulder, knee, elbow, wrist, and ankle, and for visualization and surgical procedures on spinal structures including nerve roots, foramina, and intervertebral discs. Intended for prescription use.

Regulatory Classification

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.

Predicate Devices

Orthopedic Sciences, Inc., Arthroscope (K091398)
NuVasive, Inc., Spinal Arthroscope (K992782)

Reference Devices

Sterisheet (K931202)

Related Devices

K031972 — ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, · Asap Endoscopic Products GmbH · Sep 15, 2003
K980599 — NTECH ARTHROSCOPE · N-Tech Endoscopy, Inc. · Apr 15, 1998
K991656 — AED ARTHROSCOPE · National Advanced Endoscopy Devices, Inc. · Dec 2, 1999
K112548 — ALTOMEC ARTHROSCOPE · Altomec Endoscopy, Inc. · Aug 15, 2012
K993021 — METRX SYSTEM · Surgical Navigation Technologies, Inc. · Nov 10, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ » ### 510(k) Summary Orthopedic Sciences, Inc. OSI Q System Arthroscopes K133018 February 18, 2014 ### ADMINISTRATIVE INFORMATION | Manufacturer Name | Orthopedic Sciences, Inc. 3020 Old Ranch Parkway, Suite 325 Seal Beach, CA 90740 | | | |---------------------------|----------------------------------------------------------------------------------------|------------------------------------------|--| | | Telephone: | +1 (562) 799-5550 | | | | Fax: | +1 (562) 799-5533 | | | Official Contact | James K. Brannon, MD President/CEO | | | | Representative/Consultant | Kevin A. Thomas, PhD | | | | | Floyd G. Larson | | | | | PaxMed International, LLC | | | | | 12264 El Camino Real, Suite 400 | | | | | San Diego, CA 92130 | | | | | Telephone: | +1 (858) 792-1235 | | | | Fax: | +1 (858) 792-1236 | | | | Email: | kthomas@paxmed.com flarson@paxmed.com | | ### DEVICE NAME AND CLASSIFICATION Trade/Proprietary Name Common Name Classification Name Classification Regulations Product Code Classification Panel Reviewing Branch OSI Q System Arthroscopes Arthroscope Arthroscope 21 CFR 888.1100, Class II HRX Orthopedic Joint Fixation Devices Branch Two (JFDB2) {1}------------------------------------------------ ### INTENDED USE OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots. foramina, intervertebral discs and the surrounding spinal structures. ### DEVICE DESCRIPTION OSI Q System Arthroscopes are rigid, fixed arthroscopes with a wide-angle view and a rod lens imaging system with a fiber optic illumination system to provide visualization of various anatomic structures during diagnostic and operative arthroscopic procedures. OSI Q System Arthroscopes have surgical stainless steel shafts and lens housing for durability and are available with various angles of view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surgical site and surgeon preference. OSI Q System Arthroscopes have a working length of 175.5 mm to 212.5 mm. diameters ranging from 3.1 mm to 5 mm. an angle of view (direction of view) of either 30° or 70°, and a field of view of either 90° or 100°. Visualization sheaths are provided in three designs, with diameters of either 5 mm or 6.1 mm, an angle of view of 0°, 30°, or 70°, and working lengths ranging from 151 mm to 185.5 mm. The arthroscope main body tube, insertion tube, and optic tube are all made from 304 stainless steel. The other patient contacting parts of the arthroscope are the objective window (sapphire), eutectic solder, and USP Class VI epoxy, and are the same materials used in the predicate OSI Arthroscopes (K091398). The visualization sheaths are made from 316 stainless steel. Arthroscopes are provided non-sterile and are reusable. Visualization sheaths are provided sterile for single use only. ### EQUIVALENCE TO MARKETED DEVICE OSI Q System Arthroscopes are substantially equivalent in indications and design principles to the following legally marketed predicate devices: Orthopedic Sciences, Inc., Arthroscope, K091398, and NuVasive, Inc., Spinal Arthroscope, K992782. A summary of the indications for use and the technological characteristics of the subject device and the predicate devices is provided in the following table. {2}------------------------------------------------ ﺖ | | Subject Device | Predicate Devices | | |----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | OSI Q System Arthroscopes Orthopedic Sciences, Inc. K133018 | Arthroscope Orthopedic Sciences, Inc. K091398 | Spinal Arthroscope NuVasive, Inc. K992782 | | Indications for Use | OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots, foramina, intervertebral discs and the surrounding spinal structures. | The Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears | The NuVasive Spinal Arthroscope, consisting of a rigid diagnostic arthroscope with outer sheath, is intended to achieve percutaneous vizualization of, and/or to assist in performing percutaneous surgical procedures on, the spinal nerve root, foramina, intervertebral disc, and the surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomic restrictions permit percutaneous access. The device is intended for use in conjunction with the NuVasive Guided Spinal Arthroscopy