(187 days)
Not Found
No
The summary describes a mechanical endoscopic device for visualization and fluid introduction, with no mention of image processing, AI, ML, or related performance metrics.
No
The device is used for visualization and diagnosis, not for treating a disease or condition. While used in surgical procedures, its stated function is to assist in visualization, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "arthroscopic diagnosis".
No
The device description explicitly states it is a "single-use, disposable small diameter, 14-gauge needle mini-cannula device" and mentions coupling with an arthroscope, indicating it is a physical hardware device.
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 for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- J-Scope System Function: The J-Scope System is an endoscopic device used inside the body (in vivo) for direct visualization of intra-articular structures during arthroscopic procedures. It introduces fluids to aid visualization and can be used for surgical procedures.
The description clearly indicates the device is used for direct visualization and surgical intervention within the body, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
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.
Product codes
HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, hip, wrist, ankle, knee, and elbow joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K 122411
FEB 1 1 2013
510(k) SUMMARY
| Applicant: | Myelotec, Inc
4000 Northfield Way
Suite 900
Roswell, GA 30076 USA
404-355-4485 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Richard Wunderlich
CEO |
| 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 & Assessment
Arthroscope |
| Common Name: | The J-Scope System |
| Classification Name: | Orthopedic—Arthroscope: 21 CFR 888.1100
Class II |
| Product Code: | HRX |
| 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. |
| Intended Use: | 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. |
| Substantial Equivalence: | The J-Scope System is substantially equivalent to the predicate device
as the basic features, functionality, and intended uses are similar. The
minor differences raise no new issues of safety and effectiveness and |
:
1
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).
2
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
3
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
4
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:
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.
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