The SPINAUT-P is a minimally invasive RF electrode device offered in 496mm length for percutaneous disc decompression surgery using radiofrequency energy and designed for use with radiofrequency generators in RF procedure. SPINAUT-P is intended to be placed into the epidural space or posterolateral / posterocentral area in the disc to remove, ablate or coagulate disc material in the area. The electrode consists of two stainless steel shafts with straight electrode configuration design. The shaft is housed in a coating composed of Polyamide. The device is single-use gamma radiation sterilized and is compatible with most standard electrosurgical generators that provide a cable with two pin outlet (2-pin, 22mm) with 1kVp maximum electrical capacity.

AI/ML Overview

The provided text is a 510(k) summary for the SPINAUT-P device, an electrosurgical device for disc decompression. It details the device's technical specifications and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not contain any information about a clinical study involving human patients or the performance of a device against specific acceptance criteria in a clinical setting.

The document focuses on non-clinical (bench and lab) testing to support a premarket notification for a medical device. Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria in a clinical context, or information related to human reader studies.

Here's a breakdown of what can be extracted from the document regarding non-clinical performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document primarily focuses on demonstrating that the SPINAUT-P device meets electrical safety, biocompatibility, sterilization, and some performance characteristics comparable to predicate devices. It lists test descriptions and referenced standards, implying that the acceptance criteria are met by adhering to these standards and the established "pre-set criteria" mentioned.

Acceptance Criteria (Implied)	Reported Device Performance	Comments
Electrical Safety
RF leakage current ≤ 7.2dfL mA (as per predicate)	≤ 7.2dfL mA	Explicitly stated as met, comparable to predicates.
Electrical conductivity	Electrode is able to pass electricity.	Met.
Cable Dielectric Strength	Complies with IEC 60601-2-2 Edition 5.0 2009-02, Clause 201.8.8.3.104 and 201.8.8.3.103.	Met.
High Frequency Leakage	Complies with ANSI/AAMI HF 18:2001 Electrosurgical Devices Clause 4.2.5.2.	Met.
Material & Physical Properties
Tensile Strength of Electrode Cord	Complies with ANSI/AAMI HF18:2001 Clause 4.2.5.5.	Met.
Appearance (Visual Inspection)	"Visual Inspection" conducted.	Implied satisfactory.
Size Measurement	"Measure the size of the test article by vernier calipers."	Implied satisfactory and consistent with specifications.
Sterilization
Sterility	Complies with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3 and Korean Pharmacopeia (10th Edition).	Met pre-set criteria.
Shelf Life
Shelf Life Validation	3-year shelf life validated using ASTM F1980-07 (accelerated aging).	Met pre-set criteria.
Packaging integrity
Package Tensile Test	Complies with ASTM D882-12.	Met.
Package Peeling Test	Complies with ASTM F88/F88M-09.	Met.
Package Dye Penetration Test	Complies with ASTM F1929-12.	Met.
Biocompatibility
Cytotoxicity	Complies with ISO 10993-5:2009/(R) 2014.	Supported as biocompatible.
Skin Sensitization	Complies with ISO 10993-10 Third Edition 2010-08-01.	Supported as biocompatible.
Intracutaneous reactivity	Complies with ISO 10993-10 Third Edition 2010-08-01.	Supported as biocompatible.
Acute Systemic Toxicity	Complies with ISO 10993-11 Second edition 2006-08-15.	Supported as biocompatible.
Pyrogen	Complies with USP 37-NF32:2014, <151>.	Supported as biocompatible.
Haemolysis	Complies with ISO 10993-4:2002.	Supported as biocompatible.
Performance Comparison (Porcine Spines)
Tissue Removal Performance	Demonstrated comparable performance to predicate device (L'disQ).	The test demonstrated the device being as safe and as effective as the predicate.
Durability of Electrode	Demonstrated comparable performance to predicate device (L'disQ).	The test demonstrated the device being as safe and as effective as the predicate.
Ability to be introduced, directed to and extracted from the surgical site (target area)	Demonstrated comparable performance to predicate device (L'disQ).	The test demonstrated the device being as safe and as effective as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions tests on "porcine spines" for performance comparison, but does not specify the number of porcine spines or individual tests conducted. For other tests (sterilization, shelf life, biocompatibility, electrical safety), it refers to established standards (e.g., ISO, ASTM, ANSI/AAMI, USP) which dictate sample sizes, but these specific numbers are not presented in the summary.
Data Provenance: The data is from non-clinical (bench and lab) testing, not human studies. The tests were performed by or for IMEDICOM Co., Ltd. (Republic of Korea). The specific location of testing labs is not detailed beyond the company's origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the non-clinical testing described. Ground truth or expert consensus is typically associated with clinical studies involving human data, where human experts (e.g., radiologists, pathologists) provide annotations or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical laboratory testing, not a clinical study where adjudication of human expert opinions would be necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence through non-clinical testing, not a clinical trial comparing human readers with and without AI assistance. The device itself is an electrosurgical tool, not an AI diagnostic or assistance system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not conducted. This device is an electrosurgical accessory, not an AI algorithm.

