(327 days)
Not Found
No
The summary describes a plasma electrode device for disc ablation and coagulation, focusing on its physical characteristics and performance in removing disc material. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is indicated for coagulation and ablation of disc material to treat symptomatic patients with contained herniated discs, which are therapeutic interventions.
No
The device is described as an electrosurgical tool for coagulation and ablation of disc material, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "plasma electrode" and a "single use device" with different designs based on the spine level treated. This indicates a physical, hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- L'DISQ® Function: The L'DISQ® is described as a plasma electrode used for "coagulation and ablation of disc material." This is a surgical procedure performed inside the body to treat a physical condition (herniated discs). It is not performing a diagnostic test on a sample.
The description clearly indicates a therapeutic device used for a surgical intervention, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The L'DISQ® is indicated for coagulation of disc material to treat symptomatic patients with contained herniated discs.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The L'DISQ® is a plasma electrode which is 1.0 mm(PD01, PD02, PD03, PD04, PD05, PD07 and PC01) or 0.7 mm(PC02) thickness based on the high frequency electrosurgical system. L'DISQ® removes the disc lesions that are causing pain by a plasma based radiofrequency device.
L'DISQ® is a single use device and there are 3-type of designs (L'DISQ, L'DISQ C, L'DISQ C.7) according to the level of spine treated. When using the L'DISQ® the users should also study carefully "Operation Manual" of the electrosurgical power generator as well as "Instructions for Use" and "Procedure Technique" of L'DISQ®
- L'DISQ (PD01, PD02, PD03, PD04, PD5, PD07): Device for lumbar disc
- L'DISQ consists of seven components:
- (1) BIPOLAR TIP 1.0MM (CAP + INSULATOR + RING + POLYMER TUBE + WIRE 0.2mm + COPPER WIRE)
- (2) TIP SUPPORT (25mm, 45mm, 15mm, 9mm, 35mm)
- (3) TIP PROTECTION
- (4) POLYIMIDE TUBE
- (5) RF CONNECTOR (4PIN)
- (6) MANIPULATOR
- (7) SPRING STOPPER
-
- L'DISQ C (PC01): Device for cervical disc
- L'DISQ C consists of six components:
- (1) L'DISQ C BIPOLAR TIP (CAP + INSULATOR + RING + POLYMER TUBE-C +
- WIRE 0.2mm + COPPER WIRE)
- (2) TIP SUPPORT-C 17mm
- (3) POLYIMIDE TUBE
- (4) L'DISQ C MANIPULATOR
- (5) SPRING STOPPER
- (6) MANIPULATOR CABLE
-
- L'DISQ C.7 (PC02): Device for cervical disc
- L'DISQ C.7 consists of four components:
- (1) L'DISQ C.7 BIPOLAR TIP (CAP+INSULATOR+EDM WIRE)
- (2) TIP SUPPORT
- (3) L'DISQ C.7 MANIPULATOR
- (4) MANIPULATOR CABLE
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc material, lumbar disc, cervical disc
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)
To evaluate the performance of L'DISQ®, we conducted following tests.
(1) Removal test for nucleus pulposus
(2) Durability test for electrode
The test result met all acceptance criteria and verifies that performance of the L'DISQ® is substantially equivalent to the predicate device, Perc™DC/DLR SpineWand™ (ArthroCare).
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.
K010811, K030954, K053447, K061259
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for U&I Corporation, with the letters "U&i" in a stylized font on the left and the word "CORPORATION" in bold letters on the right. Above the word "CORPORATION" is the date "JUL 3 0 2014". The text is all in black and the background is white.
5. 510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si
Gyeonggi-do, 480-859, Korea
Gyeong-Je Kwon, Regulatory Affairs Specialist |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si
Gyeonggi-do, 480-859, Korea |
| Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist |
| Date Prepared: | February 21, 2014 |
| Device Name: | Trade Name: L'DISQ® |
| Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories (GEI), per 21 CFR 878.4400 |
| Product Code: | GEI |
| Predicate Devices: | ArthroCare® Perc TMDC/DLR SpineWand™
(K010811, K030954, K053447, K061259) |
Description of Device:
The L'DISQ® is a plasma electrode which is 1.0 mm(PD01, PD02, PD03, PD04, PD05, PD07 and PC01) or 0.7 mm(PC02) thickness based on the high frequency electrosurgical system. L'DISQ® removes the disc lesions that are causing pain by a plasma based radiofrequency device.
