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.

AI/ML Overview

Acceptance Criteria and Study for OSI Q System Arthroscopes (K133018)

Based on the provided 510(k) summary, the OSI Q System Arthroscopes were determined to be substantially equivalent to previously marketed predicate devices (K091398 and K992782) and therefore did not require new clinical or non-clinical studies to establish acceptance criteria or prove performance. The submission relies on the established performance of the predicate device K091398 to demonstrate the performance of the subject device.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new studies were conducted, the "acceptance criteria" for the subject device are implicitly met by its technological characteristics being "the same as" or "similar to" the predicate devices. The performance reported for the subject device is directly tied to the predicate.

Characteristic	Acceptance Criterion (Based on Predicate K091398)	Reported Device Performance (OSI Q System Arthroscopes)
Intended Use	Same as K091398 (and K992782 for spine)	Same as K091398; spine indications similar to K992782
Operating Principle	Same as K091398	Same operating principle
Basic Design	Same as K091398	Same basic design
Materials	Same as K091398	Same or very similar materials (304 stainless steel, sapphire, eutectic solder, USP Class VI epoxy for arthroscope; 316 stainless steel for sheaths)
Packaging & Sterilization	Same as K091398	Similar packaging; sterilized using same materials and processes
Physical Dimensions	Ranges established by K091398 and K992782	Diameter: 3.1mm, 4mm, 5mm (within predicate ranges of 2mm-5mm for arthroscopes and 5mm for predicate sheath); Working Length: 175.5mm, 178mm, 179mm, 212.5mm (within predicate ranges of 40mm-400mm); Angle of View: 0°, 30°, 70° (within predicate ranges of 0°-70°); Field of View: 90°, 100° (within predicate ranges of 90°-105°)
Illumination	ACMI; Wolf/Dyonics, Storz/Olympus adapters	ACMI; Wolf/Dyonics, Storz/Olympus adapters
Resolution	8.98 line pairs/mm (Model AS-175)	8.98 line pairs/mm (Model AS-175)
Magnification	8.6 X total magnification at 10 mm (Model AS-175)	8.6 X total magnification at 10 mm (Model AS-175)
How Provided	Non-sterile, reusable (arthroscope) / Sterile, single-use (visualization sheaths)	Non-sterile, reusable (arthroscope) / Sterile, single-use (visualization sheaths)

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. No new test set was used. The submission relies on existing data and regulatory clearances of predicate devices.
Data Provenance: Not applicable for a new test set. The data provenance for the predicate device K091398 (Orthopedic Sciences, Inc., Arthroscope) and K992782 (NuVasive, Inc., Spinal Arthroscope) would be tied to their original clearances, which are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment was used for this submission.

4. Adjudication method for the test set

Not applicable. No new test set required adjudication for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an arthroscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an arthroscope, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The substantial equivalence determination is based on the comparison of the device's technological characteristics to legally marketed predicate devices, not on direct clinical ground truth generation for the subject device itself.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/machine learning device, no training set or its associated ground truth establishment methods are relevant.

Summary

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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 325Seal Beach, CA 90740
	Telephone:	+1 (562) 799-5550
	Fax:	+1 (562) 799-5533
Official Contact	James K. Brannon, MDPresident/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)

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INTENDED USE

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

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.

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ﺖ

	Subject Device	Predicate Devices
	OSI Q System ArthroscopesOrthopedic Sciences, Inc.K133018	ArthroscopeOrthopedic Sciences, Inc.K091398	Spinal ArthroscopeNuVasive, Inc.K992782
Indications forUse	OSI Q System Arthroscopes ofappropriate size and length areindicated for use in diagnostic andoperative arthroscopic proceduresto provide illumination andvisualization of the hip, shoulder,knee, elbow, wrist, and ankle, andalso to provide illumination andvisualization during open andclosed arthroscopic diagnosticprocedures and removal of loosebodies and soft tissue within thejoint.Hip Diagnostic procedures mayinclude:Staging of avascular necrosisChondral injuriesJoint sepsisSynovial chondomatosisUnresolved hip painLabral tearsOSI Q System Arthroscopes ofappropriate size and length also areindicated for visualization andperformance of arthroscopicsurgical procedures on variousstructures of the spine, includingnerve roots, foramina, intervertebraldiscs and the surrounding spinalstructures.	The Arthroscopes of appropriatesize and length are indicated foruse in diagnostic and operativearthroscopic procedures toprovide illumination andvisualization of the hip, shoulder,knee, elbow, wrist, and ankle, andalso to provide illumination andvisualization during open andclosed arthroscopic diagnosticprocedures and removal of loosebodies and soft tissue within thejoint.Hip Diagnostic procedures mayinclude:Staging of avascular necrosisChondral injuriesJoint sepsisSynovial chondomatosisUnresolved hip painLabral tears	The NuVasive SpinalArthroscope, consisting of arigid diagnostic arthroscopewith outer sheath, is intendedto achieve percutaneousvizualization of, and/or toassist in performingpercutaneous surgicalprocedures on, the spinal nerveroot, foramina, intervertebraldisc, and the surroundingtissues of the spine viauniportal or biportal posterioror posterolateral approach,where anatomic restrictionspermit percutaneous access.The device is intended for usein conjunction with theNuVasive Guided SpinalArthroscopy System under real-time radiographic visualizationvia image-intensified C-armfluoroscopy, but may also beemployed independent of thatsystem where it is compatiblein diameter and length withother commercially availablearthroscopic instruments, andwith surgical need.
Arthroscope Features
Diameter	3.1 mm, 4 mm, 5 mm	2 mm to 4 mm	5 mm (sheath)
WorkingLength, 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
Lockingmechanism: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 10mm (Model AS-175)	n/a
How Provided	Non-sterile, reusable	Non-sterile, reusable	Non-sterile, reusable

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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.

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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

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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

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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

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)

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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:

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Regulation Number and Section

§ 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.