JOINIX CANNULAR SYSTEM

• K Number: K162070
• Device Name: JOINIX CANNULAR SYSTEM
• Manufacturer: AJU Pharm Co.,Ltd.
• Date Cleared: 2017-03-16 ( 232 days)
• Product Code: HRX
• Regulation Number: 888.1100

Intended Use

For introduction of instrumentation through a portal for surgical procedure.

Device Description

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)

Predicate Devices

K920454

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function of a surgical instrument (trocar and cannula) and does not mention any computational or analytical capabilities.

Therapeutic

No
The device is described as an instrument for creating a path for surgical instruments during orthopedic surgery, not for treating a disease or condition itself.

Diagnostic

No
Explanation: The device description states its purpose is to puncture tissue for surgical instrument pathways, not to identify or determine the nature of a disease or condition. It is a surgical tool.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a cannula and trocar, which are physical hardware components used for surgical procedures. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is "For introduction of instrumentation through a portal for surgical procedure." This describes a surgical tool used during a procedure on a patient.
• Device Description: The description details a device for puncturing tissue to create a path for surgical instruments. This is a physical tool used in surgery.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health, diagnosis, or treatment.

IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical instrument used directly on the patient during a procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For introduction of instrumentation through a portal for surgical procedure.

Product codes (comma separated list FDA assigned to the subject device)

HRX

Device Description

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)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing included biocompatibility, mechanical testing 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
Test item :
Performance test : Appearance, measurement, operation test, leakage
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K920454

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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

PSC Publishing Services [phone] EF

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K162070

510(k) Summary

[as required by 807.92(c)]

1. Applicant

• Company : AJU Pharm Co.,Ltd. 1)
• 2. Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
• 3. Tel : [phone]
• 4. Fax : [phone]
• 5. Prepared date : Jul. 18, 2016
• ୧) Contact person : Peter Chung, 412-512-8802
• Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA 7)
• 8. Submission date : Jul. 20, 2016

2. Device Information

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

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

K920454, ACUFEX MICROSURGICAL, INC.

4. Device description

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)

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)
• 3. 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 instrumentation
through a portal for surgical
procedure.	For introduction of instrumentation
through a portal for surgical
procedure.	Same
Classification
name	Arthroscope	Arthroscope	Same
Trade name	JOINIX Cannular system	Clear-trac cannula	N/A
Model/type	72 model codes including
ACT45045a	N/A	N/A
Appearance	Image: Green surgical tool	Image: Grey surgical tool and trocar	Similar
Product
configuration	Cannula
Stopcock
Trocar	Cannula
Stopcock
Trocar	Same
Material	Polycarbonate	Copolyester	Different
Inside diameter	4.3mm, 5.3mm, 5.8mm, 6.3mm,
6.8mm, 7.3mm, 7.8mm, 8.1mm	5.0mm
8.0mm	Similar
Length	84mm, 85mm, 111mm, 112mm,
129mm, 130mm,	76mm	Similar
Sterilization	EO Gas sterilization
According to ISO 11135: 2007	EO Gas sterilization
According to ISO 11135: 2007	Same
Principle of
operation	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.