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.

AI/ML Overview

The provided document describes the L’DISQ® electrosurgical device for treating herniated discs and its substantial equivalence to the predicate device, Perc™DC/DLR SpineWand™ (ArthroCare). The study focuses on performance testing to support this claim.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Removal Test for Nucleus Pulposus: Not explicitly stated, but implied to be effective in removing disc lesions.	The test result met all acceptance criteria. The L'DISQ® effectively removes the disc lesions that are causing pain by a plasma based radiofrequency device.
Durability Test for Electrode: Not explicitly stated, but implied to be durable enough for its intended single-use application.	The test result met all acceptance criteria. The device is a "single use device," suggesting it passed durability for its intended short-term application.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document only states "we conducted following tests" without providing details on the number of samples or devices tested for either the removal or durability tests.
Data Provenance: Not specified. The country of origin of the data (where the tests were conducted) is not mentioned, nor is whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as the studies described are performance tests (e.g., removal, durability) for an electrosurgical device, not diagnostic studies that require expert interpretation or ground truth establishment by medical professionals.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as the studies described are performance tests, not diagnostic studies requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The L'DISQ® is a physical medical device, not a standalone algorithm. Its performance is inherent to its design and function, not an algorithm that can operate without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Removal test for nucleus pulposus" and "Durability test for electrode," the ground truth would be based on objective physical measurements or predefined criteria for effective tissue removal and electrode integrity after use, respectively. The document does not specify the exact metrics or methods used to establish this "ground truth" (e.g., amount of tissue removed, structural integrity checks).

8. The sample size for the training set

This information is not applicable. The L'DISQ® is a physical electrosurgical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of device.

Summary

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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 Corporation20, Sandan-ro 76beon-gil(Rd), Uijeongbu-siGyeonggi-do, 480-859, KoreaGyeong-Je Kwon, Regulatory Affairs Specialist
Sponsor:	U & I Corporation20, Sandan-ro 76beon-gil(Rd), Uijeongbu-siGyeonggi-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 andAccessories (GEI), per 21 CFR 878.4400
Product Code:	GEI
Predicate Devices:	ArthroCare® Perc TMDC/DLR SpineWand™(K010811, K030954, K053447, K061259)

Description of 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

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
1. 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
1. 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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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

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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 (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

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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)

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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Regulation Number and Section

§ 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.