System under real- time radiographic visualization via image-intensified C-arm fluoroscopy, but may also be employed independent of that system where it is compatible in diameter and length with other commercially available arthroscopic instruments, and with surgical need. | | Arthroscope Features | | | | | Diameter | 3.1 mm, 4 mm, 5 mm | 2 mm to 4 mm | 5 mm (sheath) | | Working Length, mm | 175.5, 178, 179, 212.5 | 40 to 300 | 400 | | Angle of View | 0°, 30°, 70° | 30° | 0°, 30°, 70° | | Field of View | 90°, 100° | 100° | 105° | | Illumination | ACMI; Wolf/Dyonics, Storz/Olympus adapters | ACMI; Wolf/Dyonics, Storz/Olympus adapters | ACMI; Wolf, Storz adapters | | Locking mechanism: Sheath/cannula- to- arthroscope | Storz style | J-lock | n/a | | Resolution | 8.98 line pairs/mm (Model AS-175) | 8.98 line pairs/mm (Model AS- 175) | n/a | | Magnification | 8.6 X total magnification at 10 mm (Model AS-175) | 8.6 X total magnification at 10 mm (Model AS-175) | n/a | | How Provided | Non-sterile, reusable | Non-sterile, reusable | Non-sterile, reusable | {3}------------------------------------------------ The subject device has the same intended use as the predicate devices, the same indications for use as the predicate K091398 (other than in the spine), and indications for use in the spine similar to those of the predicate K992782. The slight differences in the indications for the subject device and predicate devices are not critical to the intended therapeutic, prosthetic, or surgical use of the device, and do not affect the safety and effectiveness of the device when used as labeled because the technological characteristics and features of the subject device are similar or identical to the predicate devices K091398 and K992782. The subject device design, illumination and imaging characteristics, and materials are the same as those of the predicate device K091398. The subject device design includes the same ranges of physical dimensions (diameter, working length, angle of view) as the predicate devices. No new nonclinical tests were submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence because the technological performance characteristics of the subject devices are the same as the predicate device K091398. No clinical tests were submitted, referenced, or relied on in the premarket notification for a determination of substantial equivalence because the technological performance characteristics of the subject devices are the same as the predicate device K091398. The subject device and both predicate devices are rigid, reusable arthroscopes and are provided nonsterile to the end user. The subject device cleaning and sterilization instructions (provided in the Directions for Use labeling) include the following: place the OSI Q System Arthroscope into a sterilization container that is FDA cleared for the specified gravity displacement cycle; double wrap the container with a sterilization wrap that is FDA cleared for the specified gravity displacement cycle; do not stack the sterilization containers; thoroughly clean the sterilization containers before use; and check that the sterilization container is visually clean, and if not, repeat the cleaning until the container is visually clean. The sterilization wrap used in the subject device sterilization testing was Sterisheet. manufactured by Arjo Wiggins Medical, Inc., cleared under K931202. Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy. The data provided in this submission demonstrate substantial equivalence to the predicate devices listed above. Overall, OSI Q System Arthroscopes have the following similarities to the predicate devices: have the same intended use. use the same operating principle, incorporate the same basic design, incorporate the same or very similar materials, and have similar packaging and are sterilized using the same materials and processes. {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 26, 2014 Orthopedic Sciences Incorporated Kevin A. Thomas, Ph.D. PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130 Re: K133018 Trade/Device Name: OSI O System Arthroscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 12, 2014 Received: February 14, 2014 Dear Dr. Thomas: 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 {5}------------------------------------------------ Page 2 - Kevin A. Thomas, Ph.D. 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 tollfree 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, ## David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices . Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. 510(k) Number (if known) K133018 て Device Name QSI Q System Arthroscope Indications for Use (Describe) Device Name: OSI Q System Arthroscopes OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots, foramina, intervertebral discs and the surrounding spinal structures. Type of Use {Select one or both, as applicable} IX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure) # Neil R Ogden -S 2014.02.25 08:45:23 -05'00' FORM FDA 3881 (1/14) {7}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."