This device is intended to puncture the tissue for making the path of surgical instrument in the orthopedic surgery. It is consisted with cannula and trocar. This device is single-use.This device has 3 types. (Threaded type, Smooth type, All smooth type)

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for a medical device called the "JOINIX Cannular System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's clinical efficacy or diagnostic accuracy through extensive clinical trials.

As such, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning clinical performance (e.g., diagnostic accuracy, human reader improvement with AI assistance, MRMC studies, or detailed ground truth establishment for clinical data).

The "Performance data" section (Section 6) and "Predicate device comparison table" (Section 7) describe bench testing only, focusing on the device's physical properties, biocompatibility, and functional equivalence to a predicate device for its intended mechanical purpose (introduction of instrumentation through a portal for surgical procedure).

Here's why the requested information cannot be extracted from this document:

No Clinical Study: The document explicitly states "Bench test were performed." and lists mechanical and biocompatibility tests. There is no mention of a clinical study involving human subjects or real-world data collection for performance evaluation in a diagnostic or clinical decision-making context.
Device Type: The JOINIX Cannular System is an arthroscope, a surgical instrument used to create a portal. Its performance is assessed on its mechanical properties, material safety (biocompatibility), and functionality as a conduit, not on its ability to interpret medical images, make diagnoses, or assist human experts in complex tasks that would require accuracy metrics (like sensitivity, specificity, or AUC).
510(k) Scope: A 510(k) submission primarily aims to show that a new device is "substantially equivalent" to a legally marketed device (predicate device). This often relies on comparative performance against the predicate in bench tests or, if applicable, comparisons of design, materials, and intended use, rather than de novo clinical outcome studies demonstrating superiority or specific accuracy thresholds in a clinical setting.

Therefore, I cannot provide a table of acceptance criteria for clinical performance, details on test set sample sizes, expert qualifications for ground truth, MRMC studies, or training set details because this document pertains to a mechanical surgical instrument and its bench test performance for 510(k) clearance, not a diagnostic or AI-driven device requiring clinical performance validation.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a ribbon-like design flowing through them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16, 2017

AJU Pharm Co.,ltd. % Mr. Peter Chung Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K162070

Trade/Device Name: JOINIX Cannular System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 3, 2017 Received: February 8, 2017

Dear Mr. Chung:

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 of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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

510(k) Number (if known) K162070

Device Name JOINIX CANNULAR SYSTEM

Indications for Use (Describe) For introduction of instrumentation through a portal for surgical procedure.

Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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."

Type of Use (Select one or both, as applicable)

PSC Publishing Services (301) 443-6740 EF

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K162070

510(k) Summary

[as required by 807.92(c)]

1. Applicant

Company : AJU Pharm Co.,Ltd. 1)
1. Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
1. Tel : 82-31-765-4420
1. Fax : 82-31-602-7818
1. Prepared date : Jul. 18, 2016
୧) Contact person : Peter Chung, 412-512-8802
Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA 7)
1. Submission date : Jul. 20, 2016

2. Device Information

1. Trade name : JOINIX CANNULAR SYSTEM
1. Common name : Arthroscope
1. Regulation name : Arthroscope
1. Product code : HRX
Regulation number : 888.1100 5)
1. Class of device : Class II
1. Panel : Orthopedic

3. The legally marketed device to which we are claiming equivalence

K920454, ACUFEX MICROSURGICAL, INC.

4. Device description

5. Intended Use :

For introduction of instrumentation through a portal for surgical procedure.

6. Performance data:

Bench test were performed. Bench testing included biocompatibility, mechanical testing 1) including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Test standard : ISO 10993 series 2)
1. Test item :
- . Performance test : Appearance, measurement, operation test, leakage
- 1 Extraction test : Appearance, pH, KMRO4 Reducing agents, evaporating residue, heavy metal(as Pb), UVvis spectrum
- . Biocompatibility test : Cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogen

The performance tests demonstrated that JOINIX Cannular system performs in a substantially equivalent manner to the predicate device.

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K162070

7. Predicate device comparison table

Manufacturer	AJU Pharm Co.,Ltd.	Acufex Microsurgical Inc.	Remark
510(k) No.	K162070	K920454	N/A
Indication for use	For introduction of instrumentationthrough a portal for surgicalprocedure.	For introduction of instrumentationthrough a portal for surgicalprocedure.	Same
Classificationname	Arthroscope	Arthroscope	Same
Trade name	JOINIX Cannular system	Clear-trac cannula	N/A
Model/type	72 model codes includingACT45045a	N/A	N/A
Appearance	Image: Green surgical tool	Image: Grey surgical tool and trocar	Similar
Productconfiguration	CannulaStopcockTrocar	CannulaStopcockTrocar	Same
Material	Polycarbonate	Copolyester	Different
Inside diameter	4.3mm, 5.3mm, 5.8mm, 6.3mm,6.8mm, 7.3mm, 7.8mm, 8.1mm	5.0mm8.0mm	Similar
Length	84mm, 85mm, 111mm, 112mm,129mm, 130mm,	76mm	Similar
Sterilization	EO Gas sterilizationAccording to ISO 11135: 2007	EO Gas sterilizationAccording to ISO 11135: 2007	Same
Principle ofoperation	Manual	Manual	Same
Shelf-life	5 years	N/A	N/A

9. Conclusion

The device is investigated for function to compare the operation of function between JOINIX Cannular System and predicate devices.

Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.

Therefore, it is concluded that JOINIX Cannular System is substantially equivalent to the legally marketed predicate device.

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.