L'DISQ® is a single use device and there are 3-type of designs (L'DISQ, L'DISQ C, L'DISQ C.7) according to the level of spine treated. When using the L'DISQ® the users should also study carefully "Operation Manual" of the electrosurgical power generator as well as "Instructions for Use" and "Procedure Technique" of L'DISQ®
L'DISQ®
U&i CORPORATION.
1
K132797 Page 2 of 3
- L'DISQ (PD01, PD02, PD03, PD04, PD5, PD07): Device for lumbar disc
- L'DISQ consists of seven components:
- (1) BIPOLAR TIP 1.0MM (CAP + INSULATOR + RING + POLYMER TUBE + WIRE 0.2mm + COPPER WIRE)
- (2) TIP SUPPORT (25mm, 45mm, 15mm, 9mm, 35mm)
- (3) TIP PROTECTION
- (4) POLYIMIDE TUBE
- (5) RF CONNECTOR (4PIN)
- (6) MANIPULATOR
- (7) SPRING STOPPER
-
- L'DISQ C (PC01): Device for cervical disc
- L'DISQ C consists of six components:
- (1) L'DISQ C BIPOLAR TIP (CAP + INSULATOR + RING + POLYMER TUBE-C +
- WIRE 0.2mm + COPPER WIRE)
- (2) TIP SUPPORT-C 17mm
- (3) POLYIMIDE TUBE
- (4) L'DISQ C MANIPULATOR
- (5) SPRING STOPPER
- (6) MANIPULATOR CABLE
-
- L'DISQ C.7 (PC02): Device for cervical disc
- L'DISQ C.7 consists of four components:
- (1) L'DISQ C.7 BIPOLAR TIP (CAP+INSULATOR+EDM WIRE)
- (2) TIP SUPPORT
- (3) L'DISQ C.7 MANIPULATOR
- (4) MANIPULATOR CABLE
Intended Use:
The L'DISQ® is indicated for coagulation and ablation of disc material to treat symptomatic patients with contained herniated discs.
Substantial Equivalence:
In establishing substantial equivalence to the predicate device, L'DISQ® evaluated the indication for use, components, performance, approaching method, energy source, and sterilization methods of those systems.
CORPORATION
2
1. Performance Testing
To evaluate the performance of L'DISQ®, we conducted following tests.
(1) Removal test for nucleus pulposus
(2) Durability test for electrode
The test result met all acceptance criteria and verifies that performance of the L'DISQ® is substantially equivalent to the predicate device, Perc™DC/DLR SpineWand™ (ArthroCare).
2. Conclusion
The data and information provided in this submission support the conclusion that the L'DISQ® is substantially equivalent to its predicate device with respect to indications for use, components, performance, approaching method, energy source and sterilization method and other technological characteristics.
U&i CORPORATION
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The symbol is black, and the text is also black.
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
July 30, 2014
U & I Corporation Gyeong-Je Kwon Regulatory Affairs Specialist 20, Sandan-ro 76beon-gil(Rd) Uijungbu-si, Gyeonggi-do 480-059 Korea
Re: K132797 Trade/Device Name: L'DISQ® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 20, 2014 Received: June 23, 2014
Dear Kwon:
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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21
4
Page 2 - Gyeong-Je Kwon
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 regalation (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" (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 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 yours.
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132797
Device Name
L'DISQ®
Indications for Use (Describe)
The L'DISQ® is indicated for coagulation of disc material to treat symptomatic patients with contained herniated discs.
Type of Use (Select one or both, as applicable)
2 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 FOR FOR FOR FOR FOR FOR FOR USE ONLY Concurrence of Center for Devices and Radiological Heatth (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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