7. Type of Ground Truth Used

For the non-clinical performance comparison using porcine spines, the "ground truth" would be the objective measurements and observations of tissue removal, durability, and navigability, compared against the predicate device under controlled experimental conditions.
For other tests (electrical, sterility, biocompatibility), the "ground truth" is adherence to the published specifications and pass/fail criteria defined by the referenced international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP).

8. Sample Size for the Training Set

This information is not applicable. The device is an electrosurgical tool, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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

March 18, 2016

IMEDICOM Co., Ltd. c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste. 110 Fullerton, CA 92831

Re: K150915

Trade/Device Name: SPINAUT-P Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessoriesv Regulatory Class: Class II Product Code: GEI Dated: February 24, 2016 Received: February 26, 2016

Dear Ms. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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.

Jennifer R. Stevenson -A

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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Indications for Use

510(k) Number (if known) K150915

Device Name

SPINAUT-P

Indications for Use (Describe)

The SPINUAT-P is indicated for ablation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(K150915)

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Mar 17, 2016

1. Applicant / Submitter

IMEDICOM Co., Ltd. #612, 172, LS-ro, Gunpo-si, Gyeonggi-do, 435-824 Republic of Korea Tel:+82-31-479-1156 Fax:+82-31-479-1157

2. Submission Correspondent

LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

I Trade Name: SPINAUT-P
י Common Name: Electrosurgical accessory
" Classification Name: Electrosurgical cutting and coagulation device and accessories
י Product Code: GEI
י Classification regulation: 21 CFR 878.4400

4. Predicate Device:

ArthroCare® Coblator IQ™ Perc-D®, SpineWand® (Coblator IQ DLR and DLG י SpineWands) by Arthrocare Corp. (K132099)
L'DISQ by U&I Corporation (K132797) י

5. Description:

The SPINAUT-P is a minimally invasive RF electrode device offered in 496mm length for percutaneous disc decompression surgery using radiofrequency energy and designed

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for use with radiofrequency generators in RF procedure. SPINAUT-P is intended to be placed into the epidural space or posterolateral / posterocentral area in the disc to remove, ablate or coagulate disc material in the area. The electrode consists of two stainless steel shafts with straight electrode configuration design. The shaft is housed in a coating composed of Polyamide. The device is single-use gamma radiation sterilized and is compatible with most standard electrosurgical generators that provide a cable with two pin outlet (2-pin, 22mm) with 1kVp maximum electrical capacity.

6. Indication for use:

The SPINUAT-P is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

7. Basis for Substantial Equivalence

The subject device is the same as the predicate device in the indications for use, materials, energy source, performance specifications, electrode thickness, mode of operation (bipolar) and sterilization method. The major difference is the electrode length but this difference does not raise a question of safety and performance since the electrode is coated with the polyamid to protect the patient and the user from electrical leakage and burn. In this regard, the longer electrode does not raise a question of safety issue. The electrode length would not be a performance affecting factor either since the thickness of the tip would matter the most which is the only part exposed to the patient. The performance test results submitted in this 510K submission also supports that the subject device is substantially equivalent to the predicate devices despite this difference.

Trade name	SPINAUT-P	ArthroCare®Coblator IQ™ Perc-D®SpineWand®(Coblator IQ DLRand DLGSpineWands)	L'DISQ
Manufacture	IMEDICOM Co., Ltd.	Arthrocare Corp.	U&I Corporation
510(k) number	-	K132099	K132797
Product Code	GEI	GEI	GEI
	Indications for Use	The SPINUAT-P is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.	The ArthroCare Coblator IQ Perc-D Spine Wands (Coblator IQ DLR and Coblator IQ DLG SpineWands) are indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated lumbar and lumbosacral discs. The Wands are designed to be used exclusively with the ArthroCarc Coblator IQ Controller.	The L'DISQ is indicated for coagulation and ablation of disc material to treat symptomatic patients with contained herniated discs.
	Principle of Operation	Electrode is activated using the generator which starts the coblation process to ablate disc tissue. The coblation process involves use of a conductive media to create a plasma layer to ablate tissue.	Electrode is activated using the generator which starts the coblation process to ablate disc tissue. The coblation process involves use of a conductive media to create a plasma layer to ablate tissue.	Electrode is activated using the generator which starts the coblation process to ablate disc tissue. The coblation process involves use of a conductive media to create a plasma layer to ablate tissue.
Material	Electrode	Stainless Steel 304	Stainless Steel 304	Stainless Steel 304
	Handle	Polyamide	Polyamide	Polyamide
Perfor-mance	RF leakage current	≤7.2 dfL mA	≤7.2dfL mA	≤7.2dfL mA
Size	Electrode length	496.0 mm	300.0~350.0mm	210.0mm
	Electrode thickness	1.0 mm	0.8~1.0mm	0.7mm1.0mm
	Compatibility w/other devices	Standard RF generator	with the ArthroCare Coblator IQ Controller	Standard RF Generator
	Chemical Safety	Biocompatible	Biocompatible	Biocompatible

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d : the cable's smallest external dimension(unit : mm)

f : test frequency(unit : MHz)

L : length of cable submerged in saline solution

8. Non-Clinical Testing

· Sterilization validating testing has been performed in accordance with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3, and the test results met the pre-set criteria.
· The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980-07 and the test results validated 3 year shelf life.

