L'DISQ

K132797 · U&I Corporation · GEI · Jul 30, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132797
• Device Name: L'DISQ
• Applicant: U&I Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The L'DISQ® is indicated for coagulation and ablation of disc material to treat symptomatic patients with contained herniated discs.

Device Story

L'DISQ® is a plasma-based radiofrequency electrosurgical device used for coagulation and ablation of disc material. It consists of a bipolar tip (available in 1.0 mm or 0.7 mm thicknesses), manipulator, and support components. The device is used to treat symptomatic patients with contained herniated discs. It functions by delivering high-frequency energy to remove disc lesions. The device is intended for single use and is operated by a clinician in a surgical setting. The clinician uses the device in conjunction with an electrosurgical power generator to perform the procedure. By removing disc material, the device aims to alleviate pain associated with disc herniation.

Clinical Evidence

Bench testing only. Testing included nucleus pulposus removal efficacy and electrode durability. Results met all acceptance criteria, demonstrating performance equivalent to the predicate device.

Technological Characteristics

Plasma-based radiofrequency electrosurgical device. Components include bipolar tip (1.0mm or 0.7mm), manipulator, polyimide tube, and RF connector. Energy source: high-frequency electrosurgical generator. Single-use, sterile device. No software or algorithm-based processing described.

Indications for Use

Indicated for coagulation of disc material in symptomatic patients with contained herniated discs.

Regulatory Classification

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.

Predicate Devices

• ArthroCare® Perc TMDC/DLR SpineWand™ (K010811, K030954, K053447, K061259)

Submission Summary (Full Text)

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## 5. 510(k) Summary

| Manufacturer: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si<br>Gyeonggi-do, 480-859, Korea<br>Gyeong-Je Kwon, Regulatory Affairs Specialist |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si<br>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<br>Accessories (GEI), per 21 CFR 878.4400 |
| Product Code: | GEI |
| Predicate Devices: | ArthroCare® Perc TMDC/DLR SpineWand™<br>(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.

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K132797 Page 2 of 3

1. 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
- 2. 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
- 3. 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**

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#### 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

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#### 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

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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 [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" (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 [phone] or [phone] 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

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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)

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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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