Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical components and optical system of a rigid arthroscope, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".

Therapeutic

Yes
The device is used in operative arthroscopic procedures and surgical procedures, which are considered therapeutic.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in diagnostic and operative arthroscopic procedures" and lists "diagnostic procedures" as an example.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components made of surgical stainless steel, sapphire, solder, and epoxy, indicating it is a hardware device. It also describes optical and fiber optic systems for visualization.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
Device Function: The OSI Q System Arthroscopes are used for direct visualization inside the body during surgical procedures. They provide illumination and a view of anatomical structures.
Intended Use: The intended use clearly states the device is for "diagnostic and operative arthroscopic procedures to provide illumination and visualization" of various joints and spinal structures. This is an in vivo (within the living body) application.
Device Description: The description details the physical components of an endoscope designed for insertion into the body.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.

Therefore, the OSI Q System Arthroscopes are surgical instruments used for visualization during procedures performed directly on the patient, not for testing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

HRX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hip, shoulder, knee, elbow, wrist, and ankle, and also 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.

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

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.

Key Metrics

Resolution: 8.98 line pairs/mm (Model AS-175)
Magnification: 8.6 X total magnification at 10 mm (Model AS-175)

Predicate Device(s)

K091398, K992782

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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-

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | n/a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |

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."