No.	Test	Test Description / Referenced Standard
1	Appearance	Visual Inspection
2	Electrical Conductivity Test	Connect an electric circuit meter to thedevice and check electrical conductivityby electric circuit tester.
3	Tensile Strength Test of ElectrodeCord	Test in accordance with ANSI/AAMIHF18:2001 Electrosurgical devicesClause 4.2.5.5
4	Package Tensile Test	Test in accordance with ASTM D882-12,standard test methods for tensileproperties of thin plastic sheeting.(Ophthalmic)
5	Package Peeling Test	Test in accordance with ASTMF88/F88M-09, standard test method forseal strength of flexible barrier materials.(Sterility)
б	Package Dye Penetration Test	Test in accordance with ASTM F1929-12,standard test method for detecting sealleaks in porous medical packaging by dyepenetration. (Sterility)
7	Sterility Test	Test in accordance with ISO 11737-2Second edition 2009-11-15, sterilizationof medical devices - microbiologicalmethods - part 2: tests of sterilityperformed in the definition, validation andmaintenance of a sterilization process.(Sterility)

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· The following biocompatibility tests were performed in accordance with ISO 10993-4, 5, 10, 11 and USP 37 <151>, and the test results supported that the subject device is biocompatible.

No.	Test	Test Description / Referenced Standards
1	Extraction Test
2	Cytotoxicity	ISO 10993-5:2009/(R) 2014, biologicalevaluation of medical devices -- part 5:tests for in vitro cytotoxicity.(Biocompatibility)
3	Skin Sensitization	ISO 10993-10 Third Edition 2010-08-01,biological evaluation of medical devices -part 10: tests for irritation and skinsensitization. (Biocompatibility)
4	Intracutaneous reactivity	ISO 10993-10 Third Edition 2010-08-01,biological evaluation of medical devices -part 10: tests for irritation and skinsensitization. (Biocompatibility)
5	Acute Systemic Toxicity Test	ISO 10993-11 Second edition 2006-08-15,biological evaluation of medical devicespart 11: tests for systemic toxicity.(Biocompatibility)
6	Pyrogen	USP 37-NF32:2014, <151> pyrogen test(usp rabbit test). (Sterility)
7	Haemolysis	ISO 10993-4:2002 Biological evaluation ofmedical devices -- Part 4: Selection of testsfor interactions with blood

The following electrical safety and bench tests were performed to evaluate the performance and the safety of the subject device and the test results met the pre-set criteria.

No.	Test	Test Description / Referenced Standards
1	Electrical Conductivity Test	Evaluate if the electrode is able to passelectricity.
2	Cable Dielectric Strength Test	IEC 60601-2-2 Edition 5.0 2009-02,medical electrical equipment - part 2-2:particular requirements for the basic safetyand essential performance of highfrequency surgical equipment and highfrequency surgical accessories [including:technical corrigendum 1 (2014)]. (GeneralPlastic Surgery/General Hospital)

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		• Clause 201.8.8.3.104 Line voltagewithstanding capability• Clause 201.8.8.3.103 High frequencyvoltage withstanding capability
3	High Frequency Leakage Test ofElectrode	Test in accordance with ANSI/AAMI HF18:2001 Electrosurgical Devices• Clause 4.2.5.2
4	Appearance	Visual Inspection
5	Size Measurement	Measure the size of the test article byvernier calipers.
6	Tensile Strength Test ofElectrode Cord	Test in accordance with ANSI/AAMI HF18:2001 Electrosurgical Devices• Clause 4.2.5.5
7	Sterility test	Korean Pharmacopeia (10th Edition) :General Requirements for Tests andAssays / Sterility Test

〈We compared the tissue removal, durability, and ability to navigation in the lesion (performance to be introduced, directed to and extracted from the target lesion) of our RF Electrode SPINAUT-P and the predicate device, L'disQby U and I (K132797) using porcine spines. The test results demonstrated the device being as safe and as effective as the predicate device.

No.	Test	Test Description
1	Performance Comparison Test with thepredicate device using porcine spines	• Tissue Removal Performance• Durability of Electrode• Ability to be introduced, directedto and extracted from the surgicalsite(target area)

All the test results supported that the subject device is substantially equivalent to the predicate devices.

9. Conclusion

Based on the similarities, we conclude that the SPINAUT-P is substantially equivalent to the predicate devices.

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.