The J-Scope System is an endoscopic device intended to be used by physicians for introduction of fluids to assist in visualization of intra-articular structures for arthroscopic diagnosis, as well as for surgical procedures using a second J-Scope or other arthroscopic device. It is indicated for use in the shoulder, hip, wrist, ankle, knee, and elbow joints.

Device Description

The J-Scope Tissue Visualization & Assessment Mini-Cannula Kit is a single-use, disposable small diameter, 14-gauge needle mini-cannula device which, when coupled with the J-Scope semi-rigid or flexible Arthroscope, provides convenient and precise arthroscopic visualization of both major and minor joints. The micro-invasive design of the system allows the procedure to be performed comfortably with the patient under local anesthesia.

AI/ML Overview

This 510(k) submission (K122411) for the J-Scope Tissue Visualization & Assessment Mini-Cannula Kit and J-Scope Tissue Visualization & Assessment Arthroscope does not contain information about clinical studies with acceptance criteria, human reader performance, or AI assistance.

The submission focuses on establishing substantial equivalence to a predicate device (Henke Sass Wolf Arthroscope, K080560) based on design, materials, and performance standards testing.

Therefore, most of the requested information regarding acceptance criteria derived from clinical studies, human reader performance, and AI assistance cannot be extracted from the provided text.

Here is a breakdown of what can be inferred or is explicitly stated:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (J-Scope System)
Biocompatibility	Conformance with ISO 10993: Biological Evaluation of Medical Devices. (Implies meeting the safety requirements for patient contact).
Electrical Safety	Conformance with IEC 60601-2-18 - Medical Electrical Equipment - Particular requirements for the safety of endoscopic equipment, and EN60601-2-18. (Implies meeting electrical safety and performance requirements for endoscopic devices).
Sterilization	Conformance with ISO 11135-1:2007. Sterilization of Health Care Products-Ethylene Oxide, reference 7.1, Product Adoption and Process Equivalency for Ethylene Oxide Sterilization. (Implies that the device can be effectively sterilized and maintains sterility).
Shelf Life	Expiration Dating tests were performed. (Implies that the device maintains its function and sterility for its stated shelf life).
Component Validation	System component validation testing was performed. (Implies that individual components and their interaction meet specified functional requirements).
Substantial Equivalence	"The technological differences between the HSW Arthroscope and the J-Scope System do not raise any new questions of safety or effectiveness and testing demonstrates that the J-Scope is as safe and effective as the predicate devices." (The ultimate acceptance criterion for 510(k) clearance is demonstrating that the device is as safe and effective as a legally marketed predicate device. This is the overarching "performance" demonstrated through the described testing.)

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

The submission does not describe a clinical test set with a sample size for evaluating clinical performance. The testing mentioned refers to engineering and regulatory compliance testing (e.g., biocompatibility, electrical safety, sterilization).

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

Not applicable. There is no mention of a test set requiring expert-established ground truth for clinical performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a clinical test set that would require an adjudication method.

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, a physical medical device for visualization and surgical procedures, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

Not applicable. The J-Scope is a physical device that is inherently human-in-the-loop, requiring a physician for its operation and interpretation of what is viewed through it. It is not an algorithm.

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

Not applicable. The submission focuses on device safety and performance criteria evaluated through engineering and regulatory standards rather than clinical outcomes or diagnostic accuracy. "Ground truth" in this context would likely refer to established engineering standards and specifications.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, as there is no training set described.

Summary

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K 122411

FEB 1 1 2013

510(k) SUMMARY

Applicant:	Myelotec, Inc4000 Northfield WaySuite 900Roswell, GA 30076 USA404-355-4485
Contact:	Richard WunderlichCEO
Date Prepared:	July 25, 2012
Predicate Device:	Henke Sass Wolf Arthroscope, K080560
Device Identification:	Trade Name: J-Scope Tissue Visualization & Assessment Mini-Cannula Kit and J-Scope Tissue Visualization & AssessmentArthroscope
Common Name:	The J-Scope System
Classification Name:	Orthopedic—Arthroscope: 21 CFR 888.1100Class II
Product Code:	HRX
Device Description:	The J-Scope Tissue Visualization & Assessment Mini-Cannula Kit is asingle-use, disposable small diameter, 14-gauge needle mini-cannuladevice which, when coupled with the J-Scope semi-rigid or flexibleArthroscope, provides convenient and precise arthroscopicvisualization of both major and minor joints. The micro-invasivedesign of the system allows the procedure to be performedcomfortably with the patient under local anesthesia.
Intended Use:	The J-Scope System is an endoscopic device intended to be used byphysicians for introduction of fluids to assist in visualization of intra-articular structures for arthroscopic diagnosis, as well as for surgicalprocedures using a second J-Scope or other arthroscopic device. It isindicated for use in the shoulder, hip, wrist, ankle, knee, and elbow joints.
Substantial Equivalence:	The J-Scope System is substantially equivalent to the predicate deviceas the basic features, functionality, and intended uses are similar. Theminor differences raise no new issues of safety and effectiveness and

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have no effect on the performance, function, or intended use of the device.

The J-Scope System is very similar to the Henke Sass Wolf Technological Arthroscope in design and function. Both the subject and HSW Characteristics: predicate devices make use of the same, or similar, technology. The trocar sheaths, obturators, and trocars are made of stainless steel, and access ports are provided on the trocars for flushing with saline. The J-Scope differs from the HSW Arthroscope in that the cannula body and handles are made of various plastics such as polycarbonate and polyethylene while the HSW cannula is made of stainless steel and is autoclavable. The arthroscopes are very similar in design and materials.

The J-Scope was tested for conformance with the following Testing: performance standards: ISO 10993: Biological Evaluation of Medical Devices, IEC 60601-2-18 - Medical Electrical Equipment -Particular requirements for the safety of endoscopic equipment, ISO 11135-1:2007. Sterilization of Health Care Products-Ethylene Oxide, reference 7.1, Product Adoption and Process Equivalency for Ethylene Oxide Sterilization, and EN60601-2-18, Medical Electrical Equipment - Particular requirements for the safety of endoscopic equipment. In addition. Expiration Dating tests were performed, as was system component validation testing.

Conclusion: The technological differences between the HSW Arthroscope and the J-Scope System do not raise any new questions of safety or effectiveness and testing demonstrates that the J-Scope is as safe and effective as the predicate devices. Therefore the J-Scope System is substantially equivalent to the previously cleared Henke Sass Wolf Arthroscope (K080560).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three curved lines forming a shape suggestive of a person or a medical symbol.

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 11, 2013

Myelotec % Tamm Net, Incorporated Mr. Blix Winston, MPA, MS Director, Regulatory Affairs 2600 Mullinix Mill Road Mount Airy, Maryland 21771

Re: K122411

Trade/Device Name: J-Scope Tissue Visualization & Assessment Mini-Cannula Kit and J-Scope Tissue Visualization & Assessment Arthroscope

Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX . Dated: December 17, 2012 Received: December 26, 2012

Dear Mr. Winston:

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

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Page 2 - Mr. Blix Winston, MPA, MS

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

For

Peter DinRuimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122411

Device Name:

J-Scope Tissue Visualization & Assessment Mini-Cannula Kit and J-Scope Tissue Visualization & Assessment Arthroscope

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -S

Digitally signed by Long H. Chen-5
ON: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Long H. Chen-5,
0.9.2342.19200300.100.1.1=1300369056
Date: 2013.02.11 11:52:15-05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number K122